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. MCCOLLUM) 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 TITLE I—BIOTECHNOLOGICAL

4 PROCESS PATENTS

5 SEC. 101. CONDITIONS FOR PATENTABILITY; NONOBVIOUS

6 SUBJECT MATTER.

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

8 amended—
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1 (1) in the first unnumbered paragraph by in2 serting ‘‘(a)’’ before ‘‘A patent’’;

3 (2) in the second unnumbered paragraph by in4 serting ‘‘(b)’’ before ‘‘Subject matter’’; and

5 (3) by adding at the end thereof the following

6 new subsections:

7 ‘‘(c) Notwithstanding any other provision of this sec8 tion, a claimed process of making or using a machine,

9 manufacture, or composition of matter is not obvious

10 under this section if—

11 ‘‘(1) the machine, manufacture, or composition

12 of matter is novel under section 102 of this title and

13 nonobvious under this section;

14 ‘‘(2) the claimed process is a biotechnological

15 process as defined in subsection (d); and

16 ‘‘(3)(A) the machine, manufacture, or composi17 tion of matter, and the claimed process invention at

18 the time it was made, were owned by the same per19 son or subject to an obligation of assignment to the

20 same person; and

21 ‘‘(B) claims to the process and to the machine,

22 manufacture, or composition of matter—

23 ‘‘(i) are entitled to the same effective filing

24 date; and
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1 ‘‘(ii) appear in the same patent applica2 tion, different patent applications, or patent

3 which is owned by the same person and which

4 expires or is set to expire on the same date.

5 ‘‘(d) For purposes of this section, the term

6 ‘biotechnological process’ means any method of making or

7 using living organisms, or parts thereof, for the purpose

8 of making or modifying products. Such term includes re9 combinant DNA, recombinant RNA, cell fusion including

10 hybridoma techniques, and other processes involving site

11 specific manipulation of genetic material.’’.

12 SEC. 102. NO PRESUMPTION OF INVALIDITY.

13 The first unnumbered paragraph of section 282 of

14 title 35, United States Code, is amended by inserting after

15 the second sentence ‘‘A claim issued under the provisions

16 of section 103(c) of this title on a process of making or

17 using a machine, manufacture, or composition of matter

18 shall not be held invalid under section 103 of this title

19 solely because the machine, manufacture, or composition

20 of matter is determined to lack novelty under section 102

21 of this title or to be obvious under section 103 of this

22 title.’’.

23 SEC. 103. EFFECTIVE DATE.

24 The amendments made by this title shall apply to all

25 United States patents granted on or after the date of the
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1 enactment of this Act and to all applications for United

2 States patents pending on or filed after such date of enact3 ment, including any application for the reissuance of a

4 patent.

5 TITLE II—BIOTECHNOLOGICAL

6 MATERIAL PATENTS

7 SEC. 201. INFRINGEMENT BY IMPORTATION, SALE OR USE.

8 (a) INFRINGEMENT.—Section 271 of title 35, United

9 States Code, is amended by adding at the end the follow10 ing new subsection:

11 ‘‘(h) Whoever without authority imports into the

12 United States or sells or uses within the United States

13 a product which is made by using a biotechnological mate14 rial (as defined under section 154(b)) which is patented

15 in the United States shall be liable as an infringer if the

16 importation, sale, or use of the product occurs during the

17 term of such patent.’’.

18 (b) CONTENTS AND TERM PATENT.—Section 154 of

19 title 35, United States Code, is amended—

20 (1) by inserting ‘‘(a)’’ before ‘‘Every’’;

21 (2) by striking out ‘‘in this title,’’ and inserting

22 in lieu thereof ‘‘in this title (1)’’;

23 (3) by striking out ‘‘and, if the invention’’ and

24 inserting ‘‘(2) if the invention’’;
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1 (4) by inserting after ‘‘products made by that

2 process,’’ the following: ‘‘and (3) if the invention is

3 a biotechnological material used in making a prod4 uct, of the right to exclude others from using or sell5 ing throughout the United States, or importing into

6 the United States the product made or using such

7 biotechnological material,’’; and

8 (5) by adding at the end thereof the following:

9 ‘‘(b) For purposes of this section, the term

10 ‘biotechnological material’ is defined as any material (in11 cluding a host cell, DNA sequence, or vector) that is used

12 in a biotechnological process as defined under section

13 103(d).’’.

14 (c) EFFECTIVE DATE.—

15 (1) IN GENERAL.—The amendment made by

16 this section shall take effect six months after the

17 date of enactment of this Act and, subject to para18 graph (2), shall apply only with respect to products

19 made or imported after the effective date of the

20 amendments made by this section.

21 (2) EXCEPTIONS.—The amendments made by

22 this section shall not abridge or affect the right of

23 any person, or any successor to the business of such

24 person—
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1 (A) to continue to use, sell, or import

2 products in substantial and continuous sale or

3 use by such person in the United States on the

4 date of enactment of this Act; or

5 (B) to continue to use, sell, or import

6 products for which substantial preparation by

7 such person for such sale or use was made be8 fore such date, to the extent equitable for the

9 protection of commercial investment made or

10 business commenced in the United States be11 fore such date.

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