In 2013 the Supreme Court of the United States in Association for Molecular Pathology v Myriad Genetic Inc, held that genes are not patentable as they are “products of nature”. Currently under Section 101 of the Patent Act laws of nature, products of nature and abstract ideas are not patentable. However, recent proposals to amend the Patent Act sponsored by Senators Tillis and Coons (found here) would remove implicit or other judicially created exceptions for subject matter eligibility. These amendments would remove the restriction on patentability of laws of nature, products of nature and abstract ideas. With these proposals, uncertainty arises regarding the future of patentability of human genes in the United States.
This matter recently had three scheduled hearings with the Senate IP Subcommittee on June 4th, 5th and 11th , 2019. Notably, in the first of these hearings Senators Coons and Tillis stated that the intent of the proposed amendments was not to overrule Myriad. However, other witnesses at the hearings opined that the proposal did overturn Myriad.
Notably, Tillis when speaking with Science noted that the decision in Myriad would be preserved through other proposed amendments. Particularly, there would be new requirements to determine whether an invention was “useful”. He provided that these requirements would be structured in a manner that would ensure naturally occurring genes and pure laws of nature would continue to have restrictions on patentability. (Read more from Science here)
Overall, with these new proposals there comes some uncertainty regarding the future of patentability of human genes in the United States.