A medical treatment defence

21.10 The United States, like Australia, allows patent protection to be obtained for diagnostic, therapeutic or surgical methods of treatment. However, United States law has sought to address some of the objections that have been raised to such patents by introducing a limited statutory defence to infringement claims asserted against a ‘medical practitioner’ or a ‘related health care entity’ in connection with their performance of a ‘medical activity’.[3] This provision is the only defence of its kind to be found in the patent laws of comparable developed nations.

21.11 The drafting of the United States medical treatment defence reflects its legislative history. The defence was proposed in the aftermath of the United States District Court case of Pallin v Singer, in which it was claimed that a physician had infringed certain patents in performing cataract surgery.[4]

21.12 The United States medical treatment defence covers any ‘medical practitioner’, defined as any natural person who is licensed by a State to provide the medical activity, and any person who is acting under the direction of such a person.[5] The defence also covers a ‘related health care entity’, namely, 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’.[6]

21.13 The term ‘medical activity’ is defined as the performance of a medical or surgical procedure on a body, including a human body, organ or cadaver, or an animal used in medical research directly relating to the treatment of humans.[7] Certain activities are expressly excluded from the ambit of the defence. These include the use of a patented machine, manufacture, or composition of matter in violation of the patent; the practice of a patented use of a composition of matter in violation of the patent; the practice of a process in violation of a biotechnology patent;[8] and clinical laboratory services (other than those provided in a physician’s office).[9]

21.14 In summary, the United States defence has been described as limited to ‘patents claiming “pure” medical, diagnostic or surgical methods—those which do not encompass the novel uses of drugs, chemicals or biological reagents’.[10] The limited ambit of the defence means that, in practice, it does not apply to most medical applications of genetic materials and technologies. As discussed above, medical treatment involving gene patents is conducted mostly outside the body and in a laboratory. Further, relevant gene patents cover isolated genetic materials and genetic products and their uses, which are patents on biotechnology.

21.15 There have been proposals to extend the scope of United States medical treatment defences, notably in the Genomic Research and Diagnostic Accessibility Bill 2002.[11] This Bill proposed to extend the definition of medical activity covered by the defence to include ‘performance of a genetic diagnostic, prognostic, or predictive test’.[12] The co-sponsor of the Bill, the Hon Lynn Rivers, stated that this provision would ‘exempt medical practitioners utilizing genetic diagnostic tests from patent infringement remedies’.[13]

[3] This defence was introduced in 1996 and does not apply to any patent with an effective filing date before 30 September 1996: 35 USC s 287(c).

[4]Pallin v Singer 36 USPQ 2d 1050 (1995). The case caused a great deal of controversy within the medical community in the United States and provoked an immediate push for legislation. Originally, it was proposed that medical procedures should be an exclusion from patentability. This was opposed by the biotechnology and pharmaceutical industries, resulting in compromise legislation that addressed the remedies available to patent holders: See E Lee, ‘35 USC §287(c): The Physician Immunity Statute’ (1997) 79 Journal of the Patent and Trademark Office Society 701, 702–709.

[5] 35 USC s 287(c)(2)(B).

[6] 35 USC s 287(c)(2)(C).

[7] 35 USC s 287(c)(2)(A), (E), (F).

[8] 35 USC s 287(c)(2)(A)(i)–(iii).

[9] 35 USC s 287(c)(3). While the term ‘biotechnology patent’ in the third listed exclusion is not defined, the use of isolated genetic materials would generally be considered a core element of biotechnology: E Lee, ‘35 USC §287(c): The Physician Immunity Statute’ (1997) 79 Journal of the Patent and Trademark Office Society 701, 709.

[10] V Bennett, Limitation on Patents Claiming Medical or Surgical Procedures, Myers Bigel, <www.myersbigel.com/pat_articles/pat_article3.htm> at 16 June 2004.

[11] The Bill was referred to the House Subcommittee on the Courts, the Internet, and Intellectual Property on 5 May 2002, but lapsed at the end of the 107th Congress.

[12] Genomic Research and Diagnostic Accessibility Bill 2002 (HR 3967) (US) s 3.

[13] United States, Congressional Debates, House of Representatives, United States, 14 March 2002, E353 (L Rivers), E354.