Thursday, February 27, 2014

USCA Dismisses Teva, Alcon IP Suit over Vigamox

Case Filed: Dec 02, 2009

Case Closed: Feb 25, 2014

Origin Case: 1:06-cv-00234

Case Closed: Oct 20, 2009

Case Summary:
Bayer Healthcare and Alcon Pharmaceuticals filed a patent infringement suit against Teva Pharmaceuticals USA, Inc. in Delaware District Court on Apr 05, 2006, in response to Teva filing an abbreviated new drug application to block their planned generic version of Vigamox.

Plaintiffs claim that a Teva abbreviated new drug application infringes the patents covering Vigamox, an antibiotic used to treat bacterial infections of the eye. Teva notified Alcon in a letter that it planned to make its own version, according to the suit. "Alcon will suffer irreparable injury unless Teva is enjoined from infringing the patents," the complaint said.

The U.S. Food and Drug Administration granted approval in 2003 to sell a solution that contains moxifloxacin hydrochloride, which is marketed in the U.S. as Vigamox, according to the complaint. Alcon is the current holder1 of the NDA for Vigamox (source: Patent Maker). The ANDA, which Teva filed, sought FDA approval to manufacture a drug (eye solution) with the same active ingredient before the patent expires, the suit says.

The suit sought a judgment of infringement, a court order postponing the effective date of the Teva ANDA until after the patents-in-suit expire, a permanent injunction, treble damages, attorneys' fees and court costs.

The patents-in-suit are:
  •         US5607942 entitled ‘7-(1-pyrrolidinyl)-3-quinolone- and - naphthyridone-carboxylic acid derivatives as antibacterial agents and feed additives’, issued on Mar 04, 1997 and expiring2  by Mar 04, 2014
  •         US4990517 entitled ‘7-(1-pyrrolidinyl)-3-quinolone- and - naphthyridone-carboxylic acid derivatives as antibacterial agents and feed additives’, issued on Feb 05, 1991 and expired2  on Jul 15, 2008
  •         US6716830 entitled ‘Ophthalmic antibiotic compositions containing moxifloxacin’, issued on Apr 06, 2004 and expiring2 by Sep 22, 2020

The patents are currently assigned3 to Bayer Healthcare and Alcon (source: MaxVal’s Assignment Database).
In Oct 2009, Judge Sue L. Robinson signed off judgment in favor of Alcon against Teva, ruling that Teva's proposed generic Vigamox infringed the patent US6716830. Due to the court order preventing Teva from obtaining FDA approval for its version until 2020, Teva filed an appeal notice to the United States Court of Appeals for the Federal Circuit on October 20, 2009. In Feb 2014, Teva and Alcon together filed a motion to terminate appeal through dismissal. Considering the joint motion filed, USCA granted the motion and ordered the appeal be dismissed.
See 2010-1097 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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1 Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.
2 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. 
3 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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