[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5311 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 5311

 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 26, 2002

Mr. Thune (for himself, Mrs. Emerson, Mr. Kingston, Mr. Gutknecht, Mrs. 
   Northup, Mr. Manzullo, Mr. Calvert, Mr. Goode, Mr. Bereuter, Mr. 
 Hoekstra, and Mr. Goodlatte) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.

    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 ``Prescription Drug Affordability 
Act''.

SEC. 2. FINDINGS; PURPOSES.

    (a) Findings.--Congress finds that--
            (1) prescription drug costs are increasing at an alarming 
        rate and are a major worry of American families and senior 
        citizens;
            (2) enhancing competition between generic drug 
        manufacturers and brand-name manufacturers can significantly 
        reduce prescription drug costs for American families;
            (3) the pharmaceutical market has become increasingly 
        competitive during the last decade because of the increasing 
        availability and accessibility of generic pharmaceuticals, but 
        competition must be further stimulated and strengthened;
            (4) the Federal Trade Commission has discovered that there 
        are increasing opportunities for drug companies owning patents 
        on brand-name drugs and generic drug companies to enter into 
        private financial deals in a manner that could restrain trade 
        and greatly reduce competition and increase prescription drug 
        costs for consumers;
            (5) generic pharmaceuticals are approved by the Food and 
        Drug Administration on the basis of scientific testing and 
        other information establishing that pharmaceuticals are 
        therapeutically equivalent to brand-name pharmaceuticals, 
        ensuring consumers a safe, efficacious, and cost-effective 
        alternative to brand-name innovator pharmaceuticals;
            (6) the Congressional Budget Office estimates that--
                    (A) the use of generic pharmaceuticals for brand-
                name pharmaceuticals could save purchasers of 
                pharmaceuticals between $8,000,000,000 and 
                $10,000,000,000 each year; and
                    (B) generic pharmaceuticals cost between 25 percent 
                and 60 percent less than brand-name pharmaceuticals, 
                resulting in an estimated average savings of $15 to $30 
                on each prescription;
            (7) generic pharmaceuticals are widely accepted by 
        consumers and the medical profession, as the market share held 
        by generic pharmaceuticals compared to brand-name 
        pharmaceuticals has more than doubled during the last decade, 
        from approximately 19 percent to 43 percent, according to the 
        Congressional Budget Office;
            (8) expanding access to generic pharmaceuticals can help 
        consumers, especially senior citizens and the uninsured, have 
        access to more affordable prescription drugs;
            (9) Congress should ensure that measures are taken to 
        effectuate the amendments made by the Drug Price Competition 
        and Patent Term Restoration Act of 1984 (98 Stat. 1585) 
        (referred to in this section as the ``Hatch-Waxman Act'') to 
        make generic drugs more accessible, and thus reduce health care 
        costs; and
            (10) it would be in the public interest if patents on drugs 
        for which applications are approved under section 505(c) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) were 
        extended only through the patent extension procedure provided 
        under the Hatch-Waxman Act rather than through the attachment 
        of riders to bills in Congress.
    (b) Purposes.--The purposes of this Act are--
            (1) to increase competition, thereby helping all Americans, 
        especially seniors and the uninsured, to have access to more 
        affordable medication; and
            (2) to ensure fair marketplace practices and deter 
        pharmaceutical companies (including generic companies) from 
        engaging in anticompetitive action or actions that tend to 
        unfairly restrain trade.

SEC. 3. FILING OF PATENT INFORMATION WITH THE FOOD AND DRUG 
              ADMINISTRATION.

    (a) Filing After Approval of an Application.--
            (1) In General.--Section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) (as amended by section 
        9(a)(2)(B)(ii)) is amended in subsection (c) by striking 
        paragraph (2) and inserting the following:
            ``(2) Patent information.--
                    ``(A) In general.--Not later than the date that is 
                30 days after the date of an order approving an 
                application under subsection (b) (unless the Secretary 
                extends the date because of extraordinary or unusual 
                circumstances), the holder of the application shall 
                file with the Secretary the patent information 
                described in subparagraph (C) with respect to any 
                patent--
                            ``(i)(I) that claims the drug for which the 
                        application was approved; or
                            ``(II) that claims an approved method of 
                        using the drug; and
                            ``(ii) with respect to 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.
                    ``(B) Subsequently issued patents.--In a case in 
                which a patent described in subparagraph (A) is issued 
                after the date of an order approving an application 
                under subsection (b), the holder of the application 
                shall file with the Secretary the patent information 
                described in subparagraph (C) not later than the date 
                that is 30 days after the date on which the patent is 
                issued (unless the Secretary extends the date because 
                of extraordinary or unusual circumstances).
                    ``(C) Patent information.--The patent information 
                required to be filed under subparagraph (A) or (B) 
                includes--
                            ``(i) the patent number;
                            ``(ii) the expiration date of the patent;
                            ``(iii) with respect to each claim of the 
                        patent--
                                    ``(I) whether the patent claims the 
                                drug or claims a method of using the 
                                drug; and
                                    ``(II) whether the claim covers--
                                            ``(aa) a drug substance;
                                            ``(bb) a drug formulation;
                                            ``(cc) a drug composition; 
                                        or
                                            ``(dd) a method of use;
                            ``(iv) if the patent claims a method of 
                        use, the approved use covered by the claim;
                            ``(v) the identity of the owner of the 
                        patent (including the identity of any agent of 
                        the patent owner); and
                            ``(vi) a declaration that the applicant, as 
                        of the date of the filing, has provided 
                        complete and accurate patent information for 
                        all patents described in subparagraph (A).
                    ``(D) Publication.--On filing of patent information 
                required under subparagraph (A) or (B), the Secretary 
                shall--
                            ``(i) immediately publish the information 
                        described in clauses (i) through (iv) of 
                        subparagraph (C); and
                            ``(ii) make the information described in 
                        clauses (v) and (vi) of subparagraph (C) 
                        available to the public on request.
                    ``(E) Civil action for correction or deletion of 
                patent information.--
                            ``(i) In general.--A person that has filed 
                        an application under subsection (b)(2) or (j) 
                        for a drug, or a person with standing to bring 
                        an infringement action on a patent that claims 
                        an approved drug or claims an approved method 
                        of using the drug, may bring a civil action 
                        against the holder of the approved application 
                        for the drug seeking an order requiring that 
                        the holder of the application amend the 
                        application--
                                    ``(I) to correct patent information 
                                filed under subparagraph (A);
                                    ``(II) to add patent information 
                                required under subparagraph (A) or (B); 
                                or
                                    ``(III) to delete the patent 
                                information in its entirety for the 
                                reason that--
                                            ``(aa) the patent does not 
                                        claim the drug for which the 
                                        application was approved; or
                                            ``(bb) the patent does not 
                                        claim an approved method of 
                                        using the drug.
                            ``(ii) Limitations.--Clause (i) does not 
                        authorize--
                                    ``(I) a civil action to correct 
                                patent information filed under 
                                subparagraph (B); or
                                    ``(II) an award of damages in a 
                                civil action under clause (i).
                    ``(F) No claim for patent infringement.--A person 
                with standing to bring an infringement action on a 
                patent with respect to which a holder of an application 
                fails to file information on or before the date 
                required under subparagraph (A) or (B) shall be barred 
                from bringing a civil action for infringement of the 
                patent against a person that--
                            ``(i) has filed an application under 
                        subsection (b)(2) or (j); or
                            ``(ii) manufactures, uses, offers to sell, 
                        or sells a drug approved under an application 
                        under subsection (b)(2) or (j);
                unless, neither the holder of the application nor any 
                of its affiliates has any rights under the patent, 
                including without limitation, ownership, license, 
                option, or right of refusal, in which case an 
                infringement action may be brought if the person with 
                standing to bring an infringement action commences an 
                action against the holder of the application under 
                subparagraph (E) to compel the filing of the patent 
                information within 90 days of the approval of the 
                holder's application or the issuance of the patent, 
                whichever occurs later, and obtains final judgment 
                requiring the listing.''.
            (2) Transition provision.--
                    (A) Filing of patent information.--Each holder of 
                an application for approval of a new drug under section 
                505(b) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(b)) that has been approved before the date 
                of enactment of this Act shall amend the application to 
                include the patent information required under the 
                amendment made by paragraph (1) not later than the date 
                that is 30 days after the date of enactment of this Act 
                (unless the Secretary of Health and Human Services 
                extends the date because of extraordinary or unusual 
                circumstances).
                    (B) No claim for patent infringement.--A person 
                with standing to bring an infringement action on a 
                patent with respect to which a holder of an application 
                under subsection (b) of section 505 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355) fails to 
                file information on or before the date required under 
                subparagraph (A) shall be barred from bringing a civil 
                action for infringement of the patent against a person 
                that--
                            (i) has filed an application under 
                        subsection (b)(2) or (j) of that section; or
                            (ii) manufactures, uses, offers to sell, or 
                        sells a drug approved under an application 
                        under subsection (b)(2) or (j) of that section;
                unless, neither the holder of the application nor any 
                of its affiliates has any rights under the patent, 
                including without limitation, ownership, license, 
                option, or right of refusal, in which case an 
                infringement action may be brought if the person with 
                standing to bring an infringement action commences an 
                action against the holder of the application under 
                subsection 505(c)(2)(E) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355) to compel the filing of 
                the patent information within 90 days of the approval 
                of the holder's application or the issuance of the 
                patent, whichever occurs later, and obtains final 
                judgment requiring the listing.
    (b) Filing With an Application.--Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(2)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(C) with respect to a patent that claims both the 
                drug and a method of using the drug or claims more than 
                1 method of using the drug for which the application is 
                filed--
                            ``(i) a certification under subparagraph 
                        (A)(iv) on a claim-by-claim basis; and
                            ``(ii) a statement under subparagraph (B) 
                        regarding the method of use claim.''; and
            (2) in subsection (j)(2)(A), by inserting after clause 
        (viii) the following:
``With respect to a patent that claims both the drug and a method of 
using the drug or claims more than 1 method of using the drug for which 
the application is filed, the application shall contain a certification 
under clause (vii)(IV) on a claim-by-claim basis and a statement under 
clause (viii) regarding the method of use claim.''.

SEC. 4. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.

    (a) Abbreviated New Drug Applications.--Section 505(j)(5) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
            (1) in subparagraph (B)--
                    (A) in clause (iii)--
                            (i) by striking ``(iii) If the applicant 
                        made a certification described in subclause 
                        (IV) of paragraph (2)(A)(vii),'' and inserting 
                        the following:
                            ``(iii) Subclause (iv) certification with 
                        respect to certain patents.--If the applicant 
                        made a certification described in paragraph 
                        (2)(A)(vii)(IV) with respect to a patent (other 
                        than a patent that claims a process for 
                        manufacturing the listed drug) for which patent 
                        information was filed with the Secretary under 
                        subsection (c)(2)(A),''; and
                            (ii) by adding at the end the following: 
                        ``The 30-month period provided under the second 
                        sentence of this clause shall not apply to a 
                        certification under paragraph (2)(A)(vii)(IV) 
                        made with respect to a patent for which patent 
                        information was filed with the Secretary under 
                        subsection (c)(2)(B).'';
                    (B) by redesignating clause (iv) as clause (v); and
                    (C) by inserting after clause (iii) the following:
                            ``(iv) Subclause (iv) certification with 
                        respect to other patents.--
                                    ``(I) In general.--If the applicant 
                                made a certification described in 
                                paragraph (2)(A)(vii)(IV) with respect 
                                to a patent not described in clause 
                                (iii) for which patent information was 
                                published by the Secretary under 
                                subsection (c)(2)(D), the approval 
                                shall be made effective on the date 
                                that is 45 days after the date on which 
                                the notice provided under paragraph 
                                (2)(B) was received, unless a civil 
                                action for infringement of the patent, 
                                accompanied by a motion for preliminary 
                                injunction to enjoin the applicant from 
                                engaging in the commercial manufacture 
                                or sale of the drug, was filed on or 
                                before the date that is 45 days after 
                                the date on which the notice was 
                                received, in which case the approval 
                                shall be made effective--
                                            ``(aa) on the date of a 
                                        court action declining to grant 
                                        a preliminary injunction; or
                                            ``(bb) if the court has 
                                        granted a preliminary 
                                        injunction prohibiting the 
                                        applicant from engaging in the 
                                        commercial manufacture or sale 
                                        of the drug--

                                                    ``(AA) on issuance 
                                                by a court of a 
                                                determination that the 
                                                patent is invalid or is 
                                                not infringed;

                                                    ``(BB) on issuance 
                                                by a court of an order 
                                                revoking the 
                                                preliminary injunction 
                                                or permitting the 
                                                applicant to engage in 
                                                the commercial 
                                                manufacture or sale of 
                                                the drug; or

                                                    ``(CC) on the date 
                                                specified in a court 
                                                order under section 
                                                271(e)(4)(A) of title 
                                                35, United States Code, 
                                                if the court determines 
                                                that the patent is 
                                                infringed.

                                    ``(II) Cooperation.--Each of the 
                                parties shall reasonably cooperate in 
                                expediting a civil action under 
                                subclause (I).
                                    ``(III) Expedited notification.--If 
                                the notice under paragraph (2)(B) 
                                contains an address for the receipt of 
                                expedited notification of a civil 
                                action under subclause (I), the 
                                plaintiff shall, on the date on which 
                                the complaint is filed, simultaneously 
                                cause a notification of the civil 
                                action to be delivered to that address 
                                by the next business day.''; and
            (2) by inserting after subparagraph (B) the following:
                    ``(C) Failure to bring infringement action.--If, in 
                connection with an application under this subsection, 
                the applicant provides an owner of a patent notice 
                under paragraph (2)(B) with respect to the patent, and 
                the owner of the patent fails to bring a civil action 
                against the applicant for infringement of the patent on 
                or before the date that is 45 days after the date on 
                which the notice is received, the owner of the patent 
                shall be barred from bringing a civil action for 
                infringement of the patent in connection with the 
                development, manufacture, use, offer to sell, or sale 
                of the drug for which the application was filed or 
                approved under this subsection.''.
    (b) Other Applications.--Section 505(c)) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(c)) (as amended by section 
9(a)(3)(A)(iii)) is amended--
            (1) in paragraph (3)--
                    (A) in subparagraph (C)--
                            (i) by striking ``(C) If the applicant made 
                        a certification described in clause (iv) of 
                        subsection (b)(2)(A),'' and inserting the 
                        following:
                    ``(C) Clause (iv) certification with respect to 
                certain patents.--If the applicant made a certification 
                described in subsection (b)(2)(A)(iv) with respect to a 
                patent (other than a patent that claims a process for 
                manufacturing the listed drug) for which patent 
                information was filed with the Secretary under 
                paragraph (2)(A),''; and
                            (ii) by adding at the end the following: 
                        ``The 30-month period provided under the second 
                        sentence of this subparagraph shall not apply 
                        to a certification under subsection 
                        (b)(2)(A)(iv) made with respect to a patent for 
                        which patent information was filed with the 
                        Secretary under paragraph (2)(B).''; and
                    (B) by inserting after subparagraph (C) the 
                following:
                    ``(D) Clause (iv) certification with respect to 
                other patents.--
                            ``(i) In general.--If the applicant made a 
                        certification described in subsection 
                        (b)(2)(A)(iv) with respect to a patent not 
                        described in subparagraph (C) for which patent 
                        information was published by the Secretary 
                        under paragraph (2)(D), the approval shall be 
                        made effective on the date that is 45 days 
                        after the date on which the notice provided 
                        under subsection (b)(3) was received, unless a 
                        civil action for infringement of the patent, 
                        accompanied by a motion for preliminary 
                        injunction to enjoin the applicant from 
                        engaging in the commercial manufacture or sale 
                        of the drug, was filed on or before the date 
                        that is 45 days after the date on which the 
                        notice was received, in which case the approval 
                        shall be made effective--
                                    ``(I) on the date of a court action 
                                declining to grant a preliminary 
                                injunction; or
                                    ``(II) if the court has granted a 
                                preliminary injunction prohibiting the 
                                applicant from engaging in the 
                                commercial manufacture or sale of the 
                                drug--
                                            ``(aa) on issuance by a 
                                        court of a determination that 
                                        the patent is invalid or is not 
                                        infringed;
                                            ``(bb) on issuance by a 
                                        court of an order revoking the 
                                        preliminary injunction or 
                                        permitting the applicant to 
                                        engage in the commercial 
                                        manufacture or sale of the 
                                        drug; or
                                            ``(cc) on the date 
                                        specified in a court order 
                                        under section 271(e)(4)(A) of 
                                        title 35, United States Code, 
                                        if the court determines that 
                                        the patent is infringed.
                            ``(ii) Cooperation.--Each of the parties 
                        shall reasonably cooperate in expediting a 
                        civil action under clause (i).
                            ``(iii) Expedited notification.--If the 
                        notice under subsection (b)(3) contains an 
                        address for the receipt of expedited 
                        notification of a civil action under clause 
                        (i), the plaintiff shall, on the date on which 
                        the complaint is filed, simultaneously cause a 
                        notification of the civil action to be 
                        delivered to that address by the next business 
                        day.''; and
            (2) by inserting after paragraph (3) the following:
            ``(4) Failure to bring infringement action.--If, in 
        connection with an application under subsection (b)(2), the 
        applicant provides an owner of a patent notice under subsection 
        (b)(3) with respect to the patent, and the owner of the patent 
        fails to bring a civil action against the applicant for 
        infringement of the patent on or before the date that is 45 
        days after the date on which the notice is received, the owner 
        of the patent shall be barred from bringing a civil action for 
        infringement of the patent in connection with the development, 
        manufacture, use, offer to sell, or sale of the drug for which 
        the application was filed or approved under subsection 
        (b)(2).''.
    (c) Effective Date.--
            (1) In general.--The amendments made by subsections (a) and 
        (b) shall be effective with respect to any certification under 
        subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
        made after the date of enactment of this Act in an application 
        filed under subsection (b)(2) or (j) of that section.
            (2) Transition provision.--In the case of applications 
        under section 505(b) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(b)) filed before the date of enactment of 
        this Act--
                    (A) a patent (other than a patent that claims a 
                process for manufacturing a listed drug) for which 
                information was submitted to the Secretary of Health 
                and Human Services under section 505(b)(1) of the 
                Federal Food, Drug, and Cosmetic Act (as in effect on 
                the day before the date of enactment of this Act) shall 
                be subject to subsections (c)(3)(C) and (j)(5)(B)(iii) 
                of section 505 of the Federal Food, Drug, and Cosmetic 
                Act (as amended by this section); and
                    (B) any other patent (including a patent for which 
                information was submitted to the Secretary under 
                section 505(c)(2) of that Act (as in effect on the day 
                before the date of enactment of this Act)) shall be 
                subject to subsections (c)(3)(D) and (j)(5)(B)(iv) of 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (as amended by this section).

SEC. 5. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG APPLICANTS.

    (a) In General.--Section 505(j)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by section 4(a)) is 
amended--
            (1) in subparagraph (B)(v), by striking subclause (II) and 
        inserting the following:
                                    ``(II) the earlier of--
                                            ``(aa) the date of a final 
                                        decision of a court (from which 
                                        no appeal has been or can be 
                                        taken, other than a petition to 
                                        the Supreme Court for a writ of 
                                        certiorari) holding that the 
                                        patent that is the subject of 
                                        the certification is invalid or 
                                        not infringed; or
                                            ``(bb) the date of a 
                                        settlement order or consent 
                                        decree signed by a Federal 
                                        judge that enters a final 
                                        judgment and includes a finding 
                                        that the patent that is the 
                                        subject of the certification is 
                                        invalid or not infringed;''; 
                                        and
            (2) by inserting after subparagraph (C) the following:
                    ``(D) Forfeiture of 180-day period.--
                            ``(i) Definitions.--In this subparagraph:
                                    ``(I) Application.--The term 
                                `application' means an application for 
                                approval of a drug under this 
                                subsection containing a certification 
                                under paragraph (2)(A)(vii)(IV) with 
                                respect to a patent.
                                    ``(II) First application.--The term 
                                `first application' means the first 
                                application to be filed for approval of 
                                the drug.
                                    ``(III) Forfeiture event.--The term 
                                `forfeiture event', with respect to an 
                                application under this subsection, 
                                means the occurrence of any of the 
                                following:
                                            ``(aa) Failure to market.--
                                        The applicant fails to market 
                                        the drug by the later of--

                                                    ``(AA) the date 
                                                that is 60 days after 
                                                the date on which the 
                                                approval of the 
                                                application for the 
                                                drug is made effective 
                                                under clause (iii) or 
                                                (iv) of subparagraph 
                                                (B) (unless the 
                                                Secretary extends the 
                                                date because of 
                                                extraordinary or 
                                                unusual circumstances); 
                                                or

                                                    ``(BB) if 1 or more 
                                                civil actions have been 
                                                brought against the 
                                                applicant for 
                                                infringement of a 
                                                patent subject to a 
                                                certification under 
                                                paragraph 
                                                (2)(A)(vii)(IV) or 1 or 
                                                more civil actions have 
                                                been brought by the 
                                                applicant for a 
                                                declaratory judgment 
                                                that such a patent is 
                                                invalid or not 
                                                infringed, the date 
                                                that is 60 days after 
                                                the date of a final 
                                                decision (from which no 
                                                appeal has been or can 
                                                be taken, other than a 
                                                petition to the Supreme 
                                                Court for a writ of 
                                                certiorari) in the last 
                                                of those civil actions 
                                                to be decided (unless 
                                                the Secretary extends 
                                                the date because of 
                                                extraordinary or 
                                                unusual circumstances).

                                            ``(bb) Withdrawal of 
                                        application.--The applicant 
                                        withdraws the application.
                                            ``(cc) Amendment of 
                                        certification.--The applicant, 
                                        voluntarily or as a result of a 
                                        settlement or defeat in patent 
                                        litigation, amends the 
                                        certification from a 
                                        certification under paragraph 
                                        (2)(A)(vii)(IV) to a 
                                        certification under paragraph 
                                        (2)(A)(vii)(III).
                                            ``(dd) Failure to obtain 
                                        approval.--The applicant fails 
                                        to obtain tentative approval of 
                                        an application within 30 months 
                                        after the date on which the 
                                        application is filed, unless 
                                        the failure is caused by--

                                                    ``(AA) a change in 
                                                the requirements for 
                                                approval of the 
                                                application imposed 
                                                after the date on which 
                                                the application is 
                                                filed; or

                                                    ``(BB) other 
                                                extraordinary 
                                                circumstances 
                                                warranting an 
                                                exception, as 
                                                determined by the 
                                                Secretary.

                                            ``(ee) Failure to challenge 
                                        patent.--In a case in which, 
                                        after the date on which the 
                                        applicant submitted the 
                                        application, new patent 
                                        information is submitted under 
                                        subsection (c)(2) for the 
                                        listed drug for a patent for 
                                        which certification is required 
                                        under paragraph (2)(A), the 
                                        applicant fails to submit, not 
                                        later than the date that is 60 
                                        days after the date on which 
                                        the Secretary publishes the new 
                                        patent information under 
                                        paragraph (7)(A)(iii) (unless 
                                        the Secretary extends the date 
                                        because of extraordinary or 
                                        unusual circumstances)--

                                                    ``(AA) a 
                                                certification described 
                                                in paragraph 
                                                (2)(A)(vii)(IV) with 
                                                respect to the patent 
                                                to which the new patent 
                                                information relates; or

                                                    ``(BB) a statement 
                                                that any method of use 
                                                claim of that patent 
                                                does not claim a use 
                                                for which the applicant 
                                                is seeking approval 
                                                under this subsection 
                                                in accordance with 
                                                paragraph (2)(A)(viii).

                                            ``(ff) Unlawful conduct.--
                                        The Federal Trade Commission 
                                        determines that the applicant 
                                        engaged in unlawful conduct 
                                        with respect to the application 
                                        in violation of section 1 of 
                                        the Sherman Act (15 U.S.C. 1).
                                    ``(IV) Subsequent application.--The 
                                term `subsequent application' means an 
                                application for approval of a drug that 
                                is filed subsequent to the filing of a 
                                first application for approval of that 
                                drug.
                            ``(ii) Forfeiture of 180-day period.--
                                    ``(I) In general.--Except as 
                                provided in subclause (II), if a 
                                forfeiture event occurs with respect to 
                                a first application--
                                            ``(aa) the 180-day period 
                                        under subparagraph (B)(v) shall 
                                        be forfeited by the first 
                                        applicant; and
                                            ``(bb) any subsequent 
                                        application shall become 
                                        effective as provided under 
                                        clause (i), (ii), (iii), or 
                                        (iv) of subparagraph (B), and 
                                        clause (v) of subparagraph (B) 
                                        shall not apply to the 
                                        subsequent application.
                                    ``(II) Forfeiture to first 
                                subsequent applicant.--If the 
                                subsequent application that is the 
                                first to be made effective under 
                                subclause (I) was the first among a 
                                number of subsequent applications to be 
                                filed--
                                            ``(aa) that first 
                                        subsequent application shall be 
                                        treated as the first 
                                        application under this 
                                        subparagraph (including 
                                        subclause (I)) and as the 
                                        previous application under 
                                        subparagraph (B)(v); and
                                            ``(bb) any other subsequent 
                                        applications shall become 
                                        effective as provided under 
                                        clause (i), (ii), (iii), or 
                                        (iv) of subparagraph (B), but 
                                        clause (v) of subparagraph (B) 
                                        shall apply to any such 
                                        subsequent application.
                            ``(iii) Availability.--The 180-day period 
                        under subparagraph (B)(v) shall be available to 
                        a first applicant submitting an application for 
                        a drug with respect to any patent without 
                        regard to whether an application has been 
                        submitted for the drug under this subsection 
                        containing such a certification with respect to 
                        a different patent.
                            ``(iv) Applicability.--The 180-day period 
                        described in subparagraph (B)(v) shall apply to 
                        an application only if a civil action is 
                        brought against the applicant for infringement 
                        of a patent that is the subject of the 
                        certification.''.
    (b) Applicability.--The amendment made by subsection (a) shall be 
effective only with respect to an application filed under section 
505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
after the date of enactment of this Act for a listed drug for which no 
certification under section 505(j)(2)(A)(vii)(IV) of that Act was made 
before the date of enactment of this Act, except that if a forfeiture 
event described in section 505(j)(5)(D)(i)(III)(ff) of that Act occurs 
in the case of an applicant, the applicant shall forfeit the 180-day 
period under section 505(j)(5)(B)(v) of that Act without regard to when 
the applicant made a certification under section 505(j)(2)(A)(vii)(IV) 
of that Act.

SEC. 6. FAIR TREATMENT FOR INNOVATORS.

    (a) Basis for Application.--Section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(3)(B), by striking the second 
        sentence and inserting ``The notice shall include a detailed 
        statement of the factual and legal basis of the applicant's 
        opinion that, as of the date of the notice, the patent is not 
        valid or is not infringed, and shall include, as appropriate 
        for the relevant patent, a description of the applicant's 
        proposed drug substance, drug formulation, drug composition, or 
        method of use. All information disclosed under this 
        subparagraph shall be treated as confidential and may be used 
        only for purposes relating to patent adjudication. Nothing in 
        this subparagraph precludes the applicant from amending the 
        factual or legal basis on which the applicant relies in patent 
        litigation.''; and
            (2) in subsection (j)(2)(B)(ii), by striking the second 
        sentence and inserting ``The notice shall include a detailed 
        statement of the factual and legal basis of the opinion of the 
        applicant that, as of the date of the notice, the patent is not 
        valid or is not infringed, and shall include, as appropriate 
        for the relevant patent, a description of the applicant's 
        proposed drug substance, drug formulation, drug composition, or 
        method of use. All information disclosed under this 
        subparagraph shall be treated as confidential and may be used 
        only for purposes relating to patent adjudication. Nothing in 
        this subparagraph precludes the applicant from amending the 
        factual or legal basis on which the applicant relies in patent 
        litigation.''.
    (b) Injunctive Relief.--Section 505(j)(5)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) (as amended by section 
4(a)(1)) is
amended--
            (1) in clause (iii), by adding at the end the following: 
        ``A court shall not regard the extent of the ability of an 
        applicant to pay monetary damages as a whole or partial basis 
        on which to deny a preliminary or permanent injunction under 
        this clause.''; and
            (2) in clause (iv), by adding at the end the following:
                    ``(IV) Injunctive relief.--A court shall not regard 
                the extent of the ability of an applicant to pay 
                monetary damages as a whole or partial basis on which 
                to deny a preliminary or permanent injunction under 
                this clause.''.

SEC. 7. BIOEQUIVALENCE.

    (a) In General.--The amendments to part 320 of title 21, Code of 
Federal Regulations, promulgated by the Commissioner of Food and Drugs 
on July 17, 1991 (57 Fed. Reg. 17997 (April 28, 1992)), shall continue 
in effect as an exercise of authorities under sections 501, 502, 505, 
and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 
352, 355, 371).
    (b) Effect.--Subsection (a) does not affect the authority of the 
Commissioner of Food and Drugs to amend part 320 of title 21, Code of 
Federal Regulations.
    (c) Effect of Section.--This section shall not be construed to 
alter the authority of the Secretary of Health and Human Services to 
regulate biological products under the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.). Any such authority shall be exercised 
under that Act as in effect on the day before the date of enactment of 
this Act.

SEC. 8. REPORT.

    (a) In General.--Not later than the date that is 5 years after the 
date of enactment of this Act, the Federal Trade Commission shall 
submit to Congress a report describing the extent to which 
implementation of the amendments made by this Act--
            (1) has enabled products to come to market in a fair and 
        expeditious manner, consistent with the rights of patent owners 
        under intellectual property law; and
            (2) has promoted lower prices of drugs and greater access 
        to drugs through price competition.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000.

SEC. 9. CONFORMING AND TECHNICAL AMENDMENTS.

    (a) Section 505.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (a), by striking ``(a) No person'' and 
        inserting ``(a) In General.--No person'';
            (2) in subsection (b)--
                    (A) by striking ``(b)(1) Any person'' and inserting 
                the following:
    ``(b) Applications.--
            ``(1) Requirements.--
                    ``(A) In general.--Any person'';
                    (B) in paragraph (1)--
                            (i) in the second sentence--
                                    (I) by redesignating subparagraphs 
                                (A) through (F) as clauses (i) through 
                                (vi), respectively, and adjusting the 
                                margins appropriately;
                                    (II) by striking ``Such persons'' 
                                and inserting the following:
                    ``(B) Information to be submitted with 
                application.--A person that submits an application 
                under subparagraph (A)''; and
                                    (III) by striking ``application'' 
                                and inserting ``application--'';
                            (ii) by striking the third through fifth 
                        sentences; and
                            (iii) in the sixth sentence--
                                    (I) by striking ``The Secretary'' 
                                and inserting the following:
                    ``(C) Guidance.--The Secretary''; and
                                    (II) by striking ``clause (A)'' and 
                                inserting ``subparagraph (B)(i)''; and
                    (C) in paragraph (2)--
                            (i) by striking ``clause (A) of such 
                        paragraph'' and inserting ``paragraph 
                        (1)(B)(i)'';
                            (ii) in subparagraphs (A) and (B), by 
                        striking ``paragraph (1) or''; and
                            (iii) in subparagraph (B)--
                                    (I) by striking ``paragraph 
                                (1)(A)'' and inserting ``paragraph 
                                (1)(B)(i)''; and
                                    (II) by striking ``patent'' each 
                                place it appears and inserting 
                                ``claim''; and
            (3) in subsection (c)--
                    (A) in paragraph (3)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``(A) If the 
                                applicant'' and inserting the 
                                following:
                    ``(A) Clause (i) or (ii) certification.--If the 
                applicant''; and
                                    (II) by striking ``may'' and 
                                inserting ``shall'';
                            (ii) in subparagraph (B)--
                                    (I) by striking ``(B) If the 
                                applicant'' and inserting the 
                                following:
                    ``(B) Clause (iii) certification.--If the 
                applicant''; and
                                    (II) by striking ``may'' and 
                                inserting ``shall'';
                            (iii) by redesignating subparagraph (D) as 
                        subparagraph (E); and
                            (iv) in subparagraph (E) (as redesignated 
                        by clause (iii)), by striking ``clause (A) of 
                        subsection (b)(1)'' each place it appears and 
                        inserting ``subsection (b)(1)(B)(i)''; and
                    (B) by redesignating paragraph (4) as paragraph 
                (5); and
            (4) in subsection (j)--
                    (A) in paragraph (2)(A)--
                            (i) in clause (vi), by striking ``clauses 
                        (B) through ((F)'' and inserting ``subclauses 
                        (ii) through (vi) of subsection (b)(1)'';
                            (ii) in clause (vii), by striking ``(b) 
                        or''; and
                            (iii) in clause (viii)--
                                    (I) by striking ``(b) or''; and
                                    (II) by striking ``patent'' each 
                                place it appears and inserting 
                                ``claim''; and
                    (B) in paragraph (5)--
                            (i) in subparagraph (B)--
                                    (I) in clause (i)--
                                            (aa) by striking ``(i) If 
                                        the applicant'' and inserting 
                                        the following:
                            ``(i) Subclause (i) or (ii) 
                        certification.--If the applicant''; and
                                            (bb) by striking ``may'' 
                                        and inserting ``shall'';
                                    (II) in clause (ii)--
                                            (aa) by striking ``(ii) If 
                                        the applicant'' and inserting 
                                        the following:
                            ``(i) Subclause (iii) certification.--If 
                        the applicant''; and
                                            (bb) by striking ``may'' 
                                        and inserting ``shall'';
                                    (III) in clause (iii), by striking 
                                ``(2)(B)(i)'' each place it appears and 
                                inserting ``(2)(B)''; and
                                    (IV) in clause (v) (as redesignated 
                                by section 4(a)(1)(B)), by striking 
                                ``continuing'' and inserting 
                                ``containing''; and
                            (ii) by redesignating subparagraphs (C) and 
                        (D) as subparagraphs (E) and (F), respectively.
    (b) Section 505A.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i)--
                    (A) by striking ``(c)(3)(D)(ii)'' each place it 
                appears and inserting ``(c)(3)(E)(ii)''; and
                    (B) by striking ``(j)(5)(D)(ii)'' each place it 
                appears and inserting ``(j)(5)(F)(ii)'';
            (2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii)--
                    (A) by striking ``(c)(3)(D)'' each place it appears 
                and inserting ``(c)(3)(E)''; and
                    (B) by striking ``(j)(5)(D)'' each place it appears 
                and inserting ``(j)(5)(F)'';
            (3) in subsections (e) and (l)--
                    (A) by striking ``505(c)(3)(D)'' each place it 
                appears and inserting ``505(c)(3)(E)''; and
                    (B) by striking ``505(j)(5)(D)'' each place it 
                appears and inserting ``505(j)(5)(F)''; and
            (4) in subsection (k), by striking ``505(j)(5)(B)(iv)'' and 
        inserting ``505(j)(5)(B)(v)''.
    (c) Section 527.--Section 527(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360cc(a)) is amended in the second sentence by 
striking ``505(c)(2)'' and inserting ``505(c)(1)(B)''.
                                 <all>