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Biosimilars and the safe harbor provision Posted 10/04/2020

In the US, the safe harbor provision exempts drug development and approval from patent infringement provisions, and courts have interpreted the safe harbor to apply broadly to Food and Drug Administration (FDA) regulated and approved products, including biologicals. However, courts have continued to struggle with the application of the safe harbor to different types of FDA submissions as the regulatory process has become more complex – and largely have continued to expand its scope.

Specifically, 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’.

This issue is somewhat different for biosimilars compared to generics due to the ‘biosimilar patent dance’. The ‘patent dance’ was designed to balance the needs of biosimilar and originator companies in a dispute. The patent dance begins with the disclosure of the biosimilar application, as well as the process of manufacture by the biosimilar applicant [1].

Whereas for generics, FDA regulations preclude the listing of process patents in the Orange Book, which means that process patents are not included in the Hatch-Waxman patent dance.

This whole issue came to the forefront in a case involving Hospira’s Retacrit (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen, which was approved by FDA in May 2018 [2]. A Delaware court – later confirmed by the Federal Circuit – found that Hospira 14 of 21 accused batches of drug substance manufactured by Hospira were not protected by the Safe Harbor Provision because they were not reasonably related to the development and submission of information to FDA when seeking approval of its biosimilar [3].

The Amgen versus Hospira case suggests that in lawsuits involving method-of-manufacture patent claims, the question is whether the biosimilar maker used the patented manufacturing methods for routine submissions or approval submissions – which may lead the Federal Circuit to reject the Petition for Rehearing En Banc.

However, it seems that the issue is far from clear or conclusive and as the biosimilar patent dance evolves process patents will play a larger role, which can only result in more litigation and further questions for the US courts.

Related article
Hospira to pay Amgen US$70 million for epoetin alfa patent infringement

References
1. GaBI Online - Generics and Biosimilars Initiative. How will the timing of BPCI Act 180-day notice affect biosimilars? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Policies-Legislation/How-will-the-timing-of-BPCI-Act-180-day-notice-affect-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Hospira asks Federal Circuit to reconsider Safe Harbor ruling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Policies-Legislation/Hospira-asks-Federal-Circuit-to-reconsider-Safe-Harbor-ruling

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Source: Corporate Council Business Journal, FDA Law Blog, Mondaq

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