J&J Duragesic Patent Upheld; Pediatric Exclusivity Dispute Will Determine Timing Of Mylan Generic
This article was originally published in The Pink Sheet Daily
Executive Summary
Mylan claims it should be able to launch in July; J&J says the generic is blocked by pediatric exclusivity until January 2005. Mylan says J&J failed to sue within statutory 45-day period and so forfeits pediatric exclusivity protection.
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The timing of the first generic launch for a version of Johnson & Johnson's Duragesic fentanyl patch will depend on FDA's decision about a six-month pediatric exclusivity extension for the product. Burlington, Vt. federal Judge William Sessions ruled March 25 that Alza's patent no. 4,588,580 is valid and that Mylan's ANDA infringes. The ruling blocks Mylan from launching transdermal fentanyl until the '580 patent expires and directs FDA to delay the effective date of ANDA approval until that time. The ANDA was approved by FDA in November, but Mylan did not launch due to the pending litigation. The '580 patent was originally slated to expire July 23 but received a six-month pediatric extension to Jan. 23, 2005. J&J said it "intends to submit the judge's order rapidly to the FDA and request that Mylan not be permitted to market before expiration of the period of pediatric exclusivity." Mylan, however, is arguing that its ANDA should be exempt from the pediatric extension. Mylan said it "has submitted correspondence to the FDA in support of the FDA's final approval of Mylan's fentanyl ANDA notwithstanding Alza's pediatric exclusivity." Mylan included a copy of the letter in a Form 8-K filing with the Securities & Exchange Commission. 1 Mylan's letter to FDA reiterates arguments the generic firm asserted in the underlying litigation: J&J/Alza's failure to sue within 45 days of receiving notice of Mylan's Paragraph IV certification should preclude the Mylan ANDA from being held up by Alza's pediatric extension. "Because Alza failed to bring an action against Mylan within the statutory 45-day period, resulting in no 30-month injunction and final approval of Mylan's ANDA, there is 'no period during which the application may not be approved'...as required by the pediatric exclusivity statute," Mylan tells FDA. The letter further states that the court "declined Alza's request for entry of an injunction extending to Jan. 23, 2005 (the end of its alleged pediatric exclusivity)." Instead, Mylan said, "the court ordered the effective approval date for Mylan's ANDA to be no earlier than July 23, 2004, the expiration date of the '580 patent." Mylan said it will appeal the patent infringement and validity findings to the Federal Circuit. However, an appeal would have to move quickly to have an impact on the timing of a generic launch. The Duragesic case presents the second significant dispute over the scope of pediatric exclusivity to come before FDA in recent months. On March 10, a federal judge upheld FDA's determination that Pfizer's pediatric exclusivity for the antifungal Diflucan precludes Ranbaxy's generic fluconazole from entering the market until July (2 (Also see "Ranbaxy Diflucan Generic Launch Delayed Until July Under Court Ruling" - Pink Sheet, 11 Mar, 2004.)). The D.C. Circuit Court of Appeals is hearing Ranbaxy's appeal of that decision on an expedited basis. - Sue Sutter |