[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1111 Enrolled Bill (ENR)]

        S.1111

                       One Hundred Fourth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

         Begun and held at the City of Washington on Wednesday,
  the fourth day of January, one thousand nine hundred and ninety-five


                                 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).''.

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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.