[author: Donald Zuhn]

In a notice published last week in the Federal Register (77 Fed. Reg. 71170), the U.S. Patent and Trademark Office announced that it was interested in gathering "additional information" on independent second opinion genetic diagnostic testing for purposes of preparing a report on the subject as required by the Leahy-Smith America Invents Act, and as a result would be holding a public roundtable on genetic diagnostic testing from 1:00 to 4:00 pm (EST) on January 10, 2013 at the USPTO's Madison Auditorium in Alexandria, Virginia.  The Office is collecting additional information in order to complete a report to the Committee of the Judiciary for both the Senate and House pursuant to § 27 of the AIA.

AIA § 27(d) specifies that "[n]ot later than 9 months after the date of enactment of this Act, the Director shall report to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on the findings of the study and provide recommendations for establishing the availability of such independent confirming genetic diagnostic test activity."  The notice acknowledges that AIA § 27 "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)."  The notice states, however, that "[i]n the final days before the deadline for receipt of written comments [to the Office's January 2012 request for comments], the Supreme Court of the United States issued two rulings with potential ramifications for the present study."  Those two rulings were the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., and GVR order in Association for Molecular Pathology v. Myriad Genetics, granting a petition for writ of certiorari, vacating the Federal Circuit's decision, and remanding the case for reconsideration in light of Mayo.  The notice also indicates that a letter was sent by the Department of Commerce to the House and Senate Judiciary Committee leadership on August 28, 2012, updating them on the status of the genetic testing report, and stating that "[g]iven the complexity and diversity of the opinions, comments, and suggestions provided by interested parties, and the important policy considerations involved, we believe that further review, discussion, and analysis are required before a final report can be submitted to Congress."

The notice on the roundtable indicates that those wishing to share commentary at the roundtable must request an opportunity to do so in writing no later than December 20, 2012, and that such requests must include the requester's name and contact information (telephone number and e-mail address), organizations the requester represents (if any), and the amount of time the requester needs to present such commentary.  Requests must be submitted by e-mail to Saurabh Vishnubhakat at saurabh.vishnubhakat@uspto.gov.  Requesters selected to provide commentary will be expected to submit a document explaining their position for inclusion in the record of the proceedings no later than thirty days after the roundtable.

The Office is seeking commentary "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, and considerations relevant to medical costs and insurance coverage."  In addition AIA § 27 requires that the Office's report include an examination of the following topics.

(1)  The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses;

(2)  The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;

(3)  The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and

(4)  The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

The notice indicates that the roundtable will be webcast, with information regarding the webcast to be posted on the USPTO's website.

Readers may recall that the Office published a notice in the Federal Register in January seeking written comments and announcing that two hearings would be held on February 16, 2012 at the USPTO's Madison Auditorium, and on March 9, 2012 at the Joan B. Kroc Institute for Peace & Justice at the University of San Diego (see "USPTO News Briefs").  Patent Docs author Dr. Kevin Noonan provided testimony at the first hearing (see "Patent Docs Author Testifies at Genetic Diagnostic Testing Hearing").  In May, the Office published the comments it received in response to its request on a webpage on genetic diagnostic testing that was established as part of the Office's AIA implementation site (see "USPTO Posts Comments on Genetic Diagnostic Testing").  However, the June deadline passed without the completion of the report.

For additional information regarding this subject, please see:

• "USPTO News Briefs," January 26, 2012
• "USPTO to Hold Hearing on Genetic Diagnostic Testing," February 15, 2012
• "USPTO Holds First Hearing on 'Second Opinion' Genetic Testing," February 16, 2012
• "Patent Docs Author Testifies at Genetic Diagnostic Testing Hearing," February 16, 2012
• "USPTO Posts Comments on Genetic Diagnostic Testing," May 22, 2012
• "USPTO Report on Genetic Testing Delayed," June 18, 2012