USPTO to Hold Roundtable on Genetic Diagnostic Testing

by McDonnell Boehnen Hulbert & Berghoff LLP

[author: Donald Zuhn]

USPTO Building FacadeIn 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."

USPTO SealThe 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  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


Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.