To whom it may concern
January 8, 2019
Kowa Company, Ltd.,
Nissan Chemical Corporation
News of victory of patent infringement litigation at high court in the United States
regarding Livalo, blood cholesterol lowering drug

Kowa Company Ltd.( Head office: Naka-ku, Nagoya-shi; President and Representative
Director: Yoshihiro Miwa, hereinafter “Kowa”), Kowa Pharmaceuticals America, Inc.( Head
Office: Montgomery, Alabama, CEO & President: Ben Stakely, hereinafter “KPA”) andNissan Chemical Corporation (Head office: Chuo-ku, Tokyo; President and Representative
Director: Kojiro Kinoshita, hereinafter “Nissan Chemical”) announce that in December of
2018, United States Court of Appeals for the Federal Circuit (hereinafter, “CAFC”) issued ajudgement affirming the district court decision, which agreed arguments byplaintiff-appellee (Kowa, KPA and Nissan Chemical) that Amneal Pharmaceuticals LLC, ageneric drug maker, would be infringing the valid patent covering the blood cholesterol
lowering drug (hereinafter, the “patent for crystals,” expiring February 2, 2024), Livalo(non-proprietary name: pitavastatin calcium, hereinafter “Livalo”), and rejected Amneal’s
argument.

Starting in April 2014, Kowa, KPA and Nissan Chemical filed a law suit in U.S. District Court
for the Southern District of New York against Amneal, Apotex Inc. and Apotex Corp
(hereinafter collectively, “Apotex”) and 7 other companies, when these companies filed
ANDA for pitavastatin calcium (1mg, 2mg and 4 mg tablet) to the Food and Drug

Administration (FDA). Kowa, KPA and Nissan Chemical won the case in October 2017,
however, Amneal and Apotex disagreed with the district court decision and appealed to theCAFC.

Kowa, KPA and Nissan Chemical successfully entered settlement agreements with the 7other companies than Amneal and Apotex before the district court decision, and settledwith Apotex after its filing the appeal.

However, Kowa, KPA and Nissan Chemical did notreach an agreement with Amneal and consequently the judgement came out. In theappeal, Amneal pursued only an issue of validity of the patent for crystals.

About Livalo
Livalo is a drug whose active pharmaceutical ingredient is created and manufactured by
Nissan Chemical and its global evolution (development, drug manufacturing, sales andbusiness alliances) is carried out by Kowa.

In the United States, KPA markets under

tradename Livalo Tablet 1mg, Livalo Tablet 2mg, Livalo Tablet 4mg.

Livalo is a HMG-CoA

reductase inhibitor. Livalo is indicated as an adjunctive therapy to diet to reduce elevatedtotal cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),
triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or
mixed dyslipidemia*.

Livalo is prescribed to many patients with dyslipidemia in Japan andoversees.

*For product and prescription information, please see package insert (available at thewebsite)（http://www.kowapharma.com/documents/LIVALO_PI_CURRENT.pdf）

Contact Information for inquiries on the above
Kowa Company Ltd.

Nissan Chemical Corporation

Public Relations Dept.

Corporate Planning Department

Tel: 03-3279-7392

CSR & Public Relations Office
TEL：+81-3-4463-8123
E-mail: csr_pr@nissanchem.co.jp