This edition of Gibson Dunn's Federal Circuit Update offers a reminder of the upcoming American Intellectual Property Law Association (AIPLA) Annual Meeting and of Supreme Court's upcoming review of decisions coming up from the Federal Circuit.
Client Alert | October 1, 2018
Euromoney Legal Media Group recognized three Gibson Dunn partners among its inaugural list of Americas Rising Stars. Blaine Evanson was named Best in Litigation: Appellate; Stacie Fletcher was named Best in Environment; and John Partridge was named Best in Life Sciences.
Firm News | September 27, 2018
Gibson Dunn was recognized at the annual LMG Life Sciences Awards, where the firm’s win in Biogen IDEC MA v. EMD Serono et al. was named a Patent Impact Case of the Year.
Firm News | September 12, 2018
This July 2018 edition of Gibson Dunn's Federal Circuit Update discusses the recent Federal Circuit Bar Association Bench and Bar Conference, provides a summary of the pending Helsinn Healthcare case before the Supreme Court regarding the on-sale bar, and briefly summarizes the joint appendix procedure at the Federal Circuit.
Client Alert | July 31, 2018
In this mid-year analysis of government contracts litigation, Gibson Dunn examines trends and summarizes key decisions of interest to government contractors from the first half of 2018.
Client Alert | July 30, 2018
On June 14, 2018, Acting Associate Attorney General Jesse Panuccio gave remarks highlighting recent enforcement activity and policy initiatives by the Department of Justice ("DOJ").
Client Alert | June 20, 2018
Six Gibson Dunn partners were recognized by Who’s Who Legal in their respective fields. In Who’s Who Legal France 2018 guide Paris partners Nicolas Baverez and Jean-Pierre Farges were recognized in Administrative Litigation and Restructuring & Insolvency respectively.
Firm News | May 25, 2018
On April 12th, 2018, the Food and Drug Administration ("FDA") released draft guidance proposing a significant expansion of the abbreviated 510(k) pathway for medical devices that would allow applicants to rely on performance characteristics rather than direct comparisons to predicate devices ("Draft Guidance").
Client Alert | April 17, 2018
This March 2018 edition of Gibson Dunn's Federal Circuit Update discusses the three pending Federal Circuit cases before the Supreme Court that consider issues regarding inter partes review proceedings and extraterritorial damages, and a brief summary of the process for seeking an interlocutory appeal.
Client Alert | March 29, 2018
New York partners Jane Love, Robert Trenchard and Paul Torchia are the authors of "TC Heartland and Hatch-Waxman: Square Peg in a Round Hole," published in Law360 on January 30, 2018.
Article | January 30, 2018
As 2016 came to a close, pharmaceutical and medical device companies waited expectantly and wondered aloud about what 2017 and the arrival of the Trump Administration would bring.
Client Alert | January 23, 2018
This November 2017 edition of Gibson Dunn's Federal Circuit Update discusses the recent Friedman Lecture on Appellate Advocacy by Judge Alan Lourie, the two pending Federal Circuit cases before the Supreme Court that consider issues regarding inter partes review proceedings, and the Federal Circuit's en banc procedures.
Client Alert | November 30, 2017
At the midpoint of 2017, much has changed, and yet much has stayed the same for U.S. manufacturers of pharmaceuticals and medical devices. Although the new administration arrived in January, Dr. Scott Gottlieb, the new U.S.
Client Alert | August 25, 2017
Cyberthreats are ubiquitous, and significant cyberattacks on private and publicly traded companies occur on a near-daily basis. As a result of the ongoing barrage of increasingly advanced and evolving cyberattacks, even companies with sophisticated security systems are potentially susceptible to a cybersecurity breach.
Client Alert | August 8, 2017
The False Claims Act (FCA) is well-known as one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse anywhere government funds are implicated.
Webcasts | August 2, 2017
On May 22, 2017, the U.S. Supreme Court narrowed the scope of proper venue for patent infringement actions for domestic corporations. See TC Heartland LLC v. Kraft Foods Grp.
Client Alert | June 15, 2017
This March 2017 edition of Gibson Dunn's Federal Circuit Update discusses summary affirmance at the Federal Circuit, two recent Supreme Court decisions on laches and exhaustion, and the Federal Circuit cases now pending before the Supreme Court. This update also provides an overview of the process for petitioning for mandamus before the Federal Circuit. Also included are summaries of the two pending en banc cases involving motions to amend claims during inter partes review and judicial review of timeliness determinations in inter partes review, as well as a two key recent decisions relating to admissibility of settlement agreements in support of a reasonable royalty and eligibility of a patent for covered business method review.Federal Circuit NewsSummary Affirmance Before the
Client Alert | March 28, 2017
This January 2017 edition of Gibson Dunn's Federal Circuit Update discusses current news and pending Federal Circuit cases before the Supreme Court and provides an overview of the oral argument process and panel assignment at the Federal Circuit. Also included are summaries of the two pending en banc cases involving motions to amend claims during inter partes review and judicial review of timeliness determinations in inter partes review as well as a series of key recent decisions relating to the requirements for standing when appealing a decision of the Patent Trial & Appeal Board ("PTAB"), divided infringement, and indefiniteness of claims using terms of degree. Federal Circuit NewsFormer Chief Judge Rader is reportedly in consideration for leadership of the U.S.
Client Alert | January 26, 2017
This January more than most, it is tempting to focus on questions regarding what is to come. Aside from the uncertainties associated with a new administration, two key pieces of legislation seem to be heading in opposite directions.
Client Alert | January 12, 2017
Washington, D.C. associate Jonathan Phillips is the co-author of "Using and Defending Against Statistical Sampling in False Claims Act Cases," [PDF] published in AHLA Connections in January 2017.
Article | January 1, 2017
We are pleased to present Gibson Dunn's fourth "Federal Circuit Year in Review," providing a statistical overview and substantive summaries of the 134 precedential patent opinions issued by the Federal Circuit over the 2015-2016 year.
Client Alert | December 7, 2016
There is widespread speculation regarding what President-elect Donald Trump and a Republican-controlled Congress will choose to prioritize and pursue in 2017 and beyond. With the majority of pollsters and media observers incorrectly forecasting a victory for Hillary Clinton, many are just now beginning to assess how they will operate under, and the potential opportunities presented by, the policies of the Trump administration and the Republican-led Congress. We would like to share with you some of our initial observations about the potential effects that may be forthcoming in the near term. With Republicans claiming the White House and maintaining control of both the House of Representatives and the Senate, we expect a flurry of legislative and administrative activity con
Client Alert | November 15, 2016
Washington, D.C. associates Jonathan Phillips and Julie Rapoport Schenker are the authors of "Compliance Perspectives on the Developing Contours of the PSQIA" [PDF] published in the October 2016 issue of Compliance Today.
Article | October 3, 2016
This September 2016 edition of Gibson Dunn's Federal Circuit Update discusses the steep rise in appeals from the Patent Trial & Appeal Board due to the America Invents Act. The Update also includes a practice tip regarding the procedure for seeking rehearing of an adverse panel decision. Also included are summaries of the pending en banc case involving motions to amend claims during inter partes review as well as a trio of key recent decisions including two recent developments in Federal Circuit jurisprudence on patent eligibility under Section 101 and one recent decision on the application of common sense in an obviousness inquiry.Federal Circuit NewsOn September 16, 2012, the Leahy-Smith America Invents Act ("AIA") became effective and established the Patent Tri
Client Alert | September 29, 2016
From the Supreme Court to the Congress and from the federal agencies to the state legislatures, 2016 has produced noteworthy legal and regulatory developments for companies in the pharmaceutical and medical device industries. Like our 2015 Year-End FDA and Health Care Compliance and Enforcement Update, this update begins with an overview of government enforcement efforts against drug and device companies under the False Claims Act ("FCA"), the Federal Food, Drug, and Cosmetic Act ("FDCA"), and other laws.
Client Alert | July 27, 2016
Included in this May 2016 edition of Gibson Dunn's Federal Circuit Update is a brief summary of last month's Federal Circuit Judicial Conference, a summary of the pending en banc case (Medicines Co.), and a practice update regarding a clerical change to one of the Federal Circuit's rules of practice. Also included are summaries of a number of key recent decisions related to venue and forum shopping in patent cases and a trio of decisions on patent eligibility under section 101, including the Federal Circuit's second post-Alice decision reversing a district court's determination that claims were not subject matter eligible.Federal Circuit News The Federal Circuit held its annual Judicial Conference on April 11, 2016. Over 700 attorneys, judges, and federal officials
Client Alert | May 26, 2016
Included in this March 2016 edition of Gibson Dunn's Federal Circuit Update is a brief overview of the upcoming Federal Circuit Judicial Conference, a summary of the pending en banc case (Medicines Co.), and a practice update regarding a proposed change to one of the Federal Circuit's internal operating procedures. Also included are summaries of a number of key recent decisions related to patent exhaustion, the patent-agent evidentiary privilege, due process issues related to election of asserted claims, and the overlap between antitrust and inequitable conduct. Gibson Dunn prevailed in two cases since our last update: In Rembrandt Social Media, LP v. Facebook, Inc., No.
Client Alert | March 24, 2016
Gibson Dunn is pleased to announce its inaugural edition of the Federal Circuit Update, a bimonthly electronic newsletter designed to provide our clients and friends with a concise summary of recent activity at the U.S.
Client Alert | January 27, 2016
While massive mergers and pharmaceutical pricing dominated industry headlines in 2015, the U.S. Government continued to shape the drug and device industries through enforcement actions and other regulatory activities this past year.
Client Alert | January 19, 2016
Dallas partner Tracey Davies, of counsel Michael Valek, and associates Andrew Lin and Theodore Kwong are the authors of "Patent Disputes Over Biologics: Will Anyone Come To The Dance?" [PDF] published on January 7, 2016 by The Texas Lawyer.
Article | January 7, 2016
A bit less, but no less impressive--that is how we would characterize False Claims Act enforcement in 2015. This past year, the federal government recovered approximately $3.6 billion in either settlements or judgments in cases brought under the False Claims Act ("FCA" or the "Act").
Client Alert | January 6, 2016
2015 was a blockbuster year in corporate non-prosecution agreements ("NPA") and deferred prosecution agreements ("DPA"), by sheer numbers alone. Skyrocketing to 100, in 2015 the number of agreements more than doubled the numbers in every prior year since 2000, when Gibson Dunn first began tracking NPA and DPA data.
Client Alert | January 5, 2016
Orange County partner Jeffrey Thomas and associate Anne Brody are the authors of "Damages for Infringement of a Pharmaceutical Patent: A Novel Analysis" [PDF] published on January 1, 2016 by the Bloomberg BNA Pharmaceutical Law & Industry Report.
Article | January 1, 2016
On November 19, 2015, in Depomed, Inc. v. Horizon Pharma plc, the Superior Court of California, County of Santa Clara granted Depomed's request for a preliminary injunction to enjoin Horizon's hostile exchange offer to acquire Depomed.
Client Alert | November 20, 2015
We are pleased to present Gibson Dunn's third "Federal Circuit Year In Review," providing a statistical overview and substantive summaries of the 110 precedential patent opinions issued by the Federal Circuit over the 2014-2015 year.
Client Alert | November 9, 2015
In a pointed and thoughtful repudiation of FDA's longstanding policy, the U.S. District Court for the Southern District of New York held on August 7, 2015, that the First Amendment precludes the prohibition and criminalization of truthful, non-misleading off-label speech under the Federal Food, Drug, and Cosmetic Act ("FDCA"). Amarin Pharma, Inc. v.
Client Alert | August 13, 2015
Denver associate John D.W. Partridge is the co-author of "RICO Suits Challenge Off-Label Drug Marketing" [PDF] published on August 3, 2015 by Law360.
Article | August 3, 2015
On July 21, 2015, the Federal Circuit issued its much anticipated decision in Amgen v. Sandoz (No. 2015-1499) construing two key provisions of the Biologics Price Competition and Innovation Act ("BPCIA"). The split decision held something for both sides, providing that the information disclosure and exchange provisions of the BPCIA (the infamous "patent dance") are not mandatory, and that the biosimilar applicant's 180-days' pre-marketing notice may only be given after final FDA approval. It is worth reiterating that the Federal Circuit has determined that the patent dance Congress spent years choreographing is not a mandatory requirement. Judge Lourie wrote the majority opinion, with Judge Newman concurring-in-part and dissenting-in-part, and Jud
Client Alert | July 27, 2015
Over the past half year, the U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA") sustained their enforcement efforts against both businesses and individuals, raking in significant civil recoveries while pursuing criminal cases against industry participants.
Client Alert | July 16, 2015
2015 came in like a lion, bringing with it remarkable policy changes regarding corporate non-prosecution agreements ("NPA") and deferred prosecution agreements ("DPA").
Client Alert | July 8, 2015
I. INTRODUCTION There is no end in sight to the False Claims Act gold rush. After a record-setting 2014, which saw $5.7 billion in recoveries under the federal False Claims Act (FCA), 31 U.S.C.
Client Alert | July 8, 2015
Brussels associates Pablo Figueroa and Alejandro Guerrero are the authors of "EU Merger Control in the Pharmaceutical Sector" [PDF] published in the July 2015 issue of The Merger Control Review.
Client Alert | July 1, 2015
Washington, D.C. partner F. Joseph Warin and associates Oleh Vretsona and Lora MacDonald are the authors of "A Practical Guide to the Use of the Commissioned Public Report as an Effective Crisis-Management Tool" [PDF] published in the Notre Dame Journal of Law, Ethics & Public Policy, Volume 29, Issue 1.
Article | June 12, 2015
On March 25, 2015, in a unanimous vote, the U.S.
Client Alert | April 22, 2015
In 2014, food safety spurred significant rulemaking, enforcement activity, and litigation by regulators and lawmakers at both the federal and state levels. The U.S.
Article | March 2, 2015
Concerns about cybersecurity and data privacy have exploded into the public consciousness in recent years, accompanied by a host of new and rapidly developing legal issues.
Client Alert | February 17, 2015
It is no secret to those in the health care industry that since the U.S.
Client Alert | January 14, 2015
Pharmaceutical and medical device manufacturers are among the most highly regulated enterprises in the United States, and 2014 demonstrated that the regulatory landscape continues to be a minefield for these companies. This past year, the Department of Justice ("DOJ") and the U.S.
Client Alert | January 14, 2015
Just two years ago we noted the staggering level of the federal government's recovery-- approximately $5 billion--under the False Claims Act, 31 U.S.C.
Client Alert | January 7, 2015
The U.S. Department of Justice ("DOJ") and the U.S. Securities and Exchange Commission ("SEC") continue to deploy DPAs and NPAs aggressively. This past year left no doubt that such resolutions are a vital part of the federal corporate law enforcement arsenal, affording the U.S.
Client Alert | January 6, 2015