Teva sues Cipla over generic asthma inhalers
Israeli drug manufacturer Teva Pharmaceuticals is suing India-based Cipla to block the launch of generic Qvar (beclomethasone dipropionate) asthma inhalers.
In a complaint filed Friday, August 7 at the US District Court for the District of New Jersey, Teva claims that an abbreviated new drug application (ANDA) filed by Cipla violates six patents.
Cipla informed Teva in June that it intended to seek authorisation from the US Food and Drug Administration to manufacture and commercialise generic Qvar inhalers.
According to Teva, Cipla made an offer of conditional access (OCA) to its ANDA “subject to various unreasonably restrictive conditions”.
Teva says that Cipla has refused to “provide the materials necessary to evaluate its ANDA products for infringement”.
“Teva’s counsel also expressed concern that Cipla would not be able to provide necessary product samples in a timely fashion, and requested a date certain by which such samples could be made available,” the complaint said.
The Israeli company said counsel for Cipla did not respond to its correspondence inviting them to engage in further discussions on the terms of the OCA.
Cipla’s June notice letter asserted that the manufacture and sale of the ANDA products would not infringe any of the six patents-in-suit.
But this letter did “not provide information regarding Cipla’s ANDA Products sufficient to evaluate Cipla’s assertions of noninfringement,” Teva claimed.
Teva is seeking a declaration of infringement, and an award of damages and attorneys’ fees. WIPR has contacted Cipla for comment in response to Teva’s allegations.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox