Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics – Part I

Author: Adriana L. Burgy
Editor: Leslie A. McDonell and Amanda K. Murphy, Ph.D.

Patent eligibility is a balancing act; the Supreme Court explained in Mayo that “too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ides.” In an era of subject matter eligibility uncertainty, the on-going question is: How do you deal with 101 rejections and, in particular, for diagnostic inventions in the life sciences space? In a series of posts, we will explore different strategies to answer that question.

Before starting, it’s useful to keep up with the latest court decisions. The USPTO keeps a summary of patent eligibility cases, a link to which can be found here. The link is to the USPTO’s “Subject Matter Eligibility” page, which includes useful examination guidance, examples, materials, and events.

One strategy, a common prosecution tool, is to keep a continuation application pending. With the continually-developing case law on subject matter eligibility, it may be helpful to keep a continuation application on file while Congress and/or the courts continue to address the question of what is patentable subject matter. While this strategy does not solve the problem of obtaining allowable claims, it provides applicants with the ability to obtain claim coverage now based on current standards, while preserving the opportunity to obtain broader coverage once the state of the law has further developed.

While the Supreme Court and Federal Circuit decisions on patent eligibility for diagnostic life sciences claims seem rather dim, applicants can find hope in the instances in which life sciences claims are held to contain eligible subject matter. As former Chief Judge Giles Rich proclaimed, “The name of the game is the claim.” Stay tuned for Part II in which we will look at claiming strategies.

 

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