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NERA Insights Webinar | Navigating Antitrust Concerns in Biosimilar Patent Settlements
29 September 2020
Hosted By: NERA Economic Consulting
It has been seven years since the US Supreme Court issued its landmark decision in FTC v. Actavis, finding that reverse payment settlements would be tested for antitrust concerns by a rule-of-reason analysis. In recent years, as patents have expired and biosimilars have entered the marketplace, claimants have initiated antitrust litigations stemming from pay-for-delay or reverse payment allegations related to biosimilar entry agreements.
From an economic perspective, antitrust analyses of biologic reverse payment matters share some similarities with that of small-molecule reverse payment matters. However, differences between the economic and market conditions for biologic and small-molecule drugs mean that practitioners cannot simply translate analyses and arguments from small-molecule cases to biologic cases.
In this free, one-hour webinar, held on Tuesday, 29 September, at 12:00–1:00 pm EDT, Associate Director Dr. Sheng Li, former Senior Consultant Dr. Omar Robles, and White & Case Partner Bryan Gant will:
- Provide an overview of the biologics industry, including regulatory differences between generics and biosimilars;
- Discuss how the absence of state mandates for automatic substitution of biosimilars may affect the economic analyses of class certification, market power, and competitive effects; and
- Examine antitrust injuries in biosimilar reverse payment cases and potential problems with the “could have” test.
CLE
1 CLE credit hour is approved in California. CLE credit in New York is pending approval.
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Dr. Sheng Li is an Associate Director in NERA’s Antitrust and Competition Practice, and its Intellectual Property Practice, where he conducts research and economic analysis in antitrust and intellectual property matters. He has evaluated damages theories in cases involving alleged monopolization, exclusive dealing, and price fixing. Dr. Li has also assessed damages arising from patent infringement and issues related to antitrust patent misuse. He has analyzed competitive issues in a variety of industries, including medical devices, auto insurance, transoceanic shipping, and prescription eyewear. He has recently published articles in various publications of the American Bar Association’s Section of Antitrust and has been featured in a legal podcast discussing topics such as big data, artificial intelligence, and life sciences matters.
Dr. Omar Robles is a former Senior Consultant in NERA’s Intellectual Property Practice and the Antitrust and Competition Practice. He has worked on numerous cases in the life sciences industry, including cases pertaining to dietary supplements, pharmaceutical products, and medical devices. Dr. Robles actively consults on commercial success, harm resulting from patent infringement (damages, reasonable royalty and lost profits, and irreparable harm), the relevant antitrust market, and harm resulting from reverse payment settlements. His engagements have included products approved in the US, Canada, and Latin America.
Bryan Gant focuses on complex commercial litigation and counseling, primarily in the antitrust area. He has particular knowledge of the intersection of antitrust and intellectual property. A Partner in White & Case’s Global Antitrust Practice based in New York, Mr. Gant regularly represents clients in the pharmaceutical, financial services, and petroleum industries. Notable clients include Pfizer, Allergan, Boehringer Ingelheim, Experian, Novartis, OPEC, and Warner Chilcott. Bryan’s knowledge and experience span a wide range of issues, including reverse payment settlements of patent disputes, product innovation and product retirement (so-called “product hopping”), price-fixing, fraudulent procurement of patents, and other misconduct before the US Patent & Trademark Office, sham litigation, sham petitioning of the FDA, product bundling, and other antitrust theories.
To contact us about this event, please click here.