Emerging technologies such as Artificial Intelligence (AI) are increasingly playing a significant role in multiple sectors, one of which is drug discovery in the pharmaceutical industry. The number of startup drug candidate pipelines utilizing AI tools is said to now tally to an approximate 50% of the preclinical programs of large pharmaceutical firms (Jayatunga et al., Nature Reviews, March 2022). Not only has the advent of AI significantly reduced drug discovery timelines, but research also suggests that AI-driven discovery pipelines can reach the preclinical phase within an average of four years, compared to the traditional five to six years.
However, as beneficial as AI’s role in expediting drug discovery may be, it also brings to the fore some complex legal issues. The primary concern surrounds Intellectual Property (IP) rights related to drugs discovered using AI. Just as in conventional methods of drug discovery, patent exclusivity is a crucial component of IP rights in AI-driven drugs. It prevents competitors from entering the generic market until the patent expires.
As it stands, should an AI “discover” a drug, there remains a lack of legal clarity whether the pharmaceutical company will enjoy the same level of exclusivity. Two recent case decisions, albeit not relating directly to drug discovery, raise questions about the possibility of AI creating a situation whereby pharmaceutical companies may no longer uphold the same level of exclusivity. The denial of the registration of an artwork named “SURYAST” by the U.S. Copyright Office—owing to it being generated by AI and therefore lacking sufficient human authorship—highlights the complexities surrounding the recognition of AI-produced content (U.S. Copyright Office).
Moreover, in a recent case, Thaler v. Vidal, the Federal Circuit reinforced that the term “inventor” in the Patent Act could only be a natural person, ruling out AI as an inventor (43 F.3d 1207, Fed. Cir. 2022). This decision carries potential ramifications for the realm of AI-driven drug discovery, where if AI were deemed the sole inventor of a drug, the drug could be deemed ineligible for patenting under 35 U.S.C. §101, altering the landscape of patent law for pharmaceutical companies drastically.
As the law governing IP rights in AI-driven drug discovery is still developing, any future legal developments stand to bear significant implications for various sectors, underscoring the necessity for ongoing discussion and legislative action surrounding AI and its role in the world today.