ARTICLE · 27 MAY 2016

Once Again, Genetic Diagnostic Claims Found Unpatentable Under § 101

McDermott Will & Emery

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The Federal Circuit's decision appears to be consistent with the framework and logic set forth in Mayo, Alice and the new life sciences subject matter eligibility examples issued by the US Patent and Trademark Office.

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In a case relating to methods of detecting genetic variations, the US Court of Appeals for the Federal Circuit upheld the lower court's dismissal under Fed. R. Civ. P. 12(b)(6) on the grounds that the claims are directed to patent ineligible subject matter. Genetic Tech. Ltd. v. Merial LLC, Case Nos. 15-1202; -1203 (Fed. Cir., Apr. 8, 2016) (Dyk, J).

Genetic Technologies' patent claims methods of detecting a gene sequence that codes for a protein (a so-called coding sequence) in an indirect fashion, i.e., by detecting a separate region that does not code for a protein (a non-coding sequence) but happens to be genetically linked to the coding sequence (a phenomenon called linkage disequilibrium). The claims are not specific to any particular DNA coding or non-coding sequence, but are generic to the biological phenomenon that linkage disequilibrium can be used to perform such indirect detection of any DNA coding sequence. The district court granted defendants' motion

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