Orange Book

(a)

Submission of patent information for brand name drugs

Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended to read as follows:

(b) (1)Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (A)full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B)a full list of the articles used as components of such drug; (C)a full statement of the composition of such drug; (D)a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E)such samples of such drug and of the articles used as components thereof as the Secretary may require; (F)specimens of the labeling proposed to be used for such drug; (G)any assessments required under section 505B; and (H)patent information, with respect to each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, and consistent with the following requirements: (i)The applicant shall file with the application the patent number and the expiration date of— (I)any patent which claims the drug for which the applicant submitted the application and is a drug substance (including active ingredient) patent or a drug product (including formulation and composition) patent; and (II)any patent which claims the method of using such drug. (ii)If an application is filed under this subsection for a drug and a patent of the type described in clause (i) which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include such patent information.

Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (H). The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by subparagraph (A).

(b)

Conforming changes to requirements for subsequent submission of patent information

Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended— (1)by inserting after the patent number and the expiration date of any patent which the following: fulfills the criteria in subsection (b) and; (2)by inserting after the first sentence the following: Patent information that is not the type of patent information required by subsection (b) shall not be submitted.; and (3)by inserting after could not file patent information under subsection (b) because no patent the following: of the type required to be submitted in subsection (b). (c)

Listing of exclusivities

Subparagraph (A) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following:

(iv)For each drug included on the list, the Secretary shall specify each exclusivity period that is applicable and has not concluded under— (I)clause (ii), (iii), or (iv) of subsection (c)(3)(E) of this section; (II)clause (iv) or (v) of paragraph (5)(B) of this subsection; (III)clause (ii), (iii), or (iv) of paragraph (5)(F) of this subsection; (IV)section 505A; (V)section 505E; or (VI)section 527(a).

(d)

Removal of invalid patents

(1)

In general

Section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following:

(D) (i)The holder of an application approved under subsection (c) for a drug on the list shall notify within 14 days the Secretary in writing if either of the following occurs: (I)The Patent Trial and Appeals Board issues a decision from which no appeal has been or can be taken that a patent for such drug is invalid. (II)A court issues a decision from which no appeal has been or can be taken that a patent for such drug is invalid. (ii)The holder of an approved application shall include in any notification under clause (i) a copy of the decision described in subclause (I) or (II) of clause (i). (iii)The Secretary shall remove from the list any patent that is determined to be invalid in a decision described in subclause (I) or (II) of clause (i)— (I)promptly; but (II)not before the expiration of any 180-day exclusivity period under paragraph (5)(B)(iv) that relies on a certification described in paragraph (2)(A)(vii)(IV) that such patent was invalid.

(2)

Applicability

Subparagraph (D) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), as added by paragraph (1), applies only with respect to a decision described in such subparagraph that is issued on or after the date of enactment of this Act. (e)

Review and report

Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (1)solicit public comment regarding the types of patent information that should be included on the list under section 507(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)); and (2)transmit to the Congress an evaluation of such comments, including any recommendations about the types of patent information that should be included on or removed from such list.

GAO report to Congress

(a)

In general

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. (b)

Contents

The Comptroller General shall include in the report under subsection (a)— (1)data on the number of— (A)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 (B)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; (2)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; (3)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— (A)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 (B)not listing the patents described in paragraph (1)(A) would delay the market entry of one or more such drugs; and (4)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.