Mintz has secured a string of substantial victories in Hatch-Waxman litigation for innovative drug manufacturers Kowa Pharmaceutical Co., Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries Ltd. The team, led by Intellectual Property Members David Conlin and Kathleen Carr, engaged in hard-fought litigation against eight different generic manufacturers in a series of litigations and inter partes reviews relating to a unique statin called Livalo^®. The Southern District of New York handed down the second of two decisions in the litigations on September 19, 2017, closing the final chapter in the matters which date back to 2014 and 2015.

Throughout the process, the individual defendants attacked each patent with its own set of theories of invalidity and/or non-infringement, and the defendants retained 18 defense experts in an attempt to support their attacks. As a result of Mintz’s efforts, several defendants settled the litigation before trial, and another settled after trial. Three defendants, Amneal, Apotex and Lupin, remained in the litigation for trial, necessitating a 10-day trial in January 2017. 

The first decision, handed down on April 11, 2017, upheld the validity of U.S. Patent No. 5,856,336, which expires on December 25, 2020, and which covers the pharmaceutical product and its use for treating elevated cholesterol. This week’s decision upheld the validity and infringement of U.S. Patent No. 8,557,993, which expires on February 2, 2024, and which covers the polymorph of pitavastatin calcium contained in Livalo^®.

During the pendency of the litigation, Nissan Chemical also defeated three IPRs, one filed by Mylan and the other two filed by Sawai – both of which were defendants in the litigation. In an era when the majority of IPR petitions are instituted, Mintz was able to defeat all three IPRs.

In addition to Mr. Conlin and Ms. Carr, the Kowa Pharmaceuticals and Nissan Chemical legal team included Intellectual Property Members Adam Samansky, Thomas Wintner, John Bauer, and Kevin Ainsworth, Counsel Peter Cuomo, Jennifer Dereka, and Sharon O'Brien, Associates Joseph Rutkowski, Richard Maidman and Megan Yung, and paralegal Vicki Francis.