Amgen v. Sandoz Appeal: Parties Submit Supplemental Briefing; Court Grants US Extension to File Amicus Brief

Amgen v. Sandoz (filgrastim)  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News

As we previously reported, following the Supreme Court’s June 12, 2017 decision in Sandoz v. Amgen,  the Federal Circuit on July 26, 2017, 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.”

Yesterday, Amgen and Sandoz filed their respective supplemental briefs.  Amgen argues that the Federal Circuit should reverse the district court’s dismissal of Amgen’s state law claims and remand the case to the district court for further proceedings, and “submits that Sandoz waived any preemption defense, and that, in any case, the BPCIA does not preempt state-law remedies for an applicant’s failure to comply with 42 U.S.C. § 262(l)(2)(A).”  Sandoz argues that the Federal Circuit, if it decides to address the remanded issues, should affirm the dismissal of Amgen’s state law claims as preempted by the BPCIA, and that “[e]ven were Amgen’s claims not preempted, they fail on the merits.”  Sandoz again renewed its request for an immediate remand to the district court “so that the district court can address the remanded issues in the first instance along with the other claims it already is addressing.”

In related news, the Federal Circuit last week granted a motion by the United States for an extension of time until September 11, 2017 to file an amicus brief in the Amgen v. Sandoz appeal.  The motion states that the United States is currently considering whether to file an amicus brief to address the BPCIA preemption issue.

Stay tuned to the Big Molecule Watch for further updates.

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