Industries
Life Sciences
Renowned for excellence in life sciences, excelling in corporate transactions, regulatory compliance, and high-stakes disputes.
Overview
Gibson Dunn’s Life Sciences Group delivers unparalleled expertise and strategic guidance to life sciences companies at any stage.
We advise innovative biotechnology, pharmaceutical, medical device and diagnostic companies on a wide range of legal, regulatory, and strategic issues. Our services include mergers and acquisitions, strategic corporate transactions, financings, patent and product liability litigation, FDA investigations and enforcement actions, and ongoing regulatory advice. Our lawyers, many with advanced scientific degrees and hands-on experience in the life sciences industry and regulatory agencies, bring unparalleled expertise to our clients. We provide tailored legal guidance throughout the entire life cycle of life sciences companies, from early-stage startups to mature enterprises. This includes intellectual property management, antitrust, regulatory approvals, market access strategies, post-market compliance, litigation capabilities, patent validity, and potential exit strategies through M&A or public offerings.
Our Life Science lawyers represent companies in the full gamut of legal services, including:
Corporate Transactions: We manage a broad range of corporate transactions, including mergers and acquisitions, capital markets transactions, debt financing, and private equity investments. Our services also encompass strategic advisory on public and private offerings, venture financing, and royalty-based financings.
Litigation: Our team excels in handling complex patent and product liability litigation as well as antitrust matters, including high-stakes intellectual property disputes, trade secret litigation, defending against class actions and securities litigation as well as pay-for-delay and related antitrust claims.
Regulatory Compliance: We provide comprehensive counsel on FDA regulatory compliance, navigating investigations and enforcement actions by the DOJ and FTC, and ensuring adherence to industry standards and regulations.
Licensing and Strategic Alliances: Our expertise extends to negotiating and structuring licensing agreements, joint ventures, collaborations, and other strategic alliances, ensuring robust protection and commercialization of intellectual property assets.
Advisory Services: We offer strategic advice on corporate governance, securities compliance, risk management, and other critical operational aspects to help life sciences companies navigate complex legal landscapes and achieve their business objectives.
Our deep understanding of the life sciences sector, combined with our multidisciplinary approach and creativity, ensures that we can support clients through each critical phase of their development and growth.
“The Gibson Dunn team is uniquely excellent. They are fantastic lawyers who are extremely commercial – they make my life very easy.”
Chambers USA, client quote
Experience
- Abbott Labs: Secured a defense victory for Abbott Labs in a significant age discrimination jury trial in federal court in New Jersey, with the jury returning a defense verdict after just 30 minutes.
- Enanta: Acted for Enanta in a lawsuit in the District of Massachusetts, asserting that Pfizer Inc.’s Paxlovid™ infringes an Enanta patent that issued earlier that month, based on Enanta’s July 2020 patent application describing coronavirus protease inhibitors invented by its scientists.
- Esperion Therapeutics: Represented Esperion Therapeutics in a lawsuit against Daiichi Sankyo Europe (DSE) over a $200-300 million milestone payment crucial to Esperion’s financial survival. After taking over from prior counsel, Gibson Dunn swiftly set a trial date, conducted extensive discovery, and ultimately negotiated a favorable settlement just days before key depositions, securing an immediate cash payment and reduced future manufacturing costs for Esperion.
- Immunomedics: Secured a $40 million settlement in a shareholder lawsuit following the FDA’s initial withholding of approval for their now top-selling breast cancer drug, culminating in the company’s $21 billion acquisition by Gilead.
- Merck & Co.: Represented Merck in a significant victory when the Fourth Circuit vacated and remanded the district court’s certification of a class of 35 large and sophisticated drug wholesalers on numerosity grounds, clarifying that class actions are the exception and that plaintiffs must prove the impracticability of joinder through actual evidence, not merely the risk of multiple lawsuits.
- Gyroscope Therapeutics: Obtained a victory for Gyroscope Therapeutics, a clinical-stage gene therapy company focused on treatments for diseases of the eye, winning a motion to compel arbitration of a trade secrets suit.
- Northwest Biotherapeutics: Won dismissal of a securities class action for Northwest Biotherapeutics asserting claims under Sections 10(b) and 20(a) of the Securities Exchange Act and challenging the company’s public statements about the development of its cancer vaccines.
- CNS Vital Signs: Represented CNS Vital Signs, a leading neurocognitive testing software seller, in a case brought by rival Impact Applications alleging that CNS’s concussion tests and their marketing infringed Impact’s trademarks and copyrights and otherwise constituted unfair and deceptive trade practices.
- Novartis: Achieved a complete victory for Novartis in patent litigation in the District of Delaware against four generic companies challenging the patent covering GILENYA.
- Merck & Co.: Represented Merck in a Delaware District Court patent litigation brought by Mayne Pharma alleging infringement in the sale of NOXAFIL, an anti-fungal drug; achieved a complete victory after bringing and having instituted an IPR to challenge the asserted patent.
- Novartis: Represented the company in a Delaware District Court patent litigation brought by Shilpa Pharma alleging infringement of a polymorph patent by GILENYA; achieved complete victory upon instituting and then winning a parallel IPR proceeding challenging the patent.
- Amgen Inc.: Serve as lead counsel for Amgen Inc. in an antitrust lawsuit brought by Regeneron Pharmaceuticals, alleging unlawful monopolization of the cholesterol drug market through anticompetitive rebates, with the case involving novel competition issues. (ongoing)
- Novartis: Represented Novartis in Hatch-Waxman patent litigation involving oncology drug RYDAPT, a path-breaking tyrosine-kinase inhibitor.
- Sage Therapeutics: Represented Sage Therapeutics in successfully resolving collaboration agreement dispute, avoiding litigation and allowing for the public launch of a life-saving psychotropic drug.
- Novartis: Representing the company in Delaware District Court in the first-ever Hatch-Waxman litigation involving a radio-ligand cancer therapy called LUTATHERA.
- Elliott Investment Management: Advised Elliott Investment Management, a fund manager, on the $7.1 billion acquisition by a private investment consortium of Syneos Health, a biopharmaceutical solutions organization.
- Merck: Advised Merck, a pharmaceutical company, on its $3 billion acquisition of EyeBio, an ophthalmology biotech company.
- Cullgen: Advised Cullgen, a developer of new chemical entities for disease treatment, on a $1.9 billion strategic collaboration and option agreement to advance innovative targeted protein degraders with Astellas Pharma, a Tokyo-based developer of drugs for unmet medical needs.
- CTI BioPharma: Advised CTI BioPharma, a biopharmaceutical developer of targeted therapies for blood-related cancers, on its $1.7 billion acquisition by Sobi, a global hematology, immunology and specialty care biotech company.
- Amryt Pharma: Advised Amryt Pharma, a commercial-stage biopharmaceutical company, on its $1.25 billion acquisition by Chiesi Farmaceutici, an Italian biopharmaceuticals and healthcare group.
- Epygenix Therapeutics: Advised Epygenix Therapeutics, a clinical-stage developer of genetic epilepsy treatments, on its acquisition by Harmony Biosciences, developer of commercial-stage drugs for rare neurological diseases.
- CPE: Advised CPE, a private equity firm in China, on the $523 million sale of its majority stake in Acotec, a Chinese interventional medical device company, to Boston Scientific, a U.S. medical device company.
- Apogee Therapeutics: Advised Apogee Therapeutics, a developer of therapies for immunological and inflammatory disorders, on its upsized initial public offering.
- Dianthus Therapeutics: Advised Dianthus Therapeutics, a clinical-stage developer of monoclonal antibodies for autoimmune disease, on its private placement of shares of common stock and pre-funded warrants to new and existing investors.
- Bora Pharmaceuticals: Advised Bora Pharmaceuticals, a Taiwan pharmaceutical manufacturer, on its acquisition of Upsher-Smith Laboratories, a generics manufacturer, from shareholders Sawai Group, a Japanese over-the-counter drug company, and Sumitomo, a trading and investment company.
- Royalty Pharma: Advised Royalty Pharma, the largest royalty buyout fund globally, in multiple transactions, including the acquisition of Immunext, the developer of a novel multiple sclerosis drug candidate in Phase 3 clinical trials.
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