REMEDY Act

To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications. 1. Short title This Act may be cited as the Reforming Evergreening and Manipulation that Extends Drug Years Act REMEDY Act 2. Amendments to ANDA approval provision (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 (1) in subsection (c)(3)(C), by inserting in the case of a certification with respect to a patent that claims a drug substance (and not in the case of a certification with respect to a patent that claims a drug product or method of use for a drug, except that, in the case of a patent that claims a drug substance and a drug product or method of use, this subparagraph shall apply, but only to the extent the patent claims a drug substance), immediately unless, (2) in subsection (j)(5)(B)(iii), by inserting in the case of a certification with respect to a patent that claims a drug substance (and not in the case of a certification with respect to a patent that claims a drug product or method of use for a drug, except that, in the case of a patent that claims a drug substance and a drug product or method of use, this clause shall apply, but only to the extent the patent claims a drug substance), immediately unless, (b) Orange book updates with respect to invalidated patents (1) In general Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7)(A) (iv) In the case of a listed drug for which the list under clause (i) includes a patent that claims the drug or a use for such drug, and where the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office has cancelled any claim of the patent relating to such drug or such use pursuant to a determination by the Patent Trial and Appeal Board in an inter partes review conducted under chapter 31 . (2) No effect on first applicant exclusivity period Section 505(j)(5)(B)(iv)(I) is amended by adding at the end the following: This subclause shall apply even if a patent is stricken from the list under paragraph (7)(A), pursuant to the second sentence of clause (iii) of such paragraph, provided that, at the time that the first applicant submitted an application under this subsection containing a certification described in paragraph (2)(A)(vii)(IV), the patent that was the subject of such certification was included in such list with respect to the listed drug.

Summary: Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY Act This bill addresses drug patents with respect to Food and Drug Administration (FDA) approval of a drug application. Currently, when the owner of a brand-name drug approval sues a generic drug company for patent infringement based on the generic company's application for FDA approval of a generic version of the brand-name drug, there is generally a 30-month stay on the approval of the generic version. Under this bill, the stay goes into effect only if the lawsuit alleges infringement of a patent that claims the drug compound. When the U.S. Patent and Trademark Office invalidates a patent for a drug, the FDA must update its list of relevant patents for the drug.