Federal Circuit Dismisses Amgen's Appeal

August 10, 2017
The Center for Biosimilars Staff

The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.

The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.

In appealing the decision, Amgen had argued that, unless it was provided discovery of Hospira’s manufacturing process for epoetin alfa (Epogen), its right to sue over the cell-culture patents it holds for the drug would be thwarted. It alternatively sought a writ of mandamus, which would compel discovery.

The court, however, said that it lacked jurisdiction over the district court’s order, and found that Amgen failed to satisfy the prerequisites necessary for such a writ, calling it “a drastic remedy reserved for the most ‘extraordinary causes,’” in which the party has no other means of relief, and has demonstrated that it has a legal right to the writ by “clear and indisputable” means.

The court took the position that, barring an injunction under federal law (which the Supreme Court’s ruling in Sandoz v Amgen rendered unavailable), Amgen could have sought relief under state law (though it did not), sued for patent infringement, or coerced information from Hospira by bringing suit on its cell-culture patents. Moreover, the decision indicated, the Supreme Court appears to have provided for the possibility of the sponsor’s filing suit upon an applicant’s failure to disclose information.

The court stated that “the denial of discovery in this case does not undermine the purpose of the BPCIA," and that the district court was correct in its decision to deny Amgen’s motion.