Litigation
Life Sciences IP Litigation
“Tackling both transactions and disputes in the life sciences sector, Gibson Dunn & Crutcher LLP is sought out by clients engaged in Hatch-Waxman and product liability litigation…” Legal 500 U.S.
Overview
Gibson, Dunn has a robust life sciences litigation practice, representing clients in a variety of high-stakes disputes within the pharmaceutical, biotechnology, medical device, and healthcare sectors.
Gibson Dunn represents and advises cutting edge biotechnology, pharmaceutical, and medical device companies in their most important matters. We are proud to be at the forefront of helping these companies realize their mission of treating disease and alleviating suffering. We are honored to have so many of the most important companies in the industry turn to use when the stakes are high. Our litigators represent clients in defending and asserting their core patent and other intellectual property rights that are the lifeblood of the industry. Our legal and scientific expertise spans across Hatch-Waxman, competitor, and BPCIA litigation, and has involved technologies in a multitude of therapeutic and technology areas, such as oncology, immunology, genomics and many others.
The groups 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 listings 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.
The firm has significant experience in patent litigation involving life sciences technologies. This includes representing clients in cases related to drug patents, biologics, medical devices, and diagnostic technologies. Our lawyers have successfully litigated cases in federal courts, including the U.S. District Courts and the U.S. Court of Appeals for the Federal Circuit, as well as before the Patent Trial and Appeal Board (PTAB).
Learn more about our Life Sciences practice by clicking below.
Experience
Recent representations include:
- Allergan: Won Hatch-Waxman bench trial victory and permanent injunction for Allergan in the Eastern District of Texas in relation to Allergan’s claims of patent infringement by generic versions of its glaucoma drug LUMIGAN.
- Sanofi: Successfully represented Sanofi in a complicated and hotly contested case involving patents on both pharmaceutical formulations of LANTUS SOLOSTAR and delivery devices.
- Merck Sharp & Dohme Corp.: Successfully represented Merck Sharp & Dohme Corp. in ANDA patent litigation in the District of Delaware against generic-manufacturers Fresenius Kabi and Mylan Laboratories concerning NOXAFIL.
- Novartis: Achieved a complete victory for Novartis in patent litigation in the District of Delaware against four generic companies challenging the patent covering GILENYA.
- Novo Nordisk: Represented Novo Nordisk in a series of Hatch-Waxman litigations concerning NOVONORM (repaglinide and metformin) for treatment of Type II diabetes.
- Leading Pharmaceutical Co.: Obtained a favorable resolution for a leading pharmaceutical company in a Hatch-Waxman litigation in the District of Delaware concerning LETAIRIS, used to treat pulmonary arterial hypertension.
- Genzyme: Represented Genzyme in Hatch-Waxman litigations in the District of Maryland concerning patents on polymer based pharmaceuticals RENAGEL, RENVELA, and CHOLESTIPOL, for the treatment of chronic kidney disease and high cholesterol.
- Acorda Therapeutics Inc.: Won Federal Circuit victory for Acorda holding defendant Mylan Pharmaceuticals Inc. subject to specific personal jurisdiction in the District of Delaware in a Hatch-Waxman patent infringement suit.
- Assertio Therapeutics Inc.: Represented Assertio (formerly Depomed) in Hatch-Waxman litigation concerning Assertio’s most important asset, the opioid drug NUCYNTA.
- 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.
- Novartis: Represented Novartis in Hatch-Waxman patent litigation involving oncology drug Rydapt,a path-breaking tyrosine-kinase inhibitor.
- Novartis: Representing the company in Delaware District Court in the first-ever Hatch-Waxman litigation involving a radio-ligand cancer therapy called LUTATHERA.
- 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.