I 

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. 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. STUDY ON GENETIC TESTING. 

4 (a) IN GENERAL.—The Under Secretary of Com5 merce for Intellectual Property and Director of the United 

6 States Patent and Trademark Office (in this section reVerDate Mar 15 2010 07:16 Jun 24, 2011 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2276.IH H2276

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1 ferred to as the ‘‘Director’’) shall conduct a study on effec2 tive ways to provide independent, confirming genetic diag3 nostic test activity where gene patents and exclusive li4 censing for primary genetic diagnostic tests exist. 

5 (b) ITEMS INCLUDED IN STUDY.—The study shall in6 clude an examination of at least the following: 

7 (1) The impact that the current lack of inde8 pendent second opinion testing has had on the abil9 ity to provide the highest level of medical care to pa10 tients and recipients of genetic diagnostic testing, 

11 and on inhibiting innovation to existing testing and 

12 diagnoses. 

13 (2) The effect that providing independent sec14 ond opinion genetic diagnostic testing would have on 

15 the existing patent and license holders of an exclu16 sive genetic test. 

17 (3) The impact that current exclusive licensing 

18 and patents on genetic testing activity has on the 

19 practice of medicine, including but not limited to the 

20 interpretation of testing results and performance of 

21 testing procedures. 

22 (4) The role that cost and insurance coverage 

23 have on access to and provision of genetic diagnostic 

24 tests. 


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1 (c) CONFIRMING GENETIC DIAGNOSTIC TEST ACTIV2 ITY DEFINED.—For purposes of this section, the term 

3 ‘‘confirming genetic diagnostic test activity’’ means the 

4 performance of a genetic diagnostic test, by a genetic diag5 nostic test provider, on an individual solely for the purpose 

6 of providing the individual with an independent confirma7 tion of results obtained from another test provider’s prior 

8 performance of the test on the individual. 

9 (d) REPORT.—Not later than 9 months after the date 

10 of the enactment of this Act, the Director shall report to 

11 the Committee on the Judiciary of the Senate and the 

12 Committee on the Judiciary of the House of Representa13 tives on the findings of the study and provide rec14 ommendations for establishing the availability of such 

15 independent confirming genetic diagnostic test activity. 

Æ 


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