Today’s Federal Register includes a notice to the public inviting comments on independent second opinion genetic tests where patents and exclusive licenses exist that cover primary genetic diagnostic tests. The comments are collected for the purpose of preparing a report on the subject as required by Section 27 of the America Invents Act (“AIA”).  In addition to soliciting comments, the USPTO will hold two public hearings in support of the genetic testing studies. 

Section 27 of the AIA

We previously reported on this requirement of the AIA, and its implications for personalized medicine.  See our posts of Sept. 19th, Sept. 9th, and June 26th. In the earlier posts we noted that under Section 27 of the AIA, the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent Office (Director) shall report to Committee of the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on effective ways to conduct independent confirmatory genetic tests (second opinions) of genetic diagnostic tests covered by patents that are exclusively licensed. 

The Director’s report must include at least 4 items:

1. The impact of the current lack of independent second opinion testing on the ability to provide the highest level of medical care and on inhibiting innovation to existing testing and on inhibiting innovation to existing testing and diagnosis;

2. The effect that providing independent second opinion testing would have on the existing patent and license holders of the exclusive genetic test;

3. The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, such as the interpretation of testing results and performance of testing procedures;

4. The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

Nature of the Information Requested

The Federal Register notice indicates the comments are solicited to aid the USPTO in providing possible administrative or legislative recommendations that may be provided to Congress.  To that end, the USPTO is requesting comments regarding:

            (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?

            (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?

Public Hearing Testimony and Written Comment Submission

Public hearings will be held on Thursday, February 16, 2012, in Alexandria Virginia and on Friday, March 9, 2012, in San Diego California.  Those wishing to present testimony at either hearing must request an opportunity to do so in writing no later than February 8, 2012.  A preliminary written copy of the testimony must be provided.  The pubic hearings also will be available via Web cast. 

The deadline for written comments is March 26, 2012.  They should be sent by email to genetest@uspto.gov or by mail to Saurabh Vishnubhakat, Office of the Chief Economist, USPTO, Mail Stop External Affairs, P.O. Box 1450, Alexandria Virginia 22313-1450.  Written comments should be identified as “Genetic Testing Study” in the subject line of the email or the postal mailing address.