A federal appeals court ruled in favor of AbbVie on Monday, upholding an Illinois court’s decision to dismiss claims that the pharmaceutical giant created an illegal ‘patent thicket’ around its blockbuster drug. Humira.
Since its first approval in rheumatoid arthritis in 2002, Humira has become one of the industry’s top sellers, capturing a range of new indications ranging from ulcerative colitis to ankylosing spondylitis. The drug made 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 expires in 2034.
The welfare plans that pay for Humira filed a lawsuit against AbbVie in 2019, alleging the company’s patents “frighten competitors” and create a monopoly. The strategy has earned AbbVie several critics, including Sen. Ron Wyden (D-OR), who compared CEO Richard Gonzalez’s thicket patent to “Gollum with his ring.”
Earlier this year, three Republican senators and three Democratic senators called on the U.S. Patent and Trademark Office to tackle drug patent issues early, saying in a letter that the practice “hampers the production of generic drugs , harms competition and may even extend exclusivity beyond the term of a congressionally mandated patent.
A federal judge dismissed the case against AbbVie 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 has made 132 inventions, why can’t it hold 132 patents? Patent laws do not set a limit on the number of patents a person can hold, either generally or relating to a single subject. »
The judge noted that tech companies such as Apple and Microsoft have “significantly larger patent portfolios” and “Thomas Edison alone held 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 the 132 patents are invalid or unenforceable to all potential biosimilar competitors, and it is far from clear that payers would have standing to make such an argument,” he said. he writes.
AbbVie will see increased competition in the near future as the company reached an agreement with biosimilar developer Alvotech earlier this year when the latter’s biosimilar adalimumab can be launched. Although the biosimilar has not yet been approved by the FDA, the regulations remove all barriers blocking it from the market from July 1, 2023. The first Humira biosimilar was approved by the FDA in 2016, and Amgen will be the first to launch its biosimilar at the end of January.