Tuesday, April 9, 2013

Novartis sues Noven for infringing its Exelon patch patents

Noven has submitted to the USFDA an abbreviated new drug application (“ANDA”) under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, and sale of Exelon Transdermal patch (rivastigmine transdermal system, 4.6mg/24 hr and 9.5 mg/24 hr dosage strengths ). In its Para-IV application, Noven has claimed that the ‘023 and ‘031 patents protecting Exelon patch are invalid and/or will not be infringed and intends to launch a generic copy 
before the expiration of the ‘023 and ‘031 patents  
 U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) expire in 2019. The basic patent protecting Exelon expires in February 2014, and Watson is believe to have the first to file status.












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