I
103D CONGRESS
1ST SESSION
H. R. 760
To amend title 35, United States Code, with respect to patents on certain
processes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 3, 1993
Mr. BOUCHER (for himself, Mr. MOORHEAD, Mr. COBLE, Mr. KOPETSKI, Mr.
MCDERMOTT, Mr. DICKS, Mr. BLILEY, Mr. GALLEGLY, and Mr. MCCOL-
LUM) introduced the following bill; which was referred to the Committee
on the Judiciary
A BILL
To amend title 35, United States Code, with respect to
patents on certain processes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
TITLE I—BIOTECHNOLOGICAL
PROCESS PATENTS
SEC. 101. CONDITIONS FOR PATENTABILITY; NONOBVIOUS
SUBJECT MATTER.
Section 103 of title 35, United States Code, is
amended—
(1) in the first unnumbered paragraph by in-
serting ‘‘(a)’’ before ‘‘A patent’’;
(2) in the second unnumbered paragraph by in-
serting ‘‘(b)’’ before ‘‘Subject matter’’; and
(3) by adding at the end thereof the following
new subsections:
‘‘(c) Notwithstanding any other provision of this sec-
tion, a claimed process of making or using a machine,
manufacture, or composition of matter is not obvious
under this section if—
‘‘(1) the machine, manufacture, or composition
of matter is novel under section 102 of this title and
nonobvious under this section;
‘‘(2) the claimed process is a biotechnological
process as defined in subsection (d); and
‘‘(3)(A) the machine, manufacture, or composi-
tion of matter, and the claimed process invention at
the time it was made, were owned by the same per-
son or subject to an obligation of assignment to the
same person; and
‘‘(B) claims to the process and to the machine,
manufacture, or composition of matter—
‘‘(i) are entitled to the same effective filing
date; and
‘‘(ii) appear in the same patent applica-
tion, different patent applications, or patent
which is owned by the same person and which
expires or is set to expire on the same date.
‘‘(d) For purposes of this section, the term
‘biotechnological process’ means any method of making or
using living organisms, or parts thereof, for the purpose
of making or modifying products. Such term includes re-
combinant DNA, recombinant RNA, cell fusion including
hybridoma techniques, and other processes involving site
specific manipulation of genetic material.’’.
SEC. 102. NO PRESUMPTION OF INVALIDITY.
The first unnumbered paragraph of section 282 of
title 35, United States Code, is amended by inserting after
the second sentence ‘‘A claim issued under the provisions
of section 103(c) of this title on a process of making or
using a machine, manufacture, or composition of matter
shall not be held invalid under section 103 of this title
solely because the machine, manufacture, or composition
of matter is determined to lack novelty under section 102
of this title or to be obvious under section 103 of this
title.’’.
SEC. 103. EFFECTIVE DATE.
The amendments made by this title shall apply to all
United States patents granted on or after the date of the
enactment of this Act and to all applications for United
States patents pending on or filed after such date of enact-
ment, including any application for the reissuance of a
patent.
TITLE II—BIOTECHNOLOGICAL
MATERIAL PATENTS
SEC. 201. INFRINGEMENT BY IMPORTATION, SALE OR USE.
(a) INFRINGEMENT.—Section 271 of title 35, United
States Code, is amended by adding at the end the follow-
ing new subsection:
‘‘(h) Whoever without authority imports into the
United States or sells or uses within the United States
a product which is made by using a biotechnological mate-
rial (as defined under section 154(b)) which is patented
in the United States shall be liable as an infringer if the
importation, sale, or use of the product occurs during the
term of such patent.’’.
(b) CONTENTS AND TERM PATENT.—Section 154 of
title 35, United States Code, is amended—
(1) by inserting ‘‘(a)’’ before ‘‘Every’’;
(2) by striking out ‘‘in this title,’’ and inserting
in lieu thereof ‘‘in this title (1)’’;
(3) by striking out ‘‘and, if the invention’’ and
inserting ‘‘(2) if the invention’’;
(4) by inserting after ‘‘products made by that
process,’’ the following: ‘‘and (3) if the invention is
a biotechnological material used in making a prod-
uct, of the right to exclude others from using or sell-
ing throughout the United States, or importing into
the United States the product made or using such
biotechnological material,’’; and
(5) by adding at the end thereof the following:
‘‘(b) For purposes of this section, the term
‘biotechnological material’ is defined as any material (in-
cluding a host cell, DNA sequence, or vector) that is used
in a biotechnological process as defined under section
103(d).’’.
(c) EFFECTIVE DATE.—
(1) IN
GENERAL.—The amendment made by
this section shall take effect six months after the
date of enactment of this Act and, subject to para-
graph (2), shall apply only with respect to products
made or imported after the effective date of the
amendments made by this section.
(2) EXCEPTIONS.—The amendments made by
this section shall not abridge or affect the right of
any person, or any successor to the business of such
person—
(A) to continue to use, sell, or import
products in substantial and continuous sale or
use by such person in the United States on the
date of enactment of this Act; or
(B) to continue to use, sell, or import
products for which substantial preparation by
such person for such sale or use was made be-
fore such date, to the extent equitable for the
protection of commercial investment made or
business commenced in the United States be-
fore such date.
Æ