DNA — Not Patentable Subject Matter ...


Law360, New York (March 31, 2010) -- The U.S. District Court for the Southern District of New York has ruled that claims to isolated DNA and methods of use for diagnosis do not qualify as patentable subject matter in Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office, 09 Civ. 4515 (RWS), March 29, 2010. The court avoided a further ruling on whether the U.S. Patent and Trademark Office violated the First Amendment to the Constitution in issuing the patents.

This decision will likely have negative short-term implications for financing in the biotechnology sector, and hence the development of new diagnostics and therapeutics, unless it is overturned by the U.S. Court of Appeals for the Federal Circuit in the next one to two years.

It had long been viewed that the sequencing of genes and disease associated mutations for use in developing isolated diagnostic DNA probes and assays provides useful non-naturally occurring subject matter which should qualify for patentability under the statute (35 U.S.C. §101). The USPTO and most other foreign patent offices have issued thousands of such isolated DNA patents in the past.

This lawsuit was brought by the American Civil Liberties Union, certain doctors, medical researchers and patients against the patent owner Myriad Genetics, the USPTO and other defendants, over the validity of patents directed to BRCA1 and BRCA2 genetic mutations associated with breast and ovarian cancer.

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