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[104th Congress Public Law 41]
[From the U.S. Government Printing Office]

<DOC>
[DOCID: f:publ41.104]

[[Page 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. <<NOTE: Nov. 1, 1995 -  [S. 1111]>> 

    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).''.

[[Page 109 STAT. 352]]

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. <<NOTE: 35 USC 103 note.>> 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.

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.

                                  <all>
```