Hatch-Waxman Victory for Kowa Pharmaceuticals and Nissan Chemical

Industry: Life Sciences

Key Facts

Nine generic drug manufacturers filed ANDAs with the FDA.
Mintz sued the manufacturers in the Southern District of New York.
In two separate decisions, SDNY upheld the validity of all claims in both patents.

Nine generic drug manufacturers filed Abbreviated New Drug Applications (ANDA) with the US Food & Drug Administration (FDA) claiming that two of our clients’ patents are invalid and therefore not enforceable. If approved the ANDAs would threaten the exclusive rights of our clients to use the innovations protected by the patents on which the cholesterol drug Livalo® depends. At the request of our clients we sued the generic manufacturers in a series of cases filed in late 2014 and early 2015 in the Southern District of New York.

As part of their defense strategy, Mylan and Sawai petitioned for inter partes review (IPR) of numerous claims in the two patents at the Patent Trial and Appeal Board (PTAB). The Mintz team successfully defended those IPRs, resulting in the PTAB denying institution of all three petitions on every claim, a relatively rare result in a very challenging venue in which the majority of filed IPR petitions result in institution on at least one claim.

Throughout the process, the individual defendants attacked each patent with their own sets 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 the firm'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 a decision on each patent separately, five months apart.

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. The September 19 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®.

Amneal appealed the decision to the Court of Appeals for the Federal Circuit. Oral argument was held on Thursday, December 6, 2018, and the court issued a per curiam decision on Monday, December 10, affirming the lower court decision.