Sandoz Petitions Supreme Court to Review Federal Circuit Court Decision on BPCIA

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb. 16, 2016 in response to a previous judgement by the Court of Appeals for the Federal Circuit that “some – but not all – of the elaborate ‘patent dance’ procedures set out in the Biologics Price Competition and Innovation (BPCIA) for those filing abbreviated biologics license applications with the Food and Drug Administration are optional,” reported Baker & Hostetler LLP.

According to Baker & Hostetler, the petition presents the question “whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treatment Section 262(1)(8)(A) as a standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.” If granted, this may impact biologics companies and those developing biosimilars.

The July 2015 decision, Sandoz, Inc v. Amgen, Inc., ruled that information exchange and patent dance of the BPCIA are not mandatory, and that applicants can elect not to participate in them. It also ruled that for those that choose not to participate “the 180-day notice of commercial marketing requirement is mandatory, and effective notice can be provided only after the FDA has approved the abbreviated biologics application.” According to Baker & Hostetler, the court chose to not rehear its earlier decision.

Sandoz claims this decision presents a 180-day “exclusivity period” to sponsors of reference products. The company also says the court “erred by divorcing the Notice of Commercial Marketing provision set forth in Section 262(1)(8)(A), from BPCIA’s patent resolution regime.” Without court intervention, the company continued, this ruling could delay availability of FDA approved biosimilars.

According to Baker & Hostetler, Amgen has 30 days to file a brief in opposition.

Source: Baker & Hostetler LLP