On December 3, 2024, Bristol Myers Squibb announced a collaboration agreement with three-year-old startup AI Proteins.[1] According to its founder, Chris Bahl, PhD, AI Proteins uses “AI, synthetic biology, and laboratory automation to rapidly design and optimize novel miniproteins with ideal drug-like properties.”[2] The end goal of this collaboration is likely biologic products incorporating AI-generated proteins. This is the latest in a long series of signs that the pharmaceutical industry is continuing to invest in the use of artificial intelligence in drug discovery.[3]
On February 13, 2024, the United States Patent and Trademark Office (USPTO) released guidance on AI-assisted inventions.[4] This guidance was drafted in light of President Biden’s October 30, 2023, Executive Order on AI[5] and the Federal Circuit’s 2022 decision in Thaler v. Vidal, which determined that an AI system cannot be an inventor.[6] The USPTO explained that use of an AI system in inventing does not per se render an invention unpatentable, but, in the view of the USPTO, a natural person must have contributed in “some significant manner” to the invention to qualify as an inventor under the Pannu factors.[7] This view has been criticized[8], and it is unclear whether the Federal Circuit will follow the USPTO’s position.
Because the law around AI inventorship is still emerging, patent prosecutors in the biologic space and biosimilar litigators should keep a close eye on the law as it develops. It remains to be seen whether Bristol Myers Squibb’s collaboration with AI Proteins—or any other use of AI—will result in any marketed biologic product. However, if we do eventually see a proliferation of AI designed biologics, inventorship may become a major issue in future biosimilar litigation.
For now, would-be biologic innovators should keep these issues in mind, lest their patent portfolios be weakened from the inception.[9] Pharmaceutical companies investing in AI discovery tools should ensure that natural persons are still making significant contributions. Meanwhile, would-be biosimilar manufacturers should watch closely should this issue arise in BPCIA or other patent litigation.
[1] Kevin Dunleavy, AI Proteins lands $400M drug discovery deal with Bristol Myers, Fierce Biotech (Dec. 3, 2024).
[2] Id.
[3] See Carrie Arnold, Inside the nascent industry of AI-designed drugs. 29 Nat Med 1292–1295 (2023) https://doi.org/10.1038/s41591-023-02361-0; Three ways AI is changing drug discovery at AbbVie | AbbVie.
[4] Inventorship Guidance for AI-Assisted Inventions, 89 Fed. Reg. 10043 (Feb. 13, 2024) Federal Register: Inventorship Guidance for AI-Assisted Inventions.
[5] Exec. Oder No. 14110 (Oct. 30, 2023) Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence | The White House.
[6] Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022).
[7] Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998) (“All that is required of a joint inventor is that he or she (1) contribute in some significant manner to the conception or reduction to practice of the invention, (2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art.”).
[8] ABA-IPL Comment Letter to USPTO Inventorship Guidance for AI Assisted Inventions (May 14, 2024) https://downloads.regulations.gov/PTO-P-2023-0043-0051/attachment_1.pdf
[9] See Annelise Gilbert et al, AI Helps Pharma Find New Drugs But Imperils Lucrative Patents, Bloomberg Law (Apr. 4, 2024).
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