Case Filed: Aug 31, 2012
Case Closed: Sep 04, 2013
Court: Delaware District Court
Judge: Richard G. Andrews
Case Summary:
GlaxoSmithKline (GSK) filed a
patent infringement suit against Apotex concerning its filing of abbreviated
new drug application with FDA with its intent to commercialize a generic
version of Avodart. The patent involved in suit was US5565467, entitled
‘Androstenone derivative’, issued on Oct 15, 1996 and expires[i]
by Oct 15, 2013. Smithkline Beecham Corporation is the current assignee[ii]
of the patent (source: MaxVal’s Assignment
Database).
GSK alleged that Apotex’s
abbreviated new drug application (ANDA) no. 204292, to manufacture generic
Avodart capsules, filed with the FDA had infringed the ‘467 patent covering the
drug. GSK currently holds[iii]
New Drug Application (NDA) no. 21-3199 (source: MaxVal’s Patent Marker),
approved by FDA on Nov 2001 for dutasteride capsules, which it sells under the
trade name Avodart ®. The capsules are used for the treatment of symptomatic
benign prostatic hyperplasia (BPH)--essentially, enlargement of the prostate
gland. GSK wanted judgment that Apotex has infringed the patent and an
injunction barring Apotex’s products until expiration of the patent, along with
costs and expenses.
Initially, the case was stayed as
the parties requested a stay due to pending entry of judgment in another case
11-46-RGA, by Apotex Inc. against GlaxoSmithKline LLC. Later, the stay was
removed as Judgment has been entered in 11-46-RGA. In Sep, GSK filed a stipulation and proposed order, considering which Court
granted the same and ordered the case to be administratively closed.
See 1:12-cv-01090 for more details. To get alerts on cases
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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.
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