It may have gone largely unnoticed, but a significant event occurred last month with respect to divided infringement under § 271(a). On April 18, 2016, the Supreme Court denied Limelight's petition for certiorari in Limelight Networks v Akamai Tech. In denying cert., the Supreme Court remanded the en banc decision of the Federal Circuit that set forth the law of divided infringement under § 271(a). Specifically, the Federal Circuit held that an entity will be found responsible for another's performance of steps of a method "(1) where that entity directs or controls others' performance, [or] (2) where the actors form a joint enterprise."
This finding could prove to be of significant impact to many in the biotechnology and pharmaceutical industry as those fields attempt to find ways to address objections to methods of diagnosing and methods of treatment in a post Mayo world. The concern facing method claims for diagnostics and treatments for years was that while the methods could be performed by a single individual, in practice, multiple individuals were involved. This would render such claims virtually unenforceable and near valueless. For example, a nurse draws blood from a patient, a lab in the hospital or contract with hospital tests the sample, a laboratory technician reviews the test and provides the technical result, and a doctor makes a determination based on the results whether the subject fits a profile for a diagnosis to be made. These claims were further devalued in a post Mayo world where conventional steps in the method are often dismissed and subject matter eligibility determined based on the remaining limitations of the claims relating to a natural product or abstract idea. To be sure, it is rare to find a diagnostic method that doesn't use conventional methodology to apply to a new relationship to arrive at a diagnosis.
However, it may be that following Limelight Networks v Akamai Tech, not only would claims actually performed by multiple individuals (such those similar to the example provided above) have greater chance of surviving an infringement challenge, but could provide a way out of a subject matter eligibility challenge. Taking Diamond v. Diehr (method that used a mathematical equation to continually monitor and modify rubber vulcanization process) as the roadmap, a diagnostic or treatment method that has a step of altering a treatment regimen based on a test result, may be patent eligible. Previously, such claims would never have been proposed as clearly involving multiple individuals to perform, but following Limelight, this may prove a valuable avenue to seek patent protection
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