Medical Use Exception v. Divided Infringement (Part 2 of 3): All is Not Lost to the Medical Procedure Exception
January 23, 2013

As a follow up to an earlier post, Value Added to Medical Method and Diagnostic Patents through Induced Divided Infringement, what if a diagnostic test developer induced a doctor to use its specially developed test kit and perform all of the steps of the claim, resulting in infringement of the diagnostic method claim?

Consider the following representative diagnostic method claim:

1. A method of probing a target in a sample comprising:

(a) drawing a sample from a patient;

(b) exposing the sample to a probe comprising a binder coupled to an enzyme under conditions suitable for the binding of the probe to the target;

(c) reacting the probe in step (b) with an enzyme substrate coupled to a fluorescent signal generator;

(d) observing a signal from the fluorescent signal generator of step (c).

In this scenario, all of the steps of the method would be performed by a single actor—the doctor—amounting in two forms of infringement. First, there is the direct infringement of the diagnostic method patent by the doctor under 35 U.S.C. § 271(a). Second, there is the induced infringement of the patented diagnostic method by the test developer under 35 U.S.C. § 271(b).

But the patentee cannot seek damages against the doctor. The Medical Procedure Exception of 35 U.S.C. § 287(c)(1) explicitly states that “a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271 (a) or (b) … shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.” This protects the medical practitioner and its employer from liability for direct infringement, and infringement which the medical practitioner or its employer induces. A “medical activity” is the performance of a medical or surgical procedure on a body, where “procedure,” in a medical context, includes medical diagnosis. The diagnostic method claim would be subject to the medical procedure exception.

But all is not lost. The patentee can pursue remedies from the test developer’s active inducement of the doctor to infringe the diagnostic method patent. The Limelight test for induced infringement requires that (1) the inducer know about the method patent, (2) the inducer induced the performance of the steps of the method patent, and (3) that the steps of the method are performed. The doctor’s performance of the method is due to the test developer’s marketing efforts, presenting the new test kit to the doctor, educating the doctor on how to use the test kit and encouraging the doctor to use the test kit for diagnostic purposes. By marketing the test kit and enabling its use, the developer will “cause, urge, encourage, or aid” the infringing conduct and may be liable for inducing infringement under 35 U.S.C. § 271(b).

By: Douglas J. Bucklin, PhD

Note:  Special thanks to Amber Stiles, Law Clerk at Volpe and Koenig, for her contributions to this post.