II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. LIMITATION ON PATENT INFRINGEMENTS RE4 LATING TO A MEDICAL PRACTITIONER’S PER5 FORMANCE OF A MEDICAL ACTIVITY.

6 Section 287 of title 35, United States Code, is

7 amended by adding at the end the following new sub8 section:
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1 ‘‘(c)(1) With respect to a medical practitioner’s per2 formance of a medical activity that constitutes an infringe3 ment under section 271 (a) or (b) of this title, the provi4 sions of sections 281, 283, 284, and 285 of this title shall

5 not apply against the medical practitioner or against a re6 lated health care entity with respect to such medical activ7 ity.

8 ‘‘(2) This subsection does not apply to the activities

9 of any person, or employee or agent of such person (re10 gardless of whether such person is a tax exempt organiza11 tion under section 501(c) of the Internal Revenue Code

12 of 1986), who is engaged in the commercial development,

13 manufacture, sale, importation, or distribution of a ma14 chine, manufacture, or composition of matter or the provi15 sion of pharmacy or clinical laboratory services (other

16 than laboratory services provided in a physician’s office),

17 if such activities are—

18 ‘‘(A) directly related to the commercial develop19 ment, manufacture, sale, importation, or distribution

20 of a machine, manufacture, or composition of matter

21 or the provision of pharmacy or clinical laboratory

22 services (other than clinical laboratory services pro23 vided in a physician’s office); and
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1 ‘‘(B) regulated under the Federal Food, Drug,

2 and Cosmetic Act, the Public Health Service Act, or

3 the Clinical Laboratories Improvement Act.

4 ‘‘(3) For purposes of this subsection:

5 ‘‘(A) The term ‘body’ means—

6 ‘‘(i) a human body, organ, or cadaver; or

7 ‘‘(ii) a nonhuman animal used in medical

8 research or instruction directly relating to the

9 treatment of humans.

10 ‘‘(B) The term ‘medical activity’ means the per11 formance of a medical or surgical procedure on a

12 body, but shall not include—

13 ‘‘(i) the use of a patented machine, manu14 facture, or composition of matter in violation of

15 such patent;

16 ‘‘(ii) the practice of a patented use of a

17 composition of matter in violation of such pat18 ent; or

19 ‘‘(iii) the practice of a process in violation

20 of a biotechnology patent.

21 ‘‘(C) The term ‘medical practitioner’ means any

22 natural person who is—

23 ‘‘(i) licensed by a State to provide the med24 ical activity described under paragraph (1); or
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1 ‘‘(ii) acting under the direction of such

2 natural person in the performance of the medi3 cal activity.

4 ‘‘(D) The term ‘patented use of a composition

5 of matter’ does not include a claim for a method of

6 performing a medical or surgical procedure on a

7 body that recites the use of a composition of matter

8 if the use of that composition of matter does not di9 rectly contribute to achievement of the objective of

10 the claimed method.

11 ‘‘(E) The term ‘professional affiliation’ means

12 staff privileges, medical staff membership, employ13 ment or contractual relationship, partnership or

14 ownership interest, academic appointment, or other

15 affiliation under which a medical practitioner pro16 vides a medical activity on behalf of, or in associa17 tion with, a health care entity.

18 ‘‘(F) The term ‘related health care entity’—

19 ‘‘(i) means an entity with which a medical

20 practitioner has a professional affiliation under

21 which the medical practitioner performs a medi22 cal activity; and

23 ‘‘(ii) includes without limitation such an

24 affiliation with a nursing home, hospital, uni25 versity, medical school, health maintenance or-
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1 ganization, group medical practice, or a medical

2 clinic.

3 ‘‘(G) The term ‘State’ means any State or terri4 tory of the United States, the District of Columbia,

5 and the Commonwealth of Puerto Rico.

6 ‘‘(4) This subsection shall not apply to any patent

7 issued before the date of enactment of this subsection.’’.

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