[Congressional Record Volume 142, Number 133 (Tuesday, September 24, 1996)]
[Senate]
[Page S11173]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. FRIST:
  S. 2105. A bill to amend chapter 29 of title 35, United States Code, 
to provide for a limitation on patent infringements relating to a 
medical practitioner's performance of a medical activity; to the 
Committee on the Judiciary.


              patent infringements limitation legislation

 Mr. FRIST. Mr. President, I ask unanimous consent that the 
text of the bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2105

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

     SECTION 1. LIMITATION ON PATENT INFRINGEMENTS RELATING TO A 
                   MEDICAL PRACTITIONER'S PERFORMANCE OF A MEDICAL 
                   ACTIVITY.

       Section 287 of title 35, United States Code, is amended by 
     adding at the end the following new subsection:
       ``(c)(1) With respect to a medical practitioner's 
     performance of a medical activity that constitutes an 
     infringement under section 271 (a) or (b) of this title, the 
     provisions of sections 281, 283, 284, and 285 of this title 
     shall not apply against the medical practitioner or against a 
     related health care entity with respect to such medical 
     activity.
       ``(2) This subsection does not apply to the activities of 
     any person, or employee or agent of such person (regardless 
     of whether such person is a tax exempt organization under 
     section 501(c) of the Internal Revenue Code of 1986), who is 
     engaged in the commercial development, manufacture, sale, 
     importation, or distribution of a machine, manufacture, or 
     composition of matter or the provision of pharmacy or 
     clinical laboratory services (other than laboratory services 
     provided in a physician's office), if such activities are--
       ``(A) directly related to the commercial development, 
     manufacture, sale, importation, or distribution of a machine, 
     manufacture, or composition of matter or the provision of 
     pharmacy or clinical laboratory services (other than clinical 
     laboratory services provided in a physician's office); and
       ``(B) regulated under the Federal Food, Drug, and Cosmetic 
     Act, the Public Health Service Act, or the Clinical 
     Laboratories Improvement Act.
       ``(3) For purposes of this subsection:
       ``(A) the term `body' means--
       ``(i) a human body, organ, or cadaver; or
       ``(ii) a nonhuman animal used in medical research or 
     instruction directly relating to the treatment of humans.
       ``(B) The term `medical activity' means the performance of 
     a medical or surgical procedure on a body, but shall not 
     include--
       ``(i) the use of a patented machine, manufacture, or 
     composition of matter in violation of such patent;
       ``(ii) the practice of a patented use of a composition of 
     matter in violation of such patent; or
       ``(iii) the practice of a process in violation of a 
     biotechnology patent.
       ``(C) The term `medical practitioner' means any natural 
     person who is--
       ``(i) licensed by a State to provide the medical activity 
     described under paragraph (1); or
       ``(ii) acting under the direction of such natural person in 
     the performance of the medical activity.
       ``(D) The term `patented use of a composition of matter' 
     does not include a claim for a method of performing a medical 
     or surgical procedure on a body that recites the use of a 
     composition of matter if the use of that composition of 
     matter does not directly contribute to achievement of the 
     objective of the claimed method.
       ``(E) The term `professional affiliation' means staff 
     privileges, medical staff membership, employment or 
     contractual relationship, partnership or ownership interest, 
     academic appointment, or their affiliation under which a 
     medical practitioner provides a medical activity on behalf 
     of, or in association with, a health care entity.
       ``(F) The term `related health care entity'--
       ``(i) means an entity with which a medical practitioner has 
     a professional affiliation under which the medical 
     practitioner performs a medical activity; and
       ``(ii) includes without limitation such an affiliation with 
     a nursing home, hospital, university, medical school, health 
     maintenance organization, group medical practice, or a 
     medical clinic.
       ``(G) The term `State' means any State or territory of the 
     United States, the District of Columbia, and the Commonwealth 
     of Puerto Rico.
       ``(4) This subsection shall not apply to any patent issued 
     before the date of enactment of this subsection.''.
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