Court Judgment Favors Takeda in Patent Dispute

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.