Thursday, November 14, 2013

Patent Litigation Resolved between Otsuka and Teva

Case Filed: Mar 31, 2008      
Case Closed: Nov 07, 2013

Court: New Jersey District Court

Judge: Mary L. Cooper

Case Duration: 2047 Days

Case Summary:
Tokyo based pharmaceutical company Otsuka filed a patent infringement lawsuit against Teva USA and its parent company Teva Pharmaceuticals over the antipsychotic drug Abilify. The case was filed for Teva filing Abbreviated New Drug Application (ANDA) no. 90-251 for oral solution containing 1 mg/mL of aripiprazole, seeking FDA approval to manufacture a generic version of the drug.

Otsuka currently holds[i] the new drug application (NDA) no. 02-1713 and 02-1436 for aripiprazole oral solution which was approved by FDA on Nov 15, 2002 and Dec 10, 2004 and is sold under the trade name Abilify (source: Patent Marker). It is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder and also used to treat irritability and symptoms of aggression.

The complaint stated that Teva has infringed the patents by submitting ANDA No. 90-251 before the expiration date of the patents-in-suit covering the medication. The patent US5006528 entitled ‘Carbostyril derivatives’ issued on Apr 09, 1991 and expiring by Oct 20, 2014 is one among the patents-in-suit. The other is the US6977257 patent entitled ‘aripiprazole oral solution’, which was issued on Dec 20, 2005 and expiring[ii] by Apr 24, 2022. Both the patents are assigned[iii] to Otsuka (source: MaxVal’s Assignment Database).

Otsuka asked the court to enter judgment that Teva has infringed the ‘528 and ‘257 patents by submitting the NDA at issue, an injunction barring Teva from making, importing or selling the proposed generic products until after the ‘528 patent’s expiration, and award Otsuka its attorneys’ fees and costs.

It appears that the parties have settled the case and agreed stipulation was filed, pursuant to which the Court granted dismissal without prejudice and the parties will incur their own costs and expenses. 

See 3:08-cv-01583 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
* Expected expiration date using Patent Term Estimator, use our free tool or download our free Android app on Google Play Store.

[i] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.
[ii] 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
[iii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

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