Sometimes. In the United States, medical method/process patents may be granted by the United States Patent and Trademark Office. For patent rights to exist, the patent must first be granted by the appropriate governmental authority.
When is a Medical Method Patent Not Enforceable?
Pursuant to 35 U.S.C. § 287(c), a medical method/process type patent is not enforceable as follows:
(1) With respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) or (b), the provisions of sections 281, 283, 284, and 285 shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.
Speaking generally, a medical method/process patent cannot be enforced against a medical practitioner or a related health care entity.
Medical method patent owners are not awarded damages when a medical practitioner or related health care entity infringes the patented medical method/or process.
When is a Medical Method Patent Enforceable?
Provision of pharmacy or clinical laboratory services related to the patented procedure are not exempt.
Definitions: Medical Practitioner or Related Health Care Entity
35 U.S.C. § 287(c) reads as follows:
(2) For the purposes of this subsection:
(A) the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.
(B) the term “medical practitioner” means any natural person who is licensed by a State to provide the 35 U.S.C. § 287(c) described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.
(C) the term “related health care entity” shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the 35 U.S.C. § 287(c) including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.
(D) the term “professional affiliation” shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.
(E) the term “body” shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.
(F) the term “patented use of a composition of matter” does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.
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