I
103D CONGRESS
2D SESSION
H. R. 4151
To amend title 35, United States Code, to provide for the compulsory licensing
of the patents for certain products which have not been commercially
marketed or used.
IN THE HOUSE OF REPRESENTATIVES
MARCH 24, 1994
Mr. NADLER introduced the following bill; which was referred to the
Committee on the Judiciary
A BILL
To amend title 35, United States Code, to provide for the
compulsory licensing of the patents for certain products
which have not been commercially marketed or used.
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 ‘‘Essential Pharma-
ceuticals Act of 1994’’.
SEC. 2. COMPULSORY LICENSING OF PATENTS.
(a) IN GENERAL.—Chapter 14 of title 35, United
States Code, is amended by adding at the end the
following:
‘‘§ 158. Compulsory licensing of certain patents
‘‘(a) DETERMINATION BY SECRETARY OF HEALTH
AND HUMAN SERVICES.—In any case in which the Sec-
retary of Health and Human Services determines, after
notice and an opportunity for an agency hearing, that—
‘‘(1) the owner of a patent which—
‘‘(A) claims a product, a method of using
a product, or a method of manufacturing a
product, and
‘‘(B) may be extended under section 156 of
this title,
has not taken all reasonable steps toward the com-
mercial marketing or use of that product, if the
product is not already so marketed or used, and
‘‘(2) the availability of the product to the public
is of vital importance to the public health or welfare,
the Secretary shall notify the Commissioner of the
Secretary’s determination.
‘‘(b) COMPULSORY LICENSING OF PATENT.—
‘‘(1) IN GENERAL.—Upon receiving a notifica-
tion from the Secretary of Health and Human Serv-
ices under subsection (a) with respect to a product,
the Commissioner shall provide for the compulsory
licensing of all patents relating to that product, in
accordance with this section.
‘‘(2) REGULATIONS.—The Commissioner shall
issue regulations providing for the compulsory li-
censing of patents under this section. Such regula-
tions—
‘‘(A) shall provide for—
‘‘(i) the payment to the Commissioner
of fees for the use of any such patent, in
such manner and in such amounts as the
Commissioner may prescribe; and
‘‘(ii) the distribution of such fees to
the patent holders, in such manner and at
such times as the Commissioner may pre-
scribe; and
‘‘(B) may require the keeping of such
records, and the submission of such reports, as
the Commissioner considers necessary to carry
out this section.
‘‘(c) APPEALS.—
‘‘(1) TO
BOARD
OF
PATENT
APPEALS
AND
INTERFERENCES.—Any person aggrieved by a deci-
sion of the Commissioner under this section may ap-
peal that decision to the Board of Patent Appeals
and Interferences, after having paid the fee for such
appeal.
‘‘(2) TO COURT OF APPEALS FOR THE FEDERAL
CIRCUIT.—A person aggrieved by a decision of the
Board of Patent Appeals and Interferences under
paragraph (1) may appeal that decision to the Unit-
ed States Court of Appeals for the Federal Circuit.
The provisions of sections 142 and 143 of this title
shall apply to an appeal under this subsection to the
same extent as such sections apply to an appeal
under section 141 of this title.’’
(b) CONFORMING AMENDMENTS.—(1) The table of
sections at the beginning of chapter 14 of title 35, United
States Code, is amended by adding at the end the follow-
ing new item:
‘‘158. Compulsory licensing of certain patents.’’.
(2) Section 1295(a)(4) of title 28, United States
Code, is amended—
(1) by redesignating subparagraphs (B) and
(C) as subparagraphs (C) and (D), respectively; and
(2) by inserting after subparagraph (A) the
following:
‘‘(B) the Board of Patent Appeals and
Interferences of the Patent and Trademark
Office under section 158(c)(1) of title 35;’’.
SEC. 3. APPLICABILITY.
The amendments made by this Act shall apply with
respect to patents issued before, on, or after the date of
the enactment of this Act.
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