is an Intellectual Property attorney with Womble Carlyle Sandridge & Rice, LLP, with a particular background in pharmaceutical patents. Her practice includes counseling clients in ANDA and Hatch-Waxman Act litigation. Thakore practices in Womble Carlyle’s Atlanta office.
Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, providing twelve years of market exclusivity to pioneer biologics… Like the Hatch-Waxman Act, the BPCIA also sets out a process for identifying disputes over patent infringement and managing any ensuing litigation once an applicant seeks a biosimilar license… To streamline the first wave of litigation, the BPCIA mandates that following the biosimilar applicant’s receipt of the RPS’s detailed statement on infringement, the parties negotiate in good faith to select patents for litigation from the lists initially provided by the RPS and the biosimilar applicant. [§ 262(l)(4)].
Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal Circuit concluded that an aBLA filer’s participation in the patent dance is not mandatory under the BPCIA. 794 F.3d 1347 (Fed. Cir. 2015). Where an aBLA filer elects to forego the patent dance by failing to provide the aBLA and the biosimilar manufacturing information to the RPS, the only remedy available to the RPS lies in a declaratory judgment action for patent infringement, as expressly contemplated by § 262(1)(9)(C). In addition, the court concluded that an aBLA filer who did not engage in the patent dance was required to provide a notice of commercial marketing and that such notice could be effectively given only after the FDA had approved the aBLA. The court’s ruling left open the question whether an aBLA filer who participated in the patent dance was required to provide a notice of commercial manufacturing. This decision is on appeal to the Supreme Court, which has yet to decide whether it will hear the issue.