Sec. 342. GAO report to Congress
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Not later than one year after the date of enactment of this Act, the Comptroller General of the United States (referred to in this section as the Comptroller General ) shall submit to the Committee on Energy and Commerce of the House of Representatives a report on the patents included in the list published under section 505(j)(7) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 355(j)(7) ), including an analysis and evaluation of the types of patents included in such list and the claims such patents make about the products they claim. The Comptroller General shall include in the report under subsection (a)— data on the number of— patents included in the list published under paragraph
(7)of section 505(j) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 355(j) ), that claim the active ingredient or formulation of a drug in combination with a device that is used for delivery of the drug, together comprising the finished dosage form of the drug; and claims in each patent that claim a device that is used for the delivery of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug; data on the date of inclusion in the list under paragraph
(7)of such section 505(j) for all patents under such list, as compared to patents that claim a method of using the drug in combination with a device; an analysis regarding the impact of including on the list under paragraph
(7)of such section 505(j) certain types of patent information for drug product applicants and approved application holders, including an analysis of whether— the listing of the patents described in paragraph (1)(A) delayed the market entry of one or more drugs approved under such section 505(j); and not listing the patents described in paragraph (1)(A) would delay the market entry of one or more such drugs; and recommendations about which kinds of patents relating to devices described in paragraph (1)(A) should be submitted to the Secretary of Health and Human Services for inclusion on the list under paragraph
(7)of such section 505(j) and which patents should not be required to be so submitted.
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Sec. 342
GAO report to Congress
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