The US Court of Appeals for Federal circuit (CAFC) has affirmed the district court judgment in an appeal filed by Novartis against Teva w.r.t Famciclovir. The court has invalidated the Famciclovir product patent US5246937 . The district court ( decision ) eralier held the patent obvious based on prior art compound Penciclovir. Famciclovir is a prodrug of Penciclovir. For the said case court considered KSR V/s Teleflex and Takeda V/s Alpharma (pioglitazone) case while considering selection of compounds and obviousness crieteria Novartis has filed an appeal in United States court of Appeals for Federal Circuit on September 6, 2007 after getting denied preliminary injunction by The United States District Court for The District of New Jersey. Following patents are listed in orange book for this product
US5246937 (Expiry: Sep 21, 2010)- which covers purine derivatives like Famciclovir as product
US5840763 (Expiry: Sep 1, 2015)- Method of use for herpes viral infection
US5866581 (Expiry: Oct 4, 2014)- Method of use for post-herpetic neuralgia
US5916893 (Expiry: Sep 1, 2015)- Method of use for latent infection of herpesviruses
US6124304 (Expiry: Oct 4, 2014)- method of use for the treatment of zoster associated pain
Teva has approved ANDA for 125 mg, 250 mg and 500 mg tablets, the ANDA was approved on August 24, 2007. Innovator has also sued Roxane pharma who has filed Para III against the product patent '937 and Para IV against rest of the patents in March 2008.
US5246937 (Expiry: Sep 21, 2010)- which covers purine derivatives like Famciclovir as product
US5840763 (Expiry: Sep 1, 2015)- Method of use for herpes viral infection
US5866581 (Expiry: Oct 4, 2014)- Method of use for post-herpetic neuralgia
US5916893 (Expiry: Sep 1, 2015)- Method of use for latent infection of herpesviruses
US6124304 (Expiry: Oct 4, 2014)- method of use for the treatment of zoster associated pain
Teva has approved ANDA for 125 mg, 250 mg and 500 mg tablets, the ANDA was approved on August 24, 2007. Innovator has also sued Roxane pharma who has filed Para III against the product patent '937 and Para IV against rest of the patents in March 2008.
