Amgen v. Sandoz: Federal Circuit Vacates Opinion and Mandate, Reinstates Appeal, Orders Further Briefing on Remanded Issues

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions  •  U.S. Supreme Court Decisions

As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court had remanded to the Federal Circuit, i.e.  (1) whether an injunction is available under state law; and (2) whether such a state-law injunction is preempted by federal law, to the extent Sandoz preserved the preemption argument. Sandoz argued that a further remand from the Federal Circuit to the district court (N.D. Cal.) would promote judicial efficiency and allow the district court to address questions of California state law posed by the Supreme Court’s remand.  Sandoz also requested that, alternatively, the Federal Circuit recall its mandate and order briefing on the questions remanded by the Supreme Court.

Yesterday, the Federal Circuit issued an order recalling its October 23, 2015 mandate, reinstating the appeal, and vacating its July 21, 2015 opinion.  The Federal Circuit further ordered the parties to file “simultaneous supplemental briefs…stating their positions relating to the appropriate action to be taken by the court on remand following the Supreme Court’s decision…particularly whether: (1) the BPCIA preempts additional remedies under state law for an applicant’s failure to comply with 42 U.S.C. § 262(l)(2)(A); (2) Sandoz has waived any preemption defense; and (3) California law would treat noncompliance with 42 U.S.C. § 262(l)(2)(A) as “unlawful” under Cal. Bus. & Prof. Code § 17200.”

The briefs are due August 9th, two weeks from the date of yesterday’s July 26th order.

Stay tuned to the Big Molecule Watch for further updates.

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