Showing posts with label Bayer. Show all posts
Showing posts with label Bayer. Show all posts

Tuesday, December 3, 2013

Bayer, Lupin Lawsuit over Yaz Patents Ends

Case Filed: Jul 15, 2010

Case Closed: Nov 27, 2013

Case Duration: 1231 Days

Court: Nevada District Court

Judge: Kent J. Dawson

Case Summary:

A patent infringement suit was filed by Bayer Schering against Lupin for violating 3 of their patents. The patents involved in the suit are:
  •         RE37564 issued on Feb 26, 2002
  •         RE37838 issued on Sep 10, 2002
  •         RE38253 issued on Sep 16, 2003
All the patents entitled ‘Composition for contraception’ were legally issued to Jurgen Spona, Bernd Dusterberg and Frank Ludicke and expire[i] by Dec 22, 2013. Bayer Schering is the current assignee[ii] of the patents (source: MaxVal’s Assignment Database). The patents in general relate to the use of estrogen and gestagens for oral contraception and a corresponding pack containing this combination preparation.

Bayer is a German chemical and pharmaceutical company with core competencies in the fields of health care, nutrition and high-tech materials. Lupin Pharmaceuticals, an India based company, engages in the development and manufacture of branded and generic pharmaceutical products.

Bayer alleged that Lupin submitted to the FDA ANDA No. 20-1661 seeking approval to engage in the commercial manufacture of a generic version of Bayer’s Yaz® tablets, which infringe three of their patents covering the medication.

Bayer is the current holder[iii] of approved New Drug Application (NDA) No. 21-676 for Yaz® tablets (source: Patent Marker), which contain micronized drospirenone and 17α-ethinylestradiol as active ingredients. The United States Food and Drug Administration (FDA) approved Yaz® tablets for the prevention of pregnancy in women, for treatment of moderate acne and symptoms of premenstrual dysphoric disorder in women who elect to use an oral contraceptive.  Bayer sells YAZ® tablets in the United States as a 28-day oral contraceptive regimen that contains 24 tablets comprising 3 mg of micronized drospirenone and 0.02 mg of micronized 17α-ethinylestradiol plus 4 placebo tablets.

On October 16, 2013 the parties filed a joint status report in response to the Court’s order. The parties notified the Court that Bayer would not seek further review of the Federal Circuit’s judgment rendered in favor of defendants and advised the Court that the action can be closed, thereby concluding the litigation.

See 2:10-cv-01166 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

Patent Term Estimator, use our free tool or download our free Android app on Google Play Store.





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

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
Status
04/25/2012
Pending
02/13/2012
Pending
02/10/2012
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.