PUBLIC LAW 104–41—NOV. 1, 1995 109 STAT. 351

Public Law 104–41

104th Congress

An Act

To amend title 35, United States Code, with respect to patents on biotechnological

processes.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. BIOTECHNOLOGICAL PROCESS PATENTS; CONDITIONS

FOR PATENTABILITY; NONOBVIOUS SUBJECT MATTER.

Section 103 of title 35, United States Code, is amended—

(1) by designating the first paragraph as subsection (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 application 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 composition 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 otherwise inducing

a single- or multi-celled organism to—

‘‘(i) express an exogenous nucleotide sequence,

‘‘(ii) inhibit, eliminate, augment, or alter expression

of an endogenous nucleotide sequence, or

‘‘(iii) express a specific physiological characteristic not

naturally associated with said organism;

‘‘(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 subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).’’.

Nov. 1, 1995

[S. 1111]
109 STAT. 352 PUBLIC LAW 104–41—NOV. 1, 1995

LEGISLATIVE HISTORY—S. 1111 (H.R. 587):

HOUSE REPORTS: No. 104–178 accompanying H.R. 587 (Comm. on the Judiciary).

CONGRESSIONAL RECORD, Vol. 141 (1995):

Sept. 28, considered and passed Senate.

Oct. 17, H.R. 587 and S. 1111 considered and passed House.

WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 31 (1995):

Nov. 1, Presidential statement.

Æ

SEC. 2. 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 invalid 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. 3. EFFECTIVE DATE.

The amendments made by section 1 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.

Approved November 1, 1995.

35 USC 103 note.