Judge rules in AbbVie’s favour over biosimilar delay deals

Home/Policies & Legislation | Posted 03/07/2020 post-comment0 Post your comment

On 10 June 2020, a judge in Illinois dismissed a class action against AbbVie regarding its blockbuster arthritis biological, Humira (adalimumab).

Law V13C29

US-based pharma giant AbbVie gained approval from the US Food and Drug Administration (FDA) for Humira back in 2002. Humira had worldwide sales of US$19.2 billion in 2019 and accounted for approximately 58% of AbbVie’s total net revenues in 2019.

The patents on Humira expired in Europe in June 2017 [1]. However, in the US AbbVie has stated that although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022 [2].

Biosimilars of the blockbuster have been approved and launched in Europe [3]. However, in the US, faced with the 2016 patent expiration of the molecule, AbbVie filed 247 additional patents, resulting in 132 successful patents. The company then brought patent litigation against a whole host of biosimilars makers and eventually made agreements with these companies that would delay the launch of adalimumab biosimilars until June 2023 at the earliest [4].

These deals mean that the prices for Humira will remain high in the US until 2023. Faced with such high prices, consumer groups, drug wholesalers and unions (including the City of Baltimore, Miami Police Department insurance trust fund, and a Minnesota-based employee welfare benefits plan for workers in the pipe trade industries) filed a class action lawsuit against AbbVie. They alleged that AbbVie illegally blocked competition for Humira by obtaining a ‘patent thicket’ and deploying it on would-be competitors.

However, the judge found the company’s strategy to be legal. Judge Manish S Shah, of the US District Court Judge for the Northern District of Illinois said in dismissing the case that ‘AbbVie has exploited advantages conferred on it through lawful practices and to the extent this has kept prices high for Humira, existing antitrust doctrine does not prohibit it’.

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1. Derbyshire M., Shina S. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim finally signs licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Pharma-News/Boehringer-Ingelheim-finally-signs-licensing-deal-for-Humira-biosimilar

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Source: AbbVie, Patent Docs

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