By Dennis Crouch
The 2009 Biologics Price Competition and Innovation Act (BPCIA) was created as the Hatch-Waxman Act for Biologics – a mechanism for both protecting innovator investment and for encouraging third-party follow-ons albeit through “biosimilars” rather than “generics.” While parallel in theory to Hatch-Waxman, BPCIA includes many complicating twists that on the already complex innovator-generic dance. In recent oral arguments, Judge Lourie stated that Congress might be awarded “the Pulitzer Prize for complexity or uncertainty” based upon its drafting of the BPCIA.
Amgen v. Sandoz (Fed. Cir. 2015) offers the Federal Circuit a case of first-impression regarding an important element of the BPCIA – what happens when the biosimilar applicant refuses to play?
Under the BPCIA, the ‘patent-dance’ is kicked-off by the filing of a biosimilar application. Under, the statute, that applications “shall” include a set of disclosures. 42 U.S.C. § 262(l)(2). In a three-way split decision, the Federal Circuit holds that an applicant is not actually required to make the disclosure (i.e., not a “must” requirement) but instead that failure to make the disclosure merely results in the penalty defined by statute – permitting the “reference product sponsor” but not the biosimilar applicant to bring an action of declaratory judgment for infringement based merely upon the filing of the application.
Judges Lourie, Newman, and Chen all filed separate opinions. Undoubtedly, the case will receive a petition for en banc rehearing as well as a petition for writ of certiorari.
Read the Decision: https://patentlyo.com/media/2015/07/AmgenSandoz.pdf