[author: Kevin E. Noonan]
Janet Gongola, Patent Reform Coordinator at the U.S. Patent and Trademark Office, and manager of all aspects of the agency's implementation of the Leahy-Smith America Invents Act has informed Patent Docs that the Office's report on "second opinion" genetic diagnostic testing has been delayed past its nominal deadline date of June 15, 2012. Patent Reform "Czarina" Gongola (at right) explains that the Report continues to undergo "interagency clearance" that has caused the delay. Many government agencies (ncluding the National Institutes of Health (NIH) and the National Institutes of Standards and Technology (NIST)) have weighed in with "diverse views." While the Report is expected "soon," Czarina Gongola was unable to predict when interagency review would be complete and the Report would be ready to be issued.
The Report is one of several mandated by the Act, and provoked two rounds of public hearing and comment (see "USPTO to Hold Hearing on Genetic Diagnostic Testing"). Specifically, Section 27 of the Act requires the Office to conduct a study regarding the advisability of permitting "second opinions" for patented genetic diagnostic tests without patent infringement liability:
SEC. 27. STUDY ON GENETIC TESTING.
(a) IN GENERAL.—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 enact- ment 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.
In view of the importance of the question and the Office's expertise in making its recommendation, it can only be hoped that the Report will provide a balanced discussion of the issues and provide Congress with the information it needs to quell the calls for unnecessary "second opinions" in genetic diagnoses.