Clean sweep for AbbVie in Humira litigation
Boehringer Ingelheim has become the latest biosimilar maker to resolve litigation over AbbVie’s arthritis treatment Humira (adalimumab).
Under the terms of the deal, which was announced yesterday, May 14, Boehringer has agreed to park its biosimilar until July 1, 2023. AbbVie will grant Boehringer a non-exclusive licence to its Humira IP in the US, and Boehringer will pay royalties.
This marks the resolution of all Humira-related patent litigation in the US, with Boehringer becoming the eighth biosimilar maker to settle with AbbVie.
Other companies that have resolved litigation with AbbVie include Pfizer, Sandoz and Mylan.
Laura Schumacher, vice chairman, external affairs and chief legal officer at AbbVie, said: “This is an important settlement as it resolves all Humira-related patent litigation in the US and provides access for another biosimilar manufacturer seeking to enter the US.”
With this agreement, AbbVie has managed to stave off biosimilar entry in the US until 2023, while copycats have already launched in Europe.
Internationally, Humira net revenues of $1.2 billion decreased nearly 28% on a reported basis, or 23% operationally, in the first quarter of 2019, due to biosimilar competition. Meanwhile, in the US, Humira net revenues of $3.2 billion grew 7.1% in the quarter.
On the back of these settlements, AbbVie is now facing multiple antitrust class-action lawsuits, which claim that the company illegally stopped competition for Humira.
In March, a grocery workers’ union filed a suit at the US District Court for the Northern District of Illinois, accusing AbbVie of creating an exclusionary ‘patent thicket’ by securing more than 100 patents “designed solely to insulate Humira from any biosimilar competition in the US for years to come”.
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