[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 2105 Introduced in Senate (IS)]







104th CONGRESS
  2d Session
                                S. 2105

 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

           September 24 (legislative day, September 20), 1996

   Mr. Frist introduced the following bill; which was read twice and 
               referred to the Committee on the Judiciary

_______________________________________________________________________

                                 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.

    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 other 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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