[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2699 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 2699

 To promote the research and development of drugs related to neglected 
             and tropical diseases, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 2, 2006

Mr. Brownback (for himself and Mr. Lieberman) introduced the following 
    bill; which was read twice and referred to the Committee on the 
                               Judiciary

_______________________________________________________________________

                                 A BILL


 
 To promote the research and development of drugs related to neglected 
             and tropical diseases, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Elimination of Neglected Diseases 
Act of 2006''.

SEC. 2. PATENT EXTENSION AND RESTORATION.

    (a) In General.--Chapter 14 of title 35, United States Code, is 
amended by inserting after section 156 the following:
``Sec. 156a. Extension and restoration of patent terms relating to 
              neglected and tropical diseases
    ``(a) Definitions.--In this section, the term--
            ``(1) `AIDS' means the acquired immune deficiency syndrome;
            ``(2) `AIDS drug' means a drug indicated for treating HIV;
            ``(3) `eligible patent' means a patent that--
                    ``(A) claims--
                            ``(i) an approved new molecular entity 
                        standard review drug;
                            ``(ii) an active ingredient of such new 
                        molecular entity standard review drug;
                            ``(iii) a process of making or using the 
                        new molecular entity standard review drug; or
                            ``(iv) a process of making an active 
                        ingredient of such new molecular entity 
                        standard review drug; and
                    ``(B) is owned by or licensed to a person that has 
                filed and received approval of an application described 
                in section 505(b)(1) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(b)(1)), for a tropical 
                disease product;
            ``(4) `HIV' means the human immunodeficiency virus, the 
        pathogen that causes AIDS;
            ``(5) `neglected or tropical disease' means--
                    ``(A) HIV, malaria, tuberculosis, and related 
                diseases; or
                    ``(B) any other infectious disease that 
                disproportionately affects poor and marginalized 
                populations, including those diseases targeted by the 
                Special Programme for Research and Training in Tropical 
                Diseases cosponsored by the United Nations Development 
                Program, UNICEF, the World Bank, and the World Health 
                Organization;
            ``(6) `new molecular entity standard review drug'--
                    ``(A) means a drug that--
                            ``(i) has never been marketed in the United 
                        States;
                            ``(ii) appears to have therapeutic 
                        qualities superior to the therapeutic qualities 
                        of another drug that is marketed in the United 
                        States; and
                            ``(iii) is designated by the Secretary of 
                        Health and Human Services under section 524 of 
                        the Federal Food, Drug, and Cosmetic Act as 
                        having a new molecular entity chemical type 
                        classification and standard review drug 
                        treatment potential classification, other than 
                        drugs developed to treat serious or life-
                        threatening diseases; and
                    ``(B) shall not include a subpart E drug or an AIDS 
                drug;
            ``(7) `regulatory review period' means the period described 
        under section 506(g)(1)(B);
            ``(8) `subpart E drug' means a drug developed or evaluated 
        under special procedures for drugs to treat life-threatening or 
        severely debilitating illnesses under subpart E of part 312 of 
        title 21 of the Code of Federal Regulations; and
            ``(9) `tropical disease product' means a product that--
                    ``(A) is approved for use in the treatment of a 
                neglected or tropical disease;
                    ``(B) is a new drug, antibiotic drug, biological 
                product, device, diagnostic, or other tool for 
                treatment, as those terms are used in the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the 
                Public Health Service Act (42 U.S.C. 201 et seq.); and
                    ``(C) is certified by the Secretary of Health and 
                Human Services under section 524 of the Federal Food, 
                Drug, and Cosmetic Act .
    ``(b) Patent Term Extension.--The term of an eligible patent shall 
be extended by a period not to exceed 2 years and not less than 6 
months in duration if--
            ``(1) an application in conformance with the requirements 
        of subsection (d) is submitted to the Director by either the 
        owner of record of the patent or its agent on the later of--
                    ``(A) on or before the date specified under 
                subsection (d)(3); or
                    ``(B) within 45 days after the date of issuance of 
                the patent;
            ``(2) the term of the eligible patent that is the basis of 
        the application has not expired prior to the date that the 
        application is submitted under subsection (d);
            ``(3) the regulatory review period for the tropical disease 
        product has not been relied upon to support an application to 
        extend the term of another patent under this section or under 
        any other provision of law; and
            ``(4) the Food and Drug Administration has certified the 
        eligibility of that tropical disease product for patent 
        extension.
    ``(c) Patent Term Restoration.--The term of a patent for a tropical 
disease product shall be restored by a period equal to the number of 
days in the regulatory review period, if, with respect to the patent 
that is the basis for application--
            ``(1) the owner of record of the patent or its agent 
        submits an application to the Director on the later of--
                    ``(A) on or before the date specified under 
                subsection (d)(3); or
                    ``(B) on or before 45 days after the date of 
                issuance of the patent;
            ``(2) the patent has not been previously restored or 
        extended under this section;
            ``(3) the term of the patent has not expired prior to the 
        date that the owner of the record of the patent or its agent 
        submits an application to the Director;
            ``(4) the regulatory review period for the product has not 
        been relied upon to support an application to extend the term 
        of another patent under any section of this title; and
            ``(5) the Food and Drug Administration has certified the 
        eligibility of that tropical disease product for patent 
        restoration.
    ``(d) Administrative Provisions.--
            ``(1) In general.--To obtain an extension or restoration of 
        the term of an eligible patent or patent of a tropical disease 
        product under this section, the assigner of record and licensee 
        of record of the eligible patent or tropical disease product or 
        the agent of the assigner of record and licensee shall submit 
        an application to the Director.
            ``(2) Content.--The application shall contain--
                    ``(A) a description of the approved tropical 
                disease product and the Federal statute under which 
                regulatory review relating to such product occurred;
                    ``(B) the identity of--
                            ``(i) the eligible patent for which an 
                        extension is sought under this section; or
                            ``(ii) the patent for a tropical disease 
                        product for which a restoration is sought under 
                        this section;
                    ``(C) an undertaking by the applicant to make 
                publicly available independently audited financial 
                statements to verify commercialization of the approved 
                tropical disease product; and
                    ``(D) such other information as the Director may 
                require including additional information to establish 
                that the eligible patent or tropical disease product 
                meets the requirements of this section.
            ``(3) Submission of application.--Upon submission of the 
        application for approval of the tropical disease product to the 
        Food and Drug Administration, the sponsor shall give notice of 
        which patent it would extend if the patent becomes eligible for 
        the extension or restoration upon successfully completing the 
        research. The Secretary of Health and Human Services shall 
        publish the notice.
            ``(4) Irrevocable election.--The submission of an 
        application under this section is an irrevocable election of 
        the application of this section to the eligible patent or 
        patent for a tropical disease product that is the basis of the 
        application. An eligible patent or patent for a tropical 
        disease product that is the basis of an application submitted 
        under this section may not be the subject of an application 
        made under section 156 or any other provision of law.
            ``(5) Rule of construction.--Nothing in this section shall 
        be construed to prohibit an extension, under an application 
        made under any other section of this title, of the term of a 
        patent relating to a tropical disease product that, prior to 
        the effective date of this section, was approved for commercial 
        marketing for a nontropical disease use.
    ``(e) Limitation.--An eligible patent may not be extended under 
this section if--
            ``(1) the tropical disease product was approved for 
        commercial marketing prior to the date of enactment of this 
        section; or
            ``(2) the eligible patent that is the basis of the 
        application under this section expired prior to the date of 
        enactment of this section.''.
    (b) Designation for Patent Extension and Restoration.--Chapter V of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is 
amended by inserting after section 523 the following:

``SEC. 524. DESIGNATION FOR PATENT EXTENSION AND RESTORATION.

    ``(a) Definitions.--In this section:
            ``(1) New molecular entity standard review drug.--The term 
        `new molecular entity standard review drug' has the meaning 
        given that term in section 156a of title 35, United States 
        Code.
            ``(2) Tropical disease product.--The term `tropical disease 
        product' has the meaning given that term in section 156a of 
        title 35, United States Code.
    ``(b) New Molecular Entity Standard Review Drug.--The Secretary, 
acting through the Commissioner of Food and Drugs--
            ``(1) shall designate a drug as a new molecular entity 
        standard review drug for purposes of section 156a of title 35, 
        United States Code, if that drug--
                    ``(A) has a new molecular entity chemical type 
                classification and standard review drug treatment 
                potential classification; and
                    ``(B) is not a drug developed to treat serious or 
                life-threatening diseases;
            ``(2) shall apply the guidance issued in calendar year 2002 
        on serious or life-threatening diseases for purposes of 
        paragraph (1)(B);
            ``(3) shall maintain and annually update a classification 
        list of serious and life-threatening diseases; and
            ``(4) may remove the designation of a drug as a new 
        molecular entity standard review drug as designated under 
        paragraph (1).
    ``(c) Tropical Disease Products.--The Secretary shall certify 
tropical disease products for purposes of section 156a of title 35, 
United States Code.''.
    (c) Technical and Conforming Amendment.--The table of sections for 
chapter 14 of title 35, United States Code, is amended by inserting 
after the item relating to section 156 the following:

``156a. Extension and restoration of patent terms relating to neglected 
                            and tropical diseases.''.
    (d) Study and Report.--
            (1) Study.--The Director of the United States Patent and 
        Trademark Office, in conjunction with the Food and Drug 
        Administration, the Department of Health and Human Services, 
        and the United States Agency for International Development, 
        shall conduct a study on the effect of patent extension and 
        restoration on the ability of pharmaceutical companies to 
        develop and distribute tropical disease products for poor and 
        marginalized populations.
            (2) Report.--Not later than 1 year after the date of the 
        enactment of this Act, the Director of the United States Patent 
        and Trademark Office shall submit a report on the results of 
        the study under paragraph (1) to--
                    (A) the Committee on Foreign Relations of the 
                Senate and the Committee on Health, Education, Labor, 
                and Pensions of the Senate; and
                    (B) the appropriate committees of the House of 
                Representatives.
                                 <all>