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Paul, Weiss secured a major appellate victory on behalf of Vanda Pharmaceuticals Inc. before the U.S. Court of Appeals for the Federal Circuit. The decision ends a 2015 action against Roxane Laboratories, which had sought to invalidate a Vanda patent on its schizophrenia drug Fanapt® and to bring a generic version to market prior to the 2027 expiration of Vanda’s patent. The decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited upholds a lower court ruling for Vanda in the District of Delaware that held that Vanda’s patent on a method of using Fanapt® was valid and would be infringed by the proposed Roxane generic.
The decision is widely expected to have broad implications for the emerging field of “personalized” or “precision” medicine, the future of which has been clouded by legal uncertainty over what kinds of patents involving natural processes are patentable following the U.S. Supreme Court 2012 decision in Mayo v. Prometheus. In Mayo, the court had struck down a patent on optimizing the efficacy of a drug for a given patient, reasoning that such subject matter wasn’t patent-eligible because it was merely a “law of nature.”
The Vanda patent at issue involved a way of administering anti-schizophrenia drug Fanapt® based on the patient’s individual genetic characteristics. Roxane challenged the newer patent in FDA filings, leading to the suit by Vanda.
The Federal Circuit’s opinion in Vanda clarifies that those who invent new ways of treating patients can protect their patents. Following the Mayo decision there was widespread uncertainty as to whether methods of treatment that are tailored to an individual patient—the basic premise of personalized medicine—can be patented. The Federal Circuit held that they can. The court also clarifies the rules under which those patents will be enforced against those who wish to sell generic versions of the drugs. The decision found that the patent met the standard for patentability set by outlining a specific method of using natural phenomena for treatment.
“At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome,” notes Circuit Judge Alan Lourie, writing for the panel majority. “Accordingly, the claims are patent eligible.”April 13, 2018