Court Issues Judgment Favoring Insite Vision against Sandoz in Patent Dispute

Case Filed: May 26, 2011

Case Closed: Oct 04, 2013

Court: New Jersey District Court

Judge: Mary L. Cooper

Case Summary:

Insite Vision, Inspire and Pfizer jointly filed a patent infringement suit against Sandoz claiming that 5 of their patents were infringed. The cause of the suit was Sandoz’s filing of an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market a generic version of the pharmaceutical product AzaSite® before the expiration of Plaintiffs' five patents covering AzaSite® and its use. The patents involved in suit were:

•      US6159458 entitled ‘Sustained release ophthalmic compositions containing water soluble medicaments’ issued on Dec 12, 2000 and expiring* by Nov 04, 2017
•         US6861411 entitled ‘Method of treating eye infections with azithromycin’ issued on Mar 01, 2005 and expiring* by Nov 25, 2018
•         US6239113, US6569443 and US7056893 entitled ‘Topical treatment or prevention of ocular infections’, issued on May 29, 2001, May 27, 2003, Jun 06, 2006 and expiring* by Mar 31, 2019

The ‘458 and ‘893 patents are currently assigned+ to Insite Vision and ‘113 and ‘443 patents are currently assigned+ to Bausch & Lomb (source: MaxVal’s Assignment Database). As per complaint the ‘411 patent is assigned to Pfizer.  

The Court document says, InSite received notice on April 18, 2011 regarding the ANDA filing from Sandoz and stated it has 45 days to file a patent infringement lawsuit and the suit was filed within the timeframe.

Inspire currently holds± an approved New Drug Application (NDA) no. 50-810 for azithromycin ophthalmic solution 1% sterile topical ophthalmic drops, which are sold by Inspire under the trade name AzaSite® (source: Patent Marker). AzaSite is an antibiotic eye-drop medication used to treat an infection of the eye called bacterial conjunctivitis. Plaintiffs wanted judgment that Sandoz has infringed the patents and an injunction barring Sandoz’s products until expiration of the patents, along with fees, costs and expenses.

The Court rendered its final verdict ordering a judgment in favor of plaintiffs against defendant w.r.t

•         claims 3 and 5 of ‘411 patent
•         claims 6, 7, 8 and 9 of ‘113 patent
•         claims 16 and 44 of ‘443 patent
•         claims 4, 6, 7, 9, 10, 11, 12, 30, 36 and 40 of ‘893 patent
•         all counterclaims be dismissed with prejudice
•        enjoinment from commercial manufacture of generic version until the expiration date of the patents.

See 3:11-cv-03080 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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* 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.

+ MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded. 

± Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.