USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
11. Collective Redress 11.1 Group Claims
challenge a patent until it is preparing for regulatory approval of a generic or biosimilar product.
Class action lawsuits brought by consumers in the pharmaceutical industry typically involve product lia ‑ bility claims and do not intersect with patent litigation. However, patent cases involving the same patents and products are sometimes consolidated for pre-trial proceedings either informally or through multidistrict litigation (MDL) under 28 USC Section 1407. See, for example, In Re: Aflibercept Patent Litigation , MDL No 1:24-md-03103 (NDWV).
9. Alternative Dispute Resolution 9.1 ADR Options ADR processes are available for all types of cases in the US, including pharmaceutical cases. Many courts include a date in the schedule by which par ‑ ties must report that they have engaged in settlement talks. Companies in the Hatch-Waxman and BPCIA space are typically sophisticated entities that have settlement experience, and they often negotiate set ‑ tlements without the help of an arbitrator or mediator.
10. Settlement/Antitrust 10.1 Considerations and Scrutiny
Parties in Hatach-Waxman and BPCIA cases must file their settlements with the Federal Trade Commission. The US Supreme Court has held that patent settle ‑ ments can violate the antitrust laws, particularly if they include “reverse payments” in the form of money or other consideration that exceeds litigation costs for the generic manufacturer to delay entry into the mar ‑ ket. FTC v Actavis, Inc. , 570 U.S. 136, 159 (2013).
269 CHAMBERS.COM
Powered by FlippingBook