By Sherri Oslick --
Late last week, Novartis and Ranbaxy filed a joint stipulation and dismissal in their pending lawsuit over generic valsartan, the active ingredient in Novartis' Diovan®, used to treat hypertension. The suit, filed on August 9, 2007 in the District Court of New Jersey (see previous report), had been pending only 5 weeks when Ranbaxy amended its ANDA filing, converting its Paragraph IV certification to a Paragraph III certification. One week later the parties filed their stipulation and dismissal.
As noted in the stipulation, the amendment to a Paragraph III certification means that Ranbaxy agrees not to make, use, sell, offer to sell, or import into the United States any product until after the expiration of Novartis' exclusivity, or until the claims of the patent-in-suit are declared invalid or unenforceable following a final decision in a U.S. district court. The patent in suit is U.S. Patent No. 5,399,578 ("Acyl Compounds," issued March 21, 1995). Novartis' exclusivity terminates on September 21, 2012 based on a 6-month Pediatric Exclusivity granted beyond the expiration date of the '578 patent.
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