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US patent laws require human inventors as biotech adopts AI drug design

Federal rulings and changing administrative guidance require human contribution on patents even as algorithms increasingly generate chemical structures.

The short version

  • Under current US patent law, only human beings can be listed as inventors, requiring pharmaceutical firms using artificial intelligence to attribute patents to human researchers.
  • Courts have defined an inventor as an individual person, prompting companies to rely on human laboratory work, testing, and oversight to secure patent rights.
  • Legal experts warn that future drug patents could face invalidation challenges if human contributions are deemed insufficient as AI tools become more autonomous.

Key facts

  • A 2022 decision by a federal appeals court in Washington, D.C., affirmed that US patent statutes define an inventor as an individual human being, excluding machines.[MIT Technology Review]
  • Biotechnology company Insilico Medicine named five human researchers on a patent for a pulmonary fibrosis treatment that was initially proposed by its generative AI platform.[MIT Technology Review]
  • The US Patent and Trademark Office reversed earlier guidance from the Biden administration regarding human co-inventorship with AI, instead treating AI systems strictly as tools under the Trump administration.[MIT Technology Review]
  • Drug developers currently establish inventorship by having human chemists synthesize molecules, create chemical variants, and conduct animal testing.[MIT Technology Review]

What remains uncertain

  • Legal experts disagree on what minimum threshold of human involvement will legally qualify a person as an inventor as autonomous AI systems handle more of the design and testing process.[MIT Technology Review]
  • It remains untested whether future patents on AI-designed drugs will survive legal challenges attempting to invalidate them for improperly listing human inventors.[MIT Technology Review]

Sources