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Biosimilar patent litigation trends in the US Posted 05/03/2021

According to authors from Law360 the trend in biosimilar patent litigation cases has been downward, with many cases being resolved and only five cases still pending as of 31 December 2020 [1].

In the US, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was signed into law on 23 March 2010, giving the US Food and Drug Administration (FDA) the authority to approve biosimilars via an abbreviated pathway.

The BPCI Act patent litigation procedures are triggered when FDA accepts an application for a biosimilar. Therefore, after the first biosimilar applications were submitted to FDA in 2014, patent litigation first started to appear in the US, reaching a peak in 2018, but tailing off afterwards.

Of the 29 BPCI Act patent litigation cases ever filed, 14 were settled and six concluded with a final judgment or dismissal during 2018‒2020 alone. In fact, during 2019‒2020 there have been 15 case conclusions, which far exceeds the six new filings and means that only five biosimilar patent litigation cases remain pending as of 31 December 2020.

Two litigation cases were concluded in 2020, both involving Genentech and Amgen and relating to trastuzumab, which is marketed by Genentech as Herceptin, and bevacizumab, marketed by Genentech as Avastin. Genentech reached a settlement agreement with Amgen over its trastuzumab and bevacizumab biosimilars dismissing all claims and allowing Amgen to continue marketing the biosimilars [2].

New litigation in 2020 included Amgen vs Hospira regarding the filgrastim biosimilar Nivestym (filgrastim-aafi) [3], Genentech vs Samsung Bioepis and Genentech vs Centus [4].

The authors expect the current lull in biosimilar litigation to be temporary and therefore with new biosimilars expected in 2021 new litigation will follow. Submission of biosimilar applications to FDA for previously un-litigated biosimilars, such as ranibizumab, aflibercept and insulin aspart, are expected to prompt litigation. While new litigation is also expected against adalimumab, bevacizumab, etanercept and pegfilgrastim biosimilars in 2021.

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References
1. Whitehill J, Deshmukh J. After lull in biosimilar IP litigation, 2021 could bring influx. Law360. 2021 Jan 7.
2. GaBI Online - Generics and Biosimilars Initiative. Genentech and Amgen settle biosimilar disputes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Policies-Legislation/Genentech-and-Amgen-settle-biosimilar-disputes 
3. GaBI Online - Generics and Biosimilars Initiative. Amgen on both sides of the biosimilar arena [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Biosimilars/General/Amgen-on-both-sides-of-the-biosimilar-arena 
4. GaBI Online - Generics and Biosimilars Initiative. Genentech sues Centus over Avastin biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Biosimilars/General/Genentech-sues-Centus-over-Avastin-biosimilar

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Source: Law360, US FDA

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