Gene patents are currently a hotly debated topic, having caught the attention of the public and the media, including the news program 60 MinutesTM. The debate essentially pivots around the interpretation of whether a gene patent improperly covers a gene as it occurs within the human (or when isolated is no different from the natural gene), as opponents contend, or whether the patent is merely protecting an isolated version of the gene as produced by the hand of man (and therefore is no different than any other chemical compound), as proponents maintain.
The debate has been raging in federal court in New York since last May, concerning several patents owned by Myriad Genetics that involve the BRCA1 and BRCA2 genes, which are implicated in breast cancer. Last week, the judge in that case ruled that several claims of the patents were invalid for encompassing non-statutory subject matter. Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. (S.D.N.Y.). Some interpret this to mean that gene patents are invalid.
But before leaping to that conclusion, consider: only some of the claims were found invalid, leaving many other claims valid. Also, the decision concerned particular claims of certain patents; the Court did not address the broader constitutionality aspects of the case, so this decision is narrowed in its scope. Additionally, the Defendants are appealing this judgment to the Court of Appeals for the Federal Circuit, who will review the decision and may overturn it. It seems likely, though, that since this is such a significant case, it could go all the way to the U.S. Supreme Court before the public, and patentees, have a final answer on this important question.