Case Study: Mintz Levin Secures Full Victory for Innovators in Lengthy Hatch-Waxman Battle
On October 10, 2017, the Southern District of New York (SDNY) entered judgment on a decision that closed the door on contentious federal district court Hatch-Waxman litigation that Mintz Levin handled on behalf of innovator pharmaceutical clients Kowa Pharmaceuticals and Nissan Chemical, handing our clients a complete victory on all asserted claims, and protecting their unique cholesterol-lowering medication, Livalo®.
Eight generic drug manufacturers filed Abbreviated New Drug Applications (ANDAs) with the US Food & Drug Administration (FDA) in 2014 and 2015, claiming that certain of our clients’ patents are invalid and/or would not be infringed by the drugs they planned to manufacture. To protect our clients’ interests, Mintz Levin’s team sued each of the generic manufacturers in a series of cases filed in the SDNY beginning in late 2014.
As part of their attack, defendants Mylan and Sawai petitioned for inter partes review (IPR) of one of the two patents before the Patent Trial and Appeal Board (PTAB). The Mintz Levin team successfully defeated those IPRs, resulting in the PTAB denying institution of all three petitions.
Throughout the process, the individual defendants attacked each patent with multiple theories of invalidity and/or non-infringement. The various defendants retained 18 defense experts in an attempt to support their attacks. As a result of Mintz Levin’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 court issued separate decisions on each patent, with our clients prevailing in both decisions.
The first decision, handed down on April 11, 2017, upheld the validity of US Patent No. 5,856,336, which expires on December 25, 2020, and covers the active pharmaceutical ingredient in Livalo®, pitavastatin calcium, and its use for treating elevated cholesterol. The second decision, handed down on September 19, 2017, found that the proposed generic products of one of the remaining defendants would infringe (the other defendant had abandoned its non-infringement position), and upheld the validity of all asserted claims of US Patent No. 8,557,993, which expires on February 2, 2024, and which covers the polymorph of pitavastatin calcium contained in Livalo®.
The Kowa Pharmaceuticals and Nissan Chemical legal team was led by David Conlin and Kathleen Carr, and 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.