Practices

Life Sciences IP Litigation

Why Cooley

Cooley's life sciences IP litigation team brings decades of experience resolving high-stakes disputes in the pharmaceutical, biotechnology and medical device space. Our lawyers litigate matters involving complex technologies such as pharmaceutical compounds, monoclonal antibodies, biotechnology, genetically engineered organisms, biofuels, diagnostics, and biomedical technologies, among others, across key jurisdictions including district courts, the Patent Trial and Appeal Board, the US International Trade Commission, the Federal Circuit, the US Supreme Court, and in international arbitration forums.

We have significant experience representing branded pharmaceutical companies in ANDA litigation, protecting billions of dollars in sales. We are also well versed in the abbreviated biologics approval pathway under the Biologics Price Competition and Innovation Act (BPCIA). Cooley’s deep experience in litigation, patent prosecution, FDA and regulatory counseling regarding biologic products enables us to provide sophisticated analysis and advice in this specialty area.

We partner with clients to protect their commercial interests in game-changing technologies that are literally changing the world. At the outset, we develop comprehensive technical analyses to map out a winning litigation strategy and focus on breaking down complex scientific concepts to educate and persuade judges and jurors in order to achieve our clients’ goals.

Our team includes litigators with PhDs, master’s degrees and undergraduate degrees in fields such as biology, biochemistry, biophysics, chemistry, chemical engineering, immunology, microbiology, and molecular biology, among others. Many of our litigators are also members of the patent bar, and our litigation teams regularly draw from our 100+ person life sciences patent counseling and prosecution team, which is the largest team of its kind among any law firm in the US. Having such resources in-house enables us to perform in-depth internal analyses and reduces the need for costly outside experts for many litigation tasks.

Areas of Practice

  • Patent Litigation
  • Patent Office Litigation
  • Hatch-Waxman Litigation
  • Contractual and Licensing Disputes
  • Trade Secret Litigation
  • Section 337 ITC Investigations

Representative Matters

  • Leveraged a string of victories, including at the US Supreme Court, to favorably resolve a multi-year competitor patent battle for biofuels pioneer, Gevo
  • Secured multi-billion dollar victory for Gilead Sciences in "bet the company" arbitration against competitor involving exclusive rights to a breakthrough Hepatitis C drug

  • Obtained a huge win for Neptune Technologies and Bioressources against a key competitor, the largest krill oil producer in the world, in complex and extended patent litigation before the ITC and the PTAB, including an inter partes review that upheld two of Neptune’s patent claims

  • Lead trial counsel for Onyx Pharmaceuticals in a critical collaboration agreement dispute; defeated summary judgment motion and negotiated royalties and a $160 million lump sum payment from Bayer AG
  • Lead trial counsel for The Salk Institute For Biological Studies in a AAA patent license arbitration over intracellular steroid and assay technology resulting in a settlement valued at more than $17M for Salk
  • Fought off multiple PTAB challenges filed against Horizon Therapeutics’ patents regarding the drug Vimovo, including petitions filed by the hedge fund created entity “The Coalition for Affordable Drugs” (CFAD), as well as petitions filed by competitors in a parallel Hatch-Waxman litigation