After an eight-day trial in the United States District Court, Trenton, NJ, a jury invalidates Mutual Pharmaceutical’s patent for labeling for the drug Skelaxin.
Online PR News – 15-October-2010 – – (NEW YORK, NY) – Cohen Pontani Lieberman & Pavane LLP (CPLP), a preeminent intellectual property litigation firm, has won a major jury verdict on all counts in defense of its generic drug client, Sandoz Inc. The jury invalidated Mutual Pharmaceutical Co., Inc.’s patent directed to information on the label for the drug Skelaxin, known generically as metaxalone. The jury also found that Sandoz did not infringe the patent. King Pharmaceuticals, Inc., which owns the Skelaxin brand and holds a license under the patent, was also a plaintiff.
According to Martin B. Pavane, CPLP managing partner and lead trial counsel, the King/Mutual case hinged on the plaintiffs' belief that they could patent information appearing on a drug label describing how metaxalone, which has been around since the 1960's, metabolizes in the body. Because generic drug companies like Sandoz must copy the brand label, when Sandoz copied the Skelaxin label en route to obtaining FDA approval to market a generic version of Skelaxin, King/Mutual sued Sandoz for patent infringement, claiming that the information on the Sandoz label infringed Mutual's patent. The jury found otherwise, and invalidated the patent and determined that Sandoz did not infringe.
“Had the patent been sustained,” Mr. Pavane says, “it would mean that any drug company could take an old drug, even one already being sold by many generic companies, develop new information about it, persuade the FDA to require that information to be on the label, and then sue all the generic companies when they copied the label as required by the FDA. That would have been a dangerous precedent."
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