Comments on Draft Intellectual Property Consultative Framework

Kapczynski A, Kesselheim AS, Ezer T - South Africa Department of Trade, Industry, and Competition

  • Innovation Incentives and Competition

Summary:

The commenters argue that the right to health must supersede intellectual property protections and urge South Africa to replace its depository patent system with substantive search and examination, including patent opposition and priority examination mechanisms. They also recommends maximizing TRIPS flexibilities through stricter patentability criteria, streamlined government use and compulsory licensing procedures, and higher standards for granting interdicts in pharmaceutical cases.

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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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