Enforceability of Medical Procedure Patents Under 35 U.S.C. § 287(c)

July 30, 2018

By James Love & Yun Dong

      Unlike many other countries, medical procedures are not per se unpatentable in the United States. This comes with a major caveat, specifically, 35 U.S.C. § 287(c) bars a medical procedure patent owner from enforcing the patent, by obtaining an injunction, monetary damages, and attorney fees, against a medical practitioner and a related health care entity based on the medical practitioner’s performance of “a medical activity” (§ 287(c)(1)).

      In § 287(c), “medical activity” is defined as “the performance of a medical or surgical procedure on a body” (see § 287(c)(2)), where “body” is defined as “a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans” (see § 287(c)(2)(A)). However, “medical activity” does not include the use of a patented product (see § 287(c)(2)(A)(i)), a practice of a patented use of a composition of matter (see § 287(c)(2)(A)(ii)), or a patented biotechnology (see § 287(c)(2)(A)(iii)). In other words, § 287(c) is narrowly limited to “pure procedure” patents, such as a better way to suture a wound,  which generally do not require significant research investments, and does not render patents on medical devices, drugs, or their methods of use unenforceable.

      Although, as is noted above, the statute § 287(c) extensively defines the term medical activity, whether a patent owner can obtain a remedy for an infringement of a medical procedure patent has been the subject of several recent district level court opinions.

      For example, § 287(c) has barred liability on a medical practitioner from infringing a patent on diagnosing a medical condition of a patient in a satellite medical facility and providing treating instructions through video-conferencing, because the diagnosis was considered a medical procedure, where the requirement in the statute of “on a body” did not require physically touching the body (see Emtel, Inc. v. LipidLabs, Inc., 583 F. Supp. 2d 811, 821-22 (S.D. Tex. 2008). In addition, § 287(c) would likely bar remedy for an infringement of a patent directed to using virtual reality interactive system for treatment of psychological, psychiatric or medical conditions (See Lamson v. United States, 117 Fed. Cl. 755, 763 (Fed. Cl. 2014)).

      The applicability of § 287(c) is further limited by § 287(c)(3). The provision states that the statute does not apply to the activities of persons engaged in “the commercial development, manufacture, sale, importation, or distribution” of a product or a provision of pharmacy or clinical laboratory services, if such activities are (A) directly related to the afore-mentioned commercial exploitation, and (B) regulated under the statutes specified in the subsection. This provision serves to prevent drug, device manufactures and non-physician laboratories from invoking the immunity under the statute. For example, a physician’s performance of a patented medical procedure on a television show fell in this exception and was not shielded from liability by § 287(c), because the show was “overwhelmingly directed to” product promotion, and the medical device used in the procedure was regulated by the Federal Food, Drug and Cosmetics Act (See Viveve, Inc. v. Thermigen, LLC, No. 2:16-CV-1189-JRG, 2017 U.S. Dist. LEXIS 60477, at *9-14 (E.D. Tex. Apr. 40, 2017)).

      Most importantly, as an immunity, although § 287(c) prevents liability on medical practitioners, it does not preclude a finding of direct infringement by physicians performing the claimed method as a matter of law.  If the medical practitioners’ activities constitute an infringement under § 271(a), it may “supply the foundation for causes of action for indirect infringement” by suppliers or manufactures of medical device and drug, regardless of the practitioners’ immunity (See Johns Hopkins University v. Alcon Laboratories, Inc. (No. 15-525-SLR-SRF, 2018 U.S. Dist. LEXIS 70403, (D. Del. Mar. 1, 2018))).

      In particular, in Johns Hopkins v. Alcon, Hopkins asserted that Alcon encouraged performance of a patented surgical technique by making and selling certain surgical instruments. The patented methods allowed a surgeon to perform vitreoretinal surgery without the use of traditional incisions and sutures. In support of its motion for summary judgment, Alcon contended that because doctors performing the claimed surgical procedures were immune from suit under § 287(c), Alcon could not be liable for “indirect infringement stemming from the actions of surgeons immune from liability for direct infringement.” Observing that § 287(c) allows finding of direct infringement by medical practitioners, and that medical device and drug manufacturers may be liable for inducing or contributing to a medical practitioner’s direct infringement of a patented method, the Magistrate Judge suggested that the medical practitioner’s infringement would supply the foundation for Alcon’s indirect infringement, and recommended denial of Alcon’s motion for summary judgment on this issue.

      To conclude, § 287(c) is narrowly tailored to immunize medical practitioners from liabilities resulted from medical activities that infringe “pure procedure” patents and that are not directed to commercial exploitation of drugs, devices or services. That being said, patent owners of such “pure procedure” patents may still have recourse against drug or medical device manufacturers who induce or contribute to the medical practitioners’ infringements. Thus, patents for “pure” medical or surgical procedures may still be useful even in light of § 287(c).