- Ag Docket
(plaintiff challenges as invalid 15 claims contained in seven patents relating to two human breast cancer susceptibility genes that isolated DNA containing all or portions of a human breast cancer susceptibility genes and methods for comparing or analyzing the gene sequences to identify a predisposition to breast or ovarian cancer; "isolated DNA" referred to a segment of DNA nucleotides existing separate from other cellular components normally associated with native DNA, and included both DNA originating from a cell and synthesized DNA; court did not consider novelty or non-obviousness under 35 U.S.C. Secs. 102-103 and concluded that DNA's existence in isolated form did not alter fundamental quality of DNA in human body; patents at issue that were directed to isolated DNA containing sequences found in nature not sustainable as matter of law and unpatentable under 35 U.S.C. Sec. 101; mere purification of isolation did not transform DNA that was found in nature into patentable subject matter, and claimed comparisons of DNA sequences were non-patentable mental processes; on the "isolated DNA claims and argument, judge (88 year-old Carter appointee) fails to cite even a single U.S. Federal Circuit Court of Appeals opinion, and cites eight cases decided before the 1952 Patent Act which are completely inapplicable to the present issue at hand - indeed, the court in In Re Bergy, 596 F.2d 952 (C.C.P.A. 1979)warned that pre-1952 cases had to be "handled with care lest the terms used in their reasoning clash with the reformed technology of the present statute; lack of meticulous care may lead to distorted legal conclusions"; part of court's decision involving "isolated DNA" claims, even if upheld on appeal, unlikely to have broad application on patenting biopharmaceutical products and careful drafting may completely avoid court's "product of nature" concerns; court's decision to be appealed to Federal Circuit).
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