Generative artificial intelligence (AI) has opened and accelerated new and exciting areas of innovation. One of the most promising AI applications is the pharmaceutical industry.
In June 2024, the very first drug “discovered” by use of AI technology began its first human clinical trial for treatment of a chronic and progressive lung condition. If successful, it will extend and hopefully improve the lives of those with idiopathic pulmonary fibrosis for years to come.
Can AI Be Listed as an Inventor on a Patent?
While this is a fantastic development for patients, drugmakers are corporations that rely on profits. Profits are maximized when drugmakers seek patent protection for their innovations, thereby excluding others from making the drugs for the life of the patent.
Patent applications for drugs require the name(s) of the inventors. With the use of AI in drug discoveries, can AI be considered an inventor on a patent?
U.S. Patent Applicants Must Be Human
Presently in the U.S., the answer is no, AI cannot be an inventor on a patent application.
The question of AI-derived discoveries applicable for patents is one the United States Patent and Trademark Office (USPTO) has grappled with for several years. In April 2020, the USPTO issued multiple decisions denying the naming of the AI system known as DABUS (Device for the Autonomous Bootstrapping of Unified Sentience) as an inventor on certain patent applications. This decision, that AI cannot be named as an inventor on patent applications, was subsequently upheld by a U.S. District Court.
The language of 35 U.S.C. § 101 states, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” The USPTO has repeatedly emphasized that the opening word of the federal statute “whoever” refers to a natural human being and, therefore, AI cannot be named as an Inventor of any U.S. patent or patent application.
An Appeal on AI Patent Inclusion
On appeal from the DABUS decisions, the Federal Circuit further stated the language of 35 U.S.C. § 100(f) that refers to “the individual or, if a joint invention, the individuals…” can also only mean natural persons, and thus, AI is specifically excluded from inventorship under U.S. law. Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022). It’s worth noting that the “Thaler” party in Thaler v. Vidal is Stephen Thaler, the creator of the DABUS AI tool. (“Vidal” identifies the current USPTO Director Kathi Vidal.) From this, we can draw the logical conclusion that the legal action challenging the USPTO’s decision to deny DABUS the status of Inventor had to be prosecuted by the AI tool’s creator because DABUS itself did not have standing to prosecute such a lawsuit in the U.S. Courts, thus further supporting the Federal Circuit’s stance that the tool is not the legal equivalent of a natural person.
Recently Issued USPTO Guidance on AI and Patents
Following these court decisions, the USPTO conducted years of research into the issue and sought public comment on the matter. This process culminated in the USPTO’s most recently-issued guidance on the topic, which states that inventors can only be natural persons.
So while this does not mean that AI tools cannot be used in the invention process, each person named in the patent application as an inventor must still have made a “significant contribution” to the conception of the invention, per the USPTO’s February 2024 guidance.
Sorry to Siri, Alexa, DABUS, ChatGPT, Google Assistant and all other AI tools who may – one day – take offense. For more information, see the USPTO’s Guidance in the Federal Register here: https://www.federalregister.gov/documents/2024/02/13/2024-02623/inventorship-guidance-for-ai-assisted-inventions
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