Brief of Intellectual Property Scholars in xAI v. Bonta

Kesselheim AS, Tu SS - US Court of Appeals for the Ninth Circuit

  • Innovation Incentives and Competition

Summary:

xAI mischaracterizes Ruckelshaus v. Monsanto by treating it as establishing a per se taking whenever a government requires disclosure of trade secret information, as California’s AI training data transparency law does, when in fact Monsanto requires a governmental promise of secrecy, absent from the state’s law, for any such takings claim to succeed. The amici warn that accepting xAI’s broad interpretation would let companies challenge transparency mandates as unconstitutional takings across other domains, chilling state regulation of AI as well as disclosure requirements covering drug prices, hazardous chemical spills, and cosmetics ingredients.

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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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