Enforcing Medical Procedure Patents

By: William W. Cochran

Cochran Freund & Young LLC

U.S. Patent Law, 35 USC § 287(c) states that a medical practitioner’s performance of a medical activity that constitutes an infringement of an issued patent will not be held liable for damages and will not be enjoined from practicing the medical procedure claimed in the patent.  The same also applies to the health care entity where the medical practitioner works.  The term “medical activity” is the performance of “a medical or surgical procedure on a body.”  A “body” means a human body, organ or cadaver, or non-human animal used in medical research for humans.  However, if the medical or surgical procedure includes the use of (1) a patented machine, manufacture or composition of matter that results in infringement of the patented machine, manufacture or composition of matter, or (2) the practice of the patented use of a composition of matter that would result in infringement of the patented composition of matter, or (3) the practice of a process that infringes a biotechnology patent, then the activity does not comprise a ‘medical activity’ that falls within the exception to the enforcement of the patent.

In other words, if a patent is granted that claims a medical procedure, but the procedure requires the use of a patented composition of matter or a patented machine, or infringement of a biotechnology patent, the patent can be enforced against an infringer.

Also, the exception to enforcement of patents under § 287(c) relates to “medical practitioners” which are persons who are licensed by a state government to provide a medical activity, or who are acting under the direction of a person that is licensed to perform the medical activity.

Since the exception under § 287 also applies to medical care entities for which the medical practitioner works, the medical care entity is also immune from suit.  Medical care entities include health care clinics which are also immune from suit.  The exception to § 287 does not apply if a patented composition of matter, or a special tool that is patented is used in performance of the medical procedure.

All of the above applies to suing under § 287 of the patent statute for direct infringement.  However, there are two other sections of the patent statute that are directed toward indirect infringement.  Section 287(b) relates to inducement to infringe, while § 287(c) relates to contributory infringement.

Under § 287(c), a contributory infringer is an infringer that has knowledge of the patent, produces an article, machine, or composition of matter that is particularly suited for use in the patented process and the article, machine or manufacture is not a staple article of commerce which has no substantial non-infringing use.  For example, if a manufacturer produces a special tool that is particularly suited for extracting stem cells from bones and the special tool has no substantial non-infringing use, except for the use of extracting stem cells from bones, that entity may have liability as a contributory infringer.  An important aspect of this is that the special tool does not itself have to be patentable, but must be particularly suited for the patented surgical method and have no other substantial non-infringing uses.

Further, under § 271(b), a person or entity may be liable for inducement to infringe if the procedure necessitates the use of (1) an article, machine or composition of matter, (2) which is particularly suited for use in a patented process, and (3) where the person or entity is aware of the patented process and intentionally encourages others to use the article, machine, or composition of matter in a manner that would infringe the patented process.  For example, if a manufacturer produces a special tool which is specifically suited for use in a patented surgical procedure for stem cell extraction, and the entity or individual actively markets the tool for use in the patented process, which would cause the user of the tool to infringe the patented procedure, the manufacturer would be liable for active inducement under § 271(b) of the patent statute.  The medical practitioner and the clinic that perform the procedure would not be subject to damages or injunction under § 285(c), but would be direct infringers under § 271, which would result in the third party that promotes the tool being an active inducer to infringe under § 271(b).  Section 285(c) was specifically drafted so that contributory infringers and active inducers could be held liable for infringement.

As such, patent holders of patents which claim a medical procedure may wish to consider a licensing program with manufacturers of special tools or compositions used in the medical procedure and promoters of such a special tool or composition to obtain licensing revenues from these entities.

 

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