A federal appeals court ruled in AbbVie’s favor on Monday, upholding an Illinois court’s decision to dismiss allegations that the pharma giant created an unlawful “patent thicket” around its blockbuster drug Humira.
Since its first approval in rheumatoid arthritis back in 2002, Humira has become one of the industry’s top sellers, snapping up a suite of new indications ranging from ulcerative colitis to ankylosing spondylitis. The drug raked in more than $5.3 billion last quarter. Its original patent expired in 2016 — however, AbbVie has obtained 132 additional patents related to the drug, the last of which runs out in 2034.
Welfare-benefit plans that pay for Humira filed a complaint against AbbVie back in 2019, alleging that the company’s patents “scared off the competitors” and created a monopoly. The strategy has earned AbbVie several critics including Sen. Ron Wyden (D-OR), who likened CEO Richard Gonzalez’s patent of thickets to “Gollum with his ring.”
Earlier this year, three Republican and three Democrat senators called on the US Patent and Trademark Office to address pharma patent thickets early on, arguing in a letter that the practice “impedes generic drugs’ production, hurts competition, and can even extend exclusivity beyond the congressionally mandated patent term.”
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 cap on the number of patents any one person can hold—in general, or pertaining to a single subject.”
The judge noted that tech companies such as Apple and Microsoft have “much larger portfolios of patents,” and “Thomas Edison alone held 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 inapplicable to all potential biosimilar competitors, and it is far from clear that payors 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 the latter’s adalimumab biosimilar can launch. 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 first Humira biosimilar was approved by the FDA in 2016, and Amgen will be the first to launch its biosimilar in late January.