Federal Circuit Validates Claims Drawn to Isolated DNA, Invalidates Claims Drawn to Analyzing or Comparing DNA without Transformation Step


On July 29, 2011, the U.S. Court of Appeals for the Federal Circuit issued a decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, holding that several claims drawn to isolated DNA sequences encoding the BRCA1 and BRCA2 genes, as well as methods of using those sequences to screen for cancer, were valid as being drawn to statutory subject matter under 35 U.S.C. § 101. The decision overturns the lower court's decision for these claims, but the Federal Circuit upheld the lower court's holding that claims drawn to methods of using those sequences to detect cancer that did not recite any machine, apparatus, or transformative step were invalid. The much-awaited decision confirmed the expectation that the Federal Circuit would hold isolated DNA sequences as patentable. These holdings by the Federal Circuit should not affect well-counseled diagnostics companies.

Several factors in this case mean that it is "business as usual" for claims involving isolated DNA sequences. First, the claims drawn to isolated DNA were upheld as valid, so older patents with such claims are still valid and newly filed or pending applications with such claims will continue to be examined by the U.S. Patent and Trademark Office (PTO) under the same rules that have been in place for decades. Second, the method claims held invalid in this decision do not recite any machine, apparatus, or transformative step—limitations that post-Bilski claims typically contain. Thus, diagnostic companies typically will be in the same legal position as they were prior to this decision.


Under 35 U.S.C. § 101, "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title."

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