Intellectual Property Magazine
The Federal Circuit’s decision in the Association for Molecular Pathology et al. v United States Patent and Trademark Office et al. case, popularly known as the Myriad case, did not provide a bright-line test for the patentability of biological molecules in general, as many had hoped it would. The Federal Circuit reversed the district court’s controversial holding that isolated DNA molecules were not patentable under §101, instead holding that Myriad’s claimed isolated DNA did “not exist in nature” and was sufficiently “markedly different” from native DNA to qualify as patentable subject matter. The Federal Circuit, however, affirmed the district court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; holding that such claims include no transformative steps and cover only abstract, mental steps. The Federal Circuit’s decision has generated much discussion, in part because the three judge panel disagreed among itself as to the basis of its holding; differing in conclusion and reasoning on the patentability of isolated DNA. This article discusses the Myriad opinion and the uncertainty of the application of the Myriad framework to the patentability of other biological molecules.