[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 3004 Introduced in Senate (IS)]

113th CONGRESS
  2d Session
                                S. 3004

   To promote the development of meaningful treatments for patients.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 11, 2014

 Mr. Hatch (for himself and Mr. Bennet) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To promote the development of meaningful treatments for patients.

    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 ``Dormant Therapies Act of 2014''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Definitions.
Sec. 4. Capturing lost opportunities and creating new cures for 
                            patients.
Sec. 5. Implementation and effect.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) The term ``biological product'' has the meaning given 
        to that term in section 351 of the Public Health Service Act 
        (42 U.S.C. 262).
            (2) The term ``Director'' means the Under Secretary of 
        Commerce for Intellectual Property and Director of the United 
        States Patent and Trademark Office.
            (3) The term ``dormant therapy'' means a medicine 
        designated as a dormant therapy under section 4(a).
            (4) The term ``drug'' has the meaning given to that term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (5) The term ``medicine'' means a biological product or a 
        drug.
            (6) The term ``protection period'', with respect to a 
        dormant therapy, means the period that--
                    (A) begins on the date on which the Secretary first 
                approves an application under section 505(b) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
                or section 351(a) of the Public Health Service Act (42 
                U.S.C. 262(a)) for the dormant therapy for any 
                indication; and
                    (B) ends on the date that is 15 years after the 
                date of such approval.
            (7) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
            (8) The term ``sponsor'', with respect to a dormant 
        therapy, is the person who takes responsibility for the 
        designation and development of the dormant therapy. The sponsor 
        may be a single entity or an entity collaborating with one or 
        more other entities.

SEC. 4. CAPTURING LOST OPPORTUNITIES AND CREATING NEW CURES FOR 
              PATIENTS.

    (a) Designation as a Dormant Therapy.--The Secretary shall 
designate a medicine as a dormant therapy if--
            (1) the sponsor of the medicine submits a request for such 
        designation meeting the requirements under subsection (b), and 
        the request has not been withdrawn under subsection (d)(1); and
            (2) the Secretary determines that--
                    (A) the medicine is being investigated or is 
                intended to be investigated for an indication to 
                address one or more unmet medical needs;
                    (B) a suitable clinical plan for such 
                investigations of the medicine has been developed by 
                the sponsor;
                    (C) the sponsor intends to file an application 
                pursuant to section 505(b) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 355(b)) or section 351(a) 
                of the Public Health Service Act (42 U.S.C. 262(a)) for 
                approval or licensing of the medicine for an indication 
                described in subparagraph (A); and
                    (D) at the time the request for designation is 
                made, the medicine for which designation is being 
                requested contains, in the case of a drug an active 
                moiety that is not the same as, and in the case of a 
                biological product an active moiety that is not highly 
                similar to, an active moiety in a medicine for which an 
                application under section 505 of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 
                of the Public Health Service Act (42 U.S.C. 262) has 
                been submitted.
    (b) Requirements for Request for Designation as Dormant Therapy.--A 
request under subsection (a)(1) with respect to a medicine may be made 
only by the sponsor of the medicine and shall contain each of the 
following:
            (1) A listing of all United States patents and applications 
        for patents under which the sponsor has rights and that may be 
        reasonably construed to provide protection for the medicine.
            (2) A waiver of patent rights to the extent required under 
        subsection (c) to take effect, if at all, as provided under 
        subsection (c)(3).
            (3) Such additional information as the Secretary may 
        require by regulation in order to determine eligibility for 
        designation under subsection (a).
    (c) Waiver of Patent Rights Expiring After the Protection Period 
Ends.--
            (1) Patent waiver.--
                    (A) In general.--Subject to subparagraph (B), the 
                request under this subsection shall include a waiver of 
                the right to enforce or otherwise assert any patent 
                described in subsection (b)(1) (or any patent issued on 
                the basis of an application described in subsection 
                (b)(1)), which may expire after the end of the 
                protection period for the dormant therapy, against any 
                applicable product described in paragraph (2). The 
                waiver shall be made by the owner of the patent or 
                application for patent, as the case may be.
                    (B) Limitations on patent waiver.--Any patent 
                waiver provided pursuant to this section, should it 
                become effective--
                            (i) shall have no effect during the 
                        protection period for the medicine to which the 
                        waiver relates; and
                            (ii) shall have no effect with respect to 
                        the subject matter of a claimed invention in a 
                        patent that does not provide any protection for 
                        such medicine with respect to an applicable 
                        product described in paragraph (2).
            (2) Applicable products described.--An applicable product 
        is described in this paragraph only if--
                    (A) it is approved or licensed pursuant to an 
                application that--
                            (i) is filed under section 505(b)(2) or 
                        505(j) of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 355(b)(2), (j)) or section 
                        351(k) of the Public Health Service Act (42 
                        U.S.C. 262(k)); and
                            (ii) references or otherwise relies upon 
                        the approval or licensure of the dormant 
                        therapy to which the waiver relates; and
                    (B) the approval or licensure of the product occurs 
                after the expiration of the protection period 
                applicable to the medicine to which the request under 
                subsection (a)(1) relates.
            (3) Effective date of waiver.--A waiver under subsection 
        (b)(2) with respect to a patent shall take effect, if at all, 
        on the date the Director publishes the notice required under 
        subsection (e)(2)(F) relating to the patent.
    (d) Withdrawal of Request for Designation, Revocation by the 
Secretary.--
            (1) In general.--The sponsor of a medicine may withdraw a 
        request for designation under subsection (a)(1) with respect to 
        a medicine unless the medicine has been approved or licensed 
        under section 505 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355) or section 351 of the Public Health Service Act 
        (42 U.S.C. 262). The Secretary shall deny a designation request 
        or revoke any designation granted if at any time the Secretary 
        finds that the sponsor is not in compliance with subsection 
        (c)(1) or (g)(1).
            (2) Effects of withdrawal of request or revocation of 
        designation.--If the sponsor of a medicine withdraws a request 
        under subsection (b) or the Secretary denies a designation 
        request or revokes a designation with respect to the medicine--
                    (A) any patent waiver submitted under this section 
                with respect to the medicine, but not yet effective, is 
                canceled and deemed a nullity;
                    (B) any patent waiver that has taken effect under 
                this section with respect to the medicine shall remain 
                in effect;
                    (C) any patent term extension granted by the 
                Director under subsection (e)(2) with respect to the 
                medicine shall be canceled, except that the Director 
                shall maintain the patent term extension for one 
                patent, to be selected by the sponsor of the medicine, 
                for the period of extension that would have been 
                applicable under section 156 of title 35, United States 
                Code; and
                    (D) the designation, if made, otherwise shall be 
                treated as never having been requested or made or 
                having effect.
            (3) Basis for revocation.--The Secretary may revoke a 
        designation made under subsection (a), but only based upon a 
        finding by the Secretary under paragraph (1).
    (e) Guaranteed Protections for Dormant Therapies.--
            (1) Applications filed during the protection period.--
        During the protection period for a dormant therapy, 
        notwithstanding any other provision of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health 
        Service Act (42 U.S.C. 201 et seq.)--
                    (A) absent a right of reference from the holder of 
                such approved application for the dormant therapy, the 
                Secretary shall not approve an application filed 
                pursuant to section 505(b)(2) or section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(b)(2), (j)) or section 351(k) of the Public Health 
                Service Act (42 U.S.C. 262(k)) referencing or otherwise 
                relying on the approval of the dormant therapy;
                    (B) the Secretary shall not approve--
                            (i) an application filed pursuant to such 
                        section 505(b)(2) or 505(j) that references or 
                        otherwise relies on the approval of a medicine 
                        that is not the dormant therapy, was approved 
                        subsequent to the approval of the dormant 
                        therapy, and contains the same active moiety as 
                        the active moiety in the dormant therapy (or if 
                        the dormant therapy contains more than one 
                        active moiety, all of the active moieties are 
                        the same); or
                            (ii) an application filed pursuant to such 
                        section 351(k) that references or otherwise 
                        relies on the licensure of a medicine that is 
                        not the dormant therapy, was licensed 
                        subsequent to the licensure of the dormant 
                        therapy, and contains an active moiety that is 
                        highly similar to the active moiety in the 
                        dormant therapy (or if the dormant therapy 
                        contains more than one active moiety, all of 
                        the active moieties are highly similar); and
                    (C) the Secretary shall not approve an application 
                filed pursuant to section 505(b)(1) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) for 
                a drug that contains the same active moiety as the 
                active moiety in the qualifying medicine (or if the 
                qualifying medicine contains more than one active 
                moiety, all of the active moieties are the same), or an 
                application filed pursuant to section 351(a) of the 
                Public Health Service Act (42 U.S.C. 262(a)) for a 
                biological product that contains an active moiety that 
                is highly similar to the active moiety in the 
                qualifying medicine (or if the qualifying medicine 
                contains more than one active moiety, all of the active 
                moieties are highly similar), unless the information 
                provided to support approval of such application is 
                comparable in scope and extent, including with respect 
                to design and extent of preclinical and clinical 
                testing, to the information provided to support 
                approval of the application for the qualifying medicine 
                under section 505(b) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(b)) or section 351(a) of 
                the Public Health Service Act (42 U.S.C. 262(a)).
            (2) Patent term alignment with data package protection 
        period.--
                    (A) In general.--Notwithstanding any provision of 
                title 35, United States Code, a sponsor of a medicine 
                designated as a dormant therapy under subsection 
                (a)(1), upon the approval or licensure thereof under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355) or section 351 of the Public Health 
                Service Act (42 U.S.C. 262), and in lieu of filing a 
                patent term extension application under section 156(d) 
                of such title 35, shall be entitled to patent term 
                extensions in accordance with this paragraph.
                    (B) Submission of final listing of patents and 
                applications for patents following approval or 
                licensure.--
                            (i) Submission.--The sponsor of the dormant 
                        therapy, within a period to be set by the 
                        Director of not less than 2 months beginning on 
                        the date the Secretary approves or licenses the 
                        dormant therapy, shall submit to the Director--
                                    (I) the listing of patents and 
                                applications for patents provided to 
                                the Secretary under subsection (b)(1);
                                    (II) any revisions to such listing 
                                as may be required for compliance with 
                                subsection (b)(1); and
                                    (III) any documentation the 
                                Director may require from the patentee 
                                or patent applicant (as the case may 
                                be) of the waiver of patent rights 
                                required under subsection (b)(2).
                            (ii) Failure to provide sufficient 
                        documentation of waiver.--If the Director 
                        determines that the sponsor has not complied 
                        with the waiver requirements under subsection 
                        (c), after providing the sponsor the 
                        opportunity to remedy any insufficiency, the 
                        Director shall so notify the Secretary that the 
                        patent waiver requirements for designation have 
                        not been satisfied.
                    (C) Extension of patents.--
                            (i) In general.--Unless the Director has 
                        notified the Secretary of a determination under 
                        subparagraph (B)(ii), for each patent 
                        identified in a submission pursuant to 
                        subparagraph (B)(i), and for each patent 
                        issuing based upon an application for patent so 
                        identified, the Director shall, within the 3-
                        month period beginning on the date of the 
                        submission, extend the patent to expire at the 
                        end of the protection period for the dormant 
                        therapy, if the patent would otherwise expire 
                        before the end of the protection period. If the 
                        Director has so notified the Secretary under 
                        subparagraph (B)(ii), the Director shall extend 
                        one such patent, selected by the sponsor, for 
                        the period that would have been applicable had 
                        an application for extension been filed under 
                        section 156 of title 35, United States Code, 
                        with respect to such patent.
                            (ii) Application of certain provisions.--
                        During the period of an extension under clause 
                        (i)--
                                    (I) the rights under the patent 
                                shall be limited in the manner provided 
                                under section 156(b) of title 35, 
                                United States Code; and
                                    (II) the terms ``product'' and 
                                ``approved product'' in such section 
                                156(b) shall be deemed to include forms 
                                of the active moiety of the dormant 
                                therapy and highly similar active 
                                moieties that might be approved or 
                                licensed by the Secretary based upon an 
                                application filed under section 
                                505(b)(2) or 505(j) of the Federal 
                                Food, Drug, and Cosmetic Act (21 U.S.C. 
                                355(b)(2), (j)) or under section 351(k) 
                                of the Public Health Service Act (42 
                                U.S.C. 262(k)) that references or 
                                otherwise relies upon the dormant 
                                therapy.
                    (D) Interim patent extensions.--Notwithstanding any 
                provision of title 35, United States Code, with respect 
                to any patent listed (or patent issuing on an 
                application listed) under subsection (b)(1) that would 
                otherwise expire before the sponsor could make a 
                submission under subparagraph (B), the Director, upon 
                application of the patentee, shall grant to the 
                patentee an interim extension of such patent, subject 
                to the limitations in section 156(d)(5)(F) of such 
                title 35, for such period as may be necessary to permit 
                the sponsor to submit the listing under subparagraph 
                (B) and, if the patent is therein listed, to extend the 
                patent as provided under subparagraph (C). The Director 
                may require, for any patent extended under this 
                subparagraph, that the sponsor of the dormant therapy 
                to which the patent relates provide periodic 
                certifications that development of the dormant therapy 
                is continuing. The Director may terminate any interim 
                extension for which a required certification has not 
                been made.
                    (E) Notice of extension.--For each patent that is 
                extended under this paragraph, the Director shall 
                publish a notice of such extension and issue a 
                certificate of extension described in section 156(e)(1) 
                of title 35, United States Code.
                    (F) Notice of waiver.--For each patent identified 
                in a submission under subparagraph (B)(i), and each 
                patent issuing based upon an application for patent so 
                identified, that expires after the end of the 
                protection period for the dormant therapy, the Director 
                shall publish a notice that the patent is subject to 
                the limited waiver of the right to enforce described in 
                subsection (c)(1).
    (f) Certain FDA Protections Inapplicable.--If a medicine has been 
designated as a dormant therapy under subsection (a), the protections 
otherwise applicable with respect to such medicine under sections 505A, 
505E, and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a, 355f, 360cc) shall not apply. The preceding sentence shall not be 
construed to affect any protections applicable with respect to a 
medicine, including a medicine designated under section 526 of such Act 
(21 U.S.C. 360bb) for a rare disease or condition, under provisions 
other than such sections 505A, 505E, and 527.
    (g) Development Certifications.--
            (1) In general.--The Secretary shall require that the 
        sponsor of a dormant therapy provide a certification that the 
        clinical plan under subsection (a)(2)(B) has been completed, 
        and, that the initial marketing approval or licensure for the 
        qualifying medicine was based on the investigations set forth 
        in such clinical plan (including modifications to the initial 
        plan approved by the Food and Drug Administration). Prior to 
        receiving such certifications, the Secretary shall require 
        periodic certifications that the clinical plan under subsection 
        (a)(2)(B) is continuing.
            (2) Determination of noncompliance.--If the Secretary 
        concludes that the sponsor has not complied with paragraph (1), 
        after providing the sponsor the opportunity to remedy any 
        insufficiency, the Secretary shall, for purposes of subsection 
        (d)(1), determine that the sponsor is not in compliance with 
        the certification requirement under paragraph (1).
    (h) Collaboration.--Nothing in this section shall be construed as 
preventing a sponsor from collaborating with other entities in 
developing a dormant therapy or applying for a dormant therapy 
designation.

SEC. 5. IMPLEMENTATION AND EFFECT.

    (a) Effective Date.--Subject to the provisions of this section, 
this Act shall take effect on the date of enactment.
    (b) Implementing Regulations.--The Secretary, in consultation with 
the Secretary of Commerce, shall promulgate such regulations and 
finalize such guidance as necessary to implement the provisions of 
section 4. Such regulations or guidance shall take effect 18 months 
after the date of enactment of this Act.
    (c) Limitation on Determinations and Designations.--Notwithstanding 
any provision of section 4, the Secretary may not make a determination 
on a request for designation by a manufacturer or sponsor under section 
4(a) prior to the effective date of the regulations under subsection 
(b) or 30 months after the date of enactment of this Act, whichever 
occurs first, and the Secretary may not designate a medicine under 
section 4(a) unless the requirement under section 4(a)(2)(D) is met for 
such medicine as of the effective date of the regulations under 
subsection (b) or 30 months after the date of enactment of this Act, 
whichever occurs first.
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