Op-Ed: Congress Can Finally Stop Big Pharma’s Patent Abuse

Tu SS - DC Journal

  • Innovation Incentives and Competition

Summary:

Branded drug manufacturers have long exploited obviousness-type double patenting to amass dense webs of duplicative patents, forcing generic and biosimilar challengers to litigate each one and effectively blocking competition long after drugs can reasonably be considered innovative. The ETHIC Act would address this abuse by limiting brand-name companies to asserting only one patent per terminal-disclaimer-linked patent group against generic or biosimilar challengers, ensuring patent protection reflects true innovation rather than strategic gamesmanship.

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Recent Work from PORTAL

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The Impact of Semantics in Medicines Regulation

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

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

Delisted Patents on Pharmaceuticals, 1998-2024

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

  • Innovation Incentives and Competition
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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

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
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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