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Glaxo, Apotex Can Sell Generic Paxil, 3rd Circuit Rules

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By Stephanie Rabiner, Esq. on March 01, 2012 5:04 AM

Generic Paxil may soon be headed to the Third Circuit Court of Appeals. A federal judge in New Jersey has ruled in favor of GlaxoSmithKline, giving it permission to sell generic Paxil to Apotex, a Canadian pharmaceutical company.

The ruling comes in a 2010 lawsuit filed by generic drug manufacturer Mylan. The company accused Glaxo of breaching a licensing agreement that gave it an exclusive right to market and sell generic Paxil.

The judge has ruled that right only lasted for two years.

The licensing agreement is part of a 2007 settlement between the two companies. At the time, they were engaged in a patent dispute over Paxil CR, a controlled release version of the drug. To end the litigation, Glaxo agreed to give Mylan the right to market and sell generic Paxil for two years.

At the end of those two years, Glaxo entered into a licensing agreement with Apotex. Mylan sued, claiming the deal breached its 2007 agreement.

The judge disagreed, finding that the terms of license were "clear and unambiguous." As such, "the language plainly states that GSK may commence marketing and selling of authorized generic Paxil CR after Myland's two-year period of exclusivity." He further wrote, "GSK did exactly that. It marketed and sold authorized generic Paxil CR to Apotex."

Generic Paxil has brought in "hundreds of millions of dollars in sales," according to Mylan's court filings. Because adding Apotex to the mix may severely dilute these profits, it's very possible the company will appeal. The Paxil battle may never end.

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