Case Filed: Apr 05, 2010
Case Closed: May 07, 2013
Judge: Joel A. Pisano
Court: New Jersey District Court
Other Plaintiff: Ethypharm
Other Defendant: Cadila
Healthcare
Case Summary:
Takeda accused Zydus of
infringing 3 US patents for lansoprazole by filling an abbreviated new drug
application with the U.S. Food and Drug Administration. The patents involved in
this suit are:
US5464632 - Rapidly disintegratable
multiparticular tablet, issued on Feb 20, 2001 and expires[*]
by Feb 20, 2018
US6328994 - Orally disintegrable tablets, issued on Dec 11, 2001
and expires* by May 18,
2018
US7431942 - Orally disintegrable tablets, issued on Oct 07, 2008
and expires* by May 18,
2018
Takeda is the current assignee[†]
(source: MaxVal’s Assignment
Database) of the ‘994 and ‘942 patents. The ‘632 patent is owned by
Ethypharm and Takeda is the exclusive licensee.
Takeda is the current holder[‡]
of New Drug Application (NDA) No. 21-428 for 15 and 30 mg lansoprazole delayed
release orally disintegrating tablets (source: Patent Marker), which
was approved by FDA on Aug 30, 2002. Plaintiff Takeda America sells under the
name Prevacid® SoluTab™. It is used to treat and prevent stomach and intestinal
ulcers and other conditions involving excessive stomach acid such as
Zollinger-Ellison syndrome. Zydus has filed Abbreviated New Drug Application
(ANDA) No. 200-816 seeking FDA approval for lansoprazole delayed release orally
disintegrating tablets.
The case has been concluded and
is now closed. The court ordered
- Judgment in favor of Takeda against Zydus on Takeda’s claim of infringement of claim 1 of the ‘994 patent.
- The effective date of FDA approval of Zydus’s ANDA shall be no earlier than the date of expiration for ‘994 patent.
- Zydus is enjoined from engaging in the commercializing the ANDA product until expiration of the ‘994 patent.
See 3:10-cv-01723 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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[*] Expected expiration date. Patent Term
Estimator is a free
web-based tool that automatically calculates patent terms and expiration dates
for U.S. utility patents
[†] MaxVal offers Patent Assignment Alert service where subscribers
receive email alerts when assignments relating to target applications, patents
or entities of interest are recorded.
[‡] Patent Marker provides an online
environment where patentees can virtually mark products and search products for
patent-related information.