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.

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[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.