Shionogi and Nostrum Enter Settlement Agreement

Case Filed: Jul 13, 2012

Case Closed: May 03, 2013

Judge: Robert B. Kugler

Court: New Jersey District Court

Case Summary:

Shionogi and Andrx Corporation accused Nostrum of infringing two patents for Fortamet® by filing an abbreviated new drug application with the U.S. Food and Drug Administration. Shionogi is the exclusive licensee of the patents. These patents are currently assigned[i] to/owned by Andrx Corp (source: MaxVal’s Assignment Database).

The patents numbers involved in the suit are US6099859 entitled “Controlled Release Oral Tablet Having a Unitary Core,” was issued in Aug 2000 and US6866866, entitled “Controlled Release Metformin Compositions,” was issued in Mar 2005 and neither of these patents is close to expiration. (To calculate the expiration[ii] date of patents, please visit our free tool: Patent Term Estimator). 

Andrx is the current holder[iii] of New Drug Application (NDA) No. 21-574 for which the FDA granted approval for 500 mg and 1000 mg extended-release metformin hydrochloride tablets (source: MaxVal’s Patent Marker). Shionogi markets these tablets under the trade name “Fortamet®. Nostrum has filed Abbreviated New Drug Application (ANDA) No. 203-832 seeking FDA approval to sell 500 mg and 1000 mg extended-release metformin hydrochloride tablets.

Shionogi's New Jersey federal court complaint said Nostrum sent a letter in May notifying the company that it had sought approval to market the drug prior to the expiration of Shionogi's patents, which describe metformin hydrochloride tablets designed to lower blood glucose to improve glycemic control in adults with Type 2 diabetes mellitus.

The case is now concluded with the parties having settled the litigation and entered a License Agreement which allows the entry of generic version of Fortamet® before the expiration of the patents. The Judge ordered that all claims and counterclaims be dismissed with prejudice. 

See case 1:12-cv-04402 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts. 

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[i] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

[ii] 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

[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.