Pharma surging now, plan irrelevant—AI is not conceiving, human is in control, and will be listed as an inventor

What Are The Patenting Challenges When Using AI To Develop Drugs?

While AI is having a tremendous impact on drug development, a lack of clarity in patent law for AI-driven innovations means that companies may find it difficult to patent their inventions. For example, patent applications that use AI may face patent eligibility challenges as being directed to unpatentable subject matter including abstract ideas or laws of nature. It is also unclear how much disclosure in a patent application is necessary to satisfy the written description and enablement requirements, especially when drafting claims directed to antibodies (a complicated and unclear area on its own). These hurdles will each be discussed in subsequent articles.

AI-based inventions also raise considerable issues for inventorship. For a patent to be valid, every inventor listed on the application must have participated in conception of the invention and every inventor must be listed on the patent application.8 “Conception is the touchstone of inventorship”9 and requires the inventor to have formed a sufficiently definite idea of the “complete and operative invention.”10 Reducing the invention to a physical manifestation of the idea (i.e., reduction to practice) is not necessary; however, the person must at least perform the mental task of creating the entirety of invention.

In some countries, like South Africa and Australia, AI can be an inventor. However, most countries have laws that stipulate that inventors must be human. In those countries, AI cannot be an inventor.11 In U.S., the Federal Circuit recently heard arguments regarding whether the term inventor in the Patent Act is broad enough to include AI. A recent ruling in Germany held that AI cannot be an inventor, but states that the owners of AI can name themselves as the inventors on the patent application.12 The court declined to say whether the owners would properly be considered the inventors or whether this was just a way to prevent the application from immediate rejection.13 However, this ruling presents an interesting thought for how the law may evolve in the future.

At present, few AI programs are sophisticated enough to “invent.” For the most part, humans still may be considered to conceive the invention because they start with the identification of the drug target, develop the AI input parameters, control/monitor the AI output around select inclusion criteria, and assess the ultimate validity of the candidate pool based on external parameters that the scientist establishes. In this process, AI is merely a tool that the scientist uses for drug discovery in a similar manner that a “dumb” computer may have been used to help map out a combinatorial library based on predictive binding parameters in silico. As such, a strong argument can be made that drugs developed with the assistance of AI are patentable despite the uncertainty in the inventorship law.