Drugs

Humira ‘Patent Thicket’ Case Dismissal Affirmed

The 7th Circuit Court of Appeals has affirmed the decision of an Illinois federal court to dismiss a suit alleging that AbbVie violated the Sherman Antitrust Act when it obtained 132 additional patents for its Humira following the 2016 expiration of the biologic’s primary patent. The suit was brought by welfare-benefit plans that pay for Humira on behalf of covered beneficiaries. The appeals court said the plaintiffs argued that 132 patents were too many for anyone to hold, especially if they are weak and subject to challenge. They argued that establishing such a “patent thicket” violates the Sherman Act.

The court said the patent laws don’t cap the number of patents any one person can hold, either generally or on a single subject.

“Of course,” the decision says, “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 the standing to make such an argument. The validity of the patents is a subject for dispute between AbbVie and the potential competitors, with review in the Federal Circuit…. The payors insist that AbbVie’s patents are weak — too weak to monopolize the sales of such an important drug. This argument leaves us cold.”

The court acknowledged that all of AbbVie’s patent suits were settled on terms that permitted the biosimilar competitors to enter the U.S. market in 2023. It also noted that the settlements were traditional in patent litigation and AbbVie did not pay any of the would-be competitors as part of its settlements.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome