U.S. District Judge Garrett E. Brown Jr. of Trenton, New Jersey not only ruled that Teva had failed to show that the patent for Singulair was unenforceable and invalid but apparently declared the drug valid – which was a silly thing to do, as he should have declared the drug not shown to be invalid.
The patent covers montelukast, the active ingredient in Singulair, Merck’s best-selling drug for treatment of asthma and allergies. The medicine that had 2008 sales of $4.3 billion. The medicine, approved by the U.S. Food and Drug Administration in 1998, is based on research that showed one way to treat the disease is to block leukotrienes, compounds that cause muscle contraction and increase secretions in the lungs.
Merck “put forth sufficient evidence of the failed attempts of others to develop a leukotriene antagonist,” Brown said in his opinion. Thus it appears that the non-obviousness of the approach was, according to the judge, based on secondary considerations such as long-felt need.
Concurrently, the U.S. Patent and Trademark Office is reexamining the patent. Although the patent remains valid during reexamination proceedings, it is not clear that the patent will survive the scrutiny. If it does survive reexamination, the ruling will prevent Teva Pharmaceutical Industries Ltd (israel) from selling a generic version of the drug until August 2012. If it doesn’t, Brown will realize that he was wrong for declaring a patent valid.
The case is Merck Sharp & Dohme Pharmaceuticals SRL v. Teva Pharmaceuticals USA, 07cv1596, U.S. District Court, District of New Jersey (Trenton).