The United States Patent & Trademark Office (USPTO) has accepted the request of a lawfirm (probably, representing generic player Teva) on Ex partes re-examination of blockbuster anti-allergic medication Montelukast’s (Singulair) key patent.
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.
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 alleged that the said article were very important for patentability determination of ‘473 patent.
Merck is trying to prevent Teva from making a generic version of the product before its patent expires in 2012.
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.
Innovator sued Teva on April, 2007 for the infringement of '473 patent. The case is ongoing at New Jersey District. If Teva succeed in its attempt, then generic space will open early for this product in US market
Update
Innovator Merck has released a press release Here , in response to USPTO's decision of patent reexamination. As per press release, innovator opined that patent reexamination is an administrative procedure by USPTO that can be initiated by any person/organisation. Importantly, if a potential new issue of patent invalidity is raised, the USPTO will examine patent claims in the light of new issues. Further, In the event that the USPTO decides further action is warranted, it may amend or revoke the claims in the patent.
According to the USPTO website, the average time it takes the USPTO to decide ex parte reexaminations is roughly 24 months. The PTO's decision can be appealed to the Court of Appeals for the Federal Circuit before it becomes final.
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