A firm that specializes in challenging the validity of patents has requested the USPTO to re-examine innovator Merck’s Orange Book listed patent US5565473 for Montelukast Tablets (Singulair) . Independent firm Article One Partners LLC said its online community found two pieces of evidence that suggest the asthma and allergy drug's key ingredient isn't novel. Merck is trying to prevent Teva from making a generic version of the product before its patent expires in 2012. Last week, in an opening statement for the federal trial, Merck's attorney maintained the U.S. patent is valid and enforceable (as reported by CNN Here)
Teva is first para IV filer for Montelukast tablets 4 and 5 and 10 mg/tablet. Teva filed its ANDA with para IV certification on December, 2006 against following Orange Book listed patent:
US5565473 (Expiry: 8/3/2012): which covers unsaturated hydroxyalkylquinoline acids as leukotriene antagonists, including Montelukast as product.
Innovator sued Teva on April, 2007 for the infringement of '473 patent. The case is ongoing at New Jersey District Court (Discovery phase).Now, Teva has came up with strong invalidation grounds against said patent with allegation of intent to deceive USPTO against innovator, during prosecution of '473 patent
Teva has requested court that Merck withheld two important prior art documents authored by Merck's scientist Dr Robert Young during prosecution of said patent. The hearing for this case is scheduled in October, 2008.
If Teva succeed in its attempt, then generic space will open early for this product in US market
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