I
106TH CONGRESS
1ST SESSION
H. R. 1598
To provide a patent term restoration review procedure for certain drug
products.
IN THE HOUSE OF REPRESENTATIVES
APRIL 28, 1999
Mr. BRYANT (for himself, Mr. MCDERMOTT, Mrs. BONO, Mr. DUNCAN, Mr.
WICKER, Mr. JENKINS, Mr. FRANKS of New Jersey, Mr. FORD, Mr.
BLUNT, Mr. WAMP, Mr. HOYER, Mr. ROTHMAN, Mr. MENENDEZ, Mr.
GORDON, Mrs. TAUSCHER, Mr. DELAHUNT, Ms. JACKSON-LEE of Texas,
Ms. ESHOO, Mr. PASTOR, Mr. CONYERS, Mr. SMITH of Texas, Mr.
PAYNE, Mrs. EMERSON, Mr. HILLEARY, and Mr. FRELINGHUYSEN) in-
troduced the following bill; which was referred to the Committee on the
Judiciary
A BILL
To provide a patent term restoration review procedure for
certain drug products.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Patent Fairness Act
of 1999’’.
the provision of law under which the regu-
latory review occurred, and
‘‘(ii) the restoration period as revised
under subparagraph (A),
exceeds 14 years, the restoration period shall be re-
duced so that the total of such periods does not ex-
ceed 14 years; and
‘‘(C) the restoration period, after any ad-
justment required by subparagraph (A) or (B)
plus any previous extension of the patent term
under section 156(c), shall not exceed 5 years.
‘‘(5) INFRINGEMENT.—During the period of
any restoration granted under this subsection, the
rights derived from a patent the term of which is re-
stored shall be determined in accordance with sec-
tions 156(b) and 271.
‘‘(6) PROCEDURE.—
‘‘(A) TIME
FOR
FILING.—An application
under this section shall be filed with the Com-
missioner within 90 days after the date of the
enactment of this section.
‘‘(B) FILING AND DETERMINATION.—Upon
the filing of an application to the Commissioner
under this section—
‘‘(i) the Commissioner shall publish
within 30 days of its filing a notice in the
Federal Register of receipt of the applica-
tion;
‘‘(ii) any party who would be ag-
grieved by the granting of a patent term
restoration under the application may sub-
mit comments on the application within
the 30-day period beginning on the date of
publication of the notice under clause (i);
‘‘(iii) within 7 days following the expi-
ration of the 30-day comment period, the
Commissioner shall forward a copy of all
comments received to the applicant who
shall be entitled to submit a response to
such comments to the Commissioner within
30 days after receipt of the comments
from the Commissioner;
‘‘(iv) within 30 days following the re-
ceipt of the applicant’s response to com-
ments or, if there are no such comments,
within 30 days following expiration of the
30-day comment period, the Commissioner
shall, in writing—
‘‘(I) determine whether to grant
the patent term restoration for which
the application was filed; and
‘‘(II) make specific findings re-
garding the criteria set forth in para-
graph (2); and
‘‘(V) if the Commissioner grants such
patent term restoration, on the same date
that the Commissioner makes the deter-
mination under clause (iv) the Commis-
sioner shall—
‘‘(I) issue to the applicant a cer-
tificate of patent term restoration,
under seal, for the period prescribed
under paragraph (4); and
‘‘(II) record the certificate in the
official file of the patent, which cer-
tificate shall be in effect from such
date and shall be considered a part of
the original patent.
‘‘(C) INTERIM RESTORATION.—If the term
of a patent that is the subject of an application
filed under this section would otherwise expire
before a determination under subparagraph
(B)(iv) is made, the Commissioner shall extend
the term of such patent until—
‘‘(i) a determination is made under
such subparagraph to restore the term of
such patent, or
‘‘(ii) 60 days after a determination is
made under such subparagraph to not re-
store the patent term,
as applicable. If the Commissioner determines
not to restore the patent term, then during the
60-day period described in clause (ii), an appli-
cant may apply to the United States Court of
Appeals for the Federal Circuit for an order di-
recting the Commissioner to extend the patent
pending judicial review and subsequent Com-
missioner action following that review.
‘‘(D) RECORD.—The Commissioner’s de-
termination under subparagraph (B)(iv) shall
be based solely on the record developed under
this subsection.
‘‘(7) APPLICATION
FEE.—The applicant shall
pay a fee for an application made under paragraph
(6) which shall be established in accordance with the
same criteria applicable to fees required under sec-
tion 156(h). If no such fee has been established at
the time of the application, the applicant may pro-
vide the Commissioner with an undertaking, satis-
factory to the Commissioner, to pay the subse-
quently established fee.’’.
(2) TECHNICAL
AND
CONFORMING
AMEND-
MENT.—The table of sections for chapter 14 of title
35, United States Code, is amended by inserting
after the item relating to section 155A the following:
‘‘155B. Patent term restoration review procedure for certain drug products.’’.
(b) APPEAL OF DETERMINATIONS OF THE COMMIS-
SIONER.—Section 141 of the title 35, United States Code,
is amended by adding at the end the following: ‘‘The appli-
cant under section 155B or any aggrieved party that made
a submission commenting on an application made under
such section may appeal the determination of the Commis-
sioner with respect to the application involved under such
section only to the United States Court of Appeals for the
Federal Circuit.’’.
(c) COURT JURISDICTION.—Section 1295(a)(4) of
title 28, United States Code, is amended—
(1) in subparagraph (B), by striking ‘‘or’’ after
the semicolon;
(2) in subparagraph (C), by adding ‘‘or’’ after
the semicolon; and
(3) by inserting after subparagraph (C) the fol-
lowing:
‘‘(D) the Commissioner of Patents and
Trademarks under section 155B of title 35;’’.
(d) COMPENSATION.—
(1) IN GENERAL.—In the event a person has
submitted an application described in section
505(b)(2) or 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)(2),(j)) for a drug
product covered by a patent for which a patent term
restoration was provided under section 155B of title
35, United States Code (as added by subsection
(a)(1)) and such application has been found by the
Food and Drug Administration on or before the date
of the enactment of this section to be sufficiently
complete to permit substantive review, such person
shall be entitled to compensation of $1,000,000 by
the patent owner. Any holder of a Type II Drug
Master File that has permitted a reference to its
Type II Drug Master File to be made in such appli-
cation shall be entitled to compensation of $500,000
by the patent owner.
(2) LIMITS
ON
LIABILITY.—A patent owner
shall not be required to make under paragraph (1)
payments exceeding—
(A) $5,000,000 to persons submitting ap-
plications described in such paragraph, or
(B) $2,500,000 to holders of Type II Drug
Master Files.
If the aggregate limits are insufficient to pay the ap-
plicants or holders the full amounts specified in
paragraph (1), each such applicant or holder shall be
paid its per capita share of the aggregate liability
imposed by paragraph (1) upon the patent holder.
(e) EFFECT OF FILING OF ABBREVIATED APPLICA-
TIONS.—The fact that one or more applications have been
filed under section 505(b)(2) or 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2),(j))
for approval of a drug or a method of using a drug which
is claimed by a patent that is the subject of an application
under section 155B of title 35, United States Code, for
restoration of the patent term shall not affect the grant
of such patent term restoration.
(f) REPORT.—Not later than 1 year after the date
of the enactment of this section, the Commissioner of Pat-
ents and Trademarks shall submit to Congress a report
evaluating the patent term restoration review procedure
established under section 155B of title 35, United States
Code, and shall include in such report a recommendation
whether Congress should consider establishing such a pat-
ent term review procedure for patents not covered by such
section.
(g) EFFECTIVE DATE.—The owner of record of a
patent referred to in section 155B(b)(1) of title 35, United
States Code (as added by subsection (a)(1)) or an agent
of the owner shall be immediately eligible on the date of
the enactment of this section to submit an application to
the Commissioner of Patents and Trademarks for a deter-
mination in accordance with section 155B(b)(6) of such
title.
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