Monday, February 6, 2017
Biosimilars Enter the Courts: How Will Patent Infringement Settlements Be Tested for Validity Under Antitrust Laws?
Kirke M. Hasson (Pillsbury) and Maria Salgado (Cornerstone) ask Biosimilars Enter the Courts: How Will Patent Infringement Settlements Be Tested for Validity Under Antitrust Laws?
ABSTRACT: In the 30 years since the advent of generic drugs under the Hatch-Waxman Act, certain patterns of litigation and settlements have developed. We are now entering a stage where the courts are starting to deal with the entry into the market of “biosimilars”—biologic drugs that are highly similar to or interchangeable with biologic drugs that have already been approved by the FDA (“biologic reference products”). This relationship bears a number of similarities to the one between generics and branded drugs. However, the statutory procedures for, and economics applicable to, the advent of biosimilar products suggest there will potentially be some differences in the antitrust analysis of settlements between biologics and biosimilars for validity, as compared to the settlements between branded and generic drugs.