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  • Washington Highlights

    AAMC Submits Comments to USPTO on Patentable Subject Matter


    Stephen Heinig, Director, Science Policy

    The AAMC submitted comments on Oct. 15 to the U.S. Patent and Trademark Office (USPTO) as part of a public request for information to help the agency better define the types of discoveries that are ultimately patentable. The public’s input will assist the USPTO in a study, undertaken at the request of Sens. Thom Tillis (R-N.C.), Mazie Hirono (D-Hawaii), Tom Cotton (R-Ark.), and Chris Coons (D-Del.), of recent court decisions on “patentable subject matter” and how those rulings affect the ability of the USPTO to coherently assess new patent applications.

    Courts have long determined that some types of discoveries, such as natural laws or mathematical formulae, are not by themselves eligible for patent protection. Such judicial exemptions generally worked well in the 19th and 20th centuries, but new patent applications in, for example, quantum computing, artificial intelligence, or DNA-based drugs and diagnostics often make these boundaries more difficult to apply. Recent U.S. Supreme Court decisions have overturned patents on naturally occurring DNA sequences and on some types of medical diagnostic tests.

    The association previously outlined the need for judicially drawn exemptions around some types of biological subject matter in a 2011 amicus brief in a seminal case affecting medical research. The AAMC reaffirmed this need in it comments to USPTO, noting, “While an invention that embodies or exploits some understanding of natural principles may rightly belong to its creators, the ability to discover, investigate, and teach about natural processes or natural laws themselves, which exist prior to any human invention, belong to all.”

    “The AAMC believes that law and policy must protect and balance the public good, including access to timely patient care, with proprietary rights in support of science and technology, particularly in the fields of medicine and public health. We believe that these principles are reflected in current jurisprudence,” the association added.

    The AAMC also noted in its comments that an example of the balance between public good and proprietary rights can also be drawn from the current pandemic, where genetic sequence information for the SARS-CoV-2 virus could be widely shared, while protecting incentives for new drug development.

    The AAMC supports the USPTO in undertaking this study and collecting all points of view, believing that a comprehensive examination of these issues could provide coherent guidance to patent examiners and the inventor community.