In July, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009 (BPCIA). The Federal Circuit affirmed the district court’s preliminary injunction barring Apotex from selling its proposed biosimilar until 180 days after post-licensure notice of first commercial marketing. The Federal Circuit held that 180 days’ notice was mandatory regardless of whether the biosimilar maker provided its regulatory application to the innovator as prescribed at the outset of the BPCIA procedures or not. The decision has impacted other district court litigation, including the Janssen v. Celltrion/Hospira and Amgen v. Hospira cases, since the biosimilar makers in those cases also argued that they did not need to provide 180 days’ notice of commercial marketing after being licensed by FDA.
Shortly after the Amgen v. Apotex decision, Celltrion and Hospira stipulated in the Janssen case that they would follow the law without Janssen having to renew its motion for a preliminary injunction to prevent Celltrion and Hospira from launching their product until after the expiration of the 180-day notice period. Celltrion and Hospira received FDA approval for their biosimilar product on April 5 and provided a notice of commercial marketing that same day. They have now committed not to launch their product until at least 180 days later, October 3, 2016.
The Federal Circuit’s decision has also impacted the Amgen v. Hospira case before Judge Andrews in the District of Delaware. Hospira had moved to dismiss Amgen’s request for a declaration that Hospira’s refusal to give 180 days’ notice of first commercial marketing violates the notice of commercial marketing provision of the BPCIA, 42 U.S.C. § 262(l)(8)(A). Judge Andrews said he would wait for the Federal Circuit’s guidance in the Apotex case prior to deciding the motion. Shortly after the Federal Circuit’s ruling, Judge Andrews denied Hospira’s motion to dismiss.
Hospira argued that Amgen could not privately enforce the BPCIA’s (8)(A) provision. While Judge Andrews agreed with Hospira that the “Federal Circuit did not squarely address whether (8)(A) creates a private right of action” in its decision, he found that “[t]he rationale underpinning Apotex applies with equal force” to Amgen’s declaratory judgment claim for violation of (8)(A). The Federal Circuit held that (8)(A)’s notice of commercial marketing is “enforceable by injunction.” The Federal Circuit also explained that “equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command, whether in so many words, or by a necessary and inescapable inference.” Judge Andrews held that the result should be the same with respect to Amgen’s declaratory judgment claim. He noted that the “Declaratory Judgments Act was not devised to deprive courts of their equity powers” and that “the express purpose of the Federal Declaratory Judgment Act was to provide a milder alternative to the injunctive remedy.” Judge Andrews reasoned that since the Federal Circuit “already recognized the availability of injunctive relief for violations of (8)(A),” it would come to the same conclusion regarding the availability of declaratory relief, a milder remedy. He denied Hospira’s motion to dismiss on that basis.
The Amgen v. Apotex decision undoubtedly will continue to impact biosimilar litigation for years to come.
(Patterson Belknap represents Janssen in the Celltrion/Hospira case and filed an amicus brief in support of 180 days’ notice being mandatory in all circumstances in the Amgen v. Apotex appeal.)
