[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