Pfizer Inc said a federal court has upheld the company’s six-month pediatric exclusivity for its top selling anti-fungal medicine, Diflucan.
“This decision strongly supports the public health purpose Congress had in mind when it created an incentive for research-based companies to fund and conduct studies for the benefit of pediatric patients.” said Jeffrey Kindler, senior vice president and general counsel of Pfizer. “We are very pleased with the court’s decision to uphold the principle of pediatric exclusivity.”
The ruling came in response to a suit filed by the generic manufacturer Ranbaxy contending that its generic version of Diflucan was not subject to the exclusivity period for Pfizer’s product. A previous lawsuit brought by Pfizer against Ranbaxy for infringement of its patent for Diflucan was terminated on January 29, 2004, the expiration date of the patent.
The court's decision rejected Ranbaxy's contention that the termination of the patent suit made Pfizer's pediatric exclusivity inapplicable and that it should be authorized to introduce a generic Diflucan immediately. The decision provides Diflucan with U.S. marketing exclusivity until July 29, 2004.
The decision represents Pfizer’s latest success in responding to legal actions challenging the company’s patents and marketing exclusivity. On February 27, the U.S. Court of Appeals for the Federal Circuit issued a ruling preventing generic manufacturer Dr. Reddy’s from launching an alternative salt version of Pfizer’s hypertension treatment Norvasc. The decision provides Norvasc with marketing exclusivity through September 2007, the date of expiry of Pfizer’s besylate salt patent.
“These decisions properly recognize the significant efforts of our dedicated research teams in discovering and developing innovative, life-saving medicines to meet the unmet medical needs,” said Kindler.