Horizon Pharma and SkyePharma have filed a patent infringement lawsuit against Watson Laboratories (WLF) and certain related companies like Actavis Pharma, Andrx and Actavis Inc.
The lawsuit was filed in the US District Court for the District of New Jersey regarding an ANDA that WLF filed with the US FDA to market generic versions of RAYOS containing 1mg, 2mg and 5mg of prednisone.
According to the lawsuit, the US patent numbers, 6,488,960, 6,677,326, 8,168,218, 8,309,124 and 8,394,407 that were listed in the FDA's Orange Book with the latest expiration 7 January 2028 were under the infringement.
However, WLF claimed that its generic versions of RAYOS would not infringe the US patents of Horizon nor the patents are invalid or unenforceable.
Horizon has commenced the lawsuit within 45 days required to automatically stay, or bar, the FDA from approving WLF's ANDA for 30 months or until a district court decision that is adverse to the subject patents, whichever may occur earlier.