Sunday, April 28, 2013

Sandoz and Shire Enter a Settlement Agreement

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
Dec 29, 1998
Dec 20, 2020
Use of guanfacine in the treatment of behavioral disorders
Sep 11, 2001
Dec 20, 2021
Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
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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