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Hospira Requests En Banc Review of Ruling Regarding Safe Harbor

On January 15, 2020, Hospira filed a petition for rehearing en banc asking the full Federal Circuit to reconsider a prior panel’s analysis of the Safe Harbor provision and reverse the finding of infringement. In December 2019, the Federal Circuit affirmed the District of Delaware’s decision denying Hospira’s motion for judgment as a matter of law and upholding the jury’s verdict that Hospira infringed Amgen’s patent and that some batches of drug substance for Hospira’s erythropoietin biosimilar drug product were not covered by the Safe Harbor provision of 35 U.S.C. § 271(e)(1).

35 U.S.C. § 271(e)(1), also known as the Safe Harbor provision, provides that it shall not be an act of infringement to make use, offer to sell, sell, or import into the United States a patent invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

During its initial appeal, Hospira argued that the jury instructions regarding the Safe Harbor provision improperly focused the jury on the reasons why each batch of EPO was made instead of how each batch was used or whether the use was reasonably related to the development and submission of information in Hospira’s BLA. The jury instructions read, “[i]f Hospira has proved that the manufacture of a particular batch was reasonably related to developing and submitting information to the FDA in order to obtain FDA approval, Hospira’s additional underlying purposes for the manufacture and use of that batch do not remove that batch from the Safe Harbor defense.” Op. at 13-14. Hospira argued that it only had to prove the use was reasonably related to the submission of the BLA, not the manufacture.

In its opinion, the Federal Circuit panel disagreed and held that the jury instructions were proper because Section 271(e)(1) “extends to all uses of patented inventions  that are reasonably related to the development and submission of any information under the FDCA” and that each accused activity must be evaluated separately to see if the exemption applies. Op. at 14 (quoting Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005)). The Federal Circuit concluded that Amgen’s patented invention was the methods of manufacture and Hospira’s accused activity was the use of those methods of manufacture. The Federal Circuit reasoned that the correct inquiry is whether each act of manufacture was for uses reasonably related to the submission of information to the FDA. The Federal Circuit then held that substantial evidence supported the jury’s finding that some of the batches were not manufactured for the sole purpose of use reasonably related to the development and submission of information to the FDA.

In its recent petition for rehearing en banc, Hospira made two primary arguments: (1) the panel ignored binding legal precedent in its decision; and (2) the panel incorrectly applied a different rule for manufacturing process than the rule for other types of patents.

First, relying on the Supreme Court’s decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 206 (2005), Hospira argued that the panel’s analysis ignores the Supreme Court’s admonition that “all uses” reasonably related to obtaining FDA approval are exempted and that the Safe Harbor provision’s application is broader than just information required for approval. According to Hospira, it is not reasonable to expect an applicant to submit the minimum amount of data required to the FDA. Hospira argued that its accused batches were all used to generate data for the FDA as data from every accused batch was used to revise release specifications in response to the CRL.

Second, Hospira argued that the panel erred when it ruled that “because the patents-in-suit claim methods of manufacture, subsequent uses that are objectively related to obtaining FDA approval cannot bring the making of the EPO within the Safe Harbor if the manufacture itself was not ‘required,’ at the time of manufacture, for seeking FDA approval.” Pet. at 10. Hospira argued that the panel substituted the well-established test regarding the uses of the patented invention with an analysis of the underlying purpose for why each match was made. Hospira argued that the panel erred by applying a different analysis for manufacturing process patents than for other patents.

Hospira emphasized that the previous panel’s decision “threatens to eviscerate the protections Congress intended to provide under the Safe Harbor, particularly in the BPCIA context” and that this issue is of vital importance as manufacturing patents are the focus of many BPCIA cases. Pet. at 15.

We will continue to provide updates as the case continues.