Told you that generic risk was a possibility! FU Novartis and Nikos.
Novartis Sues Noven To Block Generic Dementia Patch
Law360, New York (April 03, 2013, 6:49 PM ET) -- Novartis AG slapped Hisamitsu Pharmaceutical Co. Inc. and subsidiary Noven Pharmaceuticals Inc. with a lawsuit in Delaware on Wednesday, claiming Noven infringed two patents by seeking U.S. regulatory approval for a generic version of Novartis' dementia-treating Exelon patch.
Novartis and patent co-owner LTS Lohmann Therapie-Systeme AG's complaint against Japan-based Hisamitsu and two Noven units asked the court for injunctive relief as well as an order declaring that U.S. Food and Drug Administration approval of Noven's proposed rivastigmine transdermal system can't come before the plaintiffs' rights under the two patents-in-suit expire.
Novartis Pharmaceuticals Corp., also a plaintiff, holds an approved new drug application for the Exelon patch, which contains the active ingredient rivastigmine and is indicated for the treatment of mild to moderate dementia associated with Alzheimer’s and Parkinson's diseases, said the complaint.
Noven filed an abbreviated new drug application seeking a green light to make and sell its generic rivastigmine products in two dosage strengths, and included a certification stating that the two asserted patents either were invalid or would not be infringed by the proposed generics, the plaintiffs said.
“On information and belief, when Noven filed its ANDA, it was aware of the ... patents and that the filing of its ANDA with the request for its approval prior to the expiration of the ... patents was an act of infringement,” the complaint claimed.
This isn't the first time Novartis and LTS have turned to litigation to protect the market for Exelon patches, which first won U.S. regulatory approval in 2007. Just last month they filed a suit targeting generic-drug maker Alvogen Group Inc. in the same court over the same two patents, as well as another complaint against Actavis Inc. and Watson Pharmaceuticals Inc.
Novartis sold $428 million worth of Exelon in the U.S. in 2012, and more than $1 billion worth of Exelon worldwide, according to the company's 2012 annual report.
Wednesday's complaint said Noven is looking to make generic Exelon patches in 4.6 milligram and 9.5 milligram dosage strengths before the expiration of the patents-in-suit. The commercial manufacture of the proposed generics will involve direct infringement of both patents, the plaintiffs warned.
At issue are U.S. Patent Numbers 6,316,023 and 6,335,031 — both co-owned by Novartis and LTS.
A spokesman for Noven Pharmaceuticals was not immediately available for comment Wednesday.
A U.S.-based representative for Novartis could also not be immediately reached.
Novartis and LTS are represented in the suit filed Wednesday by Daniel Silver and Michael Kelly of McCarter & English LLP and Nicholas Kallas and Filko Progo of Fitzpatrick Cella Harper & Scinto.
The case is Novartis Pharmaceuticals Corporation et al v. Noven Pharmaceuticals Inc. et al., case number 1:13-cv-00527 in the U.S. District Court for the District of Delaware.
