Key Humira patent goes down via IPR—but biosims makers shouldn't celebrate yet, analysts warn

AbbVie HQ
With its '135 Humira patent now nixed, AbbVie is still awaiting an IPR decision on its '619 patent.

One of AbbVie’s Humira patents bit the dust late Tuesday, marking a win for biosimilars makers. But they still have a long way to go before they’ll really be able to celebrate, analysts cautioned.

The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) handed down a verdict in Coherus BioSciences’ favor, striking down AbbVie’s ‘135 methods patent on its top drug after an inter partes review. Barclays analysts had previously referred to the shield as “one of the cornerstones of the Humira IP estate,” which AbbVie needs to keep intact if it wants to keep copycats away from Humira’s billions in revenue.

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“The ‘135 patent was seen as a key blocking patent for biosimilar developers required to follow the exact dosing and treatment frequency as the branded equivalent to secure U.S. FDA approval of their products,” Leerink Partners analyst Geoffrey Porges wrote to investors.

Evercore ISI analyst Umer Raffat, though, referred to the ‘135 patent as “a small part” of the Illinois pharma’s broader IP portfolio.

“Keep in mind” that the ‘135 patent was specifically directed at AbbVie’s method for treating rheumatoid arthritis, which “is an important indication,” but still only makes up one-third of the med’s total haul, he wrote to clients.

AbbVie’s ‘619 patent, which is also being challenged through the IPR process, is still “several months away” from a decision, he noted, adding that “all these IPR decisions are subject to appeal.” The company, for its part, has already indicated it would be going that route on the '135 patent, saying in a statement that it intended to appeal.

Plus, AbbVie has already prevailed in the IPR space with a few formulations patents, including some that expire in 2022. With those factors at play, “either a biosimilar needs to wait till 2022, or try to work around” the upheld patents, Raffat wrote.

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While it may still be a while before Coherus can bite into Humira sales, the victory does give the California company additional credibility when it comes to another biosimilar approval it's vying for, Credit Suisse analyst Vamil Divan wrote. It’s working to grab an approval for a copy of Amgen’s Neulasta, and “we think legal success against a large player” will help its case, Divan said.

Editor's note: This story has been updated with information from a statement from AbbVie.