Federal Circuit Update Archives

This edition of Gibson Dunn’s Federal Circuit Update for September summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning the definition of a prevailing party for purposes of 35 U.S.C. § 285, the patentability of functionally unrelated claim language, burden of proof for infringement, and untimely venue objections.

Federal Circuit News

Supreme Court:

The Supreme Court granted one petition originating in the Federal Circuit.

Trump v. V.O.S. Selections, Inc. (US Nos. 24-1287, 25-250): As we summarized in our August 2025 update, the en banc Federal Circuit held that the International Emergency Economic Powers Act (IEEPA) did not give the President the authority to impose the tariffs he ordered, and the Government’s reading of the term “regulate . . . importation” contained in the statute was too broad. Briefing before the Supreme Court will be completed by October 30, 2025, and argument has been set for November 5, 2025. So far, six amicus briefs have been filed in support of the President, one amicus brief has been filed in support of neither party, and two amicus briefs have been filed in support of the Federal Circuit’s holding.

Noteworthy Petitions for a Writ of Certiorari:

There were a few potentially impactful petitions filed before the Supreme Court in September 2025:

MSN Pharmaceuticals, Inc. v. Novartis Pharmaceuticals Corp. (US No. 25-225): The question presented is: “Whether, in a patent-infringement suit, a court may consider after-arising technology to hold that the patent is invalid under § 112(a) of the Patent Act.” After respondent waived its right to file a response, the Court requested a response, which is due November 7, 2025. Six amicus briefs have been filed.

Lynk Labs, Inc. v. Samsung Electronics Co. (US No. 25-308): The question presented is: “Whether patent applications that became publicly accessible only after the challenged patent’s critical date are ‘prior art . . . printed publications’ within the meaning of 35 U.S.C. §311(b).” The response brief is due November 17, 2025.

EcoFactor, Inc. v. Google, LLC (US No. 25-341): The questions presented are: (1) “Whether the Federal Circuit violated the Seventh Amendment by overturning the jury’s damages award . . . substituting its judgment for the jury’s on a question of fact.” (2) “Whether the Federal Circuit is permitted to apply a different, more stringent standard for the admission of expert testimony . . . [under] Federal Rule of Evidence 702.” (3) “Whether the Federal Circuit violated EcoFactor’s due process rights under the Fifth Amendment by deciding the appeal on a contract interpretation issue that was not raised in the district court, was not briefed by the parties on appeal, and was outside the scope of the en banc proceeding.” Google waived its right to file a response. The Court will consider this petition at its October 17, 2025 conference.

We provide an update below of the petitions pending before the Supreme Court, which were summarized in our August 2025 update:

In Gesture Technology Partners, LLC v. Unified Patents, LLC (US No. 24-1281), after one of the respondents waived its right to respond, the Court requested a response. The response was filed on September 26, 2025. The Court will consider this petition at its November 7, 2025 conference. The Court will consider this petition at its November 7, 2025 conference.

The Court denied the petitions in Lowe v. ShieldMark, Inc. (US No. 25-169), J. Reynolds Vapor Co. v. Altria Client Services LLC (US No. 25-158), D R Burton Healthcare, LLC v. Trudell Medical International Inc. (US No. 25-17), and Purdue Pharma L.P. v. Accord Healthcare, Inc. (US No. 24-1132).

Other Federal Circuit News:

Notice of Proposed Amendments to Federal Circuit Rules of Practice. The Federal Circuit has published proposed amendments to the Federal Circuit Rules of Practice available here: https://www.cafc.uscourts.gov/notice-of-proposed-amendments-to-the-federal-circuit-rules-of-practice-4/. Here is a summary of some of the proposed amendments:

Various rules have been updated to modify or clarify Federal Circuit procedures, including but not limited to, submission of documents by electronic filers, the hours of operation of the Federal Circuit’s night box, personally identifiable information, and page limits for appendix to briefs.
Rule 46 regarding attorneys has been amended to add a subsection on law student practice.
Practice Notes to Rule 50 has been amended to discuss the use of the cases pending list that a former court employee may not participate in or assist with.

Public comments must be received on or before October 16, 2025.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (September 2025)

Future Link Systems, LLC v. Realtek Semiconductor Corp., No. 23-1056, 23-1057 (Fed. Cir. Sept. 9, 2025): Future Link sued Realtek in two separate suits over patents related to improvements of electronic circuitry and integrated circuits with power-saving features. Several months into the litigation, Future Link entered into a licensing agreement that covered Realtek’s products. Future Link then voluntarily dismissed both cases without prejudice. Realtek sought attorneys’ fees asserting Future Link had filed objectively baseless suits. The district court denied the motion for attorneys’ fees; however, it awarded sanctions by ordering that the dismissals be with prejudice.

The Federal Circuit (Stoll, J., joined by Reyna and Bryson, JJ.) vacated-in-part, affirmed-in-part, and remanded. The Court held that Realtek was the prevailing party because the district court “awarded sanctions” to Realtek and “converted the voluntary dismissal to a dismissal with prejudice.” The Court explained that this conclusion applied even if “[p]erhaps the district court did not intend to make Realtek a prevailing party.” The Court accordingly vacated the district court’s § 285 decision and remanded for the district court to consider whether this case is exceptional and whether fees are appropriate.

Bayer Pharma Atkiengesellschaft v. Mylan Pharmaceuticals Inc. et al., No. 23-2434 (Fed. Cir. Sept. 23, 2025): Mylan petitioned for inter partes review (IPR) of Bayer’s patent claiming methods of reducing the risk of cardiovascular events in patients with coronary artery disease and/or peripheral artery disease by administering “clinically proven effective” amounts of rivaroxaban and aspirin. The Board concluded that “clinically proven effective” was non-limiting, and in the alternative, the claims were anticipated. Bayer appealed the Board’s final written decision, including the Board’s construction of “clinically proven effective.”

The Federal Circuit (Moore, C.J., joined by Cunningham and Scarsi (district judge sitting by designation), JJ.) affirmed-in-part, vacated-in-part, and remanded for further proceedings. The Court stated that it did not need to decide whether or not “clinically proven effective” was limiting, because it concluded that even if it were limiting, the term was functionally unrelated to the claimed method and therefore failed to make the claims patentable. As the Court explained, an “otherwise anticipated method of treatment was not made patentable simply by adding a limitation of ‘informing the patient’ about the benefits of the anticipated method.” Similarly, the Court “found it equally troubling that one could claw back from the public domain an anticipated method of treatment merely by adding a limitation that the method subsequently performed well in a clinical trial.” The Court therefore concluded that “clinically proven effective” was a functionally unrelated limitation that did not make the challenged claims patentable. The Court accordingly did not reach whether “clinically proven effective” was anticipated.

Finesse Wireless LLC v. AT&T Mobility LLC, No. 24-1039 (Fed. Cir. Sept. 24, 2025): Finesse owns patents related to methods for mitigating interference in radios. Following a jury trial, the jury found that AT&T and Nokia (defendants) infringed awarded Finesse over $166 million in damages. The district court then denied the defendants’ motion for judgment as a matter of law (JMOL) of noninfringement and motion for a new trial on damages.

The Federal Circuit (Moore, C.J., joined by Linn and Cunningham, JJ.) reversed the district court’s denial of judgment of a matter of law and vacated the damages award, holding that substantial evidence did not support the jury’s finding of infringement. In particular, for one of the patents, the Court concluded that Finesse’s technical expert offered self-contradictory testimony on which signals in the accused radios corresponded to the two claimed signals, which was insufficient to support a finding that the accused radios practiced the asserted claims. The Court held that “[w]hen the party with the burden of proof, such as Finesse, rests its case on an expert’s self-contradictory testimony, we may conclude the evidence is insufficient to satisfy that standard.”

Focus Products Group International, LLC v. Katri Sales Co., Inc., Nos. 23-1446, 23-1450, 23-2148, 23-2149 (Fed. Cir. Sept. 30, 2025): Focus sued Katri for infringement of patents related to hookless shower curtains. The district court denied Katri’s motion to transfer venue because it was not timely raised. It then granted summary judgment of infringement and awarded damages and attorneys’ fees to Focus.

The Federal Circuit (Chen, J., joined by Moore, C.J. and Clevenger, J.) affirmed-in-part, reversed-in-part, vacated-in-part, and remanded. TC Heartland was published on May 22, 2017, but Katri waited until September 18, 2017 to raise any venue objections. The Court therefore held that the district court did not abuse its discretion in holding that Katri forfeited its venue objection and denying its motion to transfer venue.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Evan Kratzer, and Michelle Zhu.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

Appellate and Constitutional Law:
Thomas H. Dupree Jr. – Washington, D.C. (+1 202.955.8547, tdupree@gibsondunn.com)
Allyson N. Ho – Dallas (+1 214.698.3233, aho@gibsondunn.com)
Julian W. Poon – Los Angeles (+ 213.229.7758, jpoon@gibsondunn.com)

Intellectual Property:
Kate Dominguez – New York (+1 212.351.2338, kdominguez@gibsondunn.com)
Josh Krevitt – New York (+1 212.351.4000, jkrevitt@gibsondunn.com)
Jane M. Love, Ph.D. – New York (+1 212.351.3922, jlove@gibsondunn.com)

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials. The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel. Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

This edition of Gibson Dunn’s Federal Circuit Update for August summarizes the current status of petitions pending before the Supreme Court, en banc activities before the Federal Circuit, and recent Federal Circuit decisions concerning claim construction, patent eligibility, and derivation proceedings under the America Invents Act (AIA).

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were a couple potentially impactful petitions filed before the Supreme Court in August 2025:

Lowe v. ShieldMark, Inc. (US No. 25-169): The questions presented are: “1. Whether a district court, after first deciding it lacks subject matter jurisdiction and dismissing with prejudice a cause of action, retains the power to declare an ‘alternative’ decision on the merits despite the apparent ‘advisory’ character of any such ‘alternative’ decision. Whether a court of appeals has the power to affirm a decision of a district court issued ‘in the alternative’ after that district court first decided it lacked subject matter jurisdiction to hear the cause of action on the merits.” The respondent waived its right to file a response. The Court will consider the petition at its September 29, 2025 conference.

J. Reynolds Vapor Co. v. Altria Client Services LLC (US No. 25-158): The questions presented are: “1. Does the Federal Circuit’s judicially created ‘built-in apportionment’ exception, which allows patent owners to use unrelated prior licenses to prove damages without providing ‘evidence tending to separate or apportion’ the patent’s contribution, violate Garretson v. Clark’s requirement that apportionment ‘must in every case’ be shown? 2. Alternatively, in light of the Federal Circuit’s intervening en banc decision in EcoFactor, Inc. v. Google LLC, . . . should the Court grant the petition, vacate the judgment, and remand for application of that precedent . . . ?” The respondent waived its right to file a response. The Court will consider the petition at its September 29, 2025 conference.

We provide an update below of the petitions pending before the Supreme Court, which were summarized in our July 2025 update:

The Court will consider the petitions in D R Burton Healthcare, LLC v. Trudell Medical International Inc. (US No. 25-17) and Purdue Pharma L.P. v. Accord Healthcare, Inc. (US No. 24-1132) at its September 29, 2025 conference.

In Gesture Technology Partners, LLC v. Unified Patents, LLC (US No. 24-1281), after one of the respondents waived its right to respond, the Court requested a response. The response is due September 26, 2025.

Federal Circuit En Banc Activity:

Kroy IP Holdings, LLC v. Groupon, Inc., No. 23-1359 (Fed. Cir. Aug. 1, 2025): The summary of the original panel opinion is available in our February 2025 update. As relevant here, the Court had held that a decision of invalidity from the Patent Trial and Appeal Board (Board) did not collaterally estop the patentee (Kroy) from asserting unadjudicated claims of related patents in a parallel district court litigation due to the different evidentiary standards in the two forums.

The en banc Federal Circuit denied the petition for rehearing en banc. Chief Judge Moore joined by Judge Stoll concurred in the denial for rehearing en banc, explaining that the Supreme Court has consistently reprimanded the Federal Circuit for establishing patent-specific rules for well-established principles, and collateral estoppel is a well-established doctrine. Because the standard of review before the Board for invalidity is preponderance of the evidence, whereas the district court requires clear and convincing evidence, collateral estoppel does not apply because of the differing standard of proof. And “[p]olicy implications cannot override the desire for uniformity in the application of law across different subject matters.”

Judge Dyk joined by Judge Hughes dissented from the denial for rehearing en banc, reasoning that not applying collateral estoppel would undermine the inter partes review (IPR) procedures as set forth in the AIA. Indeed, one of the central purposes of the AIA was to provide a “more efficient and less expensive alternative to costly district court invalidity litigation.” These congressional objectives would not be achieved if IPR final decisions affirmed by this Court were not given preclusive effect in district court.

V.O.S. Selections, Inc. v. Trump, No. 25-1812 (Fed. Cir. Aug. 29, 2025): Under the International Emergency Economic Powers Act (IEEPA), President Trump imposed various tariffs to address (1) a “national emergency of trafficking opioids into the country” and (2) “an unusual and extraordinary threat to national security” posed by the “lack of reciprocity in bilateral trade relationships.” Five small businesses challenged these orders before the Court of International Trade (CIT). The CIT held that the tariffs exceeded the President’s authority under the IEEPA and permanently enjoined the Government from imposing those tariffs.

The en banc Federal Circuit (per curiam) affirmed. The Court held that the IEEPA did not give the President the authority to impose the tariffs he ordered, and the Government’s reading of the term “regulate . . . importation” contained in the statute was too broad. Judge Cunningham joined by Judges Lourie, Reyna, and Stark filed additional views concluding that the IEEPA does not authorize the President to impose any tariffs and that the Government’s interpretation of “regulate” is too expansive and not supported by the plain text of the statute.

Judge Taranto joined by Chief Judge Moore and Judges Prost and Chen dissented, stating that the IEEPA’s language authorizes tariffs to regulate importation and “embodies an eyes-open congressional grant of broad emergency authority in this foreign-affairs realm.”

Other Federal Circuit News:

Release of Materials in Judicial Investigation. In the ongoing proceeding by the Judicial Council of the Federal Circuit under the Judicial Conduct and Disability Act and the implementing Rules involving Judge Pauline Newman, Judge Newman requested additional materials be released. These additional materials are available here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (August 2025)

FMC Corp. v. Sharda USA, LLC, No. 24-2335 (Fed. Cir. Aug. 1, 2025): FMC sued Sharda for infringing two of its patents directed to insecticide and miticide compositions and sought a preliminary injunction against Sharda. The district court granted the preliminary injunction, determining that Sharda failed to show that the claims were anticipated or rendered obvious by the prior art. This conclusion was based in part on the construction of the term “composition,” which the district court had construed to have a stability requirement and to exclude unstable compositions. In support of this construction, the district court reasoned that the provisional application to which the patents claim priority and another related patent in the family distinguish the prior art based on the “stability” of the composition.

The Federal Circuit (Chen, J., joined by Moore, C.J., and Barnett, J. (district judge sitting by designation)) vacated and remanded. The Court held the district court erred by relying on the provisional application and related patent to impose a stability requirement in its construction of “composition.” The Court explained that the common specification of the asserted patents had removed all references to the “stability” of the claimed composition that had been present in the provisional application and related patent. The Court therefore concluded that a skilled artisan would not understand that “composition” as claimed in the asserted patents would cover only stable formulations in light of such deletions. Because the district court’s rejection of Sharda’s anticipation and obviousness arguments was premised on its incorrect claim construction, the Court remanded with instructions for the district court to consider those arguments under the plain and ordinary meaning of “composition.”

PowerBlock Holdings, Inc. v. iFit, Inc., No. 24-1177 (Fed. Cir. Aug. 11, 2025): PowerBlock sued iFit for infringing its patent that relates to a system for selecting and adjusting the weight of “selectorized” dumbbells using an electric motor and a movable selector element. iFit moved to dismiss, arguing that the claims were patent ineligible under 35 U.S.C. § 101. The district court granted iFit’s motion as to all but one of the claims, holding in part that the claims were directed to the abstract idea of automated weight stacking. The parties stipulated to dismissal of the remaining eligible claim.

The Federal Circuit (Stoll, J., joined by Taranto and Scarsi (district judge sitting by designation), JJ.) reversed. The Court held that the district court erred in its Alice step one analysis by concluding that the claims preempted all methods of automated weight stacking. The Court reasoned that although the claims were broad, they recited “meaningful limitations” that provided a patent-eligible “specific implementation” of an automated weight stacking system, including selectorized dumbbells, an electric motor, and a movable selector coupled to one another.

Global Health Solutions LLC v. Selner, No. 23-2009 (Fed. Cir. Aug. 26, 2025): Selner filed a patent application for a method of preparing a wound treatment ointment without emulsifiers, which can irritate a patient’s skin. Global Health Solutions (GHS) filed an application for the same invention shortly thereafter. GHS then filed a petition for an AIA derivation proceeding against Selner, alleging that Selner was not the true inventor because GHS’s founder conceived of the invention before Selner and communicated it to Selner. The Board concluded that Selner had conceived of the invention first and therefore could not have derived it from GHS’s founder.

The Federal Circuit (Stark, J., joined by Stoll and Goldberg (district judge sitting by designation), JJ.) affirmed. The Court explained that in a derivation proceeding, an inventor may obtain a patent under the AIA despite filing the application second, if they can prove that the first filer derived the invention from them. While pre-AIA derivation proceedings focused on comparing the dates of conception, under the AIA, which moved the United States to a first-to-file system, the Court held that a petitioner must now “show (i) conception of the claimed invention, and (ii) communication of the conceived invention to the respondent prior to respondent’s filing of that patent application.” In turn, a respondent can “overcome the petitioner’s showing by proving independent conception prior to having received the relevant communication from the petitioner.” The Court determined that the Board erroneously focused on whether Selner was the first-to-invent, which was the derivation inquiry for pre-AIA interference proceedings. However, the Court concluded that the error was harmless because the Board indirectly determined that Selner had independently conceived of the invention and therefore did not derive it from GHS’s founder.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Julia Tabat, and Michelle Zhu.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for July summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning obviousness, prosecution history estoppel, interference estoppel, and Federal Circuit jurisdiction.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There was one potentially impactful petition filed before the Supreme Court in July 2025:

D R Burton Healthcare, LLC v. Trudell Medical International Inc. (US No. 25-17): The question presented is: “Whether a district court’s order changing the time to trial in its case management order from at least 326 days to 146 days, and its time for completion of all discovery (including expert discovery) from 231 days to 108 days, constitutes a fair legal procedure under the due process clause of the Fifth Amendment?” The respondent waived its right to file a response. The Court will consider the petition at its September 29, 2025 conference.

We provide an update below of the petitions pending before the Supreme Court, which were summarized in our June 2025 update:

In Gesture Technology Partners, LLC v. Unified Patents, LLC (US No. 24-1281), after one of the respondents waived its right to respond, the Court requested a response. The response is due September 4, 2025.

In Purdue Pharma L.P. v. Accord Healthcare, Inc. (US No. 24-1132), the respondent filed its response brief on June 2, 2025, and the petitioners filed a reply brief on June 17, 2025. The Court will consider the petition at its September 29, 2025 conference.

Other Federal Circuit News:

Release of Materials in Ongoing Judicial Investigation. In the ongoing proceeding by the Judicial Council of the Federal Circuit under the Judicial Conduct and Disability Act and the implementing Rules involving Judge Pauline Newman, Judge Newman requested additional materials be released. These additional materials are available here.

Boston Session in October 2025. The Federal Circuit announced that it intends to sit in and around Boston, Massachusetts as part of its October 2025 session here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (July 2025)

Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., No. 23-1864, 23-1940 (Fed. Cir. July 14, 2025): Cardiovascular Systems, Inc. (CSI) filed an inter partes review (IPR) petition against Shockwave’s patent directed to the treatment of plaque buildup in blood vessels with shockwave pulses. The Patent Trial and Appeal Board (Board) determined that all the challenged claims except one were unpatentable as obvious, relying in part on applicant admitted prior art (AAPA) as evidence of background knowledge in the art. Shockwave appealed the Board’s final written decision on the claims that were unpatentable, and CSI cross-appealed on the one claim that was not.

The Federal Circuit (Dyk, J., joined by Lourie and Cunningham, JJ.) affirmed Shockwave’s appeal and reversed CSI’s cross-appeal. The Court held that the Board did not improperly rely on AAPA in concluding that the claims would have been obvious, because AAPA was properly used as evidence of general background knowledge to show that missing claim limitations were known in the art and not as a basis for any of the obviousness grounds.

Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 23-2153 (Fed. Cir. July 18, 2025): Colibri filed suit against Medtronic, alleging induced infringement of Colibri’s patent directed to a method for use in implanting a replacement heart valve. The asserted independent claim recites “partially deploying a distal portion of the replacement heart valve device within the patient by pushing out the pusher member from the moveable sheath to expose the distal portion of the replacement heart valve device.” During prosecution, Colibri had pursued a second independent claim (claim 39) that included “partially deploying the replacement heart valve device within the patient by retracting the moveable sheath to expose a portion of the replacement heart valve device.” However, Colibri cancelled claim 39 in response to the examiner’s rejection of the claim for lack of written description. At trial, Colibri dropped its literal infringement claim and instead pursued a doctrine of equivalents theory that Medtronic’s partial-deployment method, which retracts a moveable sheath to deploy the heart valve, was substantially the same as pushing out the replacement heart valve as required by the asserted claim. The jury rendered a verdict of infringement. Medtronic sought judgment as a matter of law, arguing that prosecution history estoppel barred Colibri’s doctrine of equivalents argument because Colibri had cancelled the claim including the “retracting” step during prosecution. The district court denied Medtronic’s motion.

The Federal Circuit (Taranto, J., joined by Hughes and Stoll, JJ.) reversed. The Federal Circuit held that Colibri’s cancelling of claim 39 was a narrowing amendment giving rise to prosecution history estoppel and rejected the district court’s holding that estoppel did not apply because Colibri had not amended any claims to exclude the accused equivalent. The Court explained that narrowing for purposes of estoppel can exist not only when a single claim’s terms are amended but also when a closely related claim involving intertwined terminology is cancelled such that its cancellation necessarily communicates that the scope of the other claim has narrowed. The Court determined such narrowing existed here, and thus a skilled artisan would have understood that the subject matter of claim 39 was being surrendered in order to obtain allowance of the closely related remaining claims that included the pushing step.

IGT v. Zynga Inc., No. 23-2262 (Fed. Cir. July 22, 2025): IGT owns a patent directed to game playing services such as slot machines and video poker machines that securely communicates with devices over the Internet. IGT’s patent issued from an application it filed in 2002. In 2003, Zynga filed a patent application of its own, which included claims copied from IGT’s application. In 2010, the Board declared an interference between the IGT application and the Zynga application. In 2014, the Board granted judgment in IGT’s favor finding that Zynga’s application lacked adequate written description support, and therefore, did not reach the additional issue raised by Zynga of whether the claims were unpatentable as obvious. In 2021, IGT sued Zynga for infringement of its patent, and Zynga filed an IPR challenging certain claims as obvious. In response, IGT argued that the Board should deny institution of Zynga’s petition because Zynga was barred from raising its obviousness challenge based on interference estoppel under 37 C.F.R. § 41.127(a)(1). The Board rejected IGT’s interference estoppel argument because the interference proceedings were terminated based on a threshold issue of lack of adequate written description, and thus, the Board never reached the obviousness issue. IGT petitioned for Director review, and the Director affirmed the Board’s conclusion.

The Federal Circuit (Taranto, J. joined by Clevenger and Hughes, JJ.) affirmed. The Court held that the Board’s determination regarding whether interference estoppel bars institution of Zynga’s IPR petition is within the general unreviewability principle under 35 U.S.C. § 314, which states that institution decisions are final and nonappealable. While there might be exceptions to the general rule of unreviewability “where the agency engaged in blatant violations of legal constraints,” the Court found that did not apply in this case. Indeed, the Board and Director provided sufficient grounds for not applying interference estoppel, including that the interference was terminated on a threshold issue of written description.

Acorda Therapeutics, Inc. v. Alkermes PLC, No. 23-2374 (Fed. Cir. July 25, 2025): Acorda develops Ampyra®, a drug used to treat multiple sclerosis. Alkermes owns the now-expired patent that claimed the active ingredient in Ampyra. Acorda and Alkermes entered into an agreement under which Alkermes licensed its patent to Acorda, who supplied the active ingredient, in exchange for royalty payments. The patent expired in July 2018, but Acorda continued to make royalty payments without protest until July 2020, at which point it made payments but under formal protest. Acorda filed a demand in arbitration seeking recoupment of the royalty payments made after the patent expired in 2018, but the Tribunal only awarded Acorda the payments that it made under protest starting from July 2020. Acorda then filed suit in district court requesting modification of the arbitral award. The district court declined to modify the award.

The Federal Circuit (Taranto, J., joined by Hughes and Stark, JJ.) transferred the appeal to the Second Circuit. The Court determined that it lacked jurisdiction over the appeal because there was no patent-law cause of action. Acorda’s case sought modification of the arbitral award under 9 U.S.C. § 207. Acorda had presented two arguments regarding manifest error by the Tribunal, but only one, based on Brulotte, rested on federal patent law. Acorda’s second argument was based on Kaiser Steel, which did not rely on patent law, and therefore provided a way for the district court to decide the case without applying patent law. Thus, because an issue of patent law was not necessarily raised, the Court concluded that it lacked jurisdiction.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Hannah Bedard, and Michelle Zhu.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding developments at the Federal Circuit. Please contact the Gibson Dunn lawyer with whom you usually work, any leader or member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups, or the following authors:

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

Appellate and Constitutional Law:
Thomas H. Dupree Jr. – Washington, D.C. (+1 202.955.8547, tdupree@gibsondunn.com)
Allyson N. Ho – Dallas (+1 214.698.3233, aho@gibsondunn.com)
Julian W. Poon – Los Angeles (+ 213.229.7758, jpoon@gibsondunn.com)

Intellectual Property:
Kate Dominguez – New York (+1 212.351.2338, kdominguez@gibsondunn.com)
Josh Krevitt – New York (+1 212.351.4000, jkrevitt@gibsondunn.com)
Jane M. Love, Ph.D. – New York (+1 212.351.3922, jlove@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for June summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning claim construction, standing, and secondary considerations of non-obviousness.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There was a potentially impactful petition filed before the Supreme Court in June 2025:

Gesture Technology Partners, LLC v. Unified Patents, LLC (US No. 24-1281): The question presented is: “Whether the PTO has the authority to conduct administrative adjudications regarding the validity of expired patents, and thereby extinguish private property rights through a non-Article III forum without a jury, even though the patent owner no longer possesses the right to exclude the public from its invention.” Response briefs are due July 16, 2025.

We provide an update below of the petitions pending before the Supreme Court, which were summarized in our May 2025 update:

Purdue Pharma L.P. v. Accord Healthcare, Inc. (US No. 24-1132): The respondent filed its response brief on June 2, 2025, and the petitioners filed a reply brief on June 17, 2025. The Court will consider the petition at its September 29, 2025 conference.
The Court denied the petitions in In re Micron Technology, Inc. (US No. 24-1216) and McLeay v. Stewart (US No. 24-1181)

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (June 2025)

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., et al., No. 23-2357 (Fed. Cir. Jun. 4, 2025): Alnylam sued Moderna alleging that Moderna’s COVID-19 vaccine infringed Alnylam’s patents. During claim construction proceedings, the parties disputed the meaning of “branched alkyl.” The district court concluded that Alnylam had acted as its own lexicographer and construed the term to require an alkyl group with a carbon bonded to at least three other carbon atoms, consistent with the definition set forth in the specification. The parties stipulated to non-infringement under this construction, and the district court entered final judgment accordingly.

The Federal Circuit (Taranto, J., joined by Chen and Hughes, JJ.) affirmed. The Court held that the patentee had acted as its own lexicographer in defining the term “branched alkyl” to require a carbon bonded to three or more carbons (rather than at least two carbons, as would be the plain and ordinary meaning of the term). The Court reasoned that once the high threshold for lexicography is met, a similarly high threshold would have to be met before finding a departure from that controlling definition. The Court did not find Alnylam’s arguments regarding the dependent claims, prosecution history, and certain examples in the specification required a departure from the definition found in the specification.

Dolby Laboratories Licensing Corp. v. Unified Patents, LLC, Nos. 23-2110 (Fed. Cir. June 5, 2025): Dolby owns a patent directed to a prediction method using an in-loop filter. Unified Patents filed a petition for inter partes review (IPR) of Dolby’s patent in which Unified Patents asserted that it was the sole real party in interest (RPI). In response, Dolby argued that there were nine other entities that it believed should have been named as RPIs. The Patent Trial and Appeal Board (Board) has a practice of only adjuciating RPI disputes when material to the proceeding in the interest of cost and efficiency. The Board therefore declined to address the RPI dispute, reasoning that adjudicating the RPI dispute was unnecessary where there was no evidence that the nine alleged RPIs would be time-barred or estopped from bringing the IPR or that Unified Patents sought an advantage by omitting the nine alleged RPIs.

The Federal Circuit (Moore, C.J., joined by Clevenger and Chen, JJ.) dismissed the appeal because Dolby failed to show an injury-in-fact, as required to demonstrate Article III standing. The Court held that 35 U.S.C. § 112(a)(2)—which provides that a petition “may be considered only if the petition identifies all real parties in interest”—does not provide an informational right to know the identities of all RPIs in IPR proceedings, the violation of which would constitute an injury-in-fact. The Supreme Court has held that an informational right exists in other statutes, such as the Federal Election Campaign Act (FECA), where one of the express purposes of FECA is to allow the public access to certain information. By contrast, the purpose of the AIA is “to establish a more efficient and streamlined patent system that will improve patent quality and limit unnecessary and counterproductive litigation costs,” and thus, the Court held that the AIA did not create an informational right.

Ancora Technologies, Inc. v. Roku, Inc., No. 23-1674 (Fed. Cir. June 16, 2025): Ancora owns a patent directed to restricting the unauthorized use of licensed software programs on computers. Roku and Nintendo filed two IPRs against Ancora’s patent, challenging its claims as obvious. Ancora raised secondary considerations of non-obviousness, specifically citing industry praise and licensing. The Board held that the challenged claims would have been obvious, and rejected Ancora’s evidence of secondary considerations after finding Ancora failed to establish a nexus between that evidence and the challenged claims.

The Federal Circuit (per curium; Lourie, Reyna, and Hughes, JJ.) vacated and remanded. The Court affirmed the Board’s finding that Ancora failed to establish a nexus between evidence of industry praise and the claimed invention because the Board did not clearly err in finding that Ancora did not link up the press releases to the challenged claims. However, as to the Board’s finding that Ancora failed to show a nexus between the challenged claims and two licenses that Ancora entered into with other parties during settlements in other cases, the Federal Circuit found error. The Federal Circuit held that the Board “applied a more exacting nexus standard than our case law requires for license evidence.” The Court explained that licenses by its nature are directly tied to the patented technology, and therefore, do not require a showing of nexus to the specific claims at issue. Thus, the Court instructed that, on remand, the Board should reconsider the nexus issue of the licenses in its secondary considerations of non-obviousness analysis.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Hannah Bedard, Evan Kratzer, and Julia Tabat.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for May summarizes the current status of petitions pending before the Supreme Court, a recent en banc Federal Circuit decision concerning Federal Rule of Evidence 702, and recent Federal Circuit decisions concerning the safe harbor provision under 35 U.S.C. § 271(e), preliminary injunctions, and conception.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were a few potentially impactful petitions filed before the Supreme Court in May 2025:

In re Micron Technology, Inc. (US No. 24-1216): The question presented is “Does a district court clearly and indisputably err in ordering production of sensitive technical documentation without applying the standards set forth in the parties’ protective order and without considering the Executive Branch’s national-security interests in the documentation at issue?” Respondents waived the right to file a response, and the Court will consider the petition at its June 26, 2025 conference.

McLeay v. Stewart (US No. 24-1181): The question presented is “Whether a court of appeals may sua sponte revive an argument the government has impliedly waived on appeal and rely on the waived argument in ruling in the government’s favor.” The respondent waived its right to file a response, and the Court will consider the petition at its June 26, 2025 conference.

We provide an update below of the petitions pending before the Supreme Court, which were summarized in our April 2025 update:

Purdue Pharma L.P. v. Accord Healthcare, Inc. (US No. 24-1132): The respondent filed its response brief on June 2, 2025.

The Court denied the petition in Converter Manufacturing, LLC v. Tekni-Plex, Inc. (US No. 24-866) and NexStep, Inc. v. Comcast Cable Communications, LLC (US No. 24-1137).

Federal Circuit En Banc Decisions:

EcoFactor, Inc. v. Google LLC, No. 23-1101 (Fed. Cir. May 21, 2025): EcoFactor owns a patent related to the operation of smart thermostats in computer-networked heating and cooling systems. Before trial, Google moved to exclude the testimony of EcoFactor’s damages expert, Mr. Kennedy, because his royalty rate for the patented technology was unsupported by a reliable methodology or sufficient facts. The district court denied the motion. At trial, Mr. Kennedy opined that Google should pay damages at a particular royalty rate. The jury found Google infringed and awarded EcoFactor over $20 million in lump-sum damages. Google moved for a new trial on damages, which was denied. Google appealed, and a Federal Circuit panel majority (Judges Lourie and Reyna) affirmed the denial of Google’s motion for a new trial on damages with Judge Prost dissenting. Google petitioned for rehearing en banc, which the en banc Court granted as to the issue of damages and Federal Rule of Evidence 702.

The en banc majority (Moore, C.J., joined by Lourie, Dyk, Prost, Taranto, Chen, Hughes, and Stoll, JJ.) reversed and remanded for a new trial on damages. The majority concluded that the denial of Google’s motion to exclude under Rule 702 was an abuse of discretion. Specifically, the majority determined that the payment provisions in the three licenses Mr. Kennedy relied upon for his royalty rate stated that the lump-sum payments in the licenses did not reflect or constitute a reasonable royalty. And while a couple of the licenses included a clause stating what EcoFactor thought the reasonable royalty rate was, it did not suggest that the licensees had agreed to that royalty rate. The majority therefore determined that the plain language of the licenses did not support Mr. Kennedy’s opinion that the licensees would have agreed to pay the royalty rate he set forth, and thus, the district court failed to fulfill its responsibility as gatekeeper under Rule 702 by allowing that testimony at trial. The majority further determined that it could not be sure the error did not influence the jury, and thus, reversed the denial of Google’s motion for a new trial and remanded for a new trial on damages.

Judge Reyna dissented. Judge Reyna did not think the district court abused its discretion in finding that the three license agreements constituted sufficient facts or data under Rule 702. In his opinion, the majority’s question of whether the three licenses bound the contracting parties to the royalty rate was not the correct inquiry. Instead, the right question should have been whether there were sufficient facts or data to support Mr. Kennedy’s testimony of what the reasonable royalty is.

Judge Stark also dissented. Judge Stark reasoned that the majority concluded that the district court abused its discretion by permitting Mr. Kennedy to testify to an opinion that rested on disputed facts and not insufficient facts. The three licenses could have been interpreted as supporting or refuting the royalty rate from Mr. Kennedy, and the jury could have reasonably credited EcoFactor’s interpretation of the disputed evidence. Judge Stark raised a concern that the majority’s opinion would encourage future panels of the Court to engage in improper appellate factfinding.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (May 2025)

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Nos. 24-2274, 24-2277, 24-2278 (Fed. Cir. May 6, 2025): Jazz sells two sodium oxybate products (Xyrem and Xywav) for treatment of narcolepsy and idiopathic hypersomnia (IH), respectively. Xywav is the first, and currently, only FDA-approved treatment for IH. Avadel filed a paper New Drug Application (NDA) seeking FDA approval of its own product, Lumryz, for treatment of narcolepsy. Avadel’s paper NDA was eventually approved by the FDA, allowing Avadel to commercially launch Lumryz. In the interim, Jazz sued Avadel alleging its FDA submission constituted patent infringement under 35 U.S.C. § 271(e)(2)(A). Prior to trial, the parties stipulated to infringement, if the claim was not found to be invalid. A jury found that Avadel had not shown the claim to be invalid. The district court then entered a permanent injunction, which in part enjoined Avadel from initiating new clinical trials or studies for Lumryz.

The Federal Circuit (Lourie, J., joined by Reyna and Taranto, JJ.) reversed-in-part, vacated-in-part, and remanded. Under the safe-harbor provision of 35 U.S.C. § 271(e)(1), “experimentation with a patented drug product, when the purpose is to prepare for commercial activity . . . after a valid patent expires, is not patent infringement.” In addition, 35 U.S.C. § 271(e)(3) statutorily precludes such activity from being enjoined. The Court concluded that under this plain language of the statute, enjoining Avadel from initiating new clinical trials for Lumryz until after the expiration of Jazz’s patent is unlawful. The Court therefore reversed that portion of the district court’s injunction as unlawfully overbroad.

Incyte Corp. v. Sun Pharmaceutical Industries, Ltd., No. 25-1162 (Fed. Cir. May 7, 2025): Incyte sued Sun for allegedly infringing its patent, which claims deuterated versions of ruxolitinib used to treat diseases associated with autoimmune disorders. In July 2024, Sun secured FDA approval for Leqselvi, an oral deuterated ruxolitinib product for treating alopecia areata (AA) and was set to launch in October 2024. Incyte moved for a preliminary injunction to prevent the launch, which the district court granted.

The Federal Circuit (Moore, C.J., joined by Prost and Hughes, JJ.) reversed, holding that the district court clearly erred in finding irreparable harm. A patentee can be irreparably harmed by an alleged infringer’s improper “head start” because the alleged infringer can capture market share and secure a competitive lead. However, the Court determined that Sun’s head start was inevitable because it was prepared to launch imminently, while Incyte’s product would not launch until several years after the patent’s expiration in December 2026. And Incyte cannot enjoin Sun from launching after the expiration of its patent. Thus, Sun’s multi-year head start is inevitable regardless of any injunction. The Court therefore concluded that the district court’s finding that Incyte would be the first to market if the preliminary injunction were granted was clearly erroneous.

Gibson Dunn partner Paul Torchia argued this case on behalf of Sun, who was also represented by Charlotte Jacobsen, Josh Krevitt, Blaine Evanson, Alexander Harris, and Christine Ranney, also of Gibson Dunn.

Regents of the University of California v. Broad Institute, Inc., Nos. 22-1594, 22-1653 (Fed. Cir. May 12, 2025): Scientists at both Regents and Broad researched efforts relating to CRISPR (clustered regularly interspaced short palindromic repeats) technology, which is a revolutionary gene-editing technology that allows scientists to precisely modify DNA sequences. Both Regents and Broad claim to be the inventor of the CRISPR technology at issue here, and as a result the Patent Trial and Appeal Board (Board) declared an interference. The Board designated Broad as the senior party. The Board rejected Regents’ earliest asserted date of reduction to practice because Regents’ scientists did not know their CRISPR system would work before Broad’s earliest priority date.

The Federal Circuit (Reyna, J., joined by Hughes and Cunningham, JJ.) affirmed-in-part, vacated-in-part, remanded the main appeal, and dismissed the cross-appeal. The Court vacated the Board’s conception ruling, holding that the Board erred in requiring Regents’ scientists to have known their invention would work to prove conception. The Court determined that the Board focused almost exclusively on Regents’ scientists’ statements of uncertainty as to whether their invention would work, and instead, should have considered whether “routine skill” or methods were all that was necessary to reduce the Regents’ scientists’ idea to practice. The Court thus remanded for the Board to decide conception under the proper application of the legal framework.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Evan Kratzer, Julia Tabat, and Monica Grover.

This edition of Gibson Dunn’s Federal Circuit Update for April summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning provisional rights under 35 U.S.C. § 154(d), the Board’s findings regarding knowledge of a person of ordinary skill in the art, patent ineligibility under 35 U.S.C. § 101, and means-plus-function terms under 35 U.S.C. § 112 ¶ 6.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were a few potentially impactful petitions filed before the Supreme Court in April 2025:

NexStep, Inc. v. Comcast Cable Communications, LLC (US No. 24-1137): The question presented is “Whether a patentee must in every case present ‘particularized testimony and linking argument’ to establish infringement under the doctrine of equivalents.” The response is due June 5, 2025.
Purdue Pharma L.P. v. Accord Healthcare, Inc. (US No. 24-1132): The question presented is “Whether, as this Court has held, the objective indicia of non-obviousness should be analyzed flexibly to combat hindsight bias or instead subject to the Federal Circuit’s rigid rules restricting the inquiry.” The response is due June 2, 2025.

We provide an update below of the petitions pending before the Supreme Court, which were summarized in our March 2025 update:

The Court will consider the petition in Converter Manufacturing, LLC v. Tekni-Plex, Inc. (US No. 24-866) at its May 22, 2025 conference.
The Court denied the petitions in Brumfield v. IBG LLC, et al. (US No. 24-764) and Celanese International Corp. v. International Trade Commission (US No. 24-635).

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (April 2025)

In re Forest, No. 23-1178 (Fed. Cir. April 3, 2025): Mr. Forest submitted a patent application titled “Apparatus for Selecting from a Touch Screen” on December 27, 2016. The application was rejected by the examiner in part under obviousness and nonstatutory double patenting grounds and affirmed by the Patent Trial and Appeal Board (Board), which Mr. Forest now appeals. The application claims priority to another application filed on March 27, 1995, meaning that if the 2016 application were to issue as a patent, it would have an expiration date in 2015. The United States Patent and Trademark Office (PTO) therefore contends that Mr. Forest has no personal stake in the appeal because he cannot be granted any enforceable rights by a patent grant with zero term. Mr. Forest argues that he would acquire “provisional rights” under 35 U.S.C. § 154(d) if the PTO issues him an expired patent.

The Federal Circuit (Chen, J., joined by Taranto and Schall, JJ.) dismissed the appeal. The Federal Circuit held that provisional rights, which are “provisional,” means they are “temporary” and must be replaced by the statutory exclusionary rights, which runs from the date of issuance to 20 years after the priority date. Thus, a patent is only granted exclusionary rights if it issues before its expiration date. Based on this, the Court reasoned that provisional rights must therefore precede exclusionary rights, which means that provisional rights can only be granted to a patent that issues with exclusionary rights. As a result, even if Mr. Forest were granted a patent on the 2016 application, it would not lead to a conferral of provisional rights, because the patent would have expired before it issued, meaning Mr. Forest would receive no exclusionary rights.

Sage Products, LLC v. Stewart, No. 23-1603, 23-1604 (Fed. Cir. Apr. 15, 2025): Sage owns two patents directed to a sterilized chlorhexidine product in a package, such as an applicator filled with an antiseptic composition for disinfecting skin. Becton, Dickinson and Co. (BD) petitioned for inter partes review (IPR) of certain claims of Sage’s patents and the Board concluded that the challenged claims were unpatentable in part because a person of skilled in the art would have found the prior art’s disclosure of “sterile applicators” taught the “sterilized chlorhexidine product” claimed.

The Federal Circuit (Stark, J., joined by Reyna, J. and Cunningham, J.) affirmed. The Court held that the Board’s finding that a person of skill in the art would have understood the term “sterile” as used in the prior art (a publication from the United Kingdom’s (UK) health agency) to meet the claim term “sterilized” under the Board’s construction was supported by substantial evidence. The Court found no reversible error in the Board’s finding that a skilled artisan would know about the differing regulatory requirements in the United States and the UK, including recognizing that satisfying the UK regulatory standards for “sterile” would satisfy the challenged claims’ requirements for “sterilized” items.

Recentive Analytics, Inc. v. Fox Corp., No. 23-2437 (Fed. Cir. April 18, 2025): Recentive owns several patents directed to methods for generating optimized television broadcast schedules and network maps using machine learning. Specifically, the patents aimed to improve television scheduling for live events and to allocate network content across different geographic areas. The claims described the use of machine learning to dynamically predict optimal scheduling and map allocation, allegedly proposing an innovative use of artificial intelligence (AI) in the broadcasting industry. Fox moved to dismiss on the grounds that the patent claims were ineligible under 35 U.S.C. §101, and the district court granted the motion. The court held that the claims were directed to abstract ideas of producing network maps and event schedules using generic mathematical techniques, and the claims lacked an inventive concept because they involved only routine applications of machine learning technology using generic and conventional computing devices.

The Federal Circuit (Dyk, J., joined by Prost and Goldberg (district judge sitting by designation), JJ.) affirmed. At Alice Step One, the Court held that the claims were directed to abstract ideas—specifically, the use of machine learning to television broadcast scheduling and network map allocation. At Alice Step Two, the Court held that the claims merely applied generic machine learning techniques to a new field, and that the use of conventional technology did not somehow transform the claimed abstract idea into a patent-eligible invention. The Court also noted that although machine learning is a rapidly advancing field, simply applying machine learning to specific tasks, without further innovation, does not satisfy the statutory requirements for patent eligibility.

Fintiv, Inc. v. PayPal Holdings, Inc., No. 23-2312 (Fed. Cir. Apr. 30, 2025): Fintiv sued PayPal for infringement of patents related to a cloud-based transaction system. During claim construction proceedings before the district court, PayPal argued that the term “payment handler” is a means-plus-function term subject to 35 U.S.C. § 112 ¶ 6 and was indefinite for failing to disclose adequate corresponding structure.

The Federal Circuit (Prost, J., joined by Taranto and Stark, JJ.) affirmed. The Court first determined that while the payment-handler terms did not use the word “means,” PayPal overcame the presumption that § 112 ¶ 6 does not apply because the payment-handler terms recite function without reciting sufficient structure for performing that function. The Court also agreed with the district court that “handler” alone did not provide sufficient structure. The Court then looked to whether there was corresponding structure disclosed in the specification or an algorithm to achieve the functionalities performed and concluded that there was not. The Court thus concluded the term was indefinite.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Al Suarez, and Michelle Zhu.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for September 2024 summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning the level of skill of a person of ordinary skill in the art, patent eligibility under 35 U.S.C. § 101, indefiniteness, and the party presentation principle.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There was a potentially impactful petition filed before the Supreme Court in September 2024:

Norwich Pharmaceuticals Inc. v. Salix Pharmaceuticals, Ltd. (US No. 24-294): The question presented is “[w]hether 35 U.S.C. § 271(e)(4)(A) requires courts to issue injunctive orders that are broader in scope than the underlying infringement, thereby delaying FDA approval of generic drug applications for indications that have not been found to infringe any valid patent.”

We provide an update below of the petitions pending before the Supreme Court, some of which were summarized in our August 2024 update:

In Zebra Technologies Corporation v. Intellectual Tech LLC (US No. 24-114), the Court requested a response to the petition, which is due October 16, 2024. The question presented is “[w]hether a party has Article III standing to assert a claim for patent infringement against an accused infringer who has the ability to obtain a license from a third party.”
The Court denied the petitions in United Therapeutics Corp. v. Liquidia Technologies, Inc. (US No. 23-1298), Chestek PLLC v. Vidal (US No. 23-1217), and Cellect LLC v. Vidal (US No. 23-1231).

Federal Circuit En Banc Petitions:

EcoFactor, Inc. v. Google LLC, No. 2023-1101 (Fed. Cir. Sept. 25, 2024): The Federal Circuit granted Google’s petition for rehearing en banc as to the admissibility of EcoFactor’s damages expert assigning a per-unit royalty rate to the three licenses in evidence.

We summarized the original panel opinion in our June 2024 update.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (September 2024)

Osseo Imaging, LLC v. Planmeca USA Inc., No. 2023-1627 (Fed. Cir. Sept. 4, 2024): Osseo sued Planmeca for infringing patents directed to orthopedic imaging systems that use X-ray techniques to create tomographic and/or densitometric models of a scanned object. After a jury verdict of infringement and no invalidity, Planmeca moved for judgment as a matter of law of invalidity and noninfringement asserting, inter alia, that Osseo’s technical expert, Dr. Kia, did not qualify as a person of ordinary skill in the art as of the alleged date of invention, because Dr. Kia did not attain the requisite three to five years of diagnostic imaging experience until nearly ten years after the time of the invention. The district court denied Planmeca’s motion, explaining there was no requirement that an expert attain his or her expertise prior to a patent’s effective date, and concluding that the jury was free to credit Dr. Kia’s testimony in reaching its conclusions on infringement.

The Federal Circuit (Stoll, J., joined by Dyk and Clevenger, JJ.) affirmed. The Court first noted the unusual procedural posture of Planmeca’s challenge of Dr. Kia’s expert testimony—Planmeca did not file a Daubert motion or appeal the denial of a motion to exclude Dr. Kia’s testimony or denial of an objection to that testimony at trial, but instead asserts that Dr. Kia’s testimony cannot constitute substantial evidence supporting the jury’s verdict of infringement. The Court then declined to add a temporal requirement, and instead held that an expert “need not have acquired that skill level prior to the time of invention to be able to testify from the vantage point of a person of ordinary skill in the art” and “can acquire the necessary skill level later and develop an understanding of what a person of ordinary skill knew at the time of the invention.”

Contour IP Holding LLC v. GoPro, Inc., Nos. 2022-1654, 2022-1691 (Fed. Cir. Sept. 9, 2024): Contour sued GoPro for patent infringement of several of GoPro’s patents directed to “portable, point of view (‘POV’)” video camera technology. Specifically, they disclose a “‘hands-free, POV action sports video camera’ that is ‘configured for remote image acquisition control and viewing.’” The district court granted GoPro’s summary judgment motion on the basis that the claims were patent ineligible under 35 U.S.C. § 101. Under Alice step one, the court determined that a representative claim “was directed to the abstract idea of ‘creating and transmitting video (at two different resolutions) and adjusting the video’s settings remotely.” At Alice step two, the court said the claim “recites only functional, results-oriented language with ‘no indication that the physical components are behaving in any way other than their basic, generic tasks.’”

The Federal Circuit (Prost, J. joined by Schall and Reyna, JJ.) reversed. The Court held that the claims “require specific, technological means—parallel data stream recording with the low-quality recording wirelessly transferred to a remote device—that in turn provide a technological improvement to the real time viewing capabilities of a POV camera’s recordings on a remote device.” The Court further explained that the “claims are directed to a technological solution to a technological problem,” that enables the claimed POV camera to “operate differently than it otherwise could.” The Court held that the claims therefore recite patent-eligible subject matter at Alice step one, and there was thus no need to proceed to Alice step two.

Vascular Solutions LLC et al. v. Medtronic, Inc. et al., No. 2024-1398 (Fed. Cir. Sept. 16, 2024): Vascular sued Medtronic for infringing its patents directed to a “coaxial guide catheter that is deliverable through standard guide catheters by utilizing a guidewire rail segment to permit delivery without blocking use of the guide catheter.” The district court construed the phrase “substantially rigid portion/segment” as recited in all the asserted claims as indefinite and concluded the claims were therefore invalid. The parties stipulated to final judgment based on that determination.

The Federal Circuit (Mazzant, J. (district judge sitting by designation), joined by Moore, C.J., and Prost, J.) vacated and remanded. The Court first determined that the district court erred in finding that one set of claims were “mutually exclusive” from another set of claims because the first set of claims place a claimed “side opening” within the substantially rigid portion whereas the second set of claims place the side opening distal to the substantially rigid portion. The Court explained that the analysis of indefiniteness must be performed on a claim-by-claim basis, and thus, the boundary of “substantially rigid portion/segment” does not have to be consistent across all the claims. The Court acknowledged, however, that while the claim term should be construed consistently within the same claim or across other claims of the same patent, that construction may be a “functional construction” that does not specify the boundary of the “substantially rigid portion.”

Astellas Pharma, Inc. v. Sandoz Inc., et al., Nos. 2023-2032, 2023-2063, 2023-2089 (Fed. Cir. Sept. 18, 2024): Astellas sued Sandoz for infringing its patent directed to a sustained-release pharmaceutical composition for mirabegron, after Sandoz submitted an ANDA to sell and market generic versions of Astellas’s drug, Myrbetriq. Following the bench trial on issues of infringement and validity under 35 U.S.C. § 112, the district court sua sponte held that the asserted claims were ineligible under 35 U.S.C. § 101. The district court determined that in defending its patent against Sandoz’s Section 112 defenses, Astellas had stated that the “inventive concept” in the claims was the discovery of the correct “dissolution rate” to avoid adverse food effects associated with taking the drug, and that therefore Astellas had conceded its patent was ineligible as directed to a natural law.

The Federal Circuit (Lourie, J., joined by Prost and Reyna, J.J.) vacated and remanded. The principle of party presentation states that courts rely on the parties to frame the issues for decision and assign to the courts the role of neutral arbiter of matters the parties present. The Court held that the district court abused its discretion by violating the principle of party presentation in holding the claims ineligible under Section 101—a ground not raised by Sandoz. The Court explained that the presumption of validity applies equally to all grounds of validity. Accordingly, to the extent the district court believed that patent eligibility under Section 101 was a threshold inquiry and should be “treated any differently than validity under §§ 102, 103, and 112 for purposes of the party presentation principle, that was error.” The Court then declined Astellas’s request to reassign the matter to a new judge on remand, finding that although statements made by the district court evidenced a “personal frustration with the pharmaceutical industry as a whole,” it did not amount to “extraordinary circumstances” that would indicate that the judge could not impartially address the outstanding issues on remand.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Al Suarez, Vivian Lu, and Julia Tabat.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

Intellectual Property:
Kate Dominguez – New York (+1 212.351.2338, kdominguez@gibsondunn.com)
Y. Ernest Hsin – San Francisco (+1 415.393.8224, ehsin@gibsondunn.com)
Josh Krevitt – New York (+1 212.351.4000, jkrevitt@gibsondunn.com)
Jane M. Love, Ph.D. – New York (+1 212.351.3922, jlove@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for August 2024 summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning obviousness-type double patenting, Article III standing, and attorneys’ fees under Section 285.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:
There were no new potentially impactful petitions filed before the Supreme Court in August 2024. We provide an update below of the petitions pending before the Supreme Court that were summarized in our July 2024 update:

In United Therapeutics Corp. v. Liquidia Technologies, Inc. (US No. 23-1298), after the respondent waived its right to respond, a response was requested by the Court. The response brief was filed on August 27, 2024, and the reply brief was filed on September 10, 2024.
In Chestek PLLC v. Vidal (US No. 23-1217), the response brief was filed on August 14, 2024, and the reply brief was filed on August 29, 2024. Five amicus curiae briefs had been filed.
In Cellect LLC v. Vidal (US No. 23-1231), the response brief was filed on August 21, 2024, and the reply brief was filed on September 4, 2024. An additional amicus curiae brief was also filed on August 21, 2024. A total of eight amicus curiae briefs have now been filed.

All three petitions will be considered during the Court’s September 30, 2024 conference.

Other Federal Circuit News:

Release of Materials in Judicial Investigation. The Federal Circuit released additional materials in connection with the proceeding under the Judicial Conduct and Disability Act and the implementing Rules involving Judge Pauline Newman. The materials may be accessed here. In particular, the Judicial Council of the Federal Circuit has ordered that Judge Newman “not be permitted to hear or participate in any cases . . . for a period of one year beginning with the issuance of this Order.”

Amending Rule 15 to extend the time to appeal from the Secretary of Veterans Affairs from 60 days to 6 years.
Amending Rule 30 to require parties to add information in the submitted appendices designating how a document was designated at the reviewed tribunal (such as docket numbers).
Combing Rule 35 regarding en banc rehearing with Rule 40 regarding panel rehearing.

Public comments must be received on or before October 4, 2024.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (August 2024)

Allergan USA, Inc. et al. v. MSN Laboratories Private Ltd. et al., No. 2024-1061 (Fed. Cir. Aug. 13, 2024): Allergan markets and sells eluxadoline tablets under the brand name Viberzi®. Allergan owns patents that cover the drug compound and composition. The first-filed application issued as the ‘356 patent and had a total patent term adjustment (PTA) of 467 days. Continuing applications were filed claiming the same priority date as the ‘356 patent, which issued as the ‘011 and ‘709 patents. The ‘011 and ‘709 patents did not receive any PTA, and each was therefore set to expire before the ‘356 patent. Defendant argued based on In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023), that the ‘011 and ‘709 patents were obviousness-type double patenting (ODP) references that rendered the ‘356 patent invalid. The district court agreed.

The Federal Circuit (Lourie, J., joined by Dyk and Reyna, JJ.) reversed. The Court held that a “first-filed, first-issued, later-expiring claim” cannot “be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.” The Court explained that a contrary result would be “antithetical to the principles of ODP,” which is “to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.”

(Judge Dyk concurred on the ODP issue but dissented with respect to other issues addressed by the Court.)

A more detailed summary of this case may be found here.

Platinum Optics Technology Inc. v. Viavi Solutions Inc., No. 23-1227 (Fed. Cir. Aug. 16, 2024): Viavi sued Platinum Optics (PTOT) alleging infringement in two civil actions on a patent directed to optical filters including layers of hydrogenated silicon and sensor systems comprising such optical filters. PTOT then petitioned for inter partes review (IPR), and the Patent Trial and Appeal Board (Board) concluded that PTOT failed to prove that the challenged claims were unpatentable. PTOT challenges the Board’s decision in this appeal. However, before the Board issued its final written decision, Viavi’s patent infringement claims regarding the challenged patent were dismissed with prejudice in both district court cases.

The Federal Circuit (Cecchi, J. (district judge sitting by designation), joined by Moore, C.J., and Taranto, J.) dismissed the appeal for lack of standing. Although a party does not need Article III standing to appear before an agency, PTOT failed to show it had standing to seek judicial review of the agency’s final action in federal court. In particular, the Court concluded that PTOT could not show that it had suffered an injury in fact, because it had not established there were concrete plans for future activity that created a substantial risk of infringement. The Court determined that a Viavi letter that stated Viavi did “not believe” PTOT could fulfill its supply agreements without infringing was mere speculation and insufficient to show a substantial risk of future infringement. Moreover, this letter was sent prior to the start of the district court cases, and the relevant claims had been dismissed with prejudice. The Court also determined that PTOT’s declaration regarding the continued development of new bandpass filters failed to identify any concrete plans that would implicate the challenged patent.

Realtime Adaptive Streaming LLC v. Sling TV, LLC, No. 23-1035 (Fed. Cir. August 23, 2024): Realtime sued DISH and related Sling entities for infringing patents directed to digital data compression. Over the next six years, a series of events related to determinations of ineligibility or invalidity of the asserted patent and its related patents occurred in various forums, leading the district court to ultimately find the asserted claims of the asserted patent ineligible. While that determination of ineligibility was on appeal, the district court granted DISH’s motion for attorneys’ fees, highlighting six events that it considered “red flags,” finding that “Realtime’s dogged pursuit of the case notwithstanding those danger signals render[ed] this an exceptional case.”

The Federal Circuit (Albright, J. (district judge sitting by designation), joined by Moore, C.J. and Lourie, J.) vacated and remanded. The Court determined that, although the district court did not err in giving weight to the decisions from two different district courts in determining that certain claims of a related patent were ineligible (one of the “red flags”), the district court erred in giving weight to the other five red flags. The Court determined that the district court erred in finding that the Adaptive Streaming decision from the Federal Circuit should have put Realtime on notice that its patent claims were meritless. The Court explained that Adaptive Streaming was about technology that was different from that claimed in the asserted patent. The Court also determined that the district court failed to explain why the final written decisions from the Board invalidating certain claims of a related patent and non-final office actions rejecting claims of the asserted patents were relevant to its decision to award attorneys’ fees. The Court next explained that a notice letter DISH had sent to Realtime contained “no analysis sufficient to put the patentee on notice that its arguments regarding ineligibility are so meritless as to amount to an exceptional case.” “Simply being on notice of adverse case law and the possibility that opposing counsel would pursue 285 fees does not amount to clear notice” that the claims in question were invalid and therefore did not support a finding of exceptionality. Finally, the Court held that the district court erred in finding that the opinions of DISH’s expert regarding noninfringing alternatives should have put Realtime on notice that its arguments “were so without merit as to amount to an exceptional case.”

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Kate Dominguez, Jaysen Chung, Audrey Yang, Vivian Lu, Julia Tabat, and Michelle Zhu.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

Intellectual Property:Kate Dominguez – New York (+1 212.351.2338, kdominguez@gibsondunn.com)
Y. Ernest Hsin – San Francisco (+1 415.393.8224, ehsin@gibsondunn.com)
Josh Krevitt – New York (+1 212.351.4000, jkrevitt@gibsondunn.com)
Jane M. Love, Ph.D. – New York (+1 212.351.3922, jlove@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for July 2024 summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning preliminary injunctions, contempt orders, issue preclusion, motions to amend before the Patent Trial and Appeal Board (Board), and the meaning of “publicly disclosed” under the America Invest Act (AIA).

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were no new potentially impactful petitions filed before the Supreme Court in July 2024. We provide an update below of the petitions pending before the Supreme Court that were summarized in our June 2024 update:

In United Therapeutics Corp. v. Liquidia Technologies, Inc. (US No. 23-1298), after the respondent waived its right to respond, a response was requested by the Court. The response will be due on August 28, 2024.

There were no new updates in Chestek PLLC v. Vidal (US No. 23-1217) and Cellect LLC v. Vidal (US No. 23-1231). In Chestek, the response brief is still due August 14, 2024, and five amicus curiae briefs have been filed. In Cellect, the response brief is still due August 21, 2024, and seven amicus curiae briefs have been filed.

Other Federal Circuit News:

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (July 2024)

Natera, Inc. v. NeoGenomics Laboratories, Inc., Nos. 24-1324, 24-1409 (Fed. Cir. July 12, 2024): Natera and NeoGenomics manufacture products used to detect circulating tumor DNA (ctDNA), the presence of which is called molecular residual disease (MRD), which can indicate cancer relapse. Natera sued NeoGenomics alleging that NeoGenomics’ product, RaDaR, infringed two of Natera’s patents relating to methods of amplifying targeted genetic material and for detecting variations in genetic material indicative of disease, such as ctDNA. Natera uses the claimed methods in its patents in its own Signatera product. Natera moved for a preliminary injunction, which the district court granted. The preliminary injunction barred NeoGenomics from making, using, selling, or offering for sale RaDaR, but carved out exceptions for patients already using RaDaR and for ongoing research projects, studies, and clinical trials.

The Federal Circuit (Moore, C.J., joined by Taranto and Chen, JJ.) affirmed the district court’s “carefully crafted” preliminary injunction. In particular, the Court concluded that the district court carefully considered the evidence before it in evaluating the irreparable harm to Natera, including that Natera and NeoGenomics directly compete in a two-player market for tumor-informed MRD testing products that would result in lost sales to Natera and harm to Natera’s market share. Because patients using MRD therapies require continuity of care, patients who begin using RaDaR will likely not switch to Signatera, which would not only cause Natera a loss of current sales, but also repeat business in the future. The Court also concluded that the district court did not err in concluding that the public interest weighs in favor of the injunction. Natera had the capacity to take on more patients and satisfy the demand for MRD tests. To avoid disruption to ongoing treatment and research, the district court did not enjoin use of RaDaR for existing patients and ongoing clinical trials and research projects.

Backertop Licensing LLC v. Canary Connect, Inc., No. 23-2367 (Fed. Cir. July 16, 2024): Lori LaPray is the sole owner of Backertop and is also the managing member of six other LLCs that have filed at least 97 patent infringement cases in the federal district courts. Backertop is seemingly associated with IP Edge (a patent monetization firm) and Maxevar (an affiliated consulting firm). The district court had concerns that IP Edge and Maxevar had perpetrated a fraud on the court by conveying patents to a shell LLC and filing false patent assignments with the USPTO to shield IP Edge and Maxevar from any potential liability they might face in asserting those patents in litigation. As a result, it ordered Ms. LaPray to disclose communications and documents relating to concerns regarding fraud on the court. Ms. LaPray produced several documents to the district court, but the district court had concerns regarding the legitimacy of the documents and set an in-person hearing to “assess her credibility.” Ms. LaPray refused to attend the hearing and did not attend a subsequent show cause hearing the district court set. The district court therefore found Ms. LaPray in civil contempt of court and imposed a fine of $200 per day until Ms. LaPray appeared in person in court.

The Federal Circuit (Hughes, J., joined by Prost and Stoll, JJ.) affirmed. Although civil contempt orders are generally interlocutory and non-appealable, the Federal Circuit determined that the law allowed Ms. LaPray, as the officer of Backertop and a non-party, to “immediately appeal the contempt order.” The Court then held that the district court’s order for Ms. LaPray to appear in person fell within the district court’s inherent powers. Contrary to Ms. LaPray’s arguments, the district court’s order did not conflict with Rule 45’s 100-mile requirement, which only applies to a party or attorney’s efforts to subpoena a person, and not to a court’s sua sponte order to appear. The Court also found the district court had not abused its discretion in ordering Ms. LaPray to appear in person and determined that it was an appropriate means by which to investigate potential misconduct by Backertop and potential fraud on the court by IP Edge and Maxevar.

Koss Corp. v. Bose Corp., Nos. 22-2090, 23-1173, 23-1179, 23-1180, 23-1191 (Fed. Cir. July 19, 2024): Koss sued Bose alleging infringement of patents directed to wireless earphone communication. Bose in turn petitioned for inter partes review (IPR) of Koss’s patent, and the district court litigation was stayed pending the IPRs. Koss now appeals the Board’s final written decisions. Separately, Koss also sued Plantronics for infringing its patents, including the same patents asserted against Bose, which proceeded in parallel with Bose’s IPRs. Plantronics moved to dismiss on grounds that all claims of the asserted patents were ineligible under 35 U.S.C. § 101. The district court granted the motion. Koss filed an amended complaint, and Plantronics again moved to dismiss the asserted claims as ineligible under Section 101. Before the district court could rule on the motion, Koss voluntarily stipulated to dismiss the case with prejudice, but did not ask the district court to vacate its earlier ruling holding that all claims were ineligible. The district court entered final judgment, and Koss did not appeal the Plantronics judgment. Bose then moved to dismiss these current appeals as moot because all claims had been determined to be ineligible.

The Federal Circuit (Hughes, J., joined by Stoll and Cunningham, JJ.) dismissed the appeals as moot. Koss argued that the district court’s ineligibility ruling in Plantronics became a nullity upon the filing of the amended complaint. The Federal Circuit determined this was incorrect, explaining that the ineligibility ruling became final and appealable when the district court entered final judgment after Koss stipulated to dismissal of its suit. As Koss chose not to appeal that judgment, there were no viable patent claims left to assert and no longer a live case or controversy, rendering the appeals moot.

ZyXEL Communications Corp. v. UNM Rainforest Innovations, Nos. 22-2220, 22-2250 (Fed. Cir. July 22, 2024): ZyXEL filed a petition for IPR of UNMRI’s patent directed to methods for constructing frame structures (organization of information transmitted across time and frequency) in orthogonal frequency-division multiple access (OFDMA) systems. ZyXEL contended that certain claims would have been obvious in view of the asserted prior art. UNMRI filed a contingent motion to amend and requested the Board’s preliminary guidance on its motion under the Board’s MTA Pilot Program. ZyXEL opposed the motion to amend, arguing that UNMRI had not complied with the regulation requiring it to identify written support for every claimed limitation in the substitute claims—not just the newly-claimed features—in its motion. In its preliminary guidance, the Board agreed and permitted UNMRI to file an extended reply brief addressing written description support and, correspondingly, allowed ZyXEL to respond in an extended sur-reply. The Board then granted UNMRI’s motion to amend to substitute its claims and determined that the substitute claims would not have been obvious.

The Federal Circuit (Dyk, J., joined by Prost and Stark, JJ.) affirmed-in-part, reversed-in-part, and remanded-in-part as to the appeal, and affirmed as to the cross-appeal. In particular, the Court affirmed the Board’s grant of the motion to amend. Specifically, the Court noted that the purpose of the MTA Pilot Program is to provide preliminary guidance and to allow the patentees to correct errors in its original motion. The MTA Pilot Program also allows a patentee to respond to the Board’s preliminary guidance in reply. Thus, the Court determined that the Board did not err in permitting UNMRI to use its reply brief to supplement the written description support that should have been, but was not, included in its original motion.

Sanho Corp. v. Kaijet Technology International Limited, Inc., No. 23-1336 (Fed. Cir. July 31, 2024): Kaijet petitioned for IPR of Sanho’s patent directed to a port extension apparatus for devices like laptops. The Board found all challenged claims unpatentable as obvious over prior art reference Kuo. Sanho contended that Kuo was not prior art because the inventor “publicly disclosed” the relevant subject matter of Kuo through the private sale of a device called the HyperDrive before Kuo’s priority date. The Board, however, concluded that the private sale was not a public disclosure, and therefore Kuo was prior art.

The Federal Circuit (Dyk, J., joined by Clevenger and Stoll, JJ.) affirmed. Section 102(b)(2)(B) provides that a “disclosure shall not be prior art” if “the subject matter disclosed had . . . been publicly disclosed by the inventor.” Sanho argued that a private sale should be considered a “disclosure” under the statute, and that the term “publicly disclosed” would necessarily include “disclosures,” such as private sales. The Court determined this interpretation was incorrect because “publicly disclosed” is not the same as “disclosed,” and the use of different phrases suggests Congress intended the phrases to have different meanings. Additionally, Section 102(b) was meant to provide protection for an inventor who publicly discloses his invention from later disclosures made by others, as public disclosure is a major objective for providing patent protection in the first place. Thus, the Court concluded that “publicly disclosed by the inventor” must require that the invention was made available to the public. As a result, the Court decided that Sanho’s private sale did not qualify as a public disclosure under Section 102(b)(2)(B), and thus the Board did not err in determining that Kuo was prior art.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Audrey Yang, Vivian Lu, Julia Tabat, and Michelle Zhu.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for June 2024 summarizes the current status of a couple petitions pending before the Supreme Court and recent Federal Circuit decisions concerning damages, trade secret misappropriation, patent eligibility under 35 U.S.C. § 101, and induced infringement.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There was a new potentially impactful petition filed before the Supreme Court in June 2024:

United Therapeutics Corp. v. Liquidia Technologies, Inc. (US No. 23-1298): “1. Whether the IPR statute and SAS require the Federal Circuit to review de novo, or only for an abuse of discretion, the PTO’s reliance on new grounds and new printed publications—not raised in the initial petition—when deciding to cancel patent claims. 2. Whether, if § 312 is deemed ambiguous, the Court should overrule Chevron.” The respondent waived its right to respond, the Court requested a response, which is due August 12, 2024.

We also provide an update below of the petitions pending before the Supreme Court that were summarized in our May 2024 update:

In Chestek PLLC v. Vidal (US No. 23-1217), the response brief is due August 14, 2024. Five amicus curiae briefs have been filed. In Cellect LLC v. Vidal (US No. 23-1231), the response brief is due August 21, 2024, and seven amicus curiae briefs have been filed.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (June 2024)

EcoFactor, Inc. v. Google LLC, No. 23-1101 (Fed. Cir. June 3, 2024): EcoFactor sued Google alleging infringement of patents directed to smart thermostats in computer-networked heating and cooling systems, which adjusts the user’s thermostat settings to reduce strain on the electricity grid during periods of high demand. Following a jury trial, the jury found infringement and awarded damages to EcoFactor. Google moved for a new trial on damages, which the district court denied.

The majority (Reyna, J., joined by Lourie, J.) affirmed. The majority reasoned that EcoFactor’s damages expert based his royalty rate on comparable license agreements and the testimony of EcoFactor’s CEO, and thus, the royalty rate was sufficiently reliable. The majority therefore concluded that the district court did not abuse its discretion in denying the motion for a new trial.

Judge Prost dissented-in-part. Judge Prost reasoned that the royalty rate from EcoFactor’s damages expert “rests on EcoFactor’s self-serving, unilateral recitals of its beliefs in the license agreements,” which were “directly refuted” by two of the license agreements and “have no other support . . . to back them up.” Judge Prost concluded that the “law does not allow damages to be so easily manufactured.” Judge Prost then noted that the royalty rate suffered from another problem in that it included the value of non-asserted patents, which EcoFactor’s damages expert did not properly apportion. Judge Prost therefore determined that the analysis performed by EcoFactor’s damages expert was unreliable, and the district court abused its discretion by not granting a new trial on damages.

Insulet Corp. v. EOFlow, Co. Ltd., No. 24-1137 (Fed. Cir. June 17, 2024): Insulet and EOFlow manufacture insulin pump patches. Starting in the early 2000s, Insulet developed the wearable insulin pump OmniPod® followed by next generation products in 2007 and 2012. EOFlow began developing its own product in 2011, the EOPatch®, followed by its next generation product in 2017. Around that time, four former Insulet employees were hired by EOFlow, and allegedly passed confidential information to EOFlow. Insulet sued EOFlow for misappropriation of trade secrets. Insulet moved for a preliminary injunction, arguing it was likely to be irreparably harmed by the misappropriation, particularly in light of news that Medtronic would imminently acquire EOFlow, which would provide a source of capital for EOFlow and increase competition with Insulet. The district court granted the preliminary injunction.

The Federal Circuit (Lourie, J., joined by Prost and Stark, JJ.) reversed. Under the Defend Trade Secrets Act (“DTSA”), the statute of limitations to bring a trade secret misappropriation claim is three years. 18 U.S.C. § 1836(d). EOFlow had raised a statute of limitations challenge; however, the district court expressed no opinion on the matter. The Federal Circuit held that it was an abuse of discretion to ignore this argument, which was a material factor in evaluating a likelihood of success on the merits. The Court further held that, even if the statute of limitations argument had been addressed, Insulet had not established a likelihood of success on the merits because it had not alleged a trade secret with particularity, as required by the DTSA. Specifically, Insulet “advanced a hazy grouping of information that the court did not probe with particularity to determine what, if anything, was deserving of trade secret protection.” Instead, the district court should have determined what “specific information” was alleged to be the trade secret, such as “particular design drawings and specifications for each physical component and subassembly.” The Court also determined that the district court failed to assess whether the information was generally known or reasonably ascertainable through proper means, such as reverse engineering, particularly in light of tear-down videos and Insulet’s own publications that were available on the internet. And finally, the Court determined that the district court failed to consider the disclosures in Insulet’s own patents related to the OmniPod. If certain components of the OmniPod were known to the public through patent disclosures, then those components would unlikely merit trade secret protection.

Beteiro, LLC v. DraftKings Inc., No. 22-2275 (Fed. Cir. June 21, 2024): Beteiro owns four patents directed to methods that enable users to participate in online gambling using a user communication device by first determining whether the user is physically located in a state that allows gambling by using the GPS on the mobile device. DraftKings filed a motion to dismiss under Rule 12(b)(6) on the grounds that the patents were directed to patent-ineligible subject matter under 35 U.S.C. § 101, and the district court granted the motion.

The Federal Circuit (Stark, J., joined by Dyk and Prost, JJ.) affirmed. At step one, the Court stated that the claims are directed to the abstract idea of “exchanging information concerning a bet and allowing or disallowing the bet based on where the user is located.” In doing so, the Court specifically found that Beteiro’s patent claims “exhibit several features that are well-settled indicators of abstractness,” such as detecting information, generating and sending notifications, receiving messages (bets), determining legality (GPS location), and processing information (allowing/disallowing bets). The Court also determined that the claims were drafted in a result-oriented, functional manner, using language that described the desired outcomes without explaining how to achieve them. The Court further determined that the claims did not recite any improvement in the way computers operate, and thus, the claims were directed to an abstract idea. As to step two, the Court determined that the use of GPS on a mobile phone was conventional, contrary to Beteiro’s contentions.

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 23-1169 (Fed. Cir. June 25, 2024): Amarin sells icosapent ethyl (an omega-3 fatty acid commonly found in fish oils) under the brand name Vascepa® for the treatment of patients with high triglyceride levels. In 2012, Amarin received FDA approval for treatment of severe hypertriglyceridemia, a condition where a patient’s blood triglyceride is at least 500 mg/dL (“the SH indication”), and later in 2019, for treatment to reduce cardiovascular risk in patients having blood triglyceride levels of at least 150 mg/dL (“the CV indication”). Hikma submitted an Abbreviated New Drug Application (“ANDA”) for approval of its generic icosapent ethyl in 2016 when Vascepa® was only approved for the SH indication, and in 2019, opted to carve out the additional CV indication by seeking FDA approval only for uses not covered by Amarin’s newly listed CV indication patents. However, around the same time, Hikma also removed the CV limitation of use from its product label, which had originally been included when it initially filed its ANDA. Hikma then issued several press releases advertising its product as a generic version of Vascepa®, referencing Vascepa®’s $1.1 billion in sales, which included sales for all uses of Vascepa® including the CV indication that made up 75% of the sales.

Amarin sued Hikma for inducing infringement of two of its patents directed to uses of icosapent ethyl based on (1) Hikma’s public statements in press releases and on its website, and (2) the product label for its generic icosapent ethyl product. Hikma moved to dismiss under Rule 12(b)(6), and the district court granted the motion. The district court found that the removal of the CV limitation of use from the product label would not be understood by physicians as suggesting that Hikma’s product had been approved for the CV indication. The district court also found that while Hikma’s press releases and website were relevant to an intent to induce, it did not rise to the level of encouraging, recommending, or promoting Hikma’s generic for the CV indication.

The Federal Circuit (Lourie, J., joined by Moore, C.J., and Albright, J. (sitting by designation)) reversed, holding that the district court had to examine the label and public statements in its totality to determine what they “would communicate to physicians and the marketplace.” In so holding, the Court noted that while the underlying case was a traditional Hatch-Waxman case, the issue on appeal was nothing more than “a run-of-the-mill induced infringement case.” The Court concluded that while the label alone would not recommend, encourage, or promote infringement, a physician would read Hikma’s press releases as an instruction or encouragement to prescribe Hikma’s product for any FDA-approved use, which included the CV indication that Hikma carved out from its ANDA. The Court concluded that these allegations, taken together, plausibly stated a claim for induced infringement.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Audrey Yang, Al Suarez, Evan Kratzer, and Julia Tabat.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for May 2024 summarizes the current status of a new petition pending before the Supreme Court, a Federal Circuit en banc decision regarding the obviousness inquiry for design patents, and recent Federal Circuit decisions concerning standing, finality, personal jurisdiction, printed matter doctrine, and interferences under the pre-AIA statute.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were a couple new potentially impactful petitions filed before the Supreme Court in May 2024.

Chestek PLLC v. Vidal (US No. 23-1217): “Whether the PTO is exempt from notice-and-comment requirements when exercising its rulemaking power under 35 U.S.C. § 2(b)(2).” The response is due July 15, 2024.
Cellect LLC v. Vidal (US No. 23-1231): “Whether a patent procured in good faith can be invalidated on the ground that statutory Patent Term Adjustment, which requires lengthening a patent’s term to account for time lost to Patent and Trademark Office delays, can trigger a judge-made patent-invalidation doctrine.” The response is due July 22, 2024, and the New York Intellectual Property Law Association has already filed an amicus curiae brief.

Federal Circuit En Banc Opinions:

As we reported in our June 2023 update, the Federal Circuit granted the en banc petition in LKQ Corp. v. GM Global Technology Operations LLC. We provide a summary of the opinion below.

LKQ Corp. v. GM Global Technology Operations LLC, No. 21-2348, (Fed. Cir. May 21, 2024): LKQ filed a petition for inter partes review (“IPR”) challenging the validity of GM’s design patent for a vehicle fender as obvious over prior art reference Lian alone or in combination with the 2010 Hyundai Tucson fender. The Patent Trial and Appeal Board (“Board”) applied the two-part Rosen-Durling test requiring the primary reference be “basically the same” and the secondary reference be “so related” to the claimed design. The Board found that Lian could not serve as a primary reference, because it was not “basically the same” and ended its obviousness analysis. The original Federal Circuit panel affirmed the Board’s decision, holding it was bound by Rosen-Durling absent clear direction from the Supreme Court. The Federal Circuit then granted rehearing en banc.

The Federal Circuit (Stoll, J., joined by Moore, C.J., Dyk, Prost, Reyna, Taranto, Chen, Hughes, and Stark, JJ.) vacated and remanded, overruling the two-part Rosen-Durling test, which required a strict “basically the same” primary reference and “so related” secondary reference, as being “improperly rigid.” Instead, the Court adopted the obviousness analysis for utility patents, consistent with Congress’s statutory scheme as well as Supreme Court precedent. The Court did not agree with certain amici that its overruling of Rosing-Durling would create uncertainty, because the “Graham four-part obviousness test for utility patents has existed for a very long time and there is considerable precedent.” The Court thus vacated the Board’s decision and remanded for the Board to apply the new framework for evaluating obviousness of design patents.

Judge Lourie concurred with the Court’s decision to vacate and remand the Board’s decision, but disagreed that Rosing and Durling needed to be overruled. Instead, as Judge Lourie explained, to make the Rosing-Durling test less rigid, all the Court needed to do was replace the use of “must” and “only” in the analyses with words such as “generally,” “usually,” or “typically.” Thus, Judge Lourie would have modified, rather than outright overruled, Rosing and Durling.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (May 2024)

Intellectual Tech LLC v. Zebra Technologies Corp., No. 22-2207 (Fed. Cir. May 1, 2024): Intellectual Technology (“IT”) sued Zebra for patent infringement. Zebra moved to dismiss for lack of standing because a loan agreement between IT and its creditor, Main Street, granted Main Street the right to, among other things, sell, transfer, assign, encumber, and enforce IT’s patents if IT defaulted. The district court granted Zebra’s motion, holding that IT lacked constitutional standing because the agreement granted Main Street the right to license the asserted patent and thus deprived IT of all its exclusionary rights. The district court further held that the defect could not be cured because IT was in default at the time the complaint was filed.

The Federal Circuit (Prost, J., joined by Taranto and Hughes, JJ.) reversed and remanded. The Court held that IT had constitutional standing because it retained at least one exclusionary right—the right to license or assign the patents—rejecting Zebra’s interpretation of the agreement as granting all exclusionary rights to Main Street immediately upon default. Instead, Main Street and IT shared an ability to license while a default existed and therefore IT was not divested of all exclusionary rights. The Court clarified that the right of another, non-plaintiff entity to license a patent does not defeat constitutional standing.

Packet Intelligence v. NetScout Systems, Inc., No. 22-2064 (Fed. Cir. May 2, 2024): Packet Intelligence sued NetScout for infringement of patents directed to methods and apparatuses for monitoring packets exchanged over a computer network. Previously, the Federal Circuit had reversed the district court’s pre-suit damages award and vacated the award of enhanced damages (Packet I). During the pendency of that remand, the Board issued final written decisions in IPR proceedings initiated by third parties holding all challenged claims of the patents at issue unpatentable as obvious. NetScout then moved to dismiss Packet Intelligence’s infringement case against it or, in the alternative, to stay the district court litigation until the conclusion of Packet Intelligence’s appeal from the Board’s final written decisions. The district court denied NetScout’s motion to dismiss or stay the case and entered an amended final judgment of the issues litigated on remand from Packet I, eliminating pre-suit damages and reducing enhanced damages. Packet Intelligence timely appealed the Board’s decisions, and concurrently with this opinion, the Federal Circuit affirmed.

The Federal Circuit (Stark, J., joined by Lourie and Hughes, JJ.) vacated and remanded with instructions to dismiss the case as moot. The only issue before the Court was to decide if its decision in Packet I “rendered this case sufficiently final such that it is immune to the Board’s subsequent determination of unpatentability,” which occurs when that judgment “ends the litigation on the merits and leaves nothing for the court to do but execute the judgment.” The Court concluded that Packet Intelligence’s infringement case against NetScout remains pending because the Packet I decision remanded issues to the district court and did not “leave[] nothing for the court to do but execute the judgment,” rendering it vulnerable to subsequent developments. The Federal Circuit’s contemporaneous affirmance of the Board’s unpatentability decisions invalidated the patent claims, and thus, the Court remanded with instructions to dismiss the case.

SnapRays, dba SnapPower v. Lighting Defense Group, No. 23-1184 (Fed. Cir. May 2, 2024): The Amazon Patent Evaluation Express (“APEX”) is a low-cost procedure offered by Amazon to resolve claims that a third-party product infringes a utility patent. To initiate the process, a patent owner submits an APEX Agreement to Amazon identifying one claim of a patent and up to 20 allegedly infringing listings. Lighting Defense Group (“LDG”) submitted an APEX Agreement alleging certain SnapPower products sold on Amazon infringed LDG’s patent directed to a cover for an electrical receptacle. To avoid automatic removal of its listing, the seller has three options: (1) opt in to the APEX program and proceed with Amazon’s third-party evaluation, (2) resolve the claim with the patent owner directly, or (3) file a declaratory judgment action of noninfringement. SnapPower chose the third option and filed a declaratory judgment action in Utah, where SnapPower is located. LDG, a Delaware company with its principal place of business in Arizona, moved to dismiss for lack of personal jurisdiction, and the district court granted the motion.

The Federal Circuit (Moore, C.J., joined by Lourie and Dyk, JJ.) reversed and remanded. The Court determined that LDG purposefully directed its activities at SnapPower in Utah when it submitted the APEX Agreement specifically naming SnapPower’s listings. The Court noted that the SnapPower’s listings would be automatically removed if it took no action, which the Court distinguished from traditional cease and desist letters that could be ignored without automatic consequences. The intended effect would necessarily impact sales, marketing, and other activities of SnapPower in Utah.

IOENGINE, LLC v. Ingenico Inc., Nos. 21-1227, 21-1331, 21-1332 (Fed. Cir. May 3, 2024): Ingenico filed a series of IPRs challenging three IOENGINE patents directed to a portable device configured to communicate with a terminal. The Board applied the printed matter doctrine to accord no patentable weight to certain claim limitations that recited “encrypted communications” and “program code.”

The Federal Circuit (Chen, J., joined by Lourie and Stoll, JJ.) reversed-in-part and affirmed-in-part. The Court found the Board incorrectly applied the printed matter doctrine. The Court explained that the printed matter doctrine applies only to limitations that claim the content of information or in other words, the content specifically being communicated. In other words, printed matter “encompasses what is communicated . . . rather than the act of a communication itself.” In the challenged claims, “encrypted communications” and “program code” were not being claimed for any particular content they communicated, and as a result, the printed matter doctrine did not apply.

Speck v. Bates, No. 23-1147 (Fed. Cir. May 23, 2024): Speck and Bates both claimed an invention related to drug-coated balloon catheters. Speck’s patent claims priority back to a 2003 application, but did not issue until September 4, 2012. Bates’s patent application was filed on August 29, 2013, but is a continuation-in-part of and claims priority to an earlier application filed in 2001. Under pre-AIA 35 U.S.C. § 135(b)(1), a patent application that claims the “same as” or “substantially the same subject matter” as an issued patent must be filed within one year from the date on which the patent was granted unless the “applicant had been claiming substantially the same invention as the patentee” before the critical date. The Bates application was therefore filed six days before the critical date. After the critical date and during prosecution, Bates amended the claims to require the device be “free of a containment material atop the drug layer” to overcome a rejection by the examiner. The Board declared an interference on August 10, 2020, identifying Bates as the senior party and Speck as the junior party. Speck filed a motion to terminate the interference on the ground that the claims of the Bates application were time-barred under § 135(b)(1). The Board denied Speck’s motion because it found that the later amended claims did not differ materially from the pre-critical date claims.

The Federal Circuit (Dyk, J., joined by Bryson and Stoll, JJ.) reversed, vacated, and remanded, holding that the Board applied the wrong legal test. The Board only analyzed whether the post-critical date claims were present in the pre-critical date claims (i.e., the “one-way test”). However, the Court held that the “two-way test” is the proper test, meaning that the Board should have compared the two sets of claims to determine if either set contains material limitations not present in the other. Applying the two-way test, the Court held that the pre-critical date claims were materially different than the post-critical date claims, because the post-critical date claims would permit including the drug within the containment layer, but the pre-critical date claims did not. The Court therefore held that the Bates application was time-barred.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Audrey Yang, Allen Kathir, Al Suarez, Vivian Lu, and Julia Tabat.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for April 2024 summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning patent eligibility under 35 U.S.C. § 101, obviousness, and unenforceability due to inequitable conduct and unclean hands.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were no new potentially impactful petitions filed before the Supreme Court in April 2024. We provide an update below of the petitions pending before the Supreme Court that were summarized in our March 2024 update:

The petitions in Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (US No. 23-768) and Ficep Corp. v. Peddinghaus Corp. (US No. 23-796) were denied.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (April 2024)

AI Visualize, Inc. v. Nuance Communications, Inc., No. 22-2109 (Fed. Cir. Apr. 4, 2024): AI Visualize asserted four related patents in the field of visualization of medical scans. Specifically, the patents disclose using two-dimensional MRI scans to present three-dimensional views that can lead to better diagnosis and prognosis. The district court granted a motion to dismiss under Rule 12(b)(6), determining that the asserted claims were directed to patent-ineligible subject matter under 35 U.S.C. § 101.

The Federal Circuit (Reyna, J., joined by Moore, C.J., and Hughes, J.) affirmed, holding that the claims were direct to patent-ineligible subject matter. At step one, “the asserted claims are directed to converting data and using computers to collect, manipulate, and display the data” and “the steps of obtaining, manipulating, and displaying data, particularly when claimed at a high level of generality, are abstract concepts.” At step two, the Court agreed with the district court that “the asserted claims involved nothing more than the abstract idea itself” and conventional computer technology. AI argued that creation of virtual views significantly transforms the claims into patent-eligible subject matter; however, the Court determined that the specification conceded that this was known in the art, which AI also acknowledged at oral argument.

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., No. 22-2153 (Fed. Cir. Apr. 11, 2024): Norwich filed an ANDA seeking to market 550 mg tablets of a generic version of rifaximin to treat hepatic encephalopathy (“HE”) and irritable bowel syndrome with diarrhea (“IBS-D”). Salix, which sells rifaximin under the name Xifaxan® for the treatment of HE and IBS-D, sued Norwich for infringement. The district court held that (1) Norwich infringed Salix’s patents directed to the use of rifaximin for treating HE, and (2) Norwich infringed Salix’s patents directed to the use of rifaximin for treating IBS-D, but that those claims would have been obvious over certain prior art. Norwich then amended its ANDA to remove the infringing HE indication, and moved to modify the judgment under Rule 60(b) asserting that the amendment negated any possible infringement, but the district court denied this motion.

The majority (Lourie, J., joined by Chen, J.) affirmed. The majority first affirmed the district court’s holding that the asserted claims of the IBS-D patents were invalid as obvious. Salix’s patents are directed to treating IBS-D with 550 mg of rifaximin three times a day. One prior art reference had a study evaluating 550 mg doses twice a day, and a second prior art reference teaches administering 400 mg three times a day and further states that “[r]ecent data suggest that the optimal dosage of rifaximin may, in fact, be higher.” Based on the combination of these references, the majority determined that there was no clear error in the conclusion that a skilled artisan would have had a reasonable expectation of success in the claimed dosage. A skilled artisan would have discerned from the combination that the optimal dosage for treating patients suffering from IBS-D may be higher than 400 mg three times a day, and the next higher dosage unit from the clinical trial was 550 mg. The majority also concluded that the district court did not abuse its discretion in refusing to modify the judgment under Rule 60(b), because considering the amended ANDA, which removed the infringing HE indication, would “essentially be a second litigation.”

Judge Cunningham dissented-in-part, writing that she would have instead vacated the district court’s conclusion that the asserted claims of the IBS-D patents are invalid as obvious. Specifically, she concluded that the prior art references’ lack of discussion of the claimed dosage would mean that a skilled artisan would not have had a reasonable expectation of success for the claimed dosage. In particular, Judge Cunningham disagreed with the majority’s reliance on the prior art reference’s statement that “[r]ecent data suggest that the optimal dosage of rifaximin may, in fact, be higher” because that statement does not discuss an actual optimal dosage and uses the word “may.”

Luv N’ Care, Ltd. v. Laurain, Nos. 22-1905, 22-1970 (Fed. Cir. Apr. 12, 2024): Laurain (the inventor) and Eazy-PZ (“EZPZ”) alleged that Luv n’ care, Ltd. (“LNC”) infringed EZPZ’s patent directed to toddler dining mats. LNC asserted defenses of inequitable conduct and unclean hands. The district court concluded that LNC had failed to prove that the patent was unenforceable due to inequitable conduct. Although Laurain and patent prosecution counsel had made a misrepresentation to the Patent and Trademark Office (“PTO”), the district court found the misrepresentation was not but-for material to the patentability of the asserted patent. The district court, however, concluded EZPZ’s litigation conduct did amount to unclean hands, including by failing to disclose certain patent applications during discovery and attempting repeatedly to block LNC from obtaining Laurain’s prior art searches.

The Federal Circuit (Stark, J., joined by Reyna and Hughes, JJ.) affirmed-in-part, vacated-in-part, and remanded. The Court affirmed the ruling of unclean hands finding the district court did not clearly err in its determination that EZPZ’s litigation conduct, including its failure to disclose related patent applications amounted to unclean hands. For inequitable conduct, which requires showing the patentee (1) withheld information from the PTO, and (2) did so with specific intent to deceive the PTO, the Court vacated the district court’s judgment and found that the district court failed to make separate findings as to materiality and deceptive intent. Additionally, regarding materiality, the Court remanded for the district court to determine whether Laurain’s misrepresentation to the PTO amounted to “affirmative egregious misconduct” that would establish per se materiality. Regarding deceptive intent, the Court determined that the district court erred in considering the “individual acts of misconduct in isolation and failed to address the collective weight of the evidence regarding each person’s misconduct as a whole.” The Court remanded for the district court to reevaluate Laurain’s deceptive intent based on her misconduct in the aggregate and to do the same for prosecution counsel.

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Al Suarez, Evan Kratzer, and Michelle Zhu.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update for March 2024 summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning indefiniteness, obviousness, eligibility under Section 101, and the safe harbor provision under Section 271.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were no new potentially impactful petitions filed before the Supreme Court in March 2024. We provide an update below of the petitions pending before the Supreme Court that were summarized in our February 2024 update:

In Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (US No. 23-768), after the respondents waived their right to file a response, the Court requested a response, which was filed on March 18, 2024. Three amicus curiae briefs have been filed.

The Court denied the petition in Ficep Corp. v. Peddinghaus Corp. (US No. 23-796).

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (March 2024)

Chewy, Inc. v. International Business Machines Corporation, No. 22-1756 (Fed. Cir. Mar. 5. 2024): Chewy sued IBM seeking a declaratory judgment of noninfringement of several patents including two patents relating to improvements in web-based advertising. Following claim construction, the district court granted Chewy’s motion for summary judgment of noninfringement of the asserted claims for one patent, because it determined no reasonable factfinder could find Chewy’s accused products “establish[] characterizations for respective users based on the compiled data” as required by the claims. The district court also granted a motion for summary judgment that claims from the second patent were ineligible under 35 U.S.C. § 101.

The Federal Circuit (Moore, C.J., joined by Stoll and Cunningham, JJ.) affirmed-in-part and reversed-in-part. The Court reversed the grant of summary judgment of noninfringement, because it determined that Chewy’s privacy policy and other documents created a genuine dispute of material fact regarding whether Chewy “establish[es] characterizations for respective users.” Indeed, the privacy policy explained that the ads were based on information such as “browsing or purchasing,” and drawing all inferences in the nonmoving party’s favor, this provided evidence that Chewy uses a specific user’s browsing or purchasing history to provide personalized or targeted ads. The Court affirmed the grant of summary judgment that the second patent was ineligible under § 101, determining that the patent was directed to the abstract idea of “identifying advertisements based on search results.” The Court concluded that the patent claims as an ordered combination did not recite an inventive concept because none of the three distinctive concepts raised by IBM—(1) a generic database configured to associate search results with advertisements, (2) offline batching process, and (3) assigning session identifiers to a search query—transformed the claimed abstract idea into patent-eligible subject matter.

Maxell, Ltd. v. Amperex Technology Limited, No. 23-1194 (Fed. Cir. Mar. 6, 2024): Maxell sued Amperex for infringement of Maxell’s patent directed to a rechargeable lithium-ion battery. The district court conducted claim construction proceedings and held that the claims were indefinite because the claim language recited a contradiction—one limitation did not require the presence of cobalt (it was optional), whereas the second limitation did.

The Federal Circuit (Taranto, J., joined by Prost and Chen, JJ.) reversed and remanded. The Court concluded that the claim language was not indefinite because even “[i]f there are two requirements,” if “it is possible to meet both, there is no contradiction.” Moreover, “[t]hat there are other ways of drafting the claim does not render the claim language contradictory or indefinite.”

Edwards Lifesciences Corp. et al. v. Meril Life Sciences Pvt. Ltd. et al., No. 22-1877 (Fed. Cir. Mar. 25, 2024): Edwards sued Meril for patent infringement after Meril imported two transcatheter heart valve systems into the United States that it intended to display at a conference in order to, among other things, find clinical investigators for its FDA premarket submission. The district court held that their importation fell within the safe harbor provision of 35 U.S.C. § 271(e)(1), and therefore granted summary judgment of noninfringement to Meril.

The majority (Stoll, J., joined by Cunningham, J.) affirmed. Section 271(e)(1) “is a safe harbor for defendants for what would otherwise constitute infringing activity.” It states that it “shall not be an act of infringement to . . . import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law . . . .” The majority held that “solely” in § 271(e)(1) modifies the phrase “for uses,” meaning that a use falls within the safe harbor provision if it is reasonably related to preparing a regulatory submission, even if the use also has additional (e.g., commercial) purposes.

Judge Lourie dissented, reasoning that the Court has consistently erred in interpreting the word “solely” in the safe harbor provision and that the question could benefit from en banc review. Specifically, Judge Lourie explained that the plain meaning of “solely” and the legislative history of § 271(e)(1) requires an otherwise infringing use to be carried out only for regulatory purposes (i.e., not for additional or commercial purposes) to benefit from the safe harbor.

Virtek Vision International ULC v. Assembly Guidance Systems, Inc., No. 22-1998 (Fed. Cir. Mar. 27, 2024): Assembly Guidance d/b/a Aligned Vision challenged Virtek’s patent directed to an improved method for aligning a laser project with respect to a work surface in an inter partes review (“IPR”). The Patent Trial and Appeal Board (“Board”) had found that a skilled artisan would have been motivated to use the 3D coordinate system in one prior art reference (Briggs) instead of the angular direction systems found in the other prior art references (Keitler, Bridges), and that it would have been obvious to try because Briggs disclosed both. The Board issued a final written decision holding that certain claims of the patent were unpatentable.

The Federal Circuit (Moore, C.J., joined by Hughes and Stark, JJ.) reversed-in-part and affirmed-in-part. The Court concluded that the Board erred as a matter of law with regard to the motivation to combine. The Court found that although Briggs disclosed that different possible arrangements existed, this did not provide a reason why a skilled artisan would have substituted the one-camera angular direction system in Keitler and Bridges with the two-camera 3D coordinate system disclosed in Briggs. “In short, this case involves nothing other than an assertion that because two coordinate systems were disclosed in a prior art reference and were therefore ‘known,’ that satisfies the motivation to combine analysis. That is an error as a matter of law. It does not suffice to simply be known. A reason for combining must exist.”

The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Julia Tabat, Michelle Zhu, and Evan Kratzer.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning attorneys’ fees under 35 U.S.C. § 285, Article III standing, and the Board’s authority to issue a final written decision past the statutory deadline.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

As we summarized in our October 2023 update, there are a few petitions pending before the Supreme Court. We provide an update below:

In VirnetX Inc. v. Mangrove Partners Master Fund, Ltd. (US No. 23-315), the Court granted an extension for the response, which is now due December 27, 2023. An amicus curiae brief has been filed by the Cato Institute.
In Intel Corp. v. Vidal (US No. 23-135), a response was filed on November 9, 2023. Three amici curiae briefs have been filed. The petition will be considered during the Court’s January 5, 2024 conference.
The Court denied the petition in HIP, Inc. v. Hormel Foods Corp. (US No. 23-185).

Other Federal Circuit News:

New Federal Circuit Rules. The December 1, 2023 amendments to the Federal Circuit Rules are now in effect. The Federal Circuit has also approved increases to its local fees effective December 1, 2023. Details can be found here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (November 2023)

In re PersonalWeb Technologies LLC, Nos. 21-1858, 21-1859, 21-1860 (Fed. Cir. Nov. 3, 2023): This was the third appeal from a multidistrict litigation involving PersonalWeb. In 2011, PersonalWeb sued Amazon for patent infringement. After claim construction, PersonalWeb dismissed with prejudice its claims against Amazon. Then, in 2018, PersonalWeb brought claims against Amazon’s customers on the same patents. Amazon intervened and filed a motion for declaratory judgment barring PersonalWeb’s infringement actions against Amazon and its customers. The cases were consolidated. The district court ultimately entered judgment of non-infringement in favor of Amazon. Amazon then moved for attorneys’ fees and costs under 35 U.S.C. § 285. The district court granted that motion and awarded over $5 million in fees and costs.

The majority (Reyna, J., joined by Lourie, J.) affirmed, holding that the district court did not abuse its discretion in awarding fees and costs. In particular, the majority concluded that the district court did not abuse its discretion when it determined that PersonalWeb’s claims were objectively baseless because it required only a “straightforward application of Kessler,” which precludes follow-up suits against a company’s customers over the same allegedly infringing products that had already been adjudicated. The majority reasoned that a dismissal with prejudice operates as an adverse adjudication on the merits.

Judge Dyk dissented, reasoning that PersonalWeb’s claims against Amazon’s customers were not objectively baseless in light of unsettled case law surrounding the Kessler doctrine, and specifically whether the Kessler doctrine applies to a stipulated dismissal with prejudice or only to a litigated determination of non-infringement. Indeed, PersonalWeb sought certiorari on that very issue from its 2018 litigation, and the Solicitor General filed an amicus brief agreeing with PersonalWeb that its claims should not have been barred under Kessler. Thus, Judge Dyk would have remanded because, in his view, the district court abused its discretion in awarding fees based on PersonalWeb’s Kessler argument.

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 22-1889 (Fed. Cir. Nov. 6, 2023): Actelion sued Mylan for infringing two of Actelion’s patents directed to epoprostenol formulations. The parties disputed the meaning of a limitation in the patents requiring “a pH of 13 or higher.” The district court construed the phrase to encompass “values that round up or down to 13, 12.5 and 13.4,” relying exclusively on the intrinsic evidence. Mylan stipulated to infringement of Actelion’s patents under the district court’s construction, and appealed.

The Federal Circuit (Stoll, J., joined by Reyna and Stark, J.J.) vacated and remanded. The Court concluded that the intrinsic evidence was not sufficiently clear as to the level of precision required by a “pH of 13 or higher” and that the district court should have considered the extrinsic evidence the parties presented to ascertain the ordinary meaning of the phrase. Accordingly, the Court vacated the district court’s construction and remanded for the district court to consider the extrinsic evidence in the first instance.

Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, No. 22-1706 (Fed. Cir. Nov. 7, 2023): Allgenesis filed a petition for inter partes review (“IPR”) challenging Cloudbreak’s patent directed to the use of multikinase inhibitors, including nintedanib, for treating pterygium, an eye condition involving tumorous growths. During the proceeding, Cloudbreak disclaimed the genus claims, leaving only the claims that more narrowly claimed the use of nintedanib. The Board issued a final written decision finding that Allgenesis failed to show that the remaining nintedanib claims were unpatentable. Specifically, the Board found that the nintedanbi claims were sufficiently described by the specification of a provisional application from which the Cloudbreak patent claimed priority and therefore predated the alleged prior art reference.

The Federal Circuit (Moore, C.J., joined by Stoll and Cunningham, JJ.) dismissed the appeal because it determined that Allgenesis lacked Article III standing. The Court determined that Allgenesis failed to establish an injury-in-fact from potential infringement liability or that the Board’s priority analysis would have a preclusive effect, impacting Allgenesis’s patent rights in issued or still-pending continuation applications. Specifically, the Court held that collateral estoppel would not attach to the Board’s non-appealable priority determination. Instead, if an examiner were to reach the same priority determination during prosecution of Allgenesis’s pending application, “Allgenesis can challenge that determination in a separate appeal.”

Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., No. 22-1482 (Fed. Cir. Nov. 21, 2023): Purdue sued Collegium for infringement of Purdue’s patent directed to a formulation containing a gelling agent that “prevent[s] or deter[s] the abuse of opioid analgesics by the inclusion of at least one aversive agent in the dosage form.” Collegium filed a petition for post-grant review (“PGR”) of the patent. Purdue subsequently filed for bankruptcy and requested a stay of all proceedings, including the PGR. After the statutory deadline for the Board to issue a final written decision had passed, Purdue asked for the stay to be lifted for the district court proceedings only, but the bankruptcy court lifted the stay for both the district court and PGR proceedings. Purdue then moved to terminate the PGR proceeding, arguing that the Board no longer had the authority to issue a final written decision. The Board denied the motion and issued its final written decision, finding the challenged claims unpatentable for lack of written description and anticipation.

The Federal Circuit (Dyk, J., joined by Hughes and Stoll, JJ.) affirmed. The Court determined that the Board’s failure to meet the statutory deadline did not deprive the Board of authority to issue a final written decision. The Court noted that the statutory language required that the Board issue a final written decision by a certain deadline, but found no congressional intent to “deprive the agency of power” to act after the deadline passed.

The following Gibson Dunn attorneys assisted in preparing this update: Blaine Evanson, Jaysen Chung, Audrey Yang, Al Suarez, Julia Tabat*, and Vivian Lu.

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

Appellate and Constitutional Law:
Thomas H. Dupree Jr. – Washington, D.C. (+1 202.955.8547, tdupree@gibsondunn.com)
Allyson N. Ho – Dallas (+1 214.698.3233, aho@gibsondunn.com)
Julian W. Poon – Los Angeles (+ 213.229.7758, jpoon@gibsondunn.com)

Intellectual Property:
Kate Dominguez – New York (+1 212.351.2338, kdominguez@gibsondunn.com)
Y. Ernest Hsin – San Francisco (+1 415.393.8224, ehsin@gibsondunn.com)
Josh Krevitt – New York (+1 212.351.4000, jkrevitt@gibsondunn.com)
Jane M. Love, Ph.D. – New York (+1 212.351.3922, jlove@gibsondunn.com)

*Julia Tabat is an associate working in the firm’s Dallas office who currently is admitted to practice in Illinois.

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning means-plus-function claims, apportionment, and forfeiting arguments not raised in an inter partes review (“IPR”) petition.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

As we summarized in our September 2023 update, there are a few petitions pending before the Supreme Court. We provide an update below:

In Intel Corp. v. Vidal (US No. 23-135) and VirnetX Inc. v. Mangrove Partners Master Fund, Ltd. (US No. 23-315), the Court granted an extension for the responses, which are now due November 9, 2023 and December 27, 2023, respectively. Three amici curiae briefs have been filed in the Intel case.

The Court denied the petition in HIP, Inc. v. Hormel Foods Corp. (US No. 23-185).

Other Federal Circuit News:

Chief Judge Moore to Announce New Court Initiative. The Court issued an announcement on October 30, 2023 that Chief Judge Moore will announce a new Court initiative at the Federal Circuit Bar Association 2023 Annual Dinner & Reception. The announcement is here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the Court’s website.

Key Case Summaries (October 2023)

Sisvel International S.A. v. Sierra Wireless, Inc., Nos. 22-1493, 22-1547 (Fed. Cir. Oct. 6, 2023): Sierra filed an IPR petition challenging Sisvel’s patent, which claimed techniques that improve on prior channel coding techniques used when transmitting data in radio systems. One of the challenged claims included the means-plus-function term “means for detecting a need for retransmission of the received coded data block.” The Patent Trial and Appeal Board (“Board”) concluded that there was insufficient algorithmic structure disclosed for the “means for detecting” term even though the specification named various software protocols. And despite an expert testifying that these were well-known and commonly used by persons of ordinary skill in the art, the Board reasoned that the expert’s testimony could not remedy the lack of corresponding structure disclosed in the specification.

The Federal Circuit (Chen, J., joined by Moore, C.J., and Clevenger, J.) affirmed-in-part, vacated-in-part, and remanded. The Court reviewed the case law regarding computer-implemented means-plus-function claims, which is divided into two distinct groups. In the first group, there is a “total absence of structure from the specification”; and in the second group, the specification discloses an algorithm, but it is inadequate as viewed in light of the knowledge of a skilled artisan. The Court concluded that because the asserted patent named “a discrete, limited, and specific set of software protocols,” there was an “arguably adequate” disclosure of an algorithm, and the Board should have evaluated the disclosed protocols in light of the knowledge of a skilled artisan to determine if they were adequate as corresponding structure.

Finjan LLC, f/k/a Finjan, Inc., v. SonicWall, Inc., No. 22-1048 (Fed. Cir. Oct. 13, 2023): Finjan sued SonicWall for infringing Finjan’s network security patents, including a group of patents protecting devices from undesirable downloads. The district court granted summary judgment of non-infringement to SonicWall as to these patents, and excluded certain testimony from Finjan’s expert for failure to properly apportion and for including substantial non-patented features in his analysis.

The majority (Cunningham, J., joined by Reyna, J.) vacated-in-part and affirmed-in-part. The majority affirmed summary judgment of non-infringement, upholding a construction of “downloadable” that required the security system receiving the packets to reassemble those packets into executable code, based on the parties’ agreed constructions and the specification. The majority also affirmed the district court’s exclusion of Finjan’s expert testimony for failing to exclude the value attributable to the non-patented features in the apportionment analysis.

Judge Bryson concurred-in-part and dissented-in-part. Judge Bryson disagreed that the patents required packet reassembly, pointing to the differences in language between the asserted claims and specifications suggesting that packet reassembly was optional, and the fact that the majority’s construction would “not read on any network that uses packetized files.”

Cyntec Company, Ltd. v. Chilisin Electronics Corp., No. 22-1873 (Fed. Cir. Oct. 16, 2023): Cyntec sued Chilisin for infringing its patents directed to molded chokes, which is a type of inductor used to eliminate undesirable signals in a circuit. The jury returned a verdict of infringement and awarded damages in the full amount requested by Cyntec.

The Federal Circuit (Stoll, J., joined by Moore, C.J. and Cunningham, J.) affirmed-in-part, reversed-in-part, vacated-in-part, and remanded. The Court determined that the district court had abused its discretion in not excluding the opinion of Cyntec’s damages expert who relied on unreliable data sources. In particular, the expert estimated the sales of the accused products by reviewing SEC filings or annual reports of customers who purchased or acquired the infringing products. The Court determined that the revenues in these annual reports included sales of irrelevant products and services, and Cyntec’s expert failed to account for these irrelevant products and services.

Netflix, Inc. v. DivX, LLC, Nos. 22-1203, 22-1204 (Fed. Cir. Oct. 25, 2023): Netflix filed two IPR petitions against two DivX patents directed to adaptive bitrate streaming of content on a playback device, such as a phone or computer. The Board determined that Netflix had not included certain arguments in its petition directed to certain claim limitations and therefore had not met its burden in proving that the claims were unpatentable as obvious.

The majority (Chen, J., joined by Linn, J.) affirmed, concluding that because Netflix had not adequately raised certain arguments before the Board that it now raised on appeal, Netflix had forfeited them. The majority determined that “[a] petitioner may not rely on a vague, generic, and/or meandering petition and later fault the Board for failing to understand what the petition really meant.”

Judge Dyk dissented. In his opinion, Netflix adequately raised two of the arguments in its petition, and he would have remanded for the Board to consider Netflix’s arguments on the merits.

Blaine H. Evanson – Orange County (+1 949-451-3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214-698-3215, ayang@gibsondunn.com)

Please also feel free to contact any of the following practice group co-chairs or any member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups:

Appellate and Constitutional Law Group:
Thomas H. Dupree Jr. – Washington, D.C. (+1 202-955-8547, tdupree@gibsondunn.com)
Allyson N. Ho – Dallas (+1 214-698-3233, aho@gibsondunn.com)
Julian W. Poon – Los Angeles (+ 213-229-7758, jpoon@gibsondunn.com)

Intellectual Property Group:
Kate Dominguez – New York (+1 212-351-2338, kdominguez@gibsondunn.com)
Y. Ernest Hsin – San Francisco (+1 415-393-8224, ehsin@gibsondunn.com)
Josh Krevitt – New York (+1 212-351-4000, jkrevitt@gibsondunn.com)
Jane M. Love, Ph.D. – New York (+1 212-351-3922, jlove@gibsondunn.com)

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, additional materials released from the ongoing investigation by the Judicial Council of the Federal Circuit, and recent Federal Circuit decisions concerning motions to amend before the Patent Trial and Appeal Board, obviousness, and enablement.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

A new potentially impactful petition was filed before the Supreme Court in September 2023:

VirnetX Inc. v. Mangrove Partners Master Fund, Ltd. (US No. 23-315): The questions presented are:
(1) “Whether the Federal Circuit erred in upholding joinder of a party under 35 U.S.C. §315(c), where the joined party did not “properly file[] a petition” for inter partes review within the statutory time limit.”

(2) “Whether the Commissioner’s exercise of the Director’s review authority pursuant to an internal agency delegation violated the Federal Vacancies Reform Act.”

As we summarized in our August 2023 update, there are a few other petitions pending before the Supreme Court.

In Intel Corp. v. Vidal (US No. 23-135), the Court granted an extension for the response, which is now due October 16, 2023. Three amici curiae briefs have been filed.

In HIP, Inc. v. Hormel Foods Corp. (US No. 23-185), the response brief was filed on September 28, 2023.

The Court denied the petitions in Killian v. Vidal (US No. 22-1220), Ingenio, Inc. v. Click-to-Call Technologies, LP (US No. 22-873), and CareDx Inc. v. Natera, Inc. (US No. 22-1066).

Other Federal Circuit News:

Report and Recommendation in Judicial Investigation. As we summarized in our August 2023 update, there is an ongoing proceeding by the Judicial Council of the Federal Circuit under the Judicial Conduct and Disability Act and the implementing Rules involving Judge Pauline Newman. On September 20, 2023, the Special Committee released additional materials in the investigation. The materials may be accessed here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (September 2023)

Sisvel International S.A. v. Sierra Wireless, Inc., No. 22-1387 (Fed. Cir. Sept. 1, 2023): Sierra filed a petition for inter partes review asserting that certain claims of Sisvel’s patents related to mobile phone technology were invalid as anticipated and/or obvious over certain prior art. The Patent Trial and Appeal Board (“Board”) determined that all challenged claims were invalid and rejected Sisvel’s motion to amend because the amendments would improperly enlarge the scope of the claims.

The Federal Circuit (Stark, J., joined by Prost and Reyna, JJ.) affirmed. The Court agreed that Sisvel’s proposed substitute claims would have impermissibly enlarged claim scope. Sisvel argued on appeal that, when considered as a whole, the substitute claims were narrower in scope than the original claims. The Federal Circuit rejected this argument, explaining that if a substitute claim is broader “in any respect,” it is considered broader than the original claim “even though it may be narrower in other respects.”

Netflix, Inc. v. DivX, LLC, No. 22-1138 (Fed. Cir. Sept. 11, 2023): Netflix filed a petition for inter partes review asserting that certain claims of DivX’s patent, which relates to encoding and decoding multimedia files, were invalid as obvious. DivX argued in its patent owner response that one of the prior art references, Kaku, was not analogous prior art. The Board agreed with DivX that Netflix had not met its burden of establishing that Kaku was analogous prior art, in part, because Netflix had failed to identify the relevant field of endeavor.

The Federal Circuit (Stoll, J., joined by Hughes and Stark, JJ.) vacated and remanded. The Court determined that Netflix had articulated two alternative theories concerning the relevant field of endeavor, and that the Board erred in requiring Netflix to explicitly use the words “field of endeavor” when referring to them. The Court stated that it was “reluctant to affirm the Board’s factual finding” in this circumstance because it “rest[ed] on a failure to identify a field of endeavor rather than a clear analysis of why Kaku is not, in fact, directed to the same field of endeavor.” The Court therefore remanded to the Board to decide the question of whether the patent and Kaku were in the same field of endeavor.

Elekta Ltd. v. ZAP Surgical Systems, Inc., No. 21-1985 (Fed. Cir. Sept. 21, 2023): ZAP filed a petition for inter partes review of Elekta’s patent describing a method and apparatus for treating a patient using ionizing radiation. The patent claimed a linear accelerator mounted on a pair of concentric rings to deliver a beam of ionized radiation to a targeted area. The Board instituted review and determined all challenged claims were unpatentable as obvious, rejecting Elekta’s arguments that a skilled artisan would not have been motivated to combine an imaging device with a radiation device.

The Federal Circuit (Reyna, J., joined by Stoll and Stark, J.J.) affirmed. The Court found that substantial evidence, including the patentee’s statements in the prosecution history about whether imaging devices were relevant art, supported the Board’s findings that a skilled artisan would have been motivated to combine imaging systems with radiation-delivery systems. The Court rejected Elekta’s argument that the Board committed legal error by failing to expressly articulate any findings on reasonable expectation of success. Specifically, the Court held that “the Board made no error in addressing the issues of motivation to combine and reasonable expectation of success in the same blended manner that Elekta chose to present those very issues.” The Court held that “an implicit finding on reasonable expectation of success” was acceptable as long as the Court could “reasonably discern” an implicit finding by the Board on reasonable expectation of success.

Baxalta Incorporated v. Genentech, Inc., No. 22-1461 (Fed. Cir. Sept. 20, 2023): Baxalta sued Genentech alleging that Genentech’s Hemlibra^® product infringes Baxalta’s patent directed to a means of treating Hemophilia A, which is a blood clotting disorder. Baxalta’s patent relied on functional language to claim all isolated antibodies capable of binding to certain enzymes that promote blood coagulation. Sitting by designation in the District of Delaware, Judge Dyk determined that the patent did not enable the full claim scope, rending the claims invalid under Section 112.

The Federal Circuit (Moore, CJ, joined by Clevenger and Chen, JJ) affirmed. The Court noted that the inventors used “trial and error” amino acid substitution to identify 11 antibody sequences disclosed in the patent. The patent taught that this well-known substitution technique could also be used by others to find more antibodies meeting the claims from among millions of potential candidates. Following the Supreme Court’s ruling in Amgen v. Sanofi, 598 U.S. 594 (2023), the Court held that this failed to enable the full scope of the claims. As the Court explained, the patent did not disclose “any common structural (or other) feature delineating which antibodies” would meet the claims. Instead, the patent simply directed artisans “to make antibodies and test them,” leaving the public “no better equipped to make … claimed antibodies than the inventors were when they set out.” The Court held that this “roadmap” for “painstaking experimentation” did not enable the patent.

Blaine H. Evanson – Orange County (+1 949-451-3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214-698-3215, ayang@gibsondunn.com)

Please also feel free to contact any of the following practice group co-chairs or any member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups:

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, the report and recommendation from the ongoing investigation by the Judicial Council of the Federal Circuit, and recent Federal Circuit decisions concerning claim preclusion, obviousness, the “original patent” rule under 35 U.S.C. § 251, patent-eligibility under 35 U.S.C. § 101, the AIA’s first-to-file system, and enablement/written description.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There were no new potentially impactful petitions, where the petitioner was represented by counsel, filed before the Supreme Court in July 2023. As we summarized in our June 2023 update, there are a few other petitions pending before the Supreme Court. We provide an update below:

The Court will consider Killian v. Vidal (US No. 22-1220) and Ingenio, Inc. v. Click-to-Call Technologies, LP (US No. 22-873) during its September 26, 2023 conference.

In CareDx Inc. v. Natera, Inc. (US No. 22-1066), after the respondents waived their right to file a response, retired Federal Circuit Judge Paul R. Michel and Professor John F. Duffy filed an amici curiae brief in support of Petitioners. The Court thereafter requested a response, which is now due on August 9, 2023.

Other Federal Circuit News:

Report and Recommendation in Judicial Investigation. As we summarized in our June 2023 update, there is an ongoing proceeding by the Judicial Council of the Federal Circuit under the Judicial Conduct and Disability Act and the implementing Rules involving Judge Pauline Newman. On July 31, 2023, the Special Committee issued its report and recommendation, which was unanimously adopted by the Committee, finding that Judge Newman’s “continued non-cooperation justifies suspending case assignments for the fixed period of one year or at least until she ceases her misconduct and cooperates such that the Committee can complete its investigation, whichever comes sooner.” The report and recommendation, along with other prior orders and letter responses, may be accessed here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (July 2023)

Inguran, LLC v. ABS Global, Inc., No. 22-1385 (Fed. Cir. July 5, 2023): Inguran, doing business as STGenetics (“ST”), brought claims for patent infringement against ABS related to bovine sperm straws used for artificial insemination (“ABS I”), and ABS stipulated that its system directly infringed. In a second infringement suit (“ABS II”), ST learned that ABS had begun selling and licensing its system to third parties. ST then filed a third suit (“ABS III”), arguing that ABS is liable for inducing infringement by licensing its technology to third parties who were then making the straws. ABS moved to dismiss on the ground that ST’s claim was precluded by the judgment in ABS I, arguing that ST already had the opportunity to prove ABS’s infringement. The district court granted the motion.

The Federal Circuit (Reyna, J., joined by Lourie and Bryson, JJ.) reversed. On appeal, ST and ABS disputed only the second element of the three required elements for claim preclusion (res judicata): whether ABS I and ABS III involved “the same cause of action.” ST’s position was that ABS I focused on direct infringement and ABS III focused on induced infringement and were therefore not the same causes of action. The Court thus addressed whether ST could have brought the induced infringement action in ABS I, i.e., whether an induced infringement claim could have been raised out of the same transactional facts that existed in ABS I, and determined that it could not. The Court explained that ST needed additional facts to allege an induced infringement claim—facts that largely came to light during discovery in ABS II.

Axonics, Inc. v. Medtronic, Inc., Nos. 22-1451, 22-1452 (Fed. Cir. July 10, 2023): Axonics filed an inter partes review (“IPR”) petition concerning Medtronic’s patents, which describe a neurostimulation lead and method for implanting and anchoring that lead, arguing that certain claims would have been obvious over two prior art references, Young and Gerber. In particular, Axonics argued the Young reference expressly states that it could be improved to provide multiple stimulation sites, and that Gerber teaches multiple stimulation sites. The Patent Trial and Appeal Board (“Board”) rejected Axonics’s proposed combination, finding that there would have been no motivation to combine Young and Gerber because the relevant field of Medtronic’s patents was limited to implantable leads for sacral-nerve stimulation, whereas Young describes a lead for trigeminal nerve stimulation.

The Federal Circuit (Taranto, J., joined by Lourie and Dyk, JJ.) vacated and remanded. The Court held that even if the Medtronic patent claims were limited to the sacral nerve context, the Board erred by framing the obviousness inquiry as whether a relevant artisan would have been motivated to combine Young and Gerber for use in the trigeminal nerve context (taught by Young), rather than to arrive at the claimed invention.

In re Float’n’Grill LLC, Nos. 22-1438 (Fed. Cir. July 12, 2023): Float’N’Grill filed a reissue application for its patent on a float designed to support a grill top in water. The specification and claims of the original patent describe a single embodiment of a float with supports having a plurality of magnets for securing the grill to the float. Float’N’Grill sought reissue claims that eliminated the plurality of magnets limitations, and the Board rejected those claims as not complying with the “original patent” requirements of 35 U.S.C. § 251, which requires that the reissue claims be directed to the “same invention” as the original patent.

The Federal Circuit (Linn, J., joined by Prost and Cunningham, JJ.) affirmed. Because the “plurality of magnets” requirement in Float’N’Grill’s original patent was an essential part of the invention and not optional or “representative of removable fasteners generally,” Float’N’Grill could not obtain reissue claims without the “plurality of magnets” limitation.

SNIPR Technologies Ltd. v. Rockefeller University, No. 22-1260 (Fed. Cir. June 14, 2023): SNIPR is the owner of five patents that claim priority to May 3, 2016, and thus, the patents are subject to the Leahy-Smith America Invents Act (AIA). The AIA changed how priority is determined from a first-to-invent system to a first-to-file system. Rockefeller sought an interference, arguing that SNIPR’s patents were unpatentable because one of Rockefeller’s patent applications showed that Rockefeller was the first to invent the subject matter of SNIPR’s patents. The Board declared an interference, concluded that Rockefeller was the senior party with the earlier priority date, and cancelled all the claims of SNIPR’s patents.

The Federal Circuit (Chen, J., joined by Wallach and Hughes, JJ.) reversed. The Court held that the AIA eliminated interferences in switching to a first-to-file system, meaning that the Board erred by subjecting the SNIPR patents to an interference.

Trinity Info Media, LLC v. Covalent, Inc., No. 22-1308 (Fed. Cir. July 14, 2023): Trinity sued Covalent for allegedly infringing patented methods and systems for connecting users based on their answers to polling questions. The district court dismissed the complaint, concluding that the asserted patent claims were ineligible under 35 U.S.C. § 101.

The Federal Circuit (Cunningham, J., joined by Stoll and Bryson, JJ) affirmed. At step one of the Alice inquiry, the Court agreed that the claims were directed to “the abstract idea of matching based on questioning,” a mental process that “can be performed in the human mind.” At step two of the Alice inquiry, the Court held, just as claims are not patent eligible when merely applying an abstract idea “on a computer,” a claim is not rendered patent eligible merely because the abstract idea is applied “on a handheld device or using a mobile application.” Nor can inventiveness be based on “the improved speed inherent with applying the abstract idea using a computer.”

United Therapeutics Corp. v. Liquidia Technologies, Inc.., Nos, 22-2217, 23-1021 (Fed. Cir. July 24, 2023): United Therapeutics sued Liquidia for infringing two of its patents directed to methods of treating pulmonary hypertension (“PH”) and pharmaceutical compositions comprising treprostinil, the drug approved for the treatment of PH. Experts consider there to be five subgroups of PH. Group 2 PH has a differing etiology than the other four groups, and as a result, treprostinil provides no benefit to Group 2 PH patients. Liquidia argued that certain of the asserted claims were therefore invalid as lacking adequate enablement and written description because the specification fails to describe how to treat Group 2 PH patients with treprostinil, but the district court disagreed.

The Federal Circuit (Lourie, J., joined by Dyk and Stoll, JJ.) affirmed. Liquidia first argued that “treating pulmonary hypertension” requires a showing of safety and efficacy, and both parties’ experts had agreed that the claimed treatment would not benefit Group 2 PH patients. The Court rejected this argument explaining that where the claims do not incorporate safety and efficacy requirements, “questions of safety and efficacy in patent law” are matters for the FDA. Liquidia next argued that because the specification provided no guidance or examples of treating Group 2 PH patients, a skilled artisan would have to engage in undue experimentation to practice the full scope of the claims. The Court determined that it need not address this argument because, again, safety and efficacy requirements were not in the claims. However, the Court observed that even if “a subset of patients . . . would not benefit from or should not take the claimed treatment,” that “does not mean that such claims are not sufficiently enabled or supported by written description.”

Blaine H. Evanson – Orange County (+1 949-451-3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214-698-3215, ayang@gibsondunn.com)

Please also feel free to contact any of the following practice group co-chairs or any member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups:

Attorney Advertising: The enclosed materials have been prepared for general informational purposes only and are not intended as legal advice. Please note, prior results do not guarantee a similar outcome.

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court, provides an update on a proceeding by the Judicial Council of the Federal Circuit, and summarizes recent Federal Circuit decisions concerning secondary considerations, inventorship, inherency, and enablement.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

A new potentially impactful petition was filed before the Supreme Court in June 2023:

Killian v. Vidal (US No. 22-1220): The petition raises the questions (1) whether the Federal Circuit’s “departures of the Supreme Court’s Alice/Mayo jurisprudence . . . enabled the USPTO to violate the” Administrative Procedure Act (“APA”) and the Due Process Clause of the Fifth Amendment; and (2) whether the exceptions created by Article III courts to 35 U.S.C. § 101 exceeds the courts’ constitutional authority.

As we summarized in our May 2023 update, there are several other petitions pending before the Supreme Court. We provide an update below:

In CareDx Inc. v. Natera, Inc. (US No. 22-1066), after the respondents waived their right to file a response, retired Federal Circuit Judge Paul R. Michel and Professor John F. Duffy filed an amici curiae brief in support of Petitioners. The Court thereafter requested a response, which is now due on July 31, 2023.

The Court denied the petitions in Nike, Inc. v. Adidas AG (US No. 22-927) and NST Global, LLC v. Sig Sauer Inc. (US No. 22-1001). A response has been filed in Ingenio, Inc. v. Click-to-Call Technologies, LP (US No. 22-873).

Noteworthy Federal Circuit En Banc Petitions:

On June 30, 2023, the Federal Circuit granted the en banc petition filed in LKQ Corp. v. GM Global Technology Operations LLC, No. 21-2348 (Fed. Cir. June 30, 2023). The Court requested that the parties file new briefs to address questions related to the obviousness inquiry for design patents.

Other Federal Circuit News:

Release of Materials in Ongoing Judicial Investigation. As we summarized in our May 2023 update, there is an ongoing proceeding by the Judicial Council of the Federal Circuit under the Judicial Conduct and Disability Act and the implementing Rules involving Judge Pauline Newman. Last month, the Court approved and released public versions of all prior orders of the Special Committee and the Judicial Council, as well as Judge Newman’s letter responses to date. On June 20, 2023, the Court released additional materials in the ongoing investigation. The orders may be accessed here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (June 2023)

Yita LLC v. MacNeil IP LLC, No. 22-1383 (Fed. Cir. June 6, 2023): The Patent Trial and Appeal Board (“Board”) determined as part of an inter partes review (“IPR”) that the challenged claims of one of MacNeil’s patents directed to constructing a vehicle floor tray based on digital scans would not have been obvious. Despite determining that the claims would have been obvious over the asserted prior art, the Board found MacNeil’s evidence of secondary considerations “compelling” enough to overcome this determination of obviousness.

The Federal Circuit (Taranto, J., joined by Chen and Stoll, JJ.) reversed. The Court stated that under the Court’s precedent, objective evidence of nonobviousness lacks a nexus to the claimed invention if the evidence exclusively relates to a “known” feature in the prior art. The Court held that the Board therefore erred in concluding that because the feature was not “well known” in the prior art, that MacNeil’s secondary considerations evidence was sufficient to overcome its prior art based obviousness determination.

Blue Gentian, LLC v. Tristar Products, Inc., Nos. 21-2316, 21-2317 (Fed. Cir. June 9, 2023): Blue Gentian sued Tristar for infringement of its patents generally related to an expandable hose. Tristar counterclaimed that each of the asserted patents were invalid for failing to name a co-inventor, Gary Ragner. The district court agreed and concluded that Mr. Ragner contributed three key features of the invention and should have been named an inventor on the patents.

The Federal Circuit (Prost, J., joined by Chen and Stark, JJ.) affirmed. The Court first rejected Blue Gentian’s argument that the district court erred by not engaging in claim construction, holding that there must be a material dispute about claim scope to require claim construction prior to an inventorship determination. Here, Blue Gentian failed to identify “a dispute about claim scope that was material, or even related to, inventorship.” Additionally, because the patent owner argued during prosecution that the three key features at issue distinguished the invention over the prior art, the Court held that it follows that these features are not insignificant in quality and amounted to a significant contribution to conception that met the requirements needed to be considered a joint inventor.

Parus Holdings, Inc., v. Google LLC, Nos. 2022-1269, 2022-1270 (Fed. Cir. June 12, 2023): Google filed an IPR petition concerning Parus’s patents directed to an interactive voice system that allowed a user to request information from a voice web browser. Google asserted that certain claims of these patents would have been obvious over a number of prior art references, including Kovatch. Parus argued that Kovatch did not qualify as prior art because the claimed inventions were conceived of and reduced to practice before the earliest possible priority date for Kovatch. In support of its arguments, Parus submitted over 1,400 pages of material, but only cited small portions of that material in its briefs without meaningful explanation. The Board declined to consider these arguments because Parus failed to comply with 37 C.F.R. § 42.6(a)(3), which prohibits incorporation by reference.

The Federal Circuit (Lourie, J., joined by Bryson and Reyna, JJ.) affirmed. The Court held that the Board did not violate the APA. The Board had determined that Parus failed to cite to the relevant record evidence with specificity and explain the significance of the produced materials in its briefing, and incorporated its arguments by reference in violation of 37 C.F.R. § 42.6(a)(3), and thus, the Court determined that the Board’s disregard of Parus’s arguments cannot be an abuse of discretion.

In re Couvaras, No. 22-1489 (Fed. Cir. June 14, 2023): The pending claims of the patent application at issue are directed to a method of increasing prostacyclin release to improve vasodilation, which decreases blood pressure. The increased prostacyclin is achieved by co-administering two well-known antihypertensive agents. The examiner finally rejected the claims finding that the claimed results of the compounds’ administration naturally flowed from administration of the known antihypertensive agents. Couvaras then appealed to the Board. The Board agreed with the examiner and found that the increase in prostacyclin release was “inherent in the obvious administration of the two known antihypertension agents.”

The Federal Circuit (Lourie, J., joined by Dyk and Stoll, JJ.) affirmed. Courvaras argued that even if the recited mechanism of action (the increased release of prostacyclin) was inherent, the Board erred in dismissing it as having no patentable weight, because the mechanism was unexpected. The Court rejected this argument holding that “[r]eciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected.”

Medytox v. Galderma, No. 22-1165 (Fed. Cir. June 27, 2023): Galderma filed a post-grant petition of Medytox’s patent directed to a method for treating frown lines using an animal-protein-free botulinum toxin composition, which allegedly displayed an increased sustained effect compared to BOTOX^®. Medytox filed a motion to amend seeking to cancel the challenged claims and file substitute claims. In a final written decision, the Board found in part that the substitute claims were unpatentable for lack of enablement, because the specification only disclosed three responder rates: 52%, 61%, and 62%, and a skilled artisan would not have been able to achieve higher responder rates included in the claimed ranges without undue experimentation.

The Federal Circuit (Reyna, J., joined by Dyk and Stark, JJ.) affirmed. Citing the Supreme Court’s recent opinion in Amgen Inc. v. Sanofi, 143 S. Ct. 1243 (2023), the Federal Circuit determined that the Board did not err in concluding that the substitute claims were not enabled because a skilled artisan would not have been able to achieve responder rates higher than the limited examples disclosed in the specification.

Blaine H. Evanson – Orange County (+1 949-451-3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214-698-3215, ayang@gibsondunn.com)

Please also feel free to contact any of the following practice group co-chairs or any member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups:

This edition of Gibson Dunn’s Federal Circuit Update summarizes the Supreme Court’s recent decision in Amgen v. Sanofi and the current status of several other petitions pending before the Supreme Court, provides an update on a proceeding by the Judicial Council of the Federal Circuit, and summarizes recent Federal Circuit decisions concerning inventorship, attorneys’ fees, obviousness, and conception and reduction to practice.

Federal Circuit News

Supreme Court:

On May 18, 2023, the United States Supreme Court issued its decision in Amgen Inc. v. Sanofi (U.S. No. 21-757) and affirmed the Federal Circuit (see summary of Federal Circuit opinion from February 2021 update).

The Amgen patents at issue claimed an entire genus of antibodies that bind to specific amino acid residues on PCSK9 and block PCSK9 from binding to LDL receptors. Antibodies that inhibit PCSK9 from binding to and degrading LDL receptors are used to treat patients with high LDL cholesterol, which can lead to cardiovascular disease, heart attacks, and strokes. Amgen’s patents identified 26 of these PCSK9-inhibiting antibodies and disclosed two methods to make other antibodies that perform the binding and blocking functions it described. Sanofi argued that neither of these two methods enable a person of ordinary skill in the art to generate additional antibodies reliably.

The Supreme Court agreed. While the Court acknowledged that Amgen’s specification “enables the 26 exemplary antibodies it identifies,” “the claims before us sweep much broader than those 26 antibodies,” and Amgen’s two disclosed methods failed to enable a person of skill in the art how to make the entire universe of antibodies. The first method described a step-by-step trial-and-error method that Amgen followed to identify the 26 exemplary antibodies. The second method required scientists to make substitutions to the amino acid sequences of the known antibodies to determine if they work too. The Court reasoned that this would force scientists to engage in “painstaking experimentation,” which was “not enablement.”

Noteworthy Petitions for a Writ of Certiorari:

This month, there is a new potentially impactful petition pending before the Supreme Court:

CareDx Inc. v. Natera, Inc. (US No. 22-1066): The petition raises the question whether a new and useful method for measuring a natural phenomenon is eligible for patent protection under 35 U.S.C. § 101. After respondent in this case waived its right to file a response, retired Federal Circuit Judge Paul R. Michel and Professor John F. Duffy filed an amici curiae brief in support of Petitioners. The Court thereafter requested a response, which is due on June 29, 2023.

As we summarized in our April 2023 update, there are several petitions pending before the Supreme Court. We provide an update below:

After requesting a response in Avery Dennison Corp. v. ADASA, Inc. (US No. 22-822) and Arthrex, Inc. v. Smith & Nephew, Inc. (US No. 22-639), the Court denied the petitions. After requesting the views of the Solicitor General, the Court also denied the petitions in Interactive Wearables, LLC v. Polar Electro Oy (US No. 21-1281) and Tropp v. Travel Sentry, Inc. (US No. 22-22), although Justice Kavanaugh would have granted both petitions.

The Court is considering petitions in Nike, Inc. v. Adidas AG et al. (US No. 22-927) and Ingenio, Inc. v. Click-to-Call Technologies, LP (US No. 22-873), having requested a response in both cases. The response in Nike has been filed, and the response in Ingenio is due June 26, 2023.

The Court will consider NST Global, LLC v. Sig Sauer Inc. (US No. 22-1001) during its June 15, 2023 conference.

Other Federal Circuit News:

Release of Prior Orders in Ongoing Judicial Investigation. As we summarized in our April 2023 update, the Judicial Council of the Federal Circuit released a statement confirming that a proceeding under the Judicial Conduct and Disability Act and the implementing Rules had been initiated naming Judge Pauline Newman as the subject judge. On May 16, 2023 and June 5, 2023, the Federal Circuit released public versions of all prior orders of the Special Committee and the Judicial Council, as well as Judge Newman’s letter responses to date. The orders may be accessed here and here.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (May 2023)

HIP, Inc. v. Hormel Foods Corp., No. 22-1696 (Fed. Cir. May 2, 2023): HIP disputed the inventorship of a Hormel patent directed to methods of precooking bacon and meat pieces. Hormel had entered into a joint agreement with David Howard, an employee of HIP’s predecessor company, to improve on its microwave cooking process for precooked bacon. Howard alleged that during these initial meetings, he had disclosed the infrared preheating concept at issue. Subsequent testing revealed that “preheating the bacon with a microwave oven prevented condensation from washing away the salt and flavor.” Hormel then filed a patent application on this process, which was ultimately granted, but did not name Howard as an inventor. The district court concluded that Howard should have been listed as a joint inventor on the patent having contributed the preheating with an infrared oven concept in one of the independent claims.

The Federal Circuit (Lourie, J., joined by Clevenger and Taranto, JJ.) reversed. Under Federal Circuit precedent, an inventor must make a contribution to the claimed invention that is “not insignificant in quality when the contribution is measured against the dimension of the full invention.” The Court determined that Howard’s alleged contribution of using an infrared oven is “insignificant in quality” to the claimed invention. In fact, preheating with an infrared oven was mentioned only once in the patent specification as an alternative to a microwave oven. In contrast, preheating with microwave ovens featured prominently throughout the specification.

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc., No. 21-1981 (Fed. Cir. May 9, 2023): Mylan petitioned the Patent Trial and Appeal Board (“Board”) for inter partes review (“IPR”) of a Sanofi patent directed to a drug delivery device. The Board concluded that the challenged patent was unpatentable as obvious over prior art, including prior art reference, de Gennes. Sanofi argued that de Gennes was not analogous art, but the Board disagreed finding that de Gennes focused on a problem that was “reasonably pertinent” to a problem faced by an inventor of the challenged patent, in part because the problem was addressed in a second prior art reference, Burren.

The Federal Circuit (Cunningham, J., joined by Reyna and Mayer, JJ.) reversed. In determining whether a reference is analogous art, a patent challenger must compare the reference to the problem addressed by the challenged patent, not solely to the problem addressed by other prior art references. Because Mylan argued solely that de Gennes was analogous to Burren, not the challenged patent, Mylan did not meet its burden to establish de Gennes was analogous art.

OneSubsea IP UK Limited v. FMC Technologies, Inc., No. 22-1099 (Fed. Cir. May 23, 2023): OneSubsea sued FMC alleging infringement of ten OneSubsea patents related to the subsea recovering of production fluids from an oil or gas well. FMC ultimately prevailed when the district court (Judge Atlas) granted its summary judgment motion of noninfringement. FMC then filed a motion under 35 U.S.C. § 285 for attorneys’ fees. After the briefing concluded, the case was reassigned to Judge Bennett following Judge Atlas’s retirement. Judge Bennett denied FMC’s § 285 motion.

The Federal Circuit (Moore, C.J., joined by Clevenger and Dyk, JJ.) affirmed. FMC argued that instead of applying an abuse-of-discretion standard, the Court should apply de novo review to the § 285 decision because Judge Bennett only briefly “lived with the case.” The Court rejected this suggestion determining that appellate courts have consistently reviewed successor judges’ decisions on discretionary issues for abuse of discretion.

Medtronic, Inc. v. Teleflex Innovations S.À.R.L., Nos. 21-2356, 21-2358, 21-2361, 21-2363, 21-2365 (Fed. Cir. May 24, 2023): Medtronic filed thirteen IPR petitions of five related Teleflex patents directed to guide extension catheters that use a tapered inner catheter. In five of the final written decisions, the Board found that the primary prior art reference, Itou, did not qualify as prior art because the claimed inventions were conceived prior to Itou’s filing date and actually reduced to practice prior to the critical date, or diligently worked on toward constructive reduction to practice before the challenged patents’ effective filing date, which requires in part, that the invention would work for its intended purpose.

The majority (Lourie, J., joined by Moore, C.J.) affirmed. While inventor testimony may serve as evidence of reduction to practice, it must be corroborated by independent evidence. The majority concluded that the Board’s finding that the testing performed by Teleflex was sufficient to show that the claimed invention worked for its intended purpose. The majority also determined that the inventors’ actual reduction to practice was sufficiently corroborated in the form of both documentary evidence and noninventor testimony.

Judge Dyk dissented. In his opinion, the inventors’ testimony did not show that the prototypes would have worked for their intended purpose, in part because the tests were “more qualitative than quantitative,” and failed to “reproduce[] the operating conditions which would be encountered in any practical use of the invention.” He also found that Teleflex failed to corroborate the inventors’ testimony, because “Teleflex produced essentially no internal documents corroborating any testing . . . in the critical period.” Teleflex argued that this evidence likely existed at one time but had since been destroyed. Judge Dyk disagreed with the majority’s concern that this would impose an “impossible standard” by requiring that “every point of reduction to practice be corroborated.” In his opinion, a rule that favors retention of relevant documents does not create an “impossible standard” for inventors seeking to enforce a patent.

Blaine H. Evanson – Orange County (+1 949-451-3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214-698-3215, ayang@gibsondunn.com)

Please also feel free to contact any of the following practice group co-chairs or any member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups:

This edition of Gibson Dunn’s Federal Circuit Update summarizes the current status of several petitions pending before the Supreme Court. We also discuss recent Federal Circuit decisions concerning written description, motivation to combine, and requirements for stipulated judgments of non-infringement based on a district court’s claim construction.

Federal Circuit News

Supreme Court:

On March 27, 2023, the United States Supreme Court heard oral argument in Amgen Inc. v. Sanofi (U.S. No. 21-757) on the issue of enablement under 35 U.S.C. § 112. During argument, the Court expressed concern with the breadth of Amgen’s genus claims, which potentially cover millions of antibodies, and repeatedly asked petitioner to clarify what Amgen actually invented. The Court also observed that there appeared to be general agreement between the parties on the enablement legal standard (that a patent must enable a skilled artisan to practice the full scope of the claims without undue experimentation) and questioned what was left for the Court to do. A more detailed summary of the argument may be found on SCOTUSblog here.

Noteworthy Petitions for a Writ of Certiorari:

There are several new potentially impactful petitions pending before the Supreme Court:

Thaler v. Vidal (US No. 22-919): “Does the Patent Act categorically restrict the statutory term ‘inventor’ to human beings alone?” The government waived its right to file a response.

Nike, Inc. v. Adidas AG et al. (US No. 22-927): “Whether, in inter partes review, the Patent Trial and Appeal Board may raise sua sponte a new ground of unpatentability—including prior art that the petitioner neither cited nor relied upon—and whether the Board may rely on that new ground to reject a patent-holder’s substitute claim as unpatentable.” Adidas waived its right to file a response.

Avery Dennison Corp. v. ADASA, Inc. (US No. 22-822): “The question presented is whether [a] claim, by subdividing a serial number into ‘most significant bits’ that are assigned such that they remain identical across RFID tags, constitutes patent-eligible subject matter under 35 U.S.C. § 101.” After ADASA waived its right to file a response, a response was requested by the Court and is due May 2, 2023.

Ingenio, Inc. v. Click-to-Call Technologies, LP (US No. 22-873): “1. Whether 35 U.S.C. § 315(e)’s IPR estoppel provision applies only to claims addressed in the final written decision, even if other claims were or could have been raised in the petition. Whether the Federal Circuit erroneously extended IPR estoppel under 35 U.S.C. § 315(e) to all grounds that reasonably could have been raised in the petition filed before an inter partes review is instituted, even though the text of the statute applies estoppel only to grounds that “reasonably could have [been] raised during that inter partes review.” After Click-to-Call waived its right to file a response, a response was requested by the Court and is due May 26, 2023.

As we summarized in our January 2023 and February 2023 updates, the Court is considering petitions in Novartis Pharmaceuticals Corp. v. HEC Pharm Co., Ltd. (US No. 22-671) and Arthrex, Inc. v. Smith & Nephew, Inc. (US No. 22-639). The response in Arthrex is due April 12, 2023. Novartis will be considered during the Court’s April 14, 2023 conference. Gibson Dunn partners Thomas G. Hungar, Jacob T. Spencer, Jane M. Love, and Robert Trenchard are counsel for Novartis. The petitions in Interactive Wearables, LLC v. Polar Electro Oy (US No. 21-1281) and Tropp v. Travel Sentry, Inc. (US No. 22-22) are still pending the views of the Solicitor General.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (March 2023)

Regents of the University of Minnesota v. Gilead Sciences, Inc., No. 21-2168 (Fed. Cir. Mar. 6, 2023): The Patent Trial and Appeal Board (“Board”) determined that UM’s patent directed to phosphoramidate prodrugs of nucleoside derivatives (used to prevent viruses from reproducing or cancerous tumors from growing) was invalid as anticipated by one of Gilead’s patents. The Board concluded that Gilead’s patent was prior art to UM’s patent, because UM’s patent could not claim priority to its parent applications, which failed to provide sufficient written description support for the challenged claims.

The Federal Circuit (Lourie, J., joined by Dyk and Stoll, JJ.) affirmed. The Court explained that written description of a broad genus of chemical compounds requires description not only of the outer limits of the genus but also of either a representative number of members of the genus or structural features common to the members of the genus, both with enough precision for a person of skill in the art to visualize or recognize the members of the genus. The Court reasoned that the various claims in the parent applications created “a maze-like path, each step providing multiple alternative paths” that lead to so many varying options that it is “unclear how many compounds actually fall within the described genera and subgenera.” The Court therefore agreed with the Board that UM’s parent applications failed to provide adequate written description support for the challenged claims, and thus, Gilead’s patent was anticipatory prior art.

Intel Corp. v. PACT XPP Schweiz AG, No. 22-1037 (Fed. Cir. Mar. 13, 2023): The Board determined the challenged claim was not unpatentable as obvious over two prior art references (Kabemoto and Bauman). The Board concluded that prior art did not disclose the recited segment-to-segment limitation in the claim, and that one skilled in the art would not be motivated to combine the two references.

The Federal Circuit (Prost, J., joined by Newman and Hughes, JJ.) reversed and remanded. The Court concluded that Bauman plainly disclosed the segment-to-segment limitation. The Court also reversed the Board’s rejection of Intel’s motivation to combine argument, which was that when a known technique has been used to improve one device, a person of ordinary skill in the art would recognize that it would improve similar devices in the same way. Here, Bauman disclosed that a secondary cache could be used to improve cache coherency, and a person of ordinary skill in the art would have recognized that such a cache would improve similar multiprocessor systems, like the one in Kabemoto, by addressing the same cache coherency problem.

AlterWAN, Inc. v. Amazon.com, Inc., No. 22-1349 (Fed. Cir. Mar. 13, 2023): After the district court construed two disputed terms, the parties stipulated to judgment of non-infringement so that AlterWAN could appeal the constructions.

The Federal Circuit (Dyk, J., joined by Lourie and Stoll, JJ.) vacated the judgment and remanded to the district court for further proceedings on the basis that the stipulation failed to identify which claims remained at issue, and failed to specify whether the construction of both terms must be correct for Amazon to prevail. The Court explained that a stipulated judgment of non-infringement based on a district court’s claim construction must specify which claims remain at issue and which constructions affect the issue of infringement.

Blaine H. Evanson – Orange County (+1 949-451-3805, bevanson@gibsondunn.com)
Audrey Yang – Dallas (+1 214-698-3215, ayang@gibsondunn.com)

Please also feel free to contact any of the following practice group co-chairs or any member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups: