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Coherus knocked back by AbbVie’s Humira patent protection

Published on 08/11/16 at 09:30am

Coherus Biosciences, a developer of biosimilars, has suffered a blow in their petition for Inter Partes Review (IPR) of one of AbbVie’s key formulation patents for Humira.

Coherus had challenged the validity of AbbVie’s patent (the “166 Patent”) through the US Patent and Trademark Office, a cheaper and faster route than the US federal court system. However, Coherus announced on 7 November that their petition for Inter Partes Review of AbbVie’s Humira formulation patent had been denied.

“While we are disappointed by this outcome it is important to note that our longstanding strategy has been to develop and preserve multiple options pursuant to adalimumab formulation intellectual property. There are additional scientific and legal approaches available to address the various formulation intellectual property challenges, and all of the arguments raised in our IPR petition remain available in a District Court proceeding,” said Denny Lanfear, president and chief executive officer of Coherus.  “Coherus remains committed to launching our HUMIRA biosimilar once approved.”

Humira is AbbVie’s major seller, bringing in $14 billion in sales last year alone. The main patent on Humira expires at the end of the year but AbbVie have built a solid defence against potential biosimilars with 75 other patents protecting the drug; the expirations of these patents extend to as far as 2032. AbbVie do not expect a biosimilar competitor to enter the market until 2022 at the earliest and this latest twist could see this become more likely. Investors certainly seem to think that could be the case, with AbbVie’s shares up by 6% on the news. Meanwhile, shares in Coherus fell by 16%.

Ben Hargreaves