Life Sciences

LEADERS

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.

LMG Life Sciences 2017 highlighted six Gibson Dunn practices in the area of Life Sciences – Corporate, Mergers & Acquisitions, Intellectual Property, Antitrust, Product Liability, and White-Collar/Government Investigation – and noted 13 lawyers as “Life Science Stars.”  At its 2017 LMG Life Sciences Awards the publication named Gibson Dunn Finance & Transactional Firm of the Year in both the Corporate and M&A categories; recognized two of the firm’s deals as Finance & Transactional Impact Deals of the Year; and named two Gibson Dunn partners as Attorney of the Year in their respective practices.  Law360 named Gibson Dunn a 2015 Life Sciences Practice Group of the Year.
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 & 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.

​Gibson Dunn’s transactional lawyers have handled U.S. and international public and private mergers and acquisitions for companies in the life sciences sector and have provided counseling on financings, securities offerings, corporate governance, licensing and other collaborations.  Combined with our exceptional securities regulatory strength, we have breadth and insight that few firms can match in transactions including:

  • Public and private debt and equity offerings
  • Stock and asset acquisitions
  • Public and private mergers
  • Private equity and leveraged buyouts

Our clients range from large pharmaceutical companies to small biotechnology companies and include investment banks that serve as financial advisors to life sciences companies on significant acquisitions, as well as private equity funds, hedge funds and venture funds providing capital to these transactions.

Mergers & Acquisitions

Gibson Dunn’s life sciences and mergers and acquisitions lawyers regularly represent both buyers and sellers in transactions of all sizes, navigating business and legal issues effectively and efficiently.

Our life sciences M&A lawyers operate with a collaborative approach, working closely with colleagues in adjacent areas, such as FDA regulatory, intellectual property, tax, antitrust, health care, employment and employee benefits.  By providing a fully integrated team and working closely together, our M&A practitioners are able to manage our clients’ needs and present solutions to issues often before they are identified by our clients.  Additionally, given that we represent both buyers and sellers, we are able to understand the perspective of both sides in M&A transactions and effectively manage many issues to ensure a smooth transaction.

Capital Markets

Gibson Dunn’s Capital Markets Practice Group advises life sciences clients in capital-raising transactions across the debt/equity continuum.  Our experience includes IPOs, follow-on equity offerings, convertible, high-yield and investment-grade debt, preferred stock and hybrid securities.  We also regularly advise clients in connection with:

  • Shelf registrations
  • PIPEs and other private placements
  • Registered direct offerings
  • Exchange offers
  • Rights offerings
  • Warrant transactions
  • “At the market” equity offerings
  • Medium-term note programs
  • Subsidiary carve-outs
  • Spin-offs and split-offs
  • Special purpose acquisition companies (SPACs)
  • Liability management transactions such as debt tenders and consent solicitations

With an extensive representation of issuers and underwriters, combined with our exceptional securities regulatory strength, we provide comprehensive service, practiced judgment and deep understanding of the issues involved.

Licensing and Joint Ventures

Gibson Dunn lawyers represent life sciences clients in a wide variety of U.S. and international transactions involving the licensing, acquisition, development, marketing and distribution of intellectual property, including co-development and joint venture agreements.

A significant aspect of our licensing practice includes patent licensing, such as:

  • Cross-licenses
  • Licenses granted by patent pools or industry consortia
  • Licenses granted as part of a strategic licensing program
  • Licenses arising out of the settlement of litigation

We couple our experience in the pharmaceutical, medical device and biotechnology industries with our extensive IP knowledge to ensure that our clients enter into appropriate licensing transactions that protect their intellectual property rights.

RECENT PUBLICATIONS

Federal Circuit Update (November 2017)

-November 30, 2017

2017 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

-August 25, 2017

Cybersecurity & Data Privacy: An Overview for Health Care, Pharmaceutical, and Biotech Companies

-August 8, 2017

Webcast: 2017 Mid-Year Update: The False Claims Act and Drug and Device Manufacturers

-August 2, 2017

TC Heartland—A Renewed Opportunity to Challenge Venue in Patent Infringement Cases

-June 15, 2017

Federal Circuit Update (March 2017)

-March 28, 2017

Federal Circuit Update (January 2017)

-January 26, 2017

2016 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

-January 12, 2017

Using and Defending Against Statistical Sampling in False Claims Act Cases

-January 1, 2017

2015/2016 Federal Circuit Year in Review

-December 7, 2016

The Trump Presidency: Selected Initial Observations and Considerations

-November 15, 2016

Compliance Perspectives on the Developing Contours of the PSQIA

-October 3, 2016

Federal Circuit Update (September 2016)

-September 29, 2016

2016 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

-July 27, 2016

Federal Circuit Update (May 2016)

-May 26, 2016

Federal Circuit Update (March 2016)

-March 24, 2016

Federal Circuit Update (January 2016)

-January 27, 2016

2015 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

-January 19, 2016

Patent Disputes Over Biologics: Will Anyone Come To The Dance?

-January 7, 2016

2015 Year-End False Claims Act Update

-January 6, 2016

2015 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

-January 5, 2016

Damages for Infringement of a Pharmaceutical Patent: A Novel Analysis

-January 1, 2016

M&A Report – Depomed Decision Highlights Importance of Careful Monitoring of M&A Non-Disclosure & Use Obligations

-November 20, 2015

2014/2015 Federal Circuit Year in Review

-November 9, 2015

Another Successful Challenge to Restrictions on Off-Label Promotion

-August 13, 2015

RICO Suits Challenge Off-Label Drug Marketing

-August 3, 2015

Amgen v. Sandoz: Like a song from the ’80s, the Federal Circuit says “You can dance if you want to . . .”

-July 27, 2015

2015 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

-July 16, 2015

2015 Mid-Year Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

-July 8, 2015

2015 Mid-Year False Claims Act Update

-July 8, 2015

EU Merger Control in the Pharmaceutical Sector

-July 1, 2015

A Practical Guide to the Use of the Commissioned Public Report as an Effective Crisis-Management Tool

-June 12, 2015

U.S. SEC Adopts Final Rules Implementing “Regulation A+” Offering Exemption for Offerings of up to $50 Million

-April 22, 2015

2014 Year-End FDA Compliance and Enforcement Update – Food and Dietary Supplements

-March 2, 2015

Cybersecurity and Data Privacy Outlook and Review: 2015

-February 17, 2015

2014 Year-End Health Care Compliance and Enforcement Update – Providers

-January 14, 2015

2014 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

-January 14, 2015

2014 Year-End False Claims Act Update

-January 7, 2015

2014 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

-January 6, 2015

Contingent Value Rights: A Middle Ground in M&A Boom

-September 11, 2014

Long-Term Outlook for M&A is More Modest

-September 9, 2014

2014 Mid-Year False Claims Act Update

-July 9, 2014

2014 Mid-Year Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

-July 8, 2014

To Institute or Not to Institute IPR? That Question Is Not Immediately Reviewable by the Federal Circuit

-May 5, 2014

2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 2)

-May 1, 2014

2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 1)

-April 1, 2014

U.S. Supreme Court Places the Burden of Proving Infringement on Patent Holders in Declaratory Judgment Actions

-January 23, 2014

2013 Year-End False Claims Act Update

-January 8, 2014

2013 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

-January 7, 2014

Comparing Strategies in MFW Shareholders and Siga v. PharmAthene

-December 25, 2013

World War Z: Why Life Sciences Companies May be in the Path of the “New” Securities Enforcement & Litigation Onslaught, & How to Avoid Trouble

-August 1, 2013

2013 Mid-Year False Claims Act Update

-July 10, 2013

United States Sentencing Commission Adopts Greater Penalties for Fraud Offenses and Fixes Anomaly in Sentences for Tax Crimes

-April 23, 2013

The European Commission Launches a Consultation Process in Relation to the Manufacturing Practices for Medicinal Products

-February 27, 2013

2012 Year-End Health Care Enforcement Update

-February 22, 2013

Off-Label Promotion: Still a Crime?

-January 14, 2013

2012 Year-End False Claims Act Update

-January 8, 2013

2012 Year-End Update on Corporate Deferred Prosecution Agreements (DPAs) and Non-Prosecution Agreements (NPAs)

-January 3, 2013

The End of Off-Label Prosecutions? The Second Circuit Rules That a Pharmaceutical Sales Representative’s Criminal Conviction for Off-Label Promotion Violates the First Amendment

-December 4, 2012

With a Scalpel Not a Sledgehammer: Resolving FDCA Investigations through Deferred Prosecution and Non-Prosecution Agreements

-November 1, 2012

2012 Mid-Year False Claims Act Update

-July 12, 2012

2012 Mid-Year Update on Corporate Deferred Prosecution and Non-Prosecution Agreements

-July 10, 2012

U.S. Supreme Court Issues Long-Awaited Decision on the Constitutionality of the Affordable Care Act

-June 29, 2012

In a Ruling with Important Implications for Courts’ Deference to Agencies, U.S. Supreme Court Rejects Department of Labor Position on Overtime for “Outside Sales” Employees

-June 19, 2012

Supreme Court Tightens the Standard for Patent Eligibility Under Section 101 of the Patent Act

-March 21, 2012

2011 Year-End Health Care Compliance Update

-February 6, 2012