[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2276 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 2276

   To require the Director of the United States Patent and Trademark 
   Office to conduct a study on effective ways to provide confirming 
   genetic diagnostic test activity where gene patents and exclusive 
                licensing exist, and for other purposes.


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                    IN THE HOUSE OF REPRESENTATIVES

                             June 22, 2011

Ms. Wasserman Schultz introduced the following bill; which was referred 
to the Committee on the Judiciary, and in addition to the Committee on 
Energy and Commerce, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
   To require the Director of the United States Patent and Trademark 
   Office to conduct a study on effective ways to provide confirming 
   genetic diagnostic test activity where gene patents and exclusive 
                licensing exist, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. STUDY ON GENETIC TESTING.

    (a) In General.--The Under Secretary of Commerce for Intellectual 
Property and Director of the United States Patent and Trademark Office 
(in this section referred to as the ``Director'') shall conduct a study 
on effective ways to provide independent, confirming genetic diagnostic 
test activity where gene patents and exclusive licensing for primary 
genetic diagnostic tests exist.
    (b) Items Included in Study.--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.
            (4) The role that cost and insurance coverage have on 
        access to and provision of genetic diagnostic tests.
    (c) Confirming Genetic Diagnostic Test Activity Defined.--For 
purposes of this section, the term ``confirming genetic diagnostic test 
activity'' means 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.
    (d) Report.--Not later than 9 months after the date of the 
enactment of this Act, the Director shall report to the Committee on 
the Judiciary of the Senate and the Committee on the Judiciary of the 
House of Representatives on the findings of the study and provide 
recommendations for establishing the availability of such independent 
confirming genetic diagnostic test activity.
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