In its final brief submitted to the US Supreme Court on March 31, 2017, Sandoz asked the Court to reverse the decision of the US Court of Appeals for the Federal Circuit on the Biologics Price Competition and Innovation Act (BPCIA), issued on July 21, 2015. The dispute (Sandoz, Inc. v. Amgen, Inc. and Amgen, Inc. v. Sandoz, Inc., U.S., Nos. 15-1039 and 15-1195) concerns Sandoz’s filgrastim-sndz (Zarxio), biosimilar to Amgen’s filgrastim (Neupogen), and the companies’ dist inctinterpretations of the portion of the BPCIA that created a faster pathway of approval for biosimilars. The Court’s decision will likely affect how quickly biosimilars are released to the US market and how long innovators can remain the sole marketer of the drug.
Sandoz’s brief states that “Sandoz agrees with Amgen that the Biosimilars Act should be applied ‘as written.’ But that means applying the statute as written in its entirety—not just the parts Amgen rips from context and reads in isolation.” At issue are 2 BPCIA provisions, one of which requires the biosimilar applicant to give the biologic reference product sponsor (RPS) its biosimilar application and manufacturing information and to work with the sponsor on a list of the RPS patents that might be infringed; the other requires the applicant to give the RPS notice 180 days before it intends to start selling the biosimilar.
The Federal Circuit court awarded a split decision, with each side winning on 1 issue. It agreed with Sandoz and the district court that the exchange of information was optional, but disagreed with its ruling on the 180-day notice, agreeing with Amgen that the statute means the applicant can’t give notice of commercial marketing until after the FDA has approved the biosimilar for marketing, therefore delaying Zarxio’s release for 6 months.
Sandoz petitioned and Amgen cross-petitioned the Supreme Court for review. Each party requesting that the Court reverse what was unfavorable to them. The Court granted both petitions review and each side submitted opening and reply briefs.
Sandoz’s reply brief said the BPCIA, as written by Congress, lays out different routes to resolving litigation and specific consequences. Sandoz said that each step specified in the Act was a mandatory condition precedent to continuing the process, and contends that Amgen’s interpretation of the BPCIA disregards the statute’s consequences for not following them. Sandoz said it was not Congress’s intention to inject a second timing element into the statute— that there be no notice until after FDA approval. Furthermore, Sandoz said Amgen’s interpretation of the BPCIA is also contrary to the law’s purpose that patent litigation should be resolved early and not delay biosimilar competition. The brief labeled as “fantasy” Amgen’s warning that Sandoz’s BPCIA interpretation would lead to chaos, causing attorneys for RPSs to rush into litigation prior to knowing what patents were being infringed and when the product was launching.
Amgen must submit its final brief to the Court by April 14, 2017. Oral arguments are scheduled for April 26, 2017, with a decision expected by the end of June.