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. 
(Introduced in the Senate) 

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.'.