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  Intellectual property lawyers are hoping the U.S. Supreme Court will clarify some patentability issues in the field of medicine when it hears Mayo Collaborative Services v. Prometheus Laboratories Inc. On June 20, the Supreme Court granted certiorari in the case, which concerns personalized medicine patents. Prometheus’s patents cover drug dosage adjustment methods tied to a patient’s individual metabolism.  The U.S. Court of Appeals for the Federal Circuit has ruled twice in the case, which has gone up to the high court once before. In September 2009, the Federal Circuit reversed a lower court’s ruling invalidating the Prometheus patents, which are used to treat autoimmune diseases such as Crohn’s disease, depending on a patient’s particular metabolism. The Federal Circuit ruling, authored by Judge Alan Lourie, held that Prometheus’ inventions satisfy the requirements of the “machine or transformation” test in the Federal Circuit’s decision in In re Bilski because the claimed methods “‘transform an article into a different state or thing” in a way that is “central to the purpose of the claimed process.” The district court had based its ruling on the judgment that correlations between the effectiveness and toxicity of the drug for a patient and the patient’s metabolites were natural phenomena stemming from a natural body process. About a year ago, a divided Supreme Court issued its ruling in Bilski. The Court rejected a method patent, but did not issue a blanket rule against patents for business methods or processes. Nor did the Court rule out methods or processes that are not associated with a new machine and that don’t transform anything.  Shortly after its Bilski ruling, the high court granted Mayo’s petition for cert in its case against Prometheus. The Court vacated the Federal Circuit ruling and remanded the case for review in light of Bilski. The Federal Circuit then ruled again in Mayo v. Prometheus in December 2010. In another opinion authored by Lourie, the court held that Prometheus’ claims pass muster under the Patent Act and “do not encompass laws of nature or preempt natural correlations.” That ruling also noted that the Supreme Court’s Bilski decision only rejected the use of the machine-or-transformation test as a definitive test. The December 2010 ruling reaffirmed that Prometheus’s claimed treatment methods “satisfy the transformation prong of the machine-or-transformation test.” The Supreme Court’s decision to review Mayo v. Prometheus “is huge because this allows the question of patenting and personalized medicine to be decided without the emotional hot-button issues that are in the Myriad case,” said Edward Reines, a partner in the Redwood Shores, Calif., office of New York’s Weil, Gotshal & Manges. Reines submitted amicus briefs on behalf of the American Intellectual Property Law Association in the Federal Circuit reviews of the case. “Prometheus is a much better vehicle to decide the core questions of patenting and genetics than Myriad,” Reines said. The controversial Myriad case, which is officially Association for Molecular Pathology v. U.S. Patent and Trademark Office and also known as American Civil Liberties Union v. Myriad, is about whether an isolated human gene is patent-eligible. The two genes at issue are associated with an increased risk of breast and ovarian cancer.  Daniel Ravicher, executive director of the Public Patent Foundation at Yeshiva University Benjamin N. Cardozo School of Law, said the Supreme Court’s decision to hear the Mayo case “signals that the Federal Circuit’s continual support for these types of claims has doubtful or at least uncertain legal support.” The foundation submitted an amicus brief in both cert petition battles in Mayo on behalf of the foundation and AARP, formerly the American Association of Retired People. “The Supreme Court wouldn’t use one of the few cases it takes each year to affirm what a lower court has done,” Ravicher said. “We believe that the analysis that the Federal Circuit has used even after Bilski fails to abide by Supreme Court precedent.” Intellectual property lawyers have been waiting for clarity in patentable subject matter in the life sciences arena since a divided 2006 Supreme Court ruling in Lab Corp. v. Metabolite, said Jennifer Gordon a New York partner at Houston’s Baker Botts, who represented amicus Novartis Corp. in the Federal Circuit stages of the case. The case was dismissed as improvidently granted because of a technical problem at the lower court, but three dissenters vehemently argued that the court should consider limiting patentable subject matter. “There must be some justices, or perhaps all of them, who would like to finally give clarity to something we’ve all been wondering about since the dissent in the LabCorp case,” Gordon said. Sheri Qualters can be contacted at [email protected].

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