108th CONGRESS
1st Session
S. 54
To amend the Federal Food, Drug, and Cosmetic Act to provide greater
access to affordable pharmaceuticals.
IN THE SENATE OF THE UNITED STATES
January 7, 2003
Mr. SCHUMER (for himself, Mr. McCain, Mr. Edwards, Ms. Collins, Mr. Kennedy,
Mr. Miller, Mr. Johnson, Mrs. Clinton, Mr. Kohl, Mr. Feingold, Ms. Stabenow,
Mr. Daschle, Mr. Nelson of Florida, Mr. Rockefeller, Mr. Leahy, Mr. Reed,
Mr. Pryor, Mr. Durbin, and Mr. Dorgan) introduced the following bill; which
was read twice and referred to the Committee on Health, Education, Labor,
and Pensions
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 `Greater Access to Affordable Pharmaceuticals
Act of 2003'.
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:
`(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--
`(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 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); or
`(II) 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- An owner of 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).'.
(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- An owner of 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.
(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)--
(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--
(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).'.
(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:
`(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';
(A) by striking `(b)(1) Any person' and inserting the following:
`(A) IN GENERAL- Any person';
(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
(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
(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
(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
(I) by striking `(b) or'; and
(II) by striking `patent' each place it appears and inserting `claim';
and
(i) in subparagraph (B)--
(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';
(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)'.
END
