Union Calendar No. 90

104TH CONGRESS

1ST SESSION H. R. 587

[Report No. 104–178]

A BILL

To amend title 35, United States Code, with

respect to patents on biotechnological processes.

JULY 11, 1995

Committed to the Committee of the Whole House on the

State of the Union and ordered to be printed
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) introduced 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. CONYERS, 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.
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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 BIOTECHNOLOGICAL PROCESS PATENTS

4 SEC. 101. CONDITIONS FOR PATENTABILITY; NONOBVIOUS

5 SUBJECT MATTER.

6 Section 103 of title 35, United States Code, is

7 amended—

8 (1) by designating the first paragraph as sub9 section (a);

10 (2) by designating the second paragraph as

11 subsection (c); and

12 (3) by inserting after the first paragraph the

13 following:

14 ‘‘(b)(1) Notwithstanding subsection (a), and upon

15 timely election by the applicant for patent to proceed

16 under this subsection, a ‘biotechnological process’ using or

17 resulting in a composition of matter that is novel under

18 section 102 and nonobvious under subsection (a) of this

19 section shall be considered nonobvious if—

20 ‘‘(A) claims to the process and the composition

21 of matter are contained in either the same applica22 tion for patent or in separate applications having the

23 same effective filing date; and

24 ‘‘(B) the composition of matter, and the process

25 at the time it was invented, were owned by the same
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1 person or subject to an obligation of assignment to

2 the same person.

3 ‘‘(2) A patent issued on a process under paragraph

4 (1)—

5 ‘‘(A) shall also contain the claims to the com6 position of matter used in or made by that process,

7 or

8 ‘‘(B) shall, if such composition of matter is

9 claimed in another patent, be set to expire on the

10 same date as such other patent, notwithstanding

11 section 154.

12 ‘‘(3) For purposes of paragraph (1), the term

13 ‘biotechnological process’ means—

14 ‘‘(A) a process of genetically altering or other15 wise inducing a single- or multi-celled organism to—

16 ‘‘(i) express an exogenous nucleotide se17 quence,

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

19 expression of an endogenous nucleotide se20 quence, or

21 ‘‘(iii) express a specific physiological char22 acteristic not naturally associated with said or23 ganism;
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1 ‘‘(B) cell fusion procedures yielding a cell line

2 that expresses a specific protein, such as a

3 monoclonal antibody; and

4 ‘‘(C) a method of using a product produced by

5 a process defined by (A) or (B), or a combination

6 of (A) and (B).’’.

7 SEC. 102. PRESUMPTION OF VALIDITY; DEFENSES.

8 Section 282 of title 35, United States Code, is

9 amended by inserting after the second sentence of the first

10 paragraph the following: ‘‘Notwithstanding the preceding

11 sentence, if a claim to a composition of matter is held in12 valid and that claim was the basis of a determination of

13 nonobviousness under section 103(b)(1), the process shall

14 no longer be considered nonobvious solely on the basis of

15 section 103(b)(1).’’.

16 SEC. 103. EFFECTIVE DATE.

17 The amendments made by section 101 shall apply to

18 any application for patent filed on or after the date of

19 enactment of this Act and to any application for patent

20 pending on such date of enactment, including (in either

21 case) an application for the reissuance of a patent.