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 turf” around its blockbuster drug Humira.
Since its initial approval in rheumatoid arthritis in 2002, Humira has become one of the industry’s best-sellers, acquiring a number of new indications, from ulcerative colitis to ankylosing spondylitis. The drug generated more than $5.3 billion in revenue last quarter. Its original patent expired in 2016 — however, AbbVie has acquired 132 additional patents on the drug, the last of which expires in 2034.
The welfare plans that pay for Humira filed a complaint against AbbVie in 2019, claiming the company’s patents “intimidate competitors” and create a monopoly. The strategy won AbbVie several critics, including Sen. Ron Wyden (D-OR) likened CEO Richard Gonzalez’s patent bushing to “Gollum with a Ring.”
Earlier this year, three Republican and three Democratic senators urged the U.S. Patent and Trademark Office to quickly address the issue of pharmaceutical patents, saying in a letter that the practice “impedes the production of generic drugs, harms competition and may even outlaw exclusivity.” he claimed. A patent term prescribed by Congress.”
A federal judge dismissed the case against AbbVie in 2020, and Judge Frank Easterbrook upheld the ruling on Monday.
“But what’s wrong with having lots of patents?” I wrote in his opinion. “If AbbVie has 132 inventions, why can’t they have 132 patents? Patent laws do not place a limit on the number of patents any one person can have—generally, or on a subject matter.
The judge noted that tech companies like Apple and Microsoft “have larger patent portfolios” and that “Thomas Edison alone has 1,093 US patents.”
“Of course, invalid patents cannot be used to create or protect a monopoly. “However, our plaintiffs have not offered to prove that all 132 patents are invalid or inapplicable to all potential biosimilar competitors, and it is unclear whether payers would have standing to make such an argument.”
AbbVie will see some increased competition in the near future, as the company reached an agreement with biosimilar developer Alvotech earlier this year on when the latter’s adalimumab biosimilar could be launched. Although the biosimilar has yet to be approved by the FDA, the settlement clears all hurdles preventing it from entering the market on July 1, 2023. The first Humira biosimilar was approved by the FDA in 2016, and Amgen will be the first company to launch its own biosimilar. at the end of January.
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