[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1334 Introduced in Senate (IS)]


104th CONGRESS
  1st Session
                                S. 1334

  To amend chapter 28 of title 35, United States Code, to provide for 
   noninfringing uses of patents on medical and surgical procedures.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 18, 1995

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

_______________________________________________________________________

                                 A BILL


 
  To amend chapter 28 of title 35, United States Code, to provide for 
   noninfringing uses of patents on medical and surgical procedures.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Procedures Innovation and 
Affordability Act''.

SEC. 2. NONINFRINGING USE.

    Section 271 of title 35, United States Code, is amended by adding 
at the end thereof the following new subsection:
    ``(j)(1) For any patent issued on or after the effective date of 
this subsection, it shall not be an act of infringement for a patient, 
physician, or other licensed health care practitioner, or a health care 
entity with which a physician or licensed health care practitioner is 
professionally affiliated, to use or induce others to use a patented 
technique, method, or process for performing a surgical or medical 
procedure, administering a surgical or medical therapy, or making a 
medical diagnosis. This section does not apply to the use of, or 
inducement to use, such a patented technique, method, or process by any 
person engaged in the commercial manufacture, sale, or offer for sale 
of a drug, medical device, process, or other product that is subject to 
regulation under the Federal Food, Drug, and Cosmetic Act or the Public 
Health Service Act.
    ``(2) For the purposes of this subsection--
            ``(A) the term `device' has the same meaning as defined in 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h));
            ``(B) the term `drug' has the same meaning as defined in 
        section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(g));
            ``(C) the term `health care entity' means a for-profit or 
        nonprofit entity that provides health care services, including 
        a hospital, medical school, health maintenance organization, 
        group medical practice, or a medical clinic;
            ``(D) the term `licensed health care practitioner' means an 
        individual other than a physician who is licensed by a State to 
        provide health care services;
            ``(E) the term `patient' means an individual who uses a 
        patented technique, method, or process to self-administer a 
        medical procedure, therapy, or method of diagnosis prescribed 
        or recommended by a physician or other licensed health care 
        practitioner;
            ``(F) the term `physician' means a doctor of medicine or 
        osteophathy or a doctor of dental surgery or medical dentistry 
        legally authorized to practice medicine and surgery or 
        dentistry by a State;
            ``(G) the term `product' means a machine, manufacture, or 
        composition of matter or improvement thereof;
            ``(H) the term `professionally affiliated with' includes 
        privileges, medical staff membership, employment or contractual 
        relationship, partnership or ownership interest, academic 
        appointment, or other affiliation under which the physician or 
        licensed health care practitioner provides health care services 
        (including teaching or instructional services) on behalf of or 
        in association with a health care entity; and
            ``(I) the term `State' means any State or territory of the 
        United States, the District of Columbia, and the Commonwealth 
        of Puerto Rico.''.
                                 <all>