Isolated DNA Molecules Are Patentable Chemical Entities, and Patent-Eligible Diagnostic Methods Must Include Transformational Steps

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In a vindicating win for the biotechnology industry, the Court of Appeals for the Federal Circuit in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. (Fed. Cir. No. 2010-1406) on July 29, 2011, reversed the lower court and held that “isolated” DNA, including genes and sequence-specific probes for detecting breast and ovarian cancer, are patent-eligible subject matter, since these molecules are “markedly different” new chemical entities that do not exist in nature. The Federal Circuit further found Myriad’s method claims for screening therapeutic candidates to be patent-eligible since the claims recite transformative steps, rather than merely mental comparisons between sequences, but found the diagnostic method claims to be too abstract.

The defendant Myriad’s request to dismiss the case for a lack of standing was also rejected on the basis of plaintiff Dr. Ostrer’s ability to practice the claimed invention. However, lawyers for Dr. Ostrer filed a letter with the court on the same day as the decision indicating that he may no longer have that capacity at his new academic position.

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