A Sign of Future Biosimilars Litigation?
With the likely difficulty of demonstrating biosimilarity or interchangeability under the recent Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), patents covering analytical methods for biologic product characterization and quality control will likely play a larger role in providing protection for both innovator products and leaders in biosimilars development. In the recent Momenta v. Amphastar decision from the District Court for the District of Massachusetts, the court found that an alleged infringer of patented methods directed to quality control of a generic product could not seek safe harbor under § 271(e)(1) of the Hatch-Waxman Act. The court held that when such patented methods are used to test commercial batches after FDA approval of the generic product, the safe harbor provision does not shield against liability for infringement even when FDA guidelines require the generic manufacturer to practice these kinds of methods to establish "similarity" to the branded reference drug product. The decision may be a harbinger for future litigation as drug manufacturers decide how to protect and market biologics under the provisions of the BPCIA.