August 15, 2017

Willkie obtains favorable result on behalf of Hospira in a case of first impression before the Federal Circuit.

In a case of first impression before the Federal Circuit, Willkie obtained a significant victory for Hospira, Inc. over Amgen Inc. in an appeal involving the statutory framework for biologic drug products. The parties’ dispute arose from the disclosure requirements of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which allows drug manufacturers to obtain FDA approval for “biosimilar” drugs. Hospira filed one of the first applications with the FDA in December of 2014 seeking approval to market a biosimilar version of EPOGEN®, a biological product developed by Amgen. Pursuant to the BPCIA, Hospira provided a copy of its application to Amgen.

Because Hospira provided its application, Amgen was required to provide “a list of patents for which [Amgen] believes a claim of patent infringement could reasonably be asserted” against Hospira (the “3(A) List”). However, Amgen asserted that Hospira had failed to comply with the provisions of the BPCIA because it had failed to disclose additional manufacturing information, including information concerning certain components of the cell culture medium used to manufacture its product. Hospira denied that any additional information was required. Amgen provided Hospira with a 3(A) List, but chose not to include any cell culture media patents. Subsequently, Amgen sought to compel production of information regarding certain components of the cell culture medium, but the district court denied Amgen’s motion to compel as unrelated to any of the patents-in-suit.

Amgen appealed that discovery decision to the Federal Circuit under the collateral order doctrine, and alternatively sought mandamus under the All Writs Act. The Federal Circuit first held that the lack of immediate appeal over orders denying discovery of BPCIA information does not render such orders “effectively unreviewable,” a requirement to qualify for the collateral order doctrine. As such, the Federal Circuit found that it lacked jurisdiction over Amgen’s appeal under the collateral order doctrine.

The Federal Circuit then turned to Amgen’s contention that it was entitled to mandamus under the All Writs Act, focusing on whether Amgen established a “clear and indisputable” right to the discovery it sought. The court noted that although Amgen could have listed cell culture media patents on its 3(A) List, it failed to do so. Amgen argued that it was unable to list the culture medium patents because Hospira failed to provide the requested information, but the panel confirmed that no Rule 11 basis was required to include a patent on Amgen’s 3(A) List and that it could have listed cell culture media patents and obtained additional information in the so-called “patent dance.” Ultimately, the panel held that Amgen was not entitled to discovery on its unlisted cell culture media patents, and thus that Amgen had not established a clear and indisputable right to the discovery it sought. As such, the court found that Amgen failed to establish the prerequisites to issue a writ of mandamus.

The Willkie team on the appeal includes partners Thomas Meloro and Michael Johnson, associates Heather Schneider, Christopher McNamara, Tara Thieme and Andrew Shindi.

Related Practice Areas