Chugai: Filed patent infringement lawsuit in the United States: Fresenius Kabi USA, LLC
March 23, 2020
Chugai / Roche / Genentech
This is to inform you that the United States District Court for the State of Delaware has filed a patent infringement suit as follows.
1. Litigation filing date
March 19, 2020 (local time in the United States)
2. Cause of lawsuit
Fresenius Kabi USA, LLC has partnered with Fresenius Kabi Oncology Limited / Fresenius SE & Co. KGaA
For our product Alecensa® (generic name: alectinib hydrochloride, antineoplastic agent / ALK inhibitor)
An Abbreviated New Drug Application (ANDA) has been submitted to the US Food and Drug Administration (FDA).
Based on the Drug Price Competition and Patent Term Restoration Act (the so-called Hatch-Waxman Act) in the United States,
Chugai, Roche and Genentech Infringe Fresenius’s filing of ANDA with FDA infringes patents in U.S. Patents (9,126,931, 9,440,922, 9,365,514 and 10,350,214) And filed a patent infringement suit.
3. Litigation partner
(1) Name
Fresenius Kabi USA, LLC and others
(2) Location
United States Illinois 60047 Lake Zurich Three Corporate Drive and others
4. Future outlook
There is no impact on our business results at this time.
News Release | Chugai Pharmaceutical
https://www.chugai-pharm.co.jp/news/detail/20200323100000_959.html