The U.S. Patent and Trademark Office held the first of two planned hearings aimed at fulfilling one of the reporting provisions of the Leahy-Smith America Invents Act (see "USPTO to Hold Hearing on Genetic Diagnostic Testing"). 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.
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