[Pharm-policy] US patent exemption for surgical methods

[James Love]

The provision in US law that says that you cannot enforce a patent on
surgical methods was passed in 1996, in PL-208, and is codified in US
law as 35 USC 287(c)

http://www4.law.cornell.edu/uscode/35/287.html

Sec. 287. Limitation on damages and other remedies; marking and notice 

     (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) For the purposes of this subsection: 
              (A) 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. 
              (B) the term ''medical practitioner'' means any natural
              person who is licensed by a State to provide the medical 
              activity described in subsection (c)(1) or who is acting 
              under the direction of such person in the performance of 
              the medical activity. 
              (C) the term ''related health care entity'' shall mean an 
              entity with which a medical practitioner has a
              professional 
              affiliation under which the medical practitioner performs
              the medical activity, including but not limited to a 
              nursing home, hospital, university, medical school, 
              health maintenance organization, group medical practice, 
              or a medical clinic. 
              (D) the term ''professional affiliation'' shall mean staff 
              privileges, medical staff membership, employment or
              contractual 
              relationship, partnership or ownership interest, academic 
              appointment, or other affiliation under which a medical 
              practitioner provides the medical activity on behalf of,
              or in 
              association with, the health care entity. 
              (E) the term ''body'' shall mean a human body, organ or 
              cadaver, or a nonhuman animal used in medical research or 
              instruction directly relating to the treatment of humans. 
              (F) 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 where the use of that composition of
              matter does not directly contribute to achievement of the
              objective of the claimed method. 
              (G) the term ''State'' shall mean any state [1] or 
              territory of the United States, the District of Columbia,
              and the 
              Commonwealth of Puerto Rico. 
              [1] So in original. Probably should be capitalized. 
         (3) 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), 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
clinical laboratory services provided in a physician's office), where
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. 
         (4) This subsection shall not apply to any patent issued before
the date of enactment of this subsection. 
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James Love, Director           | http://www.cptech.org
Consumer Project on Technology | mailto:love@cptech.org 
P.O. Box 19367                 | voice: 1.202.387.8030
Washington, DC 20036           | fax:   1.202.234.5176
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