WHEELING – Prominent drug manufacturer Pfizer is one of three companies that says it will be irreparably harmed if two other major drug makers, including Mylan Pharmaceuticals, are allowed to sell a drug used to treat fibromyalgia.
Pfizer, Warner-Lambert Company and C.P. Pharmaceuticals International filed a lawsuit April 30 in U.S. Federal Court against Mylan Pharmaceuticals and Alphapharm over alleged infringement of the drug Lyrica.
Warner-Lambert claims it holds the title to a patent issued by the United States Patent and Trademark Office on Dec. 14, 1999. The patent is entitled "Isobutyl GABA and Its Derivatives for the Treatment of Pain."
Pfizer, through C.P. Pharmaceuticals, says it holds approved new drug applications for pregabalin capsules in 25, 50, 75, 100, 150, 200, 225 and 300 milligram dosage strengths. The drugs are more commonly known as Lyrica.
Warner-Lambert's patent is listed in an FDA publication with respect to Lyrica, the suit states.
Recently, though, Alphapharm, an Australian company, submitted an approved new drug application to the FDA seeking approval for pregabalin capsules in the same dosages as Pfizer's.
"The Alphapharm ANDA refers to and relies upon the Lyrica NDAs and contains data that, according to Alphapharm, demonstrate the bioequivalence of the Alphapharm products and Lyrica," the suit states.
On March 17, Alphapharm sent Pfizer a letter stating that the Warner-Lambert patent is invalid and that its sale of similar products will not infringe on the patent.
Pfizer, Warner-Lambert and C.P., however, contend Alphapharm is infringing on their patent. They say their companies will be substantially harmed if Alphapharm is allowed to sell the drug.
Mylan is included as a co-defendant in the suit because Alphapharm designates Mylan as its U.S. representative.
The plaintiffs are seeking a judgment declaring that Alphapharm has infringed on their patent, a judgment prohibiting Alphapharm from selling the pregabalin capsules in the United States before their patent's expiration and a judgment that Alphapharm's approved new drug application not be issued before the patent's expiration date.
Pfizer is also asking the court to issue a monetary judgment in its favor if Alphapharm is found selling the pregabalin tablets in the United States before the expiration of its patent.
Pfizer, Warner-Lamber and C.P. are seeking attorneys' fees, costs and other relief the court deems appropriate.
They are represented by William A. Kolibash of Phillips, Gardill, Kaiser and Altmeyer in Wheeling. Dimitrios T. Drivas, Jeffrey J. Oelke, Adam Gahtan and Brendan G. Woodward of White and Case in New York will serve of counsel.
U.S. District Court case number: 1:09-CV-56