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From Health Law Daily, June 22, 2016

Which side will government pick in Amgen and Sandoz biosimilars dispute?

By Anthony H. Nguyen, J.D.

The U.S. Supreme Court asked the Obama Administration for its views on biosimilar drugs in the ongoing dispute between Amgen Inc. and Sandoz Inc., which may have broad implications for the brand name and generic biologic industry. Although President Obama has requested in his annual budget proposals that marketing exclusivity for biologics be limited to seven years, the current regulatory scheme maintains a 12-year marketing exclusivity period. With the Supreme Court’s order, relating to Sandoz’s petition regarding the 180-day notice of commercial marketing and Amgen’s cross-petition on the optionality of a process to settle patent disputes known as the "patent dance," the government will have an opportunity to side with either the brand name or generic pharmaceutical industry.

The Biologics Price Competition and Innovation Act (BPCIA), which was passed in 2010 as sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), created an abbreviated pathway for FDA approval of a "biosimilar" biologic product. Amgen brought originally brought suit against Sandoz in federal court asserting various violations of Amgen’s approved license for its cancer-fighting biologic Neupogen® (filgrastim) and infringement of Amgen’s patent for a particular method of using filgrastim.

Biosimilars and the Supreme Court. In January 2016, Amgen declined to file a free-standing certiorari petition after the Federal Circuit held: (1) the 180-day notice of commercial marketing can only be given after a proposed biosimilar product receives FDA approval and (2) the patent dance was optional (see Court interprets biosimilar ‘enigma’ in favor of abbreviated biologic license applicant, July 22, 2015). As its own petition filing deadline approached, Sandoz asked the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing provision (see Reversal of fortune: Sandoz seeks Supreme Court review in Amgen biosimilars battle, February 18, 2016). On March 21, 2016, Amgen filed an opposition brief to the Sandoz petition, and in an unexpected move filed a conditional cross-petition, requested that if the Court chose to take up Sandoz’s petition on commercial marketing, it would address the issue Amgen lost before the Federal Circuit, specifically whether the BPCIA’s patent dance was mandatory.

The Supreme Court order is for case numbers 15-1039 (Sandoz Inc. v. Amgen Inc.) and 15-1195 (Amgen Inc. v. Sandoz Inc.).

Companies: Amgen Inc.; Sandoz Inc.

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