I

104TH CONGRESS

1ST SESSION H. R. 587

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

A BILL

To amend title 35, United States Code, with respect to

patents on biotechnological processes.

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);
2

HR 587 IH

1 (2) by designating the second paragraph as

2 subsection (c); and

3 (3) by inserting after the first paragraph the

4 following:

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

6 timely election by the applicant for patent to proceed

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

8 resulting in a composition of matter that is novel under

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

10 section shall be considered nonobvious if—

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

12 of matter are contained in either the same applica13 tion for patent or in separate applications having the

14 same effective filing date; and

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

16 at the time it was invented, were owned by the same

17 person or subject to an obligation of assignment to

18 the same person.

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

20 (1)—

21 ‘‘(A) shall also contain the claims to the com22 position of matter used in or made by that process,

23 or

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

25 claimed in another patent, be set to expire on the
3

HR 587 IH

1 same date as such other patent, notwithstanding

2 section 154.

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

4 ‘biotechnological process’ means—

5 ‘‘(A) a process of genetically altering or other6 wise inducing a single- or multi-celled organism to—

7 ‘‘(i) express an exogenous nucleotide se8 quence,

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

10 expression of an endogenous nucleotide se11 quence, or

12 ‘‘(iii) express a specific physiological char13 acteristic not naturally associated with said or14 ganism;

15 ‘‘(B) cell fusion procedures yielding a cell line

16 that expresses a specific protein, such as a

17 monoclonal antibody; and

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

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

20 of (A) and (B).’’.

21 SEC. 102. PRESUMPTION OF VALIDITY; DEFENSES.

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

23 amended by inserting after the second sentence of the first

24 paragraph the following: ‘‘Notwithstanding the preceding

25 sentence, if a claim to a composition of matter is held in-
4

HR 587 IH

1 valid and that claim was the basis of a determination of

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

3 no longer be considered nonobvious solely on the basis of

4 section 103(b)(1).’’.

5 SEC. 103. EFFECTIVE DATE.

6 The amendments made by section 101 shall apply to

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

8 enactment of this Act and to any application for patent

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

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

Æ