[Congressional Record Volume 141, Number 153 (Thursday, September 28, 1995)]
[Senate]
[Pages S14569-S14570]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                   BIOTECHNOLOGICAL PROCESSES PATENTS

  Mr. GRAMM. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of calendar No. 191, S. 1111.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       A bill (S. 1111) to amend title 35, United States Code, 
     with respect to patents on biotechnological processes.

  The PRESIDING OFFICER. Is there objection to the immediate 
consideration of the bill?
  There being no objection, the Senate proceeded to consider the bill.
  Mr. GRAMM. Mr. President, I ask unanimous consent that the bill be 
deemed read a third time, passed, the motion to reconsider be laid upon 
the table, and that any statements relating to the bill be placed at 
the appropriate place in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  So, the bill (S. 1111) was deemed read three times and passed as 
follows:

                                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--

[[Page S 14570]]

       (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 (A) or (B), or a combination of (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.

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