The case involves Hospira’s Retacrit (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen, which was approved by the US Food and Drug Administration (FDA) in May 2018 [2].

The Federal Circuit confirmed the jury’s decision and its finding that 14 of 21 accused batches of drug substance manufactured by Hospira were not protected by the Safe Harbor provision of 35 U.S.C. §271(e)(1) because they were not reasonably related to the development and submission of information to the FDA when seeking approval of its biosimilar.

The Safe Harbor provision of 35 U.S.C. §271(e)(1) provides that it is not an act of infringement ‘to make ... a patented 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’.

Hospira then filed a petition arguing that the panel’s Safe Harbor analysis was legally incorrect because it applied a different Safe Harbor rule for manufacturing process patents than the rule used for other types of patents. Hospira emphasized that the importance of manufacturing process patents in the context of biosimilars and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is exaggerated. The company therefore argues that the Federal Circuit panel’s decision ‘threatens to eviscerate the protections Congress intended to provide under the Safe Harbor, particularly in the BPCIA context’.

In March 2020, Amgen responded to the petition for rehearing ‘en banc’, saying that the Federal Circuit panel and the district court did not improperly focus on the underlying purpose for making the accused batches, as shown by:
(1) the jury instruction that ‘underlying purposes for the manufacture and use of [a] batch would not remove that batch from the Safe Harbor defense’; and
(2) the jury’s finding that seven of the 21 accused batches were protected by the Safe Harbor.

Amgen also insists that the panel ‘did not announce a special Safe Harbor rule for process patents’ and, instead, the panel merely stated that the Safe Harbor would apply if an ‘act of manufacture (that is, an infringing act) was for uses reasonably related to submitting information to the FDA’. Finally, Amgen argues that the panel’s decision that substantial evidence supports the jury’s verdict does not warrant rehearing en banc.

The Amgen versus Hospira case suggests that in lawsuits involving method-of-manufacture patent claims, the relevant inquiry for determining whether the Safe Harbor defense applies is why the accused party used the patented manufacturing methods. Furthermore, whether the acts of manufacturing were actually necessary to support a US FDA submission or whether the manufactured product was destined for commercial use may be an important factor in deciding whether the Safe Harbor defense applies or not.

On 16 March 2020, the US Court of Appeals for the Federal Circuit denied Hospira’s petition for rehearing. The mandate was issued on 23 March 2020.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Hospira to pay Amgen US$70 million for epoetin alfa patent infringement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/Hospira-to-pay-Amgen-US-70-million-for-epoetin-alfa-patent-infringement
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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