3 December 2013Big Pharma

Novartis takes on Roxane Laboratories over drug application

Novartis Pharmaceuticals has filed a lawsuit against US drug manufacturer Roxane Laboratories disputing an application for a schizophrenia drug.

Novartis is claiming that an Abbreviated New Drug Application (ANDA) from Roxane would infringe claims on a patent it owns.

According to the complaint, filed on November 27 at the US District Court for the District of New Jersey, Novartis holds a licence on oral tablets for the “acute treatment” of adults with schizophrenia.

The tablets, called FANAPT, contain the ingredient iloperidone and have been approved by the US Food and Drug Administration (FDA).

The dispute relates to US Patent 39198E, which covers part of the tablets.

According to its claims, it consists of compounds and pharmaceutical compositions comprising of iloperidone and methods of treating psychoses by administering it.

The patent is owned by Aventisub II, a US drug maker, but is exclusively licenced to Novartis.

The complaint says Roxane has submitted an application to the FDA seeking approval for the “commercial manufacture, use, and sale of iloperidone tablets” … before the expiration of the Novartis patent.

William Baton, partner at Saul Ewing LLP in New Jersey, US, told LSIPR the case appeared to be an ANDA case brought under the Hatch-Waxman Act, an “extremely nuanced” statutory scheme that encompasses generic company challenges to brand company patents.

“Under the act, the generic company filer of an Abbreviated New Drug Application (ANDA) submits its ANDA to the FDA seeking approval for a generic version of the brand drug prior to the expiration of the “Orange Book” patent(s) associated with that drug,” Baton said.

In the complaint, Novartis says Roxane included in its application, a certification that, “in its opinion and to the best of its knowledge,” the patent’s claims are invalid and that certain claims would not be infringed.

Novartis claims however, that Roxane did not provide assurance that claims covering the use of iloperidone would not be infringed.

“By filing its ANDA … for the purpose of obtaining approval to engage in the commercial manufacture, use, or sale of Roxane’s ANDA Products before the expiration of the patent, Roxane has committed an act of infringement,” the complaint says.

It adds:  “When Roxane filed its ANDA, it was aware of the patent and that the filing of its ANDA with the request for its approval prior to the expiration … was an act of infringement of that patent.”

Novartis claims that if Roxane’s application is approved, it will be administered to human patients for the treatment of psychoses, “which constitutes direct infringement of the … patent.”

Novartis is seeking a permanent injunction restraining Roxane from manufacturing the tablets, that no approval is granted until Novartis’ exclusivity on the patent has expired and a declaratory judgement that any commercial use of the tablets by Roxane would constitute infringement.

Novartis is also seeking damages and attorney’s fees.

A spokesman for Novartis said “There is currently one patent, exclusively licensed to Novartis, listed with expiry of November 15, 2016 and exclusivity expiry of May 6, 2014.  The Notice Letter [on the Roxane application] states that the ANDA includes a “Paragraph IV” patent certification for US RE 39,198, challenging the validity of the patent.

“Novartis strongly believes in defending the IP rights and patents of all our products and will continue to vigorously defend the validity of our patent on Fanapt.”

Roaxane did not respond to requests to comment.