Executive Intellectual Property Bulletin

The US Patent Statutes were Amended to Ban Protection of Surgical Procedures

Omnibus appropriation legislation passed in late September has now been signed into law. Section 616 of this law revived H.R. 1127, the "Ganske bill", in the form of the "Ganske compromise legislation." The Ganske bill was originally introduced in an attempt to ban "pure"medical procedures, such as methods of making incisions for cataract or open heart surgery. However, the original language of the bill would have banned patents on new uses for known compounds and many diagnostic assays. The bill was supported by a number of medical associations, but opposed by the Biotechnology Industry Organization, the American Bar Association and the American Intellectual Property Law Association.

The compromise language amended 35 U.S.C. section 287 to add a subsection exempting from infringement a medical practitioner's performance of a medical activity on a human or a laboratory animal. A "related health care entity" is also exempted from infringement. However, there are many exemptions to the primary subsection which effectively limit the term "medical activity" to "pure" surgical procedures or diagnostic procedures not involving drugs or reagents to accomplish the end result. For example, medical activities do not include the patented use of a composition of matter (new or old). Also, the term, "patented use of a composition of matter" can include a diagnostic method in which an unpatentable composition of matter "directly contributes to achievement of the claimed method." On the other hand, a claim to a surgical procedure that incidently involves use of a drug such as a disinfectant or anesthetic, that is not responsible for accomplishing the end result, would remain an exempted "medical activity."

Also, medical activities do not include activities related to the commercial development, manufacture, sale, importation of a machine or compound or the provision of pharmacy or clinical laboratory services, unless the clinical lab services are performed in the physician's office. For further information, contact: Warren D. Woessner, J.D., Ph.D. For more information on this topic and how these new guidelines may affect US industry and trade, please contact Warren D. Woessner, or any of the attorneys at Schwegman, Lundberg & Woessner, P.A. at 612-339-0331 or by facsimile at 612-339-3061 or via this web site.