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Sep 1, 2011 (Vol. 31, No. 15)

Protecting Diagnostic Inventions in the U.S.

Multifaceted Approach Essential in Light of Complexities of Patent Enforcement

  • The parties in McKesson Technologies Inc. v. Epic Systems Corp. were asked to brief two questions: First, if separate entities each perform separate steps of a method claim, under what circumstances, if any, would either entity or any third party be liable for inducing infringement or for contributory infringement? Second, does the nature of the relationship between the relevant actors affect the question of direct or indirect infringement liability?

    These two en banc decisions from the Federal Circuit should shed further light on what sorts of concerted actions by parties constitute joint infringement —with possible review by the Supreme Court thereafter.

    So how should a developer of a diagnostic process protect against unauthorized use by the combined activities of two or more parties? One solution, suggested by the Federal Circuit, is for patentees to draft claims with fewer steps, that will be practiced by a single entity. While this sounds simple, the patent applicant will need to persuade the U.S. Patent and Trademark Office that the method with fewer steps defines a complete and patentable invention.

    A second solution may be available in the form of patent protection for a diagnostic “system,” because some process inventions also can be described and claimed in a patent as systems to carry out the processes. The law relating to proving infringement of system patents has developed differently than it has for process inventions.

    For example, in the NTP case, NTP's invention was also claimed as a system relating to wireless e-mail, with components that could be geographically separate from each other.

    Defendant Research in Motion's (RIM) system included a “relay component” located in Canada, which RIM alleged prevented a finding of infringement of the U.S. patent. The Court disagreed, ruling that “[t]he use of a claimed system under section 271(a) is the place at which the system as a whole is put into service, i.e., the place where control of the system is exercised and beneficial use of the system is obtained.”

    In this case, RIM's customers in the U.S. (Blackberry handheld device users) controlled the transmission and benefitted from the exchange of information over the system. Therefore, the location of the relay in Canada did not preclude infringement of the system claims through customer use in the U.S.

    Using similar logic, the Federal Circuit recently concluded that a system claim could be infringed by a user who put the system into operation and benefitted from it, even though the components of the system were divided among multiple parties.

    For companies seeking to protect their diagnostic inventions with enforceable patents, these uncertainties with respect to the standard for infringement of process claims require careful planning and multiple strategies.

    For example, process claims remain an important component for protecting diagnostic inventions, and even when multiple parties are involved, the relationship between the parties may still satisfy the “mastermind” standard currently being applied by courts. Still, it is worthwhile to heed the Federal Circuit's advice and try to draft process claims limited to steps that will be practiced by a single party within the United States.

    In addition, consideration should be given to whether there are novel or improved tangible articles that are needed to practice the invention and that could be the subject of “product” claims.

    Finally, and significantly, consideration should be given to whether the diagnostic process can be protected with “system” patent claims because it may prove easier to enforce system claims when the activities of two or more parties are involved in practicing an invention. The sophisticated patent applicant will try to use all of these strategies for protecting a diagnostic invention with multiple patents.


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