Consulting the WTO key---they can help set standards for AI patents.

[Legal Consultant, 3 years at Suffolk University, 2 years at Istanbul University, 5 years at Koc University. She worked as a professor at Suffolk University for a year, and then became an IP lawyer at Bener Law Office before starting her own law firm.]

In evaluating access to pharmaceuticals, WHO differentiates between essential and non-essential medicines. Essential medicines are those that must be available at all times in adequate amounts at affordable prices. WHO has been publishing essential medicines lists based on current health needs since 1977. WHO’s periodically updated lists provide a guideline for countries to develop their own lists. The latest WHO list includes drugs ranging from antibiotics to drugs used for the treatment of cancer, HIV, and malaria. Access to essential medicines is “a key component of the fulfillment of the human right to health.” The models here thus focus on essential medicines. The models aim to increase access by reforming patentability standards to leave some essential medicines enabled by AI outside the scope of patentability, or alternatively, decreasing the patent term available for such medicines. Non-essential medicines will remain under the existing system, as they are less likely to have a significant impact on global health. Patents on these medicines will allow innovating companies to freely decide prices in the absence of competitors and help raise funds for future R&D investments. 2. The Path to Patent Law Reform Congress is limited by the United States Constitution in determining the sphere of patent protection and granting exclusivity for limited terms. That said, Congress is free to decide the scope and breadth of intellectual property rights. It may impose conditions on patent rights, limit duration, refuse granting privileges, or provide special rights for certain industries, as opposed to employing a uniform intellectual property system. As such, Congress has the authority to subject inventions concerning essential medicines enabled by AI to different eligibility standards, as well as to confer a different scope of rights to such inventions. Nevertheless, any reform to the existing patent system must be compliant with the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS). TRIPS requires patentability of all novel, useful, and non-obvious inventions, and prohibits differential treatment based on technology. Article 27.2 provides an exception to this rule in cases where protection of human life and health require exclusion of patentability. However, the provision indicates that an invention cannot be excluded from patentability based on this exception “merely because the exploitation is prohibited by . . . law.” The models proposed here do not exclude pharmaceuticals from patentability in general but merely change the standard of patentability, or alternatively the exclusivity period, for essential medicines enabled by AI with an aim to ensure wider access to pharmaceuticals. There is thus an argument to be made that the proposed law reforms fall within the scope of the exception. However, the best course of action is to urge the World Trade Organization to recognize the right of countries to subject essential medicines enabled by AI to different standards.