Tuesday, August 13, 2013

Pfizer, Alkem Settle Suit over Toviaz



Case Filed: Jun 24, 2013

Case Closed: Aug 08, 2013

Court: Illinois Northern District Court

Judge: Joan B. Gottschall

Case Summary:
A patent infringement case was filed by Pfizer and UCB Pharma GmbH against Alkem as a result of their filing an Abbreviated New Drug Application (ANDA) with the FDA concerning their intent to market a generic version of Toviaz®, which is used to treat overactive bladder. The patents-in-suit were:
  • US6858650: “Stable salts of novel derivatives of 3,3-diphenylpropylamines, issued on Feb 22, 2005 and expiring* by Nov 16, 2019
  • US7384980: Derivatives of 3,3-diphenylpropylamines issued on Jun 10, 2008 and expiring* by May 12, 2018
  • US7855230: Derivatives of 3,3-diphenylpropylamines issued on Dec 21, 2010 and expiring* by May 12, 2018
  • US7985772: Derivatives of 3,3-diphenylpropylamines issued on Jul 26, 2011 and expiring* by May 12, 2018
  • US8338478: Derivatives of 3,3-diphenylpropylamine issued on Dec 25, 2012 and expiring* by May 12, 2018
The ‘650, ‘980 and ‘230 patents are currently assigned+ to UCB Pharma GmbH (source: MaxVal’s Assignment Database) and ‘772 and ‘478 patents are assigned to UCB Pharma GmbH as per face page. According to the complaint, Pfizer is the exclusive licensee of the patents. 

Pfizer is the current holder± of the New Drug Application (NDA) no. 022030 for Pfizer’s Toviaz, (source: Patent Marker) for fesoterodine fumarate extended-release tablets, in 4 and 8 mg dosage strengths, that is approved by FDA on Oct 31, 2008.  Plaintiffs alleged that defendant with the Abbreviated New Drug Application (ANDA) No. 20-4827 sought FDA approval to market a generic version of Pfizer’s pharmaceutical product, Toviaz (and/or its use) that is protected by five valid patents that are enforceable.  Pfizer and UCB wanted judgment that Alkem has infringed the patents and an injunction barring Alkem’s products, along with costs, expenses and other reliefs.

It appears that the parties were directed to discuss settlement of the case. Later, plaintiffs filed a notice of voluntary dismissal pursuant to which the Court ordered civil action to be dismissed without prejudice, thereby closing the case.

See case 1:13-cv-04628 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.

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