Chapter §3.07 Remedies Exclusion for Medical/Surgical Procedures

• Jurisdiction: United States

§3.07 Remedies Exclusion for Medical/Surgical Procedures

Medical and surgical procedures are patentable subject matter in the United States as "processes" within 35 U.S.C. §101.⁸⁶¹ In 1996, however, Congress added an obscure provision to the Patent Act that rendered some of these patents essentially null and void. More precisely, the legislation created a remedies exclusion. Under 35 U.S.C. §287(c), a patent on certain medical or surgical procedures, as narrowly defined by the statute, cannot be enforced. The patentee has no remedy against direct or inducing infringement of such a patent because the provisions of 35 U.S.C. §281 (civil action for infringement), §283 (injunction), §284 (damages), and §285 (attorney fees) are not applicable.

This remedies exclusion came about when one U.S. medical doctor sued another for infringement of a patent on a surgical technique for a method of incision of the eye to implant an intraocular lens.⁸⁶² Chagrined members of the medical community lobbied Congress for an exclusion from patentability for medical and surgical procedures. In an eleventh-hour compromise, Congress passed a watered-down version of the legislation, codified at 35 U.S.C. §287(c), which does not prevent such procedures from being patented but deprives the patent owner of any remedy for infringement.⁸⁶³ In practice, the medical procedures encompassed by the statute are so narrowly defined⁸⁶⁴ that the legislation has had little more than a symbolic impact.⁸⁶⁵

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Notes:

^[861] This contrasts the views of many foreign countries, which categorically exclude methods of treatment of the human or animal body by surgery or therapy and diagnostic methods from patenting. See, e.g., EPC art. 52(4); Agreement on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, art. 27.3(a), Dec. 15, 1993, 33 I.L.M. 81 (1994) (giving member countries the option to deny such patents).

^[862] See Method of making self-sealing episcleral incision, U.S. Patent No. 5,080,111 (issued Jan. 14, 1992).

^[863] See generally Cynthia M. Ho, Patents, Patients, and Public Policy: An Incomplete Intersection at 35 U.S.C. §287(c), 33 U.C. Davis L. Rev. 601 (2000); Richard P. Burgoon, Jr., Silk Purses, Sows Ears, and Other Nuances Regarding 35 U.S.C. §287(c), 4 U. Balt. Intell. Prop. J. 69 (1996).

^[864] See 35 U.S.C. §287(c)(2)(A) (narrowly defining "medical activity" as "the performance of a medical or surgical procedure on a body, but . . . not...