Sunday, April 13, 2014

Endo Overcomes Mylan in Patent Infringement Case over Frova Generic Drug

Case Filed: Aug 16, 2011

Case Closed: Apr 08, 2014

Judge: Renee Marie Bumb

Case Summary:
Endo, Pennsylvania based pharmaceuticals sued to stop Mylan from marketing a generic copy of Frova before three patents on the migraine drug expire. The complaint was filed in district Court of Delaware. The patents involved in the suit were:
  •         US5464864 entitled ‘Use of tetrahydrocarbazone derivatives as 5HT.sub.1 receptor agonists’ issued in 1995 and expired[i] on Nov 07, 2012
  •         US5637611 entitled ‘Medicaments’ issued in 1997 and expirei by Jun 10, 2014
  •         US5827871 entitled ‘Medicaments 1,2,3,4-tetrahydrocarbazoles and 5-HT.sub.1 agonist use thereof’ issued in 1998 and expirei by Oct 27, 2015

The patents are currently assigned[ii] to Endo (source: MaxVal’s Assignment Database).

In the complaint, Endo alleged that Mylan has infringed and/or will infringe three of the patents in connection with Mylan’s submission of abbreviated new drug application (ANDA) no. 202931 seeking approval of the U.S. Food & Drug Administration (FDA) to market its generic ANDA product prior to the expiration of the patents in suit.

Endo claimed that it received notice from Mylan of an abbreviated new drug application for a version of the drug’s 2.5 milligram tablets and asked court to bar Mylan from infringing the patents covering the drug Frova.  

Vernalis submitted to the FDA NDA 21-006, which the FDA approved in Nov 2001 for Frova oral tablets and Endo is the current holder[iii] of the NDA (source: Patent Marker). As per the court records, Vernalis licensed the U.S. rights to Endo in 2004 and ultimately assigned the patents-in-suit to Endo in 2011. Endo commercially markets Frova, which is indicated for the acute treatment of migraine attacks in adults According to Endo, Frova reached net sales of 615.1 million and is considered one of their biggest sellers.

The other named defendant in the suit was Matrix Laboratories due to Endo’s allegations that Matrix accompanied Mylan in the submission of ANDA. However, Matrix was terminated from the suit in Oct 2011.

During the prosecution, Mylan maintained the patents in suit to be invalid due to obviousness, written description and enablement at a bench trial held from Nov 12 - 21, 2013. Later, the Court came to a conclusion and accordingly, entered judgment against Mylan and in favor of Endo ordering:
  •         claims related to the ‘611 and ‘871 patents as dismissed with prejudice     the ‘864 patent as valid
  •         defendant’s proposed marketing of the generic product infringes, induces infringement and/or will constitute contributory infringement of the ‘864 patent
  •        Endo’s request for attorneys’ fees and costs is denied.

See 1:11-cv-00717 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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

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