Refer to our earlier post on Montelukast reexamination Here, Now, an article published in reuters (here ) reported that USPTO has upheld the validity of the key patent during re-examination. Now, generic version would be blocked till compound patent expiry in Aug 3, 2012.
Background
Earlier, the United States Patent & Trademark Office (USPTO) had accepted the request of a Independent firm Article One Partners LLC on Ex partes re-examination of blockbuster anti-allergic medication Montelukast’s (Singulair) key patent.
Innovator Merck 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.
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). 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 had alleged that the said article were very important for patentability determination of ‘473 patent.
Earlier, U.S. District Court for the District of New Jersey has upheld the validity of said patent and opined that generic version of M/S Teva pharma would infringe the compound patent (as reported by this blog Here )
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