Court Upholds Validity of Merck’s Singulair Patent

August 19, 2009

A U.S. federal judge upheld the validity of a patent on Merck & Co Inc’s asthma and allergy drug Singulair Wednesday, dealing a blow to Teva Pharmaceutical Industries Ltd , which wanted to introduce a generic copy.

The court found that Teva infringed Merck’s patent and ordered that a permanent injunction be issued to restrain Teva from manufacturing or selling a generic version of Singulair — Merck’s biggest product — until the patent expires in 2012.

Teva challenged the validity of patent ‘473 during a trial in February before Judge Garrett Brown in Newark federal court in New Jersey.

Had Teva prevailed, its generic version would have blown a hole in Singulair’s annual U.S. sales of about $3 billion.

The ruling also resolves a second lawsuit filed by Merck against Teva in January, said Merck spokesman Ronald Rogers.

That lawsuit related to Teva’s application to sell an oral granule formulation that can be dissolved in baby formula, breast milk, applesauce or ice-cream for children, he said.

Teva is reviewing the court’s decision to determine its next course of action, the company said in a statement.

Singulair had world-wide sales of $4.3 billion in 2008, including both formulations of the drug.

Teva applied for U.S. approval for a generic version of Singulair in 2007. Merck responded by suing Teva for patent infringement, which barred the FDA from approving a generic for 30 months, or until a court decision. (Reporting by Ransdell Pierson in New York and Toni Clarke in Boston, editing by Gerald E. McCormick and Robert MacMillan)

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