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Sepracor, UMass Sue Generic Drug Maker For Allegedly Infringing Clarinex Patents

Sepracor and the University of Massachusetts together have sued generic drug manufacturer Pharmaceutical Associates for allegedly infringing a pair of patents related to an oral formulation of the allergy drug Clarinex.
The complaint, filed in September in the US District Court for the District of New Jersey, accuses Pharmaceutical Associates, also known as PAI, of infringing US Patent Nos. 7,214,683 and 7,214,684, which are co-owned by Sepracor and UMass and were exclusively licensed to Sepracor in 1997.
The complaint alleges that PAI in August filed an abbreviated new drug application with the US Food and Drug Administration for a generic version of an oral syrup containing the active ingredient desloratadine, which is marketed as Clarinex by Schering-Plough. Schering obtained a license from Sepracor to sell the prescription drug in 1997, and launched Clarinex in January 2002 for the treatment of seasonal allergic rhinitis.
According to the complaint, Sepracor and UMass received a notification letter from PAI in August stating that in PAI’s opinion, the ‘683 and ‘684 patents are invalid. The letter did not, however, claim that the IP is unenforceable, or that PAI would not be infringing them if it were to manufacture and sell its version of the therapy.
As a result, Sepracor and UMass said that they inferred that if the ANDA is approved PAI would manufacture and sell its generic product in the US.
The plaintiffs have therefore asked the court to declare that PAI has infringed one or more claims of the patents by seeking regulatory approval, and to permanently prohibit PAI from manufacturing or selling its generic drug.
Furthermore, the plaintiffs have asked the court for undisclosed damages if PAI begins manufacturing the generic drug, as well as attorney fees and other costs and expenses related to the lawsuit.
Allergic Reactions
Sepracor and UMass over the past two years have filed several similar lawsuits relating to the patents against 10 different generic drug manufacturers in the US and India, according to an August SEC filing by Sepracor. These manufacturers include Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, Orchid Chemicals and Pharmaceuticals, Mylan, Lupin Pharmaceuticals, Perrigo, Dr. Reddy’s, and Anchen Pharmaceuticals.
In March, Sepracor entered into an agreement with one of the alleged infringers, Glenmark, which agreed not to pursue its case or market a generic version of Clarinex until the patents expire or are found invalid or unenforceable.
As listed by Schering-Plough in the FDA’s listing of Approved Drug Products with Therapeutic Equivalence Evaluations, the ‘683 and ‘684 patents are set to expire on Dec. 30, 2014.
In April, the judge presiding over the cases in the New Jersey district court consolidated them, including the PAI complaint, according to the SEC filing. A court date has not yet been set, Sepracor said.
Sepracor also said in the filing that it believes all of the ANDAs filed by the 11 generic manufacturers are subject to a statutory stay of approval until at least December 2009, based on lawsuits Schering-Plough had filed against the 10 pre-PAI companies in separate civil actions involving a third, unidentified patent related to Clarinex.
UMass’ stake in the patent-infringement proceedings is unclear, as the terms of Sepracor’s original licensing with the university have not been disclosed. Calls to the UMass Medical School were not returned in time for this publication. The terms of Sepracor’s licensing deal with Schering-Plough have not been disclosed.
However, according to Sepracor’s 2007 annual report, the company recorded approximately $16.5 million, $12.2 million, and $9.4 million in royalty payments for Clarinex in 2007, 2006, and 2005, respectively, under its agreement with Schering-Plough.
According to Schering-Plough, global sales of Clarinex totaled approximately $799 million in 2007; $722 million in 2006; and $646 million in 2005.

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