IB
Union Calendar No. 90
104TH CONGRESS
1ST SESSION
H. R. 587
[Report No. 104–178]
To amend title 35, United States Code, with respect to patents on
biotechnological processes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 19, 1995
Mr. MOORHEAD (for himself, Mr. BOUCHER, Mr. SENSENBRENNER, Mr.
COBLE, Mr. FRANK of Massachusetts, Mr. GALLEGLY, Mr. GOODLATTE,
Mr. GEKAS, Mr. BONO, Mr. CANADY of Florida, and Mr. HOKE) intro-
duced the following bill; which was referred to the Committee on the
Judiciary
JULY 11, 1995
Additional sponsors: Mr. BERMAN, Ms. DANNER, Mr. ROHRABACHER, Mr.
EVANS, Mr. BRYANT of Texas, Mr. KLUG, Mr. MCHALE, Mr. FOX of
Pennsylvania, Mr. ROYCE, Mr. FORBES, Mrs. MEYERS of Kansas, Ms.
ESHOO, Mr. BLUTE, Mr. SAXTON, Mr. ZIMMER, Mr. FATTAH, Mr. CON-
YERS, and Mr. REED
JULY 11, 1995
Committed to the Committee of the Whole House on the State of the Union
and ordered to be printed
A BILL
To amend title 35, United States Code, with respect to
patents on biotechnological processes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
BIOTECHNOLOGICAL PROCESS PATENTS
SEC. 101. CONDITIONS FOR PATENTABILITY; NONOBVIOUS
SUBJECT MATTER.
Section 103 of title 35, United States Code, is
amended—
(1) by designating the first paragraph as sub-
section (a);
(2) by designating the second paragraph as
subsection (c); and
(3) by inserting after the first paragraph the
following:
‘‘(b)(1) Notwithstanding subsection (a), and upon
timely election by the applicant for patent to proceed
under this subsection, a ‘biotechnological process’ using or
resulting in a composition of matter that is novel under
section 102 and nonobvious under subsection (a) of this
section shall be considered nonobvious if—
‘‘(A) claims to the process and the composition
of matter are contained in either the same applica-
tion for patent or in separate applications having the
same effective filing date; and
‘‘(B) the composition of matter, and the process
at the time it was invented, were owned by the same
person or subject to an obligation of assignment to
the same person.
‘‘(2) A patent issued on a process under paragraph
(1)—
‘‘(A) shall also contain the claims to the com-
position of matter used in or made by that process,
or
‘‘(B) shall, if such composition of matter is
claimed in another patent, be set to expire on the
same date as such other patent, notwithstanding
section 154.
‘‘(3) For purposes of paragraph (1), the term
‘biotechnological process’ means—
‘‘(A) a process of genetically altering or other-
wise inducing a single- or multi-celled organism to—
‘‘(i) express an exogenous nucleotide se-
quence,
‘‘(ii) inhibit, eliminate, augment, or alter
expression of an endogenous nucleotide se-
quence, or
‘‘(iii) express a specific physiological char-
acteristic not naturally associated with said or-
ganism;
‘‘(B) cell fusion procedures yielding a cell line
that expresses a specific protein, such as a
monoclonal antibody; and
‘‘(C) a method of using a product produced by
a process defined by (A) or (B), or a combination
of (A) and (B).’’.
SEC. 102. PRESUMPTION OF VALIDITY; DEFENSES.
Section 282 of title 35, United States Code, is
amended by inserting after the second sentence of the first
paragraph the following: ‘‘Notwithstanding the preceding
sentence, if a claim to a composition of matter is held in-
valid and that claim was the basis of a determination of
nonobviousness under section 103(b)(1), the process shall
no longer be considered nonobvious solely on the basis of
section 103(b)(1).’’.
SEC. 103. EFFECTIVE DATE.
The amendments made by section 101 shall apply to
any application for patent filed on or after the date of
enactment of this Act and to any application for patent
pending on such date of enactment, including (in either
case) an application for the reissuance of a patent.