Intellectual Property Statement

A draft bill introduced in May 2019 sought to reform Section 101 of the U.S. Patent Act. If passed, the legislation would allow for the patenting of genes by effectively overturning the 2013 Association for Molecular Pathology (AMP) vs. Myriad Supreme Court decision. Related: Joint Letter from ASHG and ACMG Leadership to Bill Sponsors (July... Read More

In 2010, ASHG issued a policy statement outlining guiding principles related to patenting and licensing in the genetic testing arena. These principles address protection of intellectual property, quality of testing, and access to testing. Related: Guiding Principles on Protection of Intellectual Property: Patenting and Licensing in the Genetic Testing Arena (April 2010) Read More

In 2000, the U.S. Patent and Trademark Office released revised interim guidelines that raised the bar for patent eligibility of nucleic acid sequences. ASHG supports the PTO’s new standard of “specific, substantial and credible” utility in its revised guidelines, and suggested an extension of this standard to keep pace with current and planned research. Related:... Read More