In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to biologic drug makers regarding a competitor's application for a biosimilar product (adopting Sandoz's argument). On the other hand, the decision extended the statutory exclusivity period enjoyed by innovator biologic drug makers relating to when the biosimilar applicant can enter the marketplace (as Amgen argued).
The BPCIA is a component of the healthcare law commonly termed "Obamacare" and provides for the first time in the U.S. an abbreviated pathway for FDA approval of so-called "biosimilar" drugs, generic versions of biologic drugs. The Act contains complicated litigation provisions that have come to be termed the "patent dance" that prescribe how the parties (termed the "reference product sponsor" and the "biosimilar applicant") decide which patents will be litigated during the time prior to FDA approval.
The case arose over Amgen's drug Neupogen® (filgrastim) that was the subject of a biosimilar application by Sandoz. At issue was Sandoz's decision not to comply with the first provision of the law, which states that the biosimilar applicant "shall" provide to the reference product sponsor a copy of its application and also manufacturing information (because it was recognized that patents related to manufacturing might be at issue between the parties). Sandoz contended that despite using the word "shall" Congress did not intend to make these disclosures mandatory, because the law also provided remedies for reference product sponsors faced with nondisclosure from the biosimilar applicant. The District Court sided with Sandoz in its interpretation of the law, that these remedy provisions indicate that, taken as a whole, the law does not force the biosimilar applicant to make these disclosures.
Also at issue was interpretation of another provision of the law, that the biosmilar applicant provide 180 day notice to the reference product sponsor that it intended to enter the marketplace. Sandoz provided this notice prior to obtaining FDA approval, and the Court agreed with Amgen that the law does not permit marketing notice until after a biosimilar applicant has received FDA approval. Sandoz's biosimilar, under the brand name Zarxio®, obtained FDA approval on March 5, 2015, and under this aspect of the decision will be available for marketing on September 2nd.
The decision was written by Judge Lourie, who was able to persuade Judge Chen to his point of view regarding the interpretation of whether disclosure of the biosimilar application was mandatory, and Judge Newman to his opinion that the law prevents a biosimilar applicant from giving marketing notice until after FDA approved the application. Each of these judges wrote separate opinions reflecting partial concurrence and partial dissent, which gives both parties a basis for en banc review and, if necessary petitions for certiorari.
Patent Docs will provide more information on this decision in subsequent posts.
