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,
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*
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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