The Federal Circuit’s decision finding it mandatory that a biosimilar-product applicant give a post-licensure notice to the manufacturer of the original FDA-approved biologic (the reference product sponsor) 180 days prior to beginning commercial marketing will remain law, because the Supreme Court denied a petition for writ of certiorari in Apotex Inc. v. Amgen Inc. A preliminary injunction granted by a district court will remain in effect, despite the biosimilar applicant giving notice to the reference product sponsor of its filing of an application to market the biosimilar (see Biosimilar applicant must give 180-day post-licensure notice to reference sponsor, Health Law Daily, July 6, 2016).
In 2002, Amgen Inc. received a biologics license from the FDA for Neulasta® (pegfilgrastim), a human-engineered protein for patients undergoing chemotherapy. In 2014, Apotex Inc. filed an application for an FDA license to market a biosimilar version of Neulasta, invoking the abbreviated pathway for regulatory approval of follow-on biological products that are highly similar to a previously approved reference product. The abbreviated biosimilar pathway was allowed by the Biologics Price Competition and Innovation Act of 2009 (Biologics Act), which was created by sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).
Under the Biologics Act, a biosimilar-product application may not be submitted until four years after the reference product was first licensed by the FDA and a biosimilar-product license may not be made effective until 12 years after the reference product was first licensed. The Biologics Act also contains detailed requirements that are focused on ways to avoid or streamline potential patent litigation by requiring the exchange of patent information between the biosimilar-product applicant and the reference product sponsor after the FDA accepts the biosimilar-product application for review. Finally, the Biologics Act requires the biosimilar-product applicant to give notice to the reference product sponsor 180-days before commercial marketing of its FDA-licensed product.
After the FDA accepted Apotex’s application for review, Apotex and Amgen engaged in the exchange of patent information as required by the Biologics Act. After negotiations, the parties agreed to an action for infringement of two patents, but after one of the patents expired, Amgen’s patent infringement action against Apotex was only based on the one remaining disputed patent. This appeal, however, did not involve the infringement action but rather Amgen’s motion for a preliminary injunction to require Apotex to provide Amgen notice if and when it receives a license from the FDA and to delay any commercial marketing for 180 days from that notice. The Federal Circuit upheld the injunction and found that giving post-licensure notice to the manufacturer was mandatory.
In September 2016, Apotex filed a petition for writ of certiorari with the Supreme Court. It requested review of two issues: (1) whether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the Biologics Price Competition and Innovation Act for the resolution of patent disputes must also provide the reference product sponsor with a notice of commercial marketing; and (2) whether the Federal Circuit improperly extended the statutory 12-year exclusivity period to 12 1/2 years by holding that a biosimilar applicant cannot give effective notice of commercial marketing for its biosimilar product until it receives a FDA license and therefore may not commercially market its biosimilar product for 180 days after receiving its license. On December 12, 2016, the Court denied Apotex’s petition.