On October 16, 2015, the Court of Appeals for the Federal Circuit ("Federal Circuit") opted not to rehear its previously issued split decision in the court's first analysis of the Biologics Price Competition and Innovation Act (BPCIA) and rights and obligations of patent owners and biosimilar applicants under the Act. For now, the public is left with the split decision of the original panel and the many questions it leaves.
The BPCIA creates an abbreviated licensure pathway for similar versions ("biosimilars") of previously approved biologics ("reference products"). To obtain approval of a biosimilar under the Act, the applicant must demonstrate that its product is, among other things, "highly similar" to the approved reference product. Key among the provisions of the BPCIA, and at the heart of the Amgen, Inc. v. Sandoz, Inc. ruling, are the provisions on information exchange ("patent dance") and 180-day notice of commercial marketing. Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015).
In May 2014, Sandoz filed an abbreviated biologics license application ("aBLA") seeking approval of its biosimilar version of Amgen's filgrastim product Neupogen®. After failing to provide Amgen with a copy of its aBLA and manufacturing information, which Amgen asserted was mandatory under the BPCIA, Amgen filed suit against Sandoz. On July 21, 2015, a divided panel of the Federal Circuit ruled that the information exchange and patent dance procedures were optional and that a biosimilar applicant could choose not to engage in them, but that the 180-day notice of commercial marketing requirement, at least for biosimilar applicants who have opted out of the patent dance, was mandatory, and that a notice would only be effective after the FDA approved the aBLA. See: Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for Brand-Name Biologics for more details on the initial ruling.
Each party filed a petition asking the court for rehearing of the respective issue that was decided against it: Amgen sought rehearing of the majority's ruling that where a biosimilar applicant opts out of the patent dance, a reference product sponsor's sole remedy is to sue for patent infringement or a declaratory judgment; and Sandoz sought rehearing of the majority's ruling that notice of commercial marketing is not legally effective until the aBLA is approved. The court's order denying the petitions was silent as to the rationale for the denial and gave no indication how the various judges voted. The parties have until January 14, 2016, to petition for certiorari to the Supreme Court on their respective issues. We think the odds are good that both will do so.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
