Mapping Intellectual Property Abuses in the Pharmaceutical Field

Tu SS, Rutschman AS - JAMA Health Forum

  • Innovation Incentives and Competition

Summary:

This viewpoint provides an overview of how brand-name pharmaceutical manufacturers exploit patents, trade secrets, copyrights, and trademarks to block competition and keep drug prices high, often at the expense of patient access and public health. Stronger patent examination and other legal remedies can curb these intellectual property abuses.

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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
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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

  • 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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