How To Approach Tech Transfers And Sponsored Life Sciences Research In An AI Age
By Amanda DeGroote and Rajkumar Vinnakota, Cole Schotz
The use of artificial intelligence in patent applications and related inventions is a rapidly evolving landscape. While artificial intelligence is not a new concept, it is gaining traction in many fields, including academia and technology development — and in the life sciences arena. This puts companies desiring to execute technology transfers or sponsored research in a challenging position. These technology partnerships allow for the transfer of intellectual property, innovations, ideas, knowledge, and commercialization between the entities at a much more rapid pace than individual research and development. This often occurs between private companies looking to commercialize intellectual property and the entities that create such intellectual property, such as universities, innovators, and research entities.
Artificial intelligence (AI) has created new considerations and concerns when executing these transfers and collaborations. Not only do companies need to understand complex contract law, but now, they also require an understanding of the current case law on patent applications with claims conceived through artificial intelligence. This article will provide a brief overview of the standards for patenting inventions conceived with the assistance of artificial intelligence, as well as provide tips on creating technology transfer or sponsored research agreements that address the concerns of artificial intelligence use while protecting the parties to the agreement.
The Patentability Of AI Conceived Inventions
As the United States Patent and Trademark Office (USPTO) has held for decades, only a “natural person” may be an inventor in a patent application.1,2 While understanding that inventions conceived in their entirety through AI could not be patented, the question remained, could artificial intelligence be utilized in the conception of inventions and. if yes, how much AI could be utilized in conceiving an invention and still remain patentable?
The USPTO attempted to provide clarity with their release of inventorship guidance for inventors utilizing AI in their patented materials.3 This guidance made it clear that “the use of an AI system by a natural person(s) does not preclude a natural person(s) from qualifying as an inventor (or joint inventors) if the natural person(s) significantly contributed to the claimed invention.” (emphasis added). This requirement is in addition to all other requirements for patentability of the claims (i.e., subject matter eligible, novel, non-obvious, and applicable). Additionally, any listed inventors must still meet the requirements that have been required for all inventors for decades, mainly that they “(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.”4 In cases where only one inventor is listed, artificial intelligence may still have a significant role; however, the single inventor would be required to significantly contribute to all of the claims. The USPTO noted, “[i]n the event of a single person using an AI system to create an invention, that single person must make a significant contribution to every claim in the patent or patent application.” That is not to say that AI cannot contribute significantly to the potential patent claims. The guidance from the USPTO also notes that AI can make a significant contribution to the proposed patented material, including a contribution that would typically allow AI to be listed as an inventor if it were a natural person.
Life Sciences Technology Transfers And Sponsored Research
There is no doubt about the importance of technology transfers and sponsored research in the life sciences industry. They allow for accelerated innovation, competition, and, in many cases, commercial profitability. To ensure protection of intellectual property rights and protect investments made into such inventions, strong agreements between the private entity and the research entity must be executed. The following tips will provide a foundational basis on addressing the landscape of AI’s potential involvement in intellectual property when drafting such agreements.
- Conduct early discussions about the use of AI in any potential patented materials. Discussions with potential researchers, inventors, or managers about their familiarity and past use of AI tools will assist in evaluating concerns. Discuss the examples provided by the USTPO in its 2024 guidance with managers or inventors to provide insight on the requirements of significant contributions.
- Include an agreement about the acceptability and scope of AI tools utilized in the project if executed prior to conceiving the invention. This is typically articulated in any Statement of Work (SOW).
- Inquire about any planned use of AI tools in the development process for the proposed intellectual property.
- Form a close relationship with technology transfer offices if working directly with universities. Discuss their knowledge and policies on AI use.
- Clearly define the ownership of any developed intellectual property and the scope and use of any technology transfers or licenses. Discuss potential implications of AI abuse during development of the technology.
- Conduct detailed discussions during the claim drafting process to ensure compliance with inventorship requirements and USPTO invention disclosure requirements.
- Frequently review the USPTO’s AI resource page; AI-related resources | USPTO.
AI is here and by all accounts is not going anywhere. Innovation in the life sciences industry has evolved from the basic lab to sophisticated software models to advance such research and commercialization. Now, AI is the next evolution of tools available for furthering such life sciences innovation. However, the consequences of violating the policies regarding AI can range from being denied intellectual property rights through denial of claims or a patent, or even disciplinary action by the USPTO. Beyond that, the parties to the technology transfers or sponsored research agreements risk losing their time and investment in the desired intellectual property.
References
- In re Application of Application No 16/524,350, Decision on Petition, U.S. Patent and Trademark Office (April 22, 2020) (holding that artificial intelligence systems cannot be listed as inventors on a U.S. patent).
- Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022) (holding that artificial intelligence systems cannot considered inventors).
- Inventorship Guidance for AI-assisted Inventions, 2024-02623, 89 FR 10043 (2024).
- Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997).
About The Authors:
Rajkumar (“Kumar”) Vinnakota is a member of the Life Sciences group at Cole Schotz. His practice focuses on complex commercial litigation in both federal and state courts, and various administrative agencies, including intellectual property, trade secrets, energy, business torts, partnership disputes, and insurance matters. Vinnakota’s intellectual property practice focuses on managing, licensing, and enforcing patent portfolios, and representing and defending domestic and international clients and research institutes. Vinnakota also counsels technology and startup companies on how to navigate the complex legal environment to protect their intellectual property and achieve commercial success.
Amanda L. Degroote is an associate in the Litigation and Intellectual Property Departments at Cole Schotz. She primarily focuses her practice on commercial litigation. With a background in chemistry, Degroote is a part of the firm’s Life Sciences department tackling complex issues in supporting and defending intellectual property rights. Prior to joining Cole Schotz, Degroote served as a law clerk to the Honorable Amanda Maxfield Green, Magistrate Judge for the United States District Court for the Western District of Oklahoma.