Monday, December 3, 2012

Bayer Pharma sues Lupin

On Wednesday, November 28, 2012, Bayer (plaintiff) lodged a complaint on Lupin (defendant) in the U.S. District Court of Delaware (case no. 1:12-cv-01592) for seeking FDA approval to market a generic version of the drug Natazia®. 

Bayer is a German chemical and pharmaceutical company well known for its original brand of Aspririn. Bayer is an enterprise with core competencies in the fields of health care, nutrition and high-tech materials.  Lupin is a manufacturer of the anti-TB drugs based in Mumbai, Maharashtra, India. The company production lines include the cardiovascular (prils and statins), diabetology, asthma, pediatrics, CNS, GI domains, apart from anti-infectives and NSAIDs.

The patent involved in this suit US8071577 is currently assigned[*] to Bayer Pharma (source: MaxVal’s Assignment Database). The patent entitled was issued on June 12, 2011 and expires[†] by April 15, 2025. 

Bayer is the current holder[‡] of New Drug Application (NDA) no. 022252 for Natazia® (source: Maxval’s Patent Marker) that is approved by FDA as a birth control pill. Its active ingredients are estradiol valerate and dienogest. According to the complaint, defendant with the Abbreviated New Drug Application (ANDA) no. 203307 is looking for FDA approval to market a generic version of Bayer’s Natazia® tablets that infringe the ‘577 patent. 

Bayer, in 2012 has filed suit against Watson Pharmaceuticals and the details are as below:
Case Number
Date Filed
Dismissed without prejudice (closed on 25 Sep 2012)
If you are interested in knowing more about the cases filed by Bayer, please contact us.

For more details, visit MaxVal-IP and subscribe to our Litigation Alerts.

[*]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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