Novartis sues three over generic Zometa

Swiss pharmaceutical firm Novartis has filed a lawsuit against Accord Healthcare, Fresenius Kabi and Hikma Farmaceutica for applying to market generic versions of its cancer drug Zometa.

In a complaint filed at the US District Court for New Jersey on Friday, April 12, Novartis has accused the drugs makers of infringing its US patent for Zometa by seeking approval to market competing generics before the patent's expiry date.

Zometa is a zoledronic acid medicine used to treat high levels of calcium in the blood caused by cancer. According to Novartis, US sales of Zometa were more than $1.4 billion in 2011.

Three of Novartis’s patents covering its uses of zoledronic acid expired in March this year, but the company claims Accord, Fresenius and Hikma’s generics will infringe a patent  filed in 2006 and granted in December last year for a method of delivering a 4mg dose of the drug over a 15 minute period.

Novartis is seeking a declaration of infringement and an injunction blocking US sales of the generics until its patent expires.

Novartis has also been battling against attempts to market generic Zometa by Actavis, Apotex and Sun Pharmaceuticals, and agreed a settlement in 2010 allowing Teva to launch its generic zoledronic acid treatment in the US this year. Teva has also been granted approval to market generic Zometa in Europe.