Life Sciences

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.

View our Life Sciences 2024 Outlook: Highlights from the past year in life sciences and a look to the year ahead.

LMG Life Sciences 2021/2022 recognized Gibson Dunn in five practice areas in the field of life sciences – Competition & Antitrust, Corporate, General Patent Litigation, Mergers and Acquisitions, and White-Collar/Government Investigations – also noting 13 lawyers as Life Sciences Stars. The publication honored Gibson Dunn as its “General Patent Litigation Firm of the Year,” featuring Novartis Pharmaceuticals v. Accord Healthcare as “Hatch-Waxman Impact Case of the Year” and United States v. Arthrex as “Patent Impact Case of the Year.” Additionally, Law360 named Gibson Dunn a 2021 Life Sciences Practice Group of the Year, for the second consecutive year, noting the firm’s work “on major deals for pharmaceutical giants, including Merck’s $11.5 billion acquisition of a cancer and rare disease biotech and its spinoff of a $9 billion women’s health care company. ” Law360 also named Jane Love a 2021 Life Sciences MVP for her win on behalf of Novartis Pharmaceuticals and its multiple sclerosis drug Gilenya.

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.

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.

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.

Life Sciences

LEADERS

Jane M. Love, Ph.D.

Ryan A. Murr

Overview

EXPERIENCE & RECENT REPRESENTATIONS

RECENT PUBLICATIONS

Federal Circuit Update (March 2024)

Ryan Murr and Saee Muzumdar Named Among 2023 Top Ten Mid Cap M&A Lawyers in North America

Webcast: Life Sciences 2024 Outlook

Behind The ‘CVR Spin’ Method Of Unlocking Assets In M&A

Life Sciences Review and Outlook – 2024

Federal Circuit Update (February 2024)

Federal Circuit Update (January 2024)

How Biotech Cos. Can Utilize Synthetic Royalty Financing

Federal Circuit Update (December 2023)

Federal Circuit Update (November 2023)

Federal Circuit Update (October 2023)

False Claims Act Risks for Cyber Device Manufacturers Arising under New Requirements Subject to FDA Enforcement Beginning October 1, 2023

FDA Publishes Proposed Rule Asserting Medical-Device Jurisdiction over Laboratory-Developed Tests

Federal Circuit Update (September 2023)

FDA Draft Guidance Sheds Light on Agency’s Evaluation of Prescription Drug Use-Related Software

LMG Life Sciences 2023 Recognizes Gibson Dunn in Six Practices and Names 14 Lawyers Stars

Federal Circuit Update (August 2023)

Federal Circuit Update (July 2023)

Two Gibson Dunn Deals Named Impact Deals of the Year at the LMG Life Sciences Awards EMEA 2023

Gibson Dunn Represents Apogee Therapeutics, Inc. in Upsized Initial Public Offering

Federal Circuit Update (June 2023)

Federal Circuit Update (April 2023)

Federal Circuit Update (March 2023)

Who’s Who Legal Recognizes 39 Gibson Dunn Partners in its Inaugural Thought Leaders USA Guide

Euromoney’s Rising Star Awards 2022 Recognizes 16 Gibson Dunn Partners

LMG Life Sciences 2022 Recognizes Gibson Dunn in Six Practices and Names 13 Lawyers Stars

11 Gibson Dunn Partners Named Lawyers of the Year

Two Who’s Who Legal 2022 Guides Recognize Seven Gibson Dunn Partners

Gibson Dunn Named a 2021 Firm of the Year

LMG Life Sciences Recognizes Gibson Dunn in Six Practices and Names 13 Lawyers Stars

Gibson Dunn Named Patent Litigation Firm of the Year by LMG Life Sciences

Law360 Names Six Gibson Dunn Partners as 2021 MVPs

Webcast: The Supreme Court’s Omnicare Decision: A Key Tool for Defending Securities Litigation Brought Against Life Sciences Companies

Gibson Dunn Named a 2020 Firm of the Year

LMG Life Sciences Names 13 Partners as Stars

Thirteen Gibson Dunn Partners Recognized in Expert Guides’ Women in Business Law

Corporate Partner Robert Phillips Joins Gibson Dunn in San Francisco

Jane Love Named Among Top Women in IP 2020

Update on Intellectual Property-Related Issues in the Response to COVID-19

Webcast: Pharma, Medical Device, and Biotech Antitrust Update: New Developments and What They Mean

Jane Love Named a Health Care/Life Science Trailblazer

COVID-19 And Life Sciences Companies – 10 Actions To Consider

Life Sciences Partner Karen Spindler Joins Gibson Dunn

Law360 Names Nine Gibson Dunn Partners as 2019 MVPs

Gibson Dunn Lawyers Recognized in the Best Lawyers in America® 2020

Four Gibson Dunn Partners Recognized in Who’s Who Legal 2019 in Tax, Life Sciences and Insurance

Supreme Court Holds That Courts, Not Juries, Must Decide Whether The FDA’s Rejection Of A Proposed Warning Label Provides “Clear Evidence” To Preempt A State-Law Failure-To-Warn Claim

2018 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

LMG Life Sciences Recognizes Gibson Dunn in Six Practices and Names 11 Lawyers Stars

SEC Warns Public Companies on Cyber-Fraud Controls

Federal Circuit Update (October 2018)

Three Gibson Dunn Partners Recognized Among Americas Rising Stars

Gibson Dunn Win Recognized at LMG Life Sciences Awards

Federal Circuit Update (July 2018)

2018 Mid-Year Government Contracts Litigation Update

Acting Associate AG Panuccio Highlights DOJ’s False Claims Act Enforcement Reform Efforts

Who’s Who Legal Recognizes Six Gibson Dunn Partners

FDA Releases Draft Guidance Proposing a Significant Expansion of the Abbreviated 510(k) Pathway for Medical Devices

Federal Circuit Update (March 2018)

TC Heartland and Hatch-Waxman: Square Peg in a Round Hole

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

Federal Circuit Update (November 2017)

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

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

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

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

Federal Circuit Update (March 2017)

Federal Circuit Update (January 2017)

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

Using and Defending Against Statistical Sampling in False Claims Act Cases

2015/2016 Federal Circuit Year in Review

The Trump Presidency: Selected Initial Observations and Considerations

Compliance Perspectives on the Developing Contours of the PSQIA