On April 27, 2011, a case was
filed against Sandoz, a subsidiary of Novartis and generic drug maker for
infringing the Shire Patents.
Patent
Number
Current
Assignee[i]
|
Issue Date
|
Expiration Date
|
Title
|
US5854290
|
Dec 29, 1998
|
Dec 20, 2020
|
Use
of guanfacine in the treatment of behavioral disorders
|
US6287599
|
Sep 11, 2001
|
Dec 20, 2021
|
Sustained release pharmaceutical
dosage forms with minimized pH dependent dissolution profiles
|
US6811794
|
Nov 2, 2004
|
Sep 21, 2015
|
Sustained
release pharmaceutical dosage forms with minimized pH dependent dissolution
profiles
|
Source: MaxVal’s Assignment Database . Shire has the exclusive license to the above patents as stated in
the complaint.
These patents in general covers the FDA approved guanfacine hydrochloride
extended release tablets, Eq. 1 mg Base, Eq. 2 mg Base, Eq. 3 mg Base and Eq. 4
mg Base, which is marketed by Shire under the name of Intuniv® and currently[ii] holds the NDA no. 022037 (source: Patent Marker).
The suit was filed by Shire et al. against Sandoz for seeking FDA approval to
market a generic version of Intuniv (Sandoz Product) (ANDA no. 202568).
The case now turns out to be closed as the parties entered a Settlement Agreement under which Shire granted
Sandoz the license to ‘Shire Patents’. Sandoz admitted that all the claims in
the Shire Patents are valid and enforceable and the sale of Sandoz Product
would constitute infringement of the Shire Patents in the absence of license.
As the parties have agreed to terminate the pending litigation it is ordered
that case is dismissed.
Case Details
Court: Colorado District Court
Judge: Philip A. Brimmer
Other Defendants: Supernus Pharmaceuticals, Amy F.T. Arnsten,
Pasko Rakic and Robert D. Hunt
Closed On: Apr 18, 2013
See case 1:11-cv-01110 for more details. To get alerts on cases filed/closed,
subscribe to our Litigation Alerts.
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[i] MaxVal offers Patent Assignment Alert service where subscribers
receive email alerts when assignments relating to target applications, patents
or entities of interest are recorded.
[ii] Patent Marker provides an online
environment where patentees can virtually mark products and search products for
patent-related information.
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