Wednesday, March 31, 2010

"Isolated DNA" Patents Fail to Claim Patentable Subject Matter

The court granted plaintiff's motion for summary judgment of invalidity as to defendants' patent claims relating to human breast cancer susceptibility genes, BRCA1 and BRCA2. "[T]he issue presented in the present motions with respect to the composition claims is whether or not the claims directed to isolated DNA containing naturally-occurring sequences fall within the products of nature exception to §101. . . . [T]he clear line of Supreme Court precedent and accompanying lower court authorities . . . establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess 'markedly different characteristics' in order to satisfy the requirements of §101. . . . While the absence of proteins and other nucleotide sequences is currently required for DNA to be useful for the cited purpose, the purification of native DNA does not alter its essential characteristic -- its nucleotide sequence -- that is defined by nature and central to its biological function within the cells and its utility as a research tool in the lab."

Association For Molecular Pathology et al v. United States Patent and Trademark Office et al., 1-09-cv-04515 (NYSD March 29, 2010, Opinion) (Sweet, J.)

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