Tuesday, November 12, 2013

Bayer Schering, Sun End Patent Dispute over Yaz Patents

Case Filed: Jan 12, 2011

Case Closed: Nov 05, 2013

Court: Nevada District Court

Judge: Kent J. Dawson

Case Duration: 1028 Days

Case Summary:
A patent infringement suit was brought by Bayer Schering against Sun for violating 3 of their reissue 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 well known for its original brand Aspirin. Bayer is an enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Sun Pharmaceutical, an India-based Company manufactures and markets pharmaceuticals for domestic and international distribution, its portfolio including the areas of diabetes, cardiology, neurology, psychiatry and gastroenterology.

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 and for the 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.

Bayer alleged that Sun submitted to the FDA ANDA No. 20-2318 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 sought judgment that Sun Pharmaceutical has infringed the three patents, an order delaying the release of any approval of Sun’s ANDA product until expiration of the patents, and damages for any commercial activity arising from the infringing drug.

In the year 2011, Bayer filed stipulation of dismissal and stay, which was granted by the Court. Later in the year 2013, Sun filed stipulated/consent judgment pursuant to which Judge granted and ordered:

·        judgment in favor of Sun against Bayer
·        asserted claims of ‘564 patent are invalid
·        all claims and counterclaims w.r.t ’838 and ‘253 are dismissed with prejudice
·        parties are to incur their own costs.

See 2:11-cv-00054 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
* Expected expiration date using 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 for patentees to virtually mark products and search for patent related information.

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