On Sep 20, 2017, District court of New York issued decision upholding the validity of Livalo® (Pitavastatin) patent & found Amneal, Apotex infringing the Japanese drugmaker Kowa Co. Ltd’s patent.
Kowa Co Ltd holds NDA for Livalo (Pitavastatin) tablet which was approved by USFDA on Aug 03, 2009. Orange book currently lists 4 patents. Kowa filed lawsuit against many ANDA filers in Apr 2014.
While eight PIV cases were filed in defense of this product, only two ANDA applicants (Amneal and Apotex) completed trial which ended in Feb2017. In this case, the Court issued an Opinion concerning one patent (US5,856,336) which Amneal argued was invalid due to obviousness-type double patenting. As such, the District Court concluded that the ‘336 patent is valid. While no Final Judgment was entered, there is a second patent where Amneal and Apotex concluded trial over the US8,557,993 patent. New York federal judge delivered the verdict that Kowa’s patent US ‘993 was valid and that the defendants failed to show it was anticipated or obvious.