A federal appeals court ruled in favor of AbbVie Monday, upholding the decision of an Illinois court to dismiss allegations that the pharmaceutical giant had created an illegal “patent thicket” around its blockbuster drug Humira.
Since its first approval for rheumatoid arthritis in 2002, Humira has become one of the top sellers in the industry, picking up a range of new indications ranging from ulcerative colitis to ankylosing spondylitis. The drug raised more than $5.3 billion last quarter. The original patent expired in 2016, but AbbVie has obtained 132 additional patents for the drug, the last of which expires in 2034.
Welfare benefits that pay for Humira filed a complaint against AbbVie in 2019, alleging that the company’s patents “deter the competitors” and create a monopoly. The strategy has brought AbbVie several critics, including Senator Ron Wyden (D-OR), who likened CEO Richard Gonzalez’s patent on scrub to “Gollum with his ring.”
Earlier this year, three Republican and three Democratic senators called on the US Patent and Trademark Office to tackle the undergrowth of pharmaceutical patents early on, arguing in a letter that the practice “impedes the production of generic drugs, harms competition and even the exclusivity can extend beyond the Congress-mandated patent term.”
A federal judge dismissed the case against AbbVie in 2020 and Judge Frank Easterbrook upheld the decision on Monday.
“But what’s wrong with a lot of patents?” he wrote in his opinion. “If AbbVie has made 132 inventions, why can’t it have 132 patents? The patent laws do not set a limit on the number of patents a person can hold – in general or in relation to a single subject.”
The judge noted that tech companies such as Apple and Microsoft have “much larger patent portfolios” and that “only Thomas Edison owned 1,093 U.S. 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 do not apply to all potential biosimilar competitors, and it is far from clear that payers could make such an argument,” he wrote.
AbbVie will see some more competition in the near future, as the company reached a settlement with biosimilar developer Alvotech earlier this year, when the latter’s adalimumab biosimilar can be launched. While the biosimilar has yet to be approved by the FDA, the settlement removes any barriers blocking the biosimilar from the market as of July 1, 2023. The first Humira biosimilar was approved by the FDA in 2016 and Amgen will be the first to launch its biosimilar in late January.