Clearing Dense Drug-Patent Thickets

Chao B, Whalen R, Kesselheim AS, Tu SS - New England Journal of Medicine

  • Innovation Incentives and Competition

Summary:

Two proposed patent reforms, the USPTO terminal disclaimer rule and a bipartisan bill to address patent thickets, could significantly reduce patent thickets on biologic and small molecule products. For two products, adalimumab (Humira), and lenalidomide (Revlimid), the USPTO rule would reduce each product’s thicket by 43% and 70%, respectively, while the legislationw would making only 25 of 105 Humira patents and 12 of 30 Revlimid patents enforceable.

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Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

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Delisted Patents on Pharmaceuticals, 1998-2024

Kirby-Rivera L, Feldman WB, Kim M, Kosmopoulou G, Kesselheim AS, Tu SS - Journal of Law, Medicine, & Ethics

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Delays in Access to Generic Semaglutide Point to Key Missing Pieces in Canada’s Drug Approval System

Eisenkraft Klein D, Kesselheim AS - Health Policy

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Canada approved its first generic semaglutide nearly four months after market exclusivity expired, with delays arising from the absence of clear standards for demonstrating equivalence between fully synthetic generics and the brand-name product. Regulators should publish equivalence standards so manufacturers can build the required evidence into their initial submissions, helping lower-cost alternatives reach patients sooner.
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