The Justice Department of the United States government recently filed an amicus brief in an appeal of a U.S. Federal Court decision regarding the patentability of naturally-occurring DNA sequences, taking the position that that these are not patentable as “part of nature.” While this position contradicts a long-standing policy of the U.S.P.T.O., it supports the basic holding of a recent U.S. District Court decision. However, the Justice Department’s brief did not rule out the patentability of genes entirely, and suggests that manipulated DNA, including cDNA, should be patentable. The brief also does not challenge patent claims related to methods of use of gene sequences.

Last March, the U.S. District Court in Manhattan in Association of Molecular Pathology et. al. v. U.S. Patent and Trademark Office et. al. (referred to popularly as the “Myriad decision”) ruled that patents covering a naturally-occurring but isolated human gene sequence related to breast cancer were invalid. The Court held that it was not enough to merely isolate naturally-occurring gene sequences to make them patentable.

The case was immediately appealed by co-defendant Myriad Genetics, Inc. and the Plaintiffs filed a motion last June to have Federal Circuit Chief Judge Randall Rader recuse himself if he is picked for the panel that will decide the case on the basis of comments he made regarding this decision at the Biotechnology Industry Organization 2010 International Convention last May in Chicago.

Curiously, no U.S.P.T.O. attorneys were listed on the Department of Justice brief and David Kappos, undersecretary of commerce for intellectual property and director of the patent office, has said publically that the U.S.P.T.O. will continue to consider applications for gene patents until a binding court ruling is issued, contrary to the position of the Justice Department.

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