Fipronil Generics Launch Amid Legal Battle

A new flea and tick preventative product will be available from Novartic Animal Health this summer.

Novartis Animal Health US Inc. has launched new EPA-approved flea and tick control products for dogs and cats to be available through U.S. veterinarians this summer.

Parastar for dogs and EasySpot for cats are species-specific formulations of fipronil, a flea and tick adulticide. Parastar and EasySpot are registered in more than 40 states.

Meanwhile, the U.S. District Court for the Middle District of Georgia granted contempt motions filed by Merial Ltd. and Merial SAS against Velcera and FidoPharm and their contract manufacturer for PetArmor Plus, Cipla Limited.

The court stayed its order for 60 days to allow for an appeal to the U.S. Court of Appeals. PetArmor Plus remains on the market at Walmarts and Sam’s Clubs.

Velcera and FidoPharm say they intend to seek an expedited appeal and will defend their ability to continue selling PetArmor Plus, a generic fipronil formulation.

Velcera and FidoPharm say they intend to pursue the action they filed in federal district court in Delaware in February, seeking a declaratory judgment that Merial’s patent on a particular composition containing fipronil and s-methoprene is invalid and not infringed by PetArmor Plus. The validity of Merial’s patent was not at issue in the Georgia court proceedings.

In the Georgia ruling, Clay D. Land, U.S. district judge, found that Cipla Ltd. and Velcera Inc. were aware that their sales of PetArmor Plus products infringed on Merial’s patent and barred the companies from further sales of these products in the U.S. The court ordered the seizure of any existing inventory in the U.S. The judge stayed his order from taking effect for 60 days to permit appeal.

“We are in the process of filing an appeal,” said S. Radhakrishnan, CFO of Cipla Ltd., in a regulatory filing. “We believe that there is a good chance that we may be able to overcome this order.”

Cipla officials say the company has sold $10 million worth of PetArmor products.

Land found Cipla in contempt of a March 6, 2008, order prohibiting the company from infringing on Merial’s patents covering Frontline Plus brand flea and tick control products.

“We are pleased that the court recognized the contumacious nature of Velcera and Cipla’s conduct and prevented them from further violating Merial’s intellectual property rights,” said José Barella, executive chairman of Merial. “Merial has invested considerable time and resources developing its flagship Frontline Plus products and is confident that Judge Land’s well-reasoned order will be affirmed.”

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