W. Chad Shear

Chad represents pharmaceutical companies in high-stakes patent litigation in the US and abroad. He is known globally for successfully protecting intellectual property rights and assets for his clients in make-or-break disputes that determine returns on multibillion-dollar investments and decades of research.

Over the course of his career, Chad has represented clients involving some of the top drugs on the market, including name brands, such as Gilead Sciences’ Sovaldi, Harvoni, Epclusa, Ranexa, Vemlidy, Descovy, Odefsey and Descovy for PrEP; Dainippon Sumitomo Pharma’s Latuda and Aptiom; and Iroko Pharmaceuticals’ Zorvolex and Vivlodex. Many of Chad’s cases are global, often involving multiple jurisdictions and major markets in Europe, North America and the Asia-Pacific region. Even in the most challenging of circumstances, Chad is known for his approachability, pragmatism, legal and business acumen, unwavering dedication to his clients and unflappability.

Chad’s trial experience is unmatched. He has served as lead trial attorney or as a member of the trial team in nearly two dozen trials, including numerous Hatch-Waxman cases. He is well versed in representing clients across multiple venues and jurisdictions, including the US Patent Trial and Appeal Board, the European Patent Office (EPO) and the US Court of Appeals for the Federal Circuit. Chad provides strategic legal counsel on a wide range of business matters by combining his litigation experience, network of scientific and business experts, and detailed knowledge of clients’ companies. He speaks and writes frequently on issues such as biosimilars and generics, Hatch-Waxman litigation, Markman hearings, and biotechnology and pharmaceutical patent due diligence. Chad also teaches life sciences trial and patent practice courses around the US. From 2001 to 2003, Chad clerked for Judge Haldane Robert Mayer of the US Court of Appeals for the Federal Circuit.

Chad’s recent representative experience

• Served as lead counsel in a Hatch-Waxman litigation for Gilead Sciences involving the company’s HIV compound tenofovir alafenamide; the matter involved nine generic drug companies and 15 abbreviated new drug applications, following the trend for such cases to become increasingly large each year, with the case favorably settling the night before trial was to begin*
• Helped persuade the Federal Circuit to overturn a California federal district court’s $1.2 billion judgment against client Kite Pharma, a Gilead subsidiary; the Federal Circuit ruled that a patent covering a form of cancer immunotherapy asserted by Bristol Myers Squibb’s Juno Therapeutics and the Sloan Kettering Institute for Cancer Research was invalid, with the US Supreme Court later denying a petition for rehearing en banc (Juno Therapeutics Inc. v. Kite Pharma Inc., 2:17cv7639, C.D. Cal.)*
• Helped wipe out the $2.5 billion willful infringement jury verdict against Gilead Sciences’ blockbuster drugs Sovaldi, Harvoni and Epclusa, which cure hepatitis C, in a case with the largest patent damages award in history, which was reversed after the legal team won a rare motion for judgment as a matter of law; in addition to federal court cases and post-grant proceedings at the US Patent and Trademark Office, the five-year battle included litigation in Norway, the UK, Canada, Germany and Australia – and before the EPO – with the team convincing the judge that a reasonable jury, even taking all of the evidence in the light most favorable to Idenix, could only conclude that Idenix’s patent was invalid due to lack of enablement (Idenix Pharmaceuticals LLC et al. v. Gilead Sciences, Inc.)*
• Served as co-lead counsel for client Dainippon Sumitomo Pharma (Sunovion) in protecting its multibillion-dollar branded drug Latuda, the company’s best-selling product, with the first wave of litigation involving 16 generic drug company defendants and the case being settled on the first day of trial (the magnitude of the result was reflected in the company’s stock, which went up nearly 20% in a matter of hours after settlement details were made public); to prevail in such a large case, Chad created and led an issue-focused sub-team, which provided strategic input on specifically defined aspects of the case*
• Handled 10 inter partes reviews (IPRs) filed by Initiative for Medicines, Access, and Knowledge (I-MAK) against multiple Gilead patents; the dispute was short-lived, with the legal team’s efforts preventing all of I-MAK’s IPRs from being instituted*
• Helped win three IPRs for Coherus BioSciences that invalidated patents for the blockbuster drug Humira; the Coherus case was among the most closely watched life sciences IPRs in 2017 due to its broader implications for the biosimilar industry (Coherus BioSciences, Inc. v. AbbVie Biotechnology Ltd.)*
• Led IP due diligence for Gilead’s successful $11.9 billion acquisition of Kite Pharma, which immediately positioned Gilead as a leader in cell therapy; since the deal, Chad has been tapped to help Gilead on several other related matters, and while this work falls outside IP litigation, he was invited to participate because of the trust and rapport he developed through his efforts to fully understand his client’s operations and to be their strategic business consultant*

* Representation handled prior to joining Cooley