[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]
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