A Supplemental Note on the Medical Practitioner's Act

A Supplemental Note on the Medical Practitioner's Act

Bijel Dholakia sent in these questions via the PIUG Web Site Comments and Questions form:

1. What are some good patent search tips / techniques when searching for surgical processes or methods?

2. Are there any good training seminars / courses on how to search medical patents that you recommend? Who runs them?

Edward T. Mickelson, Ph.D., Patent Agent, replied stating in part "bearing in mind that such processes and methods are not patentable in Europe and are essentially meaningless in the US, as physicians are immune from infringement suits regarding surgical/medical processes and methods."

Ed was referring to the Medical Practitioner's Act codified at 35 USC 287(c)(4) (See the AIPA enacted in 1999). However, there are a LOT of twists to that statute. Medical practitioners licensed by a State or Territory of the U.S. are immune from liability of a patented method, as is their "related health care entity" such as the hospital in which they practice the patented method if they have a professional affiliation with the hospital.

However, amongst other things, that immunity from liability from patent infringement DOES NOT apply (1) to PATENTS issued from an application having an "effective filing date" prior to September 30, 1996 and (2) to ENTITIES engaged in "commercial development, manufacture, sale, importation,..." etc. where such ACTIVITIES are "directly related to commercial development, manufacture, sale, importation..." etc that are "regulated [by a variety of U.S. government agencies like the FDA].

What does this mean? Generally speaking, it means that old U.S. medical method patents are enforceable against physicians, and that all U.S. medical method patents are enforceable against manufacturers or regulated products. Generally, because there may be exceptions to the exceptions. Read 35 USC 287 in detail, and perhaps Gerry Mossinghoff's article in the JPTOS on the subject. My understanding is that Gerry was central to the drafting of this provision.

For those interested, I discussed the AIPA, and the meaning of "effective filing date" prior to September 30, 1996 in my article on the AIPA, now posted at http://www.neifeld.com/advart4.html