An Unclear Diagnosis


What constitutes patentable subject matter? The

tension between the broad language of 35 U.S.C. Section 101 and the limitations of its scope by the courts is playing out in the context of patent eligibility of process claims. For claims directed to diagnostics and other aspects of personalized medicine, the issue has been framed in terms of pre-emption; do the claims impermissibly seek to monopolize a law of nature?

In 2008, the Federal Circuit in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) re-examined the requirements for determining patent eligibility of process claims under Section 101. Although the patent at issue in Bilski is directed to a business method, the decision has farreaching effects that impact medical diagnostics and personalized medicine patents.

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