[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3748-3750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1481]
[[Page 3748]]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-P-2012-0003]
Request for Comments and Notice of Public Hearings on Genetic
Diagnostic Testing
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Request for comments; notice of public hearings.
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SUMMARY: The United States Patent and Trademark Office (``USPTO'') is
interested in gathering information on the 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 provide comments and to
attend public hearings addressing genetic diagnostic testing.
Public Hearings: The USPTO will hold two public hearings in support
of the genetic testing study. The first public hearing will be held on
Thursday, February 16, 2012, beginning at 9 a.m., Eastern Standard Time
(EST), and ending at 4 p.m., EST, in Alexandria, Virginia. The second
public hearing will be held on Friday, March 9, 2012, beginning at 9
a.m., Pacific Standard Time (PST), and ending at 4 p.m., PST, in San
Diego, California.
Those wishing to present oral testimony at either hearing must
request an opportunity to do so in writing no later than February 8,
2012. Requests to testify should indicate the following: (1) The name
of the person wishing to testify; (2) the person's contact information
(telephone number and email address); (3) the organization(s) the
person represents, if any; (4) an indication of the amount of time
needed for the testimony; and (5) a preliminary written copy of the
testimony. The USPTO asks for a preliminary written copy of the
testimony in order to better prepare for pre-scheduled witness
testimony. Requests to testify must be submitted by email to Saurabh
Vishnubhakat at [email protected]. Based upon the requests
received, an agenda for witness testimony will be sent to testifying
requesters and posted on the USPTO Internet Web site (address:
www.uspto.gov/americainventsact).
Speakers providing testimony at the hearings should submit a
written copy of their testimony for inclusion in the record of the
proceedings no later than March 26, 2012.
The public hearings will be available via Web cast. Information
about the Web cast will be posted on the USPTO's Internet Web site
(address: http://www.uspto.gov/americainventsact) before the public
hearing.
Transcripts of the hearings will be available on the USPTO Internet
Web site (address: www.uspto.gov/americainventsact) shortly after the
hearings.
Written Comments: Written comments should be sent by email to
[email protected]. Comments may also be submitted by postal mail
addressed to Saurabh Vishnubhakat, Attorney Advisor, Office of Chief
Economist, United States Patent and Trademark Office, Mail Stop
External Affairs, P.O. Box 1450, Alexandria, VA 22313-1450. Although
comments may be submitted by postal mail, the USPTO prefers to receive
comments via email. The deadline for receipt of written comments is
March 26, 2012. Written comments should be identified in the subject
line of the email or postal mailing as ``Genetic Testing Study.''
Because written comments and testimony will be made available for
public inspection, information that a respondent does not desire to be
made public, such as a phone number, should not be included in the
testimony or written comments.
ADDRESSES: The first public hearing 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.
The second public hearing will be held at the Joan B. Kroc
Institute for Peace & Justice, University of San Diego, 5998
Alcal[aacute] Park, San Diego, California 92110.
FOR FURTHER INFORMATION CONTACT: Saurabh Vishnubhakat, Attorney
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 shall
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 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.
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 questions enumerated below are a preliminary guide to aid
the USPTO in collecting relevant information and to evaluate possible
administrative or legislative recommendations that may be provided to
Congress. The tenor of the following questions 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 answer any or all of
these questions. The public is also invited to submit comments on other
issues that they believe are relevant to the scope of the study in
addition to those listed below.
(1) Currently, how widely available are primary genetic diagnostic
tests? How often are such tests prescribed? What are the limitations,
if any, on the availability of primary genetic diagnostic tests? If
there are limitations on such availability, what are the consequences
in terms of the quality of care, human health and medical costs of such
limitations? How has the practice of medicine, the quality of care that
patients receive, and medical costs and insurance coverage been
affected, if at all, by the availability of primary genetic diagnostic
tests?
[[Page 3749]]
(2) What is the amount and scope of patenting in the field of
genetic diagnostic testing? What role, if any, does patenting play in
the availability of primary genetic diagnostic testing?
(3) With respect to primary genetic diagnostic tests, how widely
available are independent second opinion genetic diagnostic tests? What
are the various organizational methods used to make such independent
second opinion genetic diagnostic tests available?
(a) What are the limitations, if any, on the availability of such
independent second opinion diagnostic tests?
(b) Are any such limitations organizational, associated with the
level of quality or demand, or driven by other internal or external
factors?
(4) What impact does the availability of independent second opinion
genetic diagnostic tests have on the level of care that physicians are
able to provide?
(a) Does the current level of availability of independent second
opinion genetic diagnostic tests affect the medical decisions and
judgment of physicians?
(b) Does the current level of availability of independent second
opinion genetic diagnostic tests affect the quality of care received by
patients?
(c) Does the current level of availability of independent second
opinion genetic diagnostic tests affect the reliability of information
presented to patients?
(d) Are there practical consequences of the current availability of
independent second opinion genetic diagnostic tests, in terms of
patient health, quality of life, and longevity? In terms of the
practice of medical care? Are these consequences, if any, relatively
rare, or common and widespread?
(5) Is the availability of independent second opinion genetic
diagnostic tests related in any manner to innovation in the health care
field, especially as relates to the introduction of new or improved
techniques associated with existing genetic tests and diagnostic
methods?
(6) To the extent that independent second opinion genetic
diagnostic tests are not available, what are the appropriate methods
for making them more widely provided?
(a) What entities or institutions, if any, should play an active
role in ensuring that independent second opinion genetic diagnostic
tests are more widely provided? What is the basis for your
recommendation in terms of providing the maximum benefit at the
appropriate level of cost?
(b) What entities or institutions, if any, should not play a role
in ensuring that independent second opinion genetic diagnostic tests
are more widely provided?
(7) What public policies, if any, should the Federal Government
explore in order to ensure that independent second opinion genetic
diagnostic tests are more widely provided? Is the widespread
availability of such tests the only issue the Federal Government should
consider in fashioning such public policies? Are there public policies
that the Federal Government should not explore?
(8) What effect would providing more widespread access to
independent second opinion genetic diagnostic tests have on existing
owners and license holders of patents that cover genetic diagnostic
tests? How should policy makers consider the relationship of patents,
which may cover purified genetic substances, to proprietary data
derived from conducting tests, each of which may be useful in both
improving high quality and wide access to testing but may also provide
important competitive advantages that can drive investments in research
and development?
(9) What effects, if any, do patents and exclusive licenses have on
genetic diagnostic testing?
(a) What effects, if any, do patents and exclusive licenses on
genetic diagnostic tests have upon the development of new testing
procedures?
(b) What effects, if any, do patents and exclusive licenses on
genetic diagnostic tests have upon how new testing procedures are
performed?
(c) What effects, if any, do patents and exclusive licenses on
genetic diagnostic tests have upon the interpretation of testing
results?
(d) What effects, if any, do patents and exclusive licenses on
genetic diagnostic tests have upon the further improvement of testing
procedures?
(10) What are the pecuniary costs associated with genetic
diagnostic testing?
(a) Are there substantial differences between the pecuniary costs
of patented genetic diagnostic tests and unpatented genetic diagnostic
tests? To the extent that there are cost differences, are these
differences attributable to the patents themselves, or are there other
factors that may be driving the differences?
(b) Are there substantial differences between the pecuniary costs
of patented genetic diagnostic tests and unpatented genetic diagnostic
tests available for the same medical disorder? To the extent that there
are cost differences, are these differences attributable to the patents
themselves, or are there other factors that may be driving the
differences?
(11) What effect does pecuniary cost have on patient access to
genetic diagnostic tests?
(a) What effect does the cost of primary genetic diagnostic testing
have on the likelihood that patients will request such tests? What
effect does the cost of an independent second opinion genetic
diagnostic testing have on the likelihood that patients will request
such tests?
(b) What effect does the cost of primary genetic diagnostic testing
have on the likelihood that physicians will prescribe such tests? What
effect does the cost of independent second opinion genetic diagnostic
testing have on the likelihood that physicians will prescribe such
tests?
(12) How extensive is medical insurance coverage for genetic
diagnostic testing? What are the differences, if any, between the level
of insurance coverage available for genetic diagnostic tests covered by
patents and the level of insurance coverage of unpatented genetic
diagnostic tests for the same diseases or disorders?
(13) What effect does insurance coverage have on patient access to
genetic diagnostic tests?
(a) What effect does the insurance coverage of genetic diagnostic
testing have on the likelihood that patients will request such tests?
What effect does the insurance coverage of independent second-opinion
genetic diagnostic testing have on the likelihood that patients will
request such tests?
(b) What effect does the insurance coverage of genetic diagnostic
testing have on the likelihood that physicians will prescribe such
tests? What effect does the insurance coverage of independent second-
opinion genetic diagnostic testing have on the likelihood that
physicians will prescribe such tests?
(14) What effect do patents and exclusive licenses have on the
availability of insurance coverage for genetic diagnostic tests?
(a) To what extent, if at all, do insurance companies currently
cover the costs of independent second opinion genetic diagnostic tests?
(b) Can you provide evidence that any price differential in the
cost of such tests is attributable to patents and exclusive licenses,
and that any such price differential is a substantial barrier to
insurance coverage of independent second opinion genetic diagnostic
tests?
[[Page 3750]]
Dated: January 18, 2012.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2012-1481 Filed 1-24-12; 8:45 am]
BILLING CODE 3510-16-P