‘What’s improper with having numerous patents?’ Federal appeals choose sides with AbbVie in Humira case – Endpoints Information

A federal appeals court ruled in favor of AbbVie on Monday, upholding an Illinois court decision to dismiss allegations that the pharmaceutical giant created an illegal “patent toy” around its blockbuster drug Humira.

Since it was first approved in rheumatoid arthritis back in 2002, Humira has been one of the best sellers in the industry, adding a range of new indications from ulcerative colitis to ankylosing spondylitis. The drug grew by more than $5.3 billion last quarter. Its original patent expired in 2016 – however, AbbVie has received 132 additional patents related to the drug, the last of which expires in 2034.

Benefit plans that pay for Humira filed a complaint against AbbVie back in 2019, alleging that the company’s patents “scared away competitors” and created a monopoly. The AbbVie strategy has earned some critics including Senator Ron Wyden (D-OR), who compared CEO Richard Gonzalez’s patent to “Gollum with his ring.”

Earlier this year, three Republican and three Democratic senators called on the US Patent and Trademark Office to address pharmaceutical patent infringement early, arguing in a letter that the practice “impedes the production of generic drugs, harm to competition, and can even extend the exclusivity. patent term mandated by congress.”

Frank Easterbrook

A federal judge dismissed the case against AbbVie back in 2020, and Judge Frank Easterbrook upheld the decision on Monday.

“But what’s wrong with having lots of patents?” he wrote in his opinion. “If AbbVie made 132 inventions, why can’t it hold 132 patents? The patent laws do not set a limit on the number of patents that any person can hold—generally, or relating to a single subject.”

The judge noted that technology companies such as Apple and Microsoft have “much larger patent portfolios” and that “Thomas Edison alone had 1,093 US patents.”

“Of course, invalid patents cannot be used to create or protect a monopoly. But our plaintiffs have not offered to prove that all 132 patents are invalid or unenforceable with respect to all potential biosimilar competitors, and it is far from clear that payers would have standing to make such an argument,” he wrote .

AbbVie will see some increased competition in the near future, as the company settled with biosimilar developer Alvotech earlier this year on when to launch the latter’s biosimilar adalimumab. Although the biosimilar has yet to be approved by the FDA, the settlement removes any barriers blocking it from the market starting July 1, 2023. The FDA approved the first Humira biosimilar in 2016, and Amgen will be the first to launched its biosimilar. in late January.

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