Using Patent Data to Assess the Value of Pharmaceutical Innovation

Kesselheim AS, Avorn J - Journal of Law, Medicine & Ethics

  • Innovation Incentives and Competition

Summary:

Despite the pharmaceutical industry’s claims that its research is primarily responsible for new medicines, an analysis of drug innovation found that while industry generates a greater volume of drug-related patents, those originating from non-profit research institutions appear to hold greater importance, underscoring the significant role of publicly funded research in driving drug development. This finding emerged amid concerns about declining FDA approvals, which fell to just 22 new molecular entities and biologics in 2007 (the lowest in 24 years), even as industry revenues continued to rise and regulatory review times remained stable.

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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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