Generic pharma giant Teva Pharma (announced in a press release Here ) that the U.S. District Court for the District of New Jersey has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Singulair® (Montelukast Sodium) Tablets, holding that product patent listed in Orange Bokk is valid and enforceable. Teva is currently reviewing the Court's decision to determine its next course of action.
Earlier in a major victory for Innovator Merck, U.S. District Court for the District of New Jersey opined that Teva’s generic product would infringe plaintiff’s valid patent. The Judge ordered Teva not to make generic Singulair, and ordered the U.S. Food and Drug Administration not to approve the generic Singulair until after Merck's patent expires in 2012.
Innovator has listed following disputed patent in Orange Book for Montelukast’s (Singulair) 10 mg tablets and 4 mg granules:
US5565473 (Expiry: Aug 3, 2012): which covers unsaturated hydroxyalkylquinoline acids as leukotriene antagonists, including Montelukast as product.The said patent is a blocking patent for other generic players and is a barrier to generic entry.
Earlier, independent firm Article One Partners LLC announced that its online community found two pieces of evidence that suggest the asthma and allergy drug's key ingredient isn't novel. Law firm has alleged that innovator during prosecution of ‘473 patent has not disclosed some articles authored by Merck's scientist Dr. Robert Young (who proposed a receptor model on anti-allergic effects). Further, law firm alleged that the said article were very important for patentability determination of ‘473 patent. The same grounds were the basis for validity attack by generic player Teva. However, court was not convinced with the invalidation grounds.
Teva is first para IV filer for Montelukast tablets 10 mg/tablet. Teva filed its ANDA with para IV certification on December, 2006. Further, in May, 2009 Teva got tentative approval from USFDA for Montelukast 10 mg Tablets (Singulair) .
In March 2009, 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). The said patent is under re-examination by USPTO.
Earlier news of IP Pharma Doc on this product Here
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