Thursday, December 20, 2012

Merz Pharmaceuticals and Par Pharma



Plaintiff: Merz Pharmaceuticals

Defendant: Par Pharma

Case Number: 1:12-cv-01723

Date Filed: December 17, 2012

Patents-in-Suit: US7638552 and US7816396

Patent Number
Current Assignee[*]
Issued Date
Expiration Date[†]
Title

Dec 29, 2009
Aug 20, 2023
Method for increasing the bioavailability of glycopyrrolate

Oct 19, 2010
Aug 20, 2023
Method for increasing the bioavailability of glycopyrrolate
Table information sourced from Maxval’s Assignment Database

The ‘552 patent describes a method of increasing the bioavailability of glycopyrrolate by administration of a therapeutically effective amount of glycopyrrolate without food. The invention also provides a kit comprising a pharmaceutical composition comprising a therapeutically effective amount of glycopyrrolate and a pharmaceutically acceptable carrier, prescribing information including advice regarding the administration of glycopyrrolate without food to improve bioavailability, and a container.

The ‘396 patent describes a method of treating sialorrhea in a human patient comprising orally administering glycopyrrolate in a liquid solution under fasted conditions.

About the Parties:
Merz is an international healthcare company specializing in the research, development and marketing of pharmaceuticals for the treatment of neurological and psychiatric diseases. 

Par Pharma develops, manufactures and markets generic and branded specialty pharmaceuticals. 

As in Compliant:
Merz is the current holder[‡] of the New Drug Application (NDA) no. 22-571 for Cuvposa® (source: Maxval’s Patent Marker) that is approved by FDA. Cuvposa is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions. The complaint is filed against the defendant for seeking FDA approval with the Abbreviated New Drug Application (ANDA) no. 204438  to market a generic version of Cuvposa® (Par’s Proposed Product) that infringes the above patents.  

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[*]MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[†]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.
[‡]Patent Marker provides an online environment for patentees to virtually mark products and search for patent related information.

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