[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71170-71171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28890]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. PTO-C-2012-0049]


Notice of Public Roundtable on Genetic Diagnostic Testing

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of public roundtable.

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SUMMARY: The United States Patent and Trademark Office (``USPTO'') is 
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 America Invents Act (``AIA'' or 
``Act''). To assist in gathering this information, the USPTO invites 
the public to attend a roundtable focused on genetic diagnostic 
testing.
    Public Roundtable: The USPTO will hold a public roundtable in 
support of the genetic testing study. The roundtable will be held on 
Thursday, January 10, 2013, beginning at 1:00 p.m. Eastern Standard 
Time (EST) and ending at 4:00 p.m. (EST) in Alexandria, Virginia.
    Those wishing to share commentary at the roundtable must request an 
opportunity to do so in writing no later than December 20, 2012. The 
request must include the following: (1) The name of the person wishing 
to share commentary; (2) the person's contact information (telephone 
number and email address); (3) the organization(s) the person 
represents, if any; and (4) an indication of the amount of time 
requested for the commentary. Requests to share commentary must be 
submitted by email to Saurabh Vishnubhakat at 
[email protected]. Based upon the requests received, an 
agenda will be sent to all requesters and posted on the USPTO Internet 
Web site (address: www.uspto.gov/americainventsact).
    Speakers sharing commentary at the roundtable must submit a 
document explaining their position for inclusion in the record of the 
proceedings no later than thirty days after the roundtable. Written 
commentary should not exceed 25 pages using at least 12-point and 
double-spaced font. Because written commentary will be made available 
for public inspection, information that a speaker does not desire to be 
made public, such as a telephone number, should not be included in the 
written comments.
    The public roundtable will be available via Web cast. Information 
about how to access the Web cast will be posted on the USPTO's Internet 
Web site (address: http://www.uspto.gov/americainventsact) before the 
public roundtable.
    A transcript of the roundtable will be available on the USPTO 
Internet Web site (address: www.uspto.gov/americainventsact) shortly 
after the roundtable.

ADDRESSES: The public roundtable will be held at the USPTO in the 
Madison Auditorium on the concourse level of the Madison Building, 
located at 600 Dulany Street, Alexandria, Virginia 22314.

FOR FURTHER INFORMATION CONTACT: Saurabh Vishnubhakat, Expert Advisor, 
Office of Chief Economist, by telephone at 571-272-9300, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 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. Congress has mandated that the study include 
an examination of at least the following:
    (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

[[Page 71171]]

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.
    In the Act, Congress defined the term ``confirming genetic 
diagnostic test activity'' to mean the performance of a genetic 
diagnostic test, by a genetic diagnostic test provider, on an 
individual solely for the purpose of providing the individual with an 
independent confirmation of results obtained from another test 
provider's prior performance of the test on the individual.
    Recognizing the diversity and complexity of the public policy 
issues surrounding independent second opinion genetic diagnostic 
testing, the USPTO conducted a thorough review of the academic and 
scientific literature, took notice of several published reports, and 
actively sought diverse and sophisticated input from the public. In 
that last regard, the Office published a notice in the Federal Register 
and on the USPTO public Web site dedicated to AIA implementation (AIA 
micro-site), seeking written comments and announcing two public 
hearings for this study. See Request for Comments and Notice of Public 
Hearings on Genetic Diagnostic Testing, 77 FR 3748 (Jan. 25, 2012). The 
Office also provided the public with a dedicated email address and a 
contact person in the USPTO to receive comments.
    As announced in the Federal Register and on the AIA micro-site, the 
Office held two public hearings dedicated to taking public comment for 
this report. The first occurred at the USPTO headquarters in 
Alexandria, Virginia, on Thursday, February 16, 2012, and the second 
took place at the University of San Diego School of Law in San Diego, 
California, on Friday, March 9, 2012. At the hearings, witnesses 
provided pre-scheduled testimony, and members of the audience provided 
spontaneous testimony. Representatives from the USPTO attended the 
hearings and actively questioned all witnesses. Also, witnesses 
exchanged comments with the audience.
    In the final days before the deadline for receipt of written 
comments, the Supreme Court of the United States issued two rulings 
with potential ramifications for the present study. The first was a 
memorandum opinion in Mayo Collaborative Services v. Prometheus 
Laboratories, Inc., 132 S. Ct. 1289 (2012). The second was an order in 
Association for Molecular Pathology v. Myriad Genetics, 132 S. Ct. 1794 
(2012), granting the petition for a writ of certiorari, vacating the 
decision of the United States Court of Appeals for the Federal Circuit 
(CAFC), and remanding the case for reconsideration in light of the Mayo 
decision. Accordingly, the USPTO published a notice on the AIA micro-
site seeking additional public input, within ten calendar days, 
regarding the impact of the Supreme Court's actions on independent 
second opinion genetic diagnostic testing.
    Through the Federal Register notice and hearings, the Office 
received twenty-seven sets of written comments and testimony from 
eighteen witnesses. Respondents with written comments, many of whom 
also testified, included four U.S. intellectual property organizations, 
thirteen U.S. companies and organizations, three U.S. patent 
practitioners, and seven members of the public speaking as individuals.
    On August 28, 2012, the Department of Commerce sent a letter to the 
House and Senate Judiciary Committee leadership updating them on the 
status of the genetic testing report. The letter stated in part: 
``Given 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.'' After this additional public roundtable, the USPTO will 
follow next steps and fulfill its obligation to Congress.
    Issues for Comment: 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, and considerations relevant to medical costs and insurance 
coverage. The issues enumerated below are as posed in the AIA and serve 
as a preliminary guide to aid the USPTO in collecting further relevant 
information and to evaluate possible administrative or legislative 
recommendations that may be provided to Congress. The tenor of the 
following issues should not be taken as an indication that the USPTO 
has taken a position or is predisposed to any particular views. The 
public is invited to address any or all of these issues. The public 
also is invited to provide input on other issues believed to be 
relevant to the scope of the study in addition to those listed below.
    (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.

    Dated: November 21, 2012.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2012-28890 Filed 11-28-12; 8:45 am]
BILLING CODE 3510-16-P