January 25, 2012

Press Release, 12-06

USPTO Announces Public Hearings and Request for Comments on Genetic Diagnostic Testing per the America Invents Act

Public input will help the USPTO complete report in a quality manner

Washington – The United States Patent and Trademark Office (USPTO) is gathering information on genetic diagnostic testing for purposes of preparing a report for Congress on the subject as required by the America Invents Act (AIA). To assist in gathering this information, the USPTO invites the public to provide written comments and/or to testify at public hearings addressing genetic diagnostic testing on February 16, 2012 (9:00 a.m. ET) at the Alexandria, Virginia campus and on March 9, 2012 (9:00 a.m. PT) at the Joan B. Kroc Institute for Peace and Justice, University of San Diego in San Diego, California.

Section 27 of the AIA charges the Director of the USPTO with delivering to Congress a study and recommendations no later than nine months after the enactment of the Act (i.e., by June 15, 2012) regarding independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests. 

The USPTO seeks comments on how to address the issue of independent second opinion genetic diagnostic testing and its relationship to medical care and medical practice, the rights of innovators, considerations relevant to medical costs and insurance coverage, in addition to other issues relevant to the scope of the study. The USPTO will use the collected information to evaluate possible administrative or legislative recommendations that may be provided to Congress. A full list of questions, information on prescheduling hearing testimony, and written comment submission details can be found in the Federal Register Notice available at www.uspto.gov/aia_implementation/2012-1481_genetic-testing-hearing-notice.pdf.

The public hearings will be available via Web cast. Information about the Web cast will be posted at www.uspto.gov/americainventsact before the public hearing. Transcripts of the hearings will be available for review through the same URL following the hearings.

For non-press inquiries, contact Stuart Graham, Chief Economist, (571)-272-6900, Office of the Chief Economist.

Stay current with the USPTO’s implementation of the America Invents Act by subscribing to receive e-mail updates. Visit our Subscription Center at www.uspto.gov/subscribe.

###