Request for Comments and Notice of Public Hearings on Genetic Diagnostic Testing, 3748-3750 [2012-1481]
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3748
Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
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
United States Patent and
Trademark Office, Commerce.
ACTION: Request for comments; notice of
public hearings.
AGENCY:
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
saurabh.vishnubhakat@uspto.gov.
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.
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SUMMARY:
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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: https://
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
genetest@uspto.gov. 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 Alcala 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
saurabh.vishnubhakat@uspto.gov.
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
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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?
E:\FR\FM\25JAN1.SGM
25JAN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
(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
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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?
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3749
(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?
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3750
Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
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
DEPARTMENT OF DEFENSE
Department of the Air Force
U.S. Air Force Academy Board of
Visitors Notice of Meeting
U.S. Air Force Academy Board
of Visitors.
ACTION: Meeting notice.
AGENCY:
In accordance with 10 U.S.C.
9355, the United States Air Force
Academy (USAFA) Board of Visitors
(BoV) will hold a meeting in Harmon
Hall at the United States Air Force
Academy in Colorado Springs, Colorado
on 10–11 Feb 2012. The meeting
sessions on 10 Feb will begin at 4 p.m.
and the meeting sessions on 11 Feb will
begin at 8 a.m. The purpose of this
meeting is to review morale and
discipline, social climate, curriculum,
instruction, infrastructure, fiscal affairs,
academic methods, and other matters
relating to the Academy. Specific topics
for this meeting include a Faculty Focus
Group; Religious Training and Respect;
the Superintendent and Command Chief
Update; Diversity in the Athletic
Department; the Air Force Academy
Athletic Corporation Transition Plan
Update; Character Update; Focus Group
(Gold Bar Lieutenants on Diversity
Recruiting); Center for Character and
Leadership Development Military
Construction Update; and the Personnel
Update. In accordance with 5 U.S.C.
552b, as amended, and 41 CFR 102–
3.155, the Administrative Assistant to
the Secretary of the Air Force, in
consultation with the Office of the Air
Force General Counsel, has determined
in writing that the public interest
requires two sessions of this meeting
shall be closed to the public because
they will involve matters covered by
subsection (c)(6) of 5 U.S.C. 552b.
Public attendance at the open
portions of this USAFA BoV meeting
shall be accommodated on a first-come,
first-served basis up to the reasonable
and safe capacity of the meeting room.
In addition, any member of the public
wishing to provide input to the USAFA
BoV should submit a written statement
in accordance with 41 CFR 102–3.140(c)
and section 10(a)(3) of the Federal
Advisory Committee Act and the
procedures described in this paragraph.
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SUMMARY:
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Written statements must address the
following details: The issue, discussion,
and a recommended course of action.
Supporting documentation may also be
included as needed to establish the
appropriate historical context and
provide any necessary background
information. Written statements can be
submitted to the Designated Federal
Officer (DFO) at the Air Force address
detailed below at any time. However, if
a written statement is not received at
least 10 calendar days before the first
day of the meeting which is the subject
of this notice, then it may not be
provided to, or considered by, the BoV
until its next open meeting. The DFO
will review all timely submissions with
the BoV Chairperson and ensure they
are provided to members of the BoV
before the meeting that is the subject of
this notice. For the benefit of the public,
rosters that list the names of BoV
members and any releasable materials
presented during the open portions of
this BoV meeting shall be made
available upon request.
If, after review of timely submitted
written comments, the BoV Chairperson
and DFO deem appropriate, they may
choose to invite the submitter of the
written comments to orally present the
issue during an open portion of the BoV
meeting that is the subject of this notice.
Members of the BoV may also petition
the Chairperson to allow specific
personnel to make oral presentations
before the BoV. In accordance with 41
CFR 102–3.140(d), any oral
presentations before the BoV shall be in
accordance with agency guidelines
provided pursuant to a written
invitation and this paragraph. Direct
questioning of BoV members or meeting
participants by the public is not
permitted except with the approval of
the DFO and Chairperson.
For
additional information or to attend this
BoV meeting, contact Capt Bobby Hale,
Chief of Holm Center Programs,
Commissioning Programs Division, AF/
A1DO, 1500 Perimeter Road, Suite 4750,
Joint Base Andrews, MD 20762–6604,
(240) 612–6252.
FOR FURTHER INFORMATION CONTACT:
Bao-Anh Trinh,
Air Force Federal Register Liaison Officer.
[FR Doc. 2012–1357 Filed 1–24–12; 8:45 am]
BILLING CODE 5001–10–P
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DEPARTMENT OF DEFENSE
Department of the Navy
Notice of Intent To Grant a Partially
Exclusive License; Cobalt
Technologies, Inc.
Department of the Navy, DoD.
Notice.
AGENCY:
ACTION:
The Department of the Navy
hereby gives notice of its intent to grant
to Cobalt Technologies, Inc., a
revocable, nonassignable, partially
exclusive license in the United States to
practice the Government-owned
inventions described in the following:
patent application 61/562231: Water
and Contaminants Removal From
Butanol Fermentation Solutions and/or
Broths Using a Brine Solution, filed on
November 21, 2011.//patent application
61/527943: Dehydration of Bio-Derived
Alcohols to Alkenes Using Highly
Selective Catalysts, filed on August 26,
2011.//patent application 12/511796:
Diesel and Jet Fuels Based on the
Oligomerization of 1-Butene, filed on
July 29, 2009.//patent application 12/
769757: Turbine and Diesel Fuels and
Methods of Making the Same, filed on
April 29, 2010.//patent application 13/
095245: Selective Isomerization and
Oligomerization of Olefin Feedstocks for
the Production of Turbine and Diesel
Fuels, filed on April 27, 2011.//patent
application 13/095290: Selective
Isomerization and Oligomerization of
Olefin Feedstocks for the Production of
Turbine and Diesel Fuels, filed on April
27, 2011.//patent application 13/
095201: Selective Isomerization and
Oligomerization of Olefin Feedstocks for
the Production of Turbine and Diesel
Fuels, filed on April 27, 2011.//patent
application 61/585943: New
Homogeneous Metallocene Ziegler-Natta
Catalysts for the Oligomerization of
Olefins in Aliphatic-Hydrocarbon
Solvents, filed on January 12, 2012.
DATES: Anyone wishing to object to the
grant of this license must file written
objections along with supporting
evidence, if any, not later than February
9, 2012.
ADDRESSES: Written objections are to be
filed with the Office of Research and
Technology Applications, Naval Air
Warfare Center Weapons Division, Code
4L4000D, 1900 N. Knox Road Stop
6312, China Lake, CA 93555–6106.
FOR FURTHER INFORMATION CONTACT:
Michael D. Seltzer, Ph.D., Office of
Research and Technology Applications,
Naval Air Warfare Center Weapons
Division, Code 4L4000D, 1900 N. Knox
Road Stop 6312, China Lake, CA 93555–
SUMMARY:
E:\FR\FM\25JAN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3748-3750]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 saurabh.vishnubhakat@uspto.gov. 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: https://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
genetest@uspto.gov. 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 saurabh.vishnubhakat@uspto.gov.
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
