Life Sciences

Industry Group Leaders

Daniel J. Thomasch New York
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Tracey B. Davies Dallas
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Ryan A. Murr San Francisco
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Overview

The Life Sciences Practice Group represents and advises innovative biotechnology, pharmaceutical and medical device companies on a wide range of legal, regulatory and strategic issues, including patent and product liability litigation, U.S. Food and Drug Administration (FDA) investigations and enforcement actions, and corporate transactions and financings.  Many Gibson, Dunn & Crutcher lawyers hold advanced scientific degrees and have hands-on experience working in life sciences companies or within the government agencies that regulate the industry.  Law360 named Gibson Dunn one of the top five Life Sciences Practice Groups of the Year for 2015.   

In addition to advising biotechnology, pharmaceutical and medical device companies, we also regularly represent:

  • Investment banks, venture capital funds, private equity firms, royalty monetization firms, private investment and hedge funds, as well as individual investors focused on funding life sciences-related companies
  • Diagnostic companies, as well as companies developing and commercializing research tools for use in the life sciences industry
  • Health care IT companies  
  • Academic medical centers and research institutions
  • Veterinary, agricultural and industrial life sciences companies

The Life Sciences group has significant experience handling major litigation, transactional and other matters for companies engaged in the research and development of life science products and therapies.  The wide range of skills, knowledge and experience of the group includes: 

  • Patent and product liability litigation
  • Actions under the U.S. False Claims Act
  • FDA regulatory compliance and enforcement
  • White collar defense and investigations
  • Antitrust and trade regulation
  • Mergers and acquisitions
  • Capital markets transactions
  • Monetization and debt financing transactions
  • Licensing, collaborations, joint ventures, and strategic alliances

The Life Sciences group's lawyers represent biotech, pharmaceutical and medical device companies in patent litigation, including matters involving the Hatch-Waxman Act, as well as in product liability and commercial litigation.  The group also has a broad range of experience responding to regulatory investigations and enforcement actions involving life sciences companies, including FDA compliance and U.S. Department of Justice and Federal Trade Commission antitrust and consumer matters.   

The group's lawyers have addressed and successfully litigated some of the most difficult topics facing the pharmaceutical industry, including the enforcement of second- and third-generation patents, combination drug patents, formulation patents, regulations governing patent listing and use codes, and follow-on antitrust litigation by direct and indirect purchasers.  We also represent medical device companies in all forms of commercial litigation. 

Our corporate lawyers have handled significant deals and financings in the life sciences sector.  They routinely represent issuers, as well as financial institutions acting as underwriters, placement agents and financial advisers in industry transactions.  Combined with our exceptional securities regulatory strength, we have breadth and insight that few firms can match in transactions including venture financing transactions, initial public offerings, public and private debt and equity offerings, PIPEs, stock and asset acquisitions, public and private mergers, and private equity and leveraged buyouts.

Experience and Recent Representations

  • In the most significant hostile takeover action involving a California corporation in years, we scored a resounding win for Depomed, Inc., a specialty pharmaceutical company focused on pain and other central nervous system conditions, defeating a hostile takeover bid by Horizon Pharma plc initially valued at $2.2 billion.  Following Horizon's launch of a public, unsolicited all-stock offer, our corporate team reinforced Depomed's structural defenses through the adoption of a "poison pill" and amended organizational documents to ensure a fair and orderly process for considering and responding to Horizon's bid.  With these measures in place, Horizon was unable to close on a hostile exchange offer or rush to a premature special meeting to replace Depomed's directors.  At the same time, our litigation team filed a lawsuit against Horizon alleging that its bid was unlawful and should be enjoined because it was premised on misuse of highly confidential information about Depomed's principal asset.  Following expedited discovery, briefing and argument, the Superior Court of Santa Clara County issued a rare preliminary injunction stopping the takeover.  Less than one hour after the ruling, Horizon dropped the attempt altogether.  This was an exceedingly rare case in which a hostile takeover was enjoined on the basis of a breach of a confidentiality agreement.
  • Successfully represented Sanofi in a complicated and hotly contested case involving patents on both pharmaceutical formulations and delivery devices.  At issue was Sanofi's Lantus/SoloSTAR® product, which is the third best-selling prescription drug in the United States and provides long-acting insulin for the treatment of diabetes.  This drug product is protected by patents covering the insulin glargine formulation as well as pen injector devices.  Eli Lilly and Company had filed New Drug Applications with the U.S. Food and Drug Administration seeking approval to market competitive insulin pen injector products.  In response, on behalf of Sanofi we brought an infringement suit under the Hatch-Waxman Act, asserting that Lilly's proposed product would infringe multiple patents owned by Sanofi.  On the morning of trial, just before opening statements, Lilly consented to, and the District of Delaware entered, an order enjoining Eli Lilly from selling its proposed product for more than a year.  As part of the negotiated resolution of this dispute, Lilly further agreed to a royalty-bearing license to certain Sanofi patents.
  • Also for Sanofi we secured dismissal of a novel False Claims Act lawsuit by qui tam relator Amphastar Pharmaceuticals, Inc..  The suit, which related to U.S. federal and state reimbursements for Sanofi's blockbuster anticoagulant drug Lovenox®, sought damages and fines exceeding $5 billion.  After a four-day evidentiary hearing, the Central District of California found that rather than independently developing  a generic version of Lovenox®, Amphastar had copied the teachings of Sanofi's patent.  As a result, the court determined that Amphastar had failed to prove that it qualified as an "original source" of the information underlying its allegations, a jurisdictional requirement under the False Claims Act for suits based on publicly disclosed information.  On that basis, the suit was dismissed.
  • Won Federal Circuit reinstatement of declaratory judgment claims for non-infringement, invalidity, and priority of invention for Danisco US Inc., against an adverse patent owned by Novozymes A/S.  An infringement suit had not been threatened or begun against Danisco's product (recombinant enzymes used in the production of fuel ethanol from corn) because the challenged patent issued the same day Danisco filed the declaratory judgment action.   However, Danisco anticipated such a development because of Novozymes's past conduct, including during prior patent litigation over similar recombinant enzyme products (in which we also successfully represented the company), and during prosecution before the U.S. Patent and Trademark Office (PTO).  The district court dismissed for lack of jurisdiction.  An appeal was filed presenting a question of first impression for the Federal Circuit: Could declaratory judgment jurisdiction be based exclusively on Novozymes's pre-patent issuance conduct (and thus during a period before Novozymes even could have filed an infringement suit)?  The Federal Circuit agreed with Gibson Dunn and unanimously reversed.  This decision represented the first time the Federal Circuit squarely held that declaratory judgment jurisdiction can be established in a patent case based on pre-patent issuance conduct.   
  • Obtained summary judgment of non-infringement in favor of St. Jude Medical in a suit in the Southern District of Florida accusing St. Jude's implantable pacemakers and defibrillators of infringing a patent directed to wireless networking and communication protocols.  Shortly after St. Jude was sued, we won a motion to dismiss under the recently enacted Leahy-Smith America Invents Act, as the plaintiff had improperly joined St. Jude with one of its primary competitors.  In a separate case then filed by the plaintiff against St. Jude, Gibson Dunn first obtained a favorable claim construction ruling, and then a favorable Daubert ruling, striking the plaintiff's entire damages expert report, which sought $798 million in damages.  We then won summary judgment of non-infringement on all asserted claims.
  • Won a Hatch-Waxman bench trial victory and permanent injunction for Allergan in the Eastern District of Texas, on Allergan's claims of patent infringement by generic versions of its glaucoma drug Lumigan X.  The court found all five Allergan patents valid, and that they would be infringed by sales of the generics.  The court issued a permanent injunction prohibiting the four defendant generic drug companies from launching their drugs.  The ruling protected this major Allergan product with annual sales of approximately $500 million. 
  • Won a bench trial and Federal Circuit affirmance for Allergan finding that its patents were valid and that proposed generic drugs would infringe them.  Gibson Dunn conducted the trial in federal court in Delaware in this Hatch-Waxman case against two generic drug manufacturers seeking to launch generic versions of Lumigan, Allergan's $400 million-per-year glaucoma drug.  The generic drug companies sought permission to launch their products years before Allergan's Lumigan patents were to expire, contending that the patents did not cover Lumigan or were invalid. The trial court gave a complete victory to Allergan. 
  • Secured Eighth Circuit affirmance on behalf of K-V Pharmaceutical Company and three of its executives of dismissal of a putative securities class action.  The company's stock price declined after the FDA announced it would not enforce K-V's market exclusivity over its new drug, Makena, which prevented preterm births in at-risk women.  K-V stockholders sued, alleging that the defendants knew or should have known that the FDA would not enforce market exclusivity.  In dismissing, the district court held among other things that defendants' statements were forward-looking, accompanied by meaningful cautionary language, and thus within the safe harbor of the Private Securities Litigation Reform Act.  The Eighth Circuit considered for the first time the safe harbor provision and in affirming also held K-V's statements to be within it and thus not actionable as a basis for a securities fraud action.  The Circuit also held that the district court had properly exercised its discretion in denying plaintiffs' attempt to amend their complaint.   
  • Obtained a victory on behalf of the directors of Allergan, Inc. in the Supreme Court of Delaware in derivative lawsuits brought by shareholders.  The substantively identical lawsuits against Allergan's directors were filed in both California and Delaware.  The court ultimately agreed with Gibson Dunn that a previous California dismissal by the Delaware Court of Chancery precluded further proceedings in Delaware, holding that under constitutional principles of full faith and credit, the preclusion law of California, not of Delaware, must be applied; and that under established California preclusion law, the dismissal of one shareholder derivative complaint precludes complaints by other shareholders on the same allegations and theories.
  • Secured reversal from the Delaware Supreme Court of a $250 million jury verdict in a breach of contract action against Covidien subsidiary ev3, Inc. arising from its purchase of Appriva, a company owning a single medical device, from plaintiffs, Appriva's shareholders.  Pursuant to the parties' final merger agreement, plaintiffs were entitled to milestone payments based on the device's regulatory approval.  They were not paid when, also pursuant to the agreement, ev3 exercised its "sole discretion" not to fund pursuit of the milestones, determining that the device was not commercially viable.  Gibson Dunn, retained for the appeal, presented argument before a panel of the court, which then submitted the appeal to the en banc court, before which Gibson Dunn presented re-argument.  The court held that the trial judge erred by allowing plaintiffs to argue that the parties' non-binding letter of intent should be used to inform the meaning of the final merger agreement, and ordered a new trial. 
  • Ultragenyx Pharmaceutical Inc., a biopharmaceutical company developing drugs to treat rare genetic and metabolic diseases, in a series of capital markets transactions, including public follow-on equity offerings raising nearly $280 million in proceeds.
  • A biotechnology hedge fund in a novel cross-border investment in a NASDAQ-listed issuer involving American Depositary Receipts (ADRs) and the creation of a parallel ADR structure in the United States.  The transaction involved collaboration across our San Francisco and London offices.
  • Avanir Pharmaceuticals, Inc. in connection with a $230 million follow-on equity offering, which was later followed by the sale of Avanir to Otsuka Pharmaceutical of Japan for $3.5 billion.
  • Allergan, Inc. in its $958 million acquisition of MAP Pharmaceuticals, a biopharmaceutical company.
  • Arrowhead Research Corporation in its acquisition of Novartis AG's RNAi research and development portfolio and associated assets.
  • St. Jude Medical, Inc. in numerous acquisitions, including its:
    • $375 million acquisition of the remaining 81% ownership of CardioMEMS, a medical device manufacturer
    • Acquisition of Endosense SA, a Switzerland-based medical device company, for up to $331 million
    • $200 million acquisition of NeuroTherm, a medical device company 
  • Covidien plc in its $1.5 billion refinancing of its senior revolving credit facility.
  • Lazard, Ltd. as financial advisor to Alexion Pharmaceuticals in the $8.4 billion acquisition of Synageva BioPharma. 
  • Heron Therapeutics, Inc. in multiple follow-on offerings, raising approximately $200 million in aggregate gross proceeds.
  • La Jolla Pharmaceutical Company in its numerous follow-on financings, including various PIPEs and underwritten offerings.