Wednesday, June 4, 2014

Pfizer Wins Patent Fight against Novel to Block Generic Lyrica

Case Filed: Jan 07, 2011

Case Closed: May 28, 2014

Court: Delaware District Court

Judge: Gregory M. Sleet

Case Summary:
Pfizer filed a patent infringement lawsuit against Novel Laboratories for filing abbreviated new drug application (ANDA) with FDA seeking approval to market a generic version of Pfizer’s pharmaceutical product Lyrica, prior to expiry of U.S. patents covering the drug and its use.

The patents involved in this suit are:
  •        US6197819 entitled ‘Gamma amino butyric acid analogs and optical isomers,’ issued on Mar 06, 2001 and expires* by Mar 06, 2018
  •    US5563175 entitled ‘GABA and L-glutamic acid analogs for antiseizure treatment,’ issued on Oct 10, 1996 and expired* on Oct 03, 2013
  •      RE41920 entitled ‘Isobutylgaba and its derivatives for the treatment of pain,’ issued on Nov 09, 2010 and expires* by Jul 16, 2017

The ‘819 and ‘920 patents are currently+ assigned to Northwestern University and Warner-Lambert (source: MaxVal’s Assignment Database.)

The patents relate to compounds that are analogs of glutamic acid and gamma-aminobutyric acid (GABA). The analogs are useful as antiseizure therapy for central nervous system disorders such as epilepsy, Huntington's chorea, cerebral ischemia, Parkinson's disease, tardive dyskinesia and spasticity.

As in Complaint:
Pfizer and Northwestern received a notice letter stating that Novel had submitted ANDA no. 202269 and the patents-in-suit are invalid, unenforceable, or will not be infringed by the commercial manufacture of the Novel’s ANDA product.

Novel’s Counterclaim:
Novel asserted counterclaims, including declaratory judgment of non-infringement and invalidity of the '819, '175 and '920 patents and for a declaration of unenforceability of the '819 and '920 patents’ term extensions.

Lyrica NDA:
Pfizer currently± holds approved new drug application (NDA) no. 22-488  approved by FDA for a pregabalin oral solution containing 20mg/mL of pregabalin (source: Patent Marker). The patents-in-suit are listed in the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” with respect to Lyrica.

District Court Proceedings:
On July 2012, the court concluded that the asserted claims of the '819, '175 and '920 patents are not invalid and the '819 and '920 patents’ term extensions are not invalid and defendants' proposed products infringe claims 1 and 4 of the '819 patent. Accordingly judgment was entered in favor of Pfizer. The judgment was appealed (2012-1576) and the federal court affirmed that claim 2 of the '819 patent is infringed and not invalid and affirmed the judgment of the district court. In Mar 2013, district court entered a stipulated order staying the action pending final disposition of appeal.

The stay is now removed and Novel is enjoined from commercially manufacturing of their proposed ANDA product, prior to Dec 30, 20I8. The claims and counterclaims are dismissed with no costs imposed on parties.

See 1:11-cv-00027 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

Max-Insight enables you to access all of our patent tools such as Patent Term Estimator, Patent Family Tree, Has This Patent Been Litigated, etc. in one location. Max-Insight is available in 4 different subscriptions: FreeBronzeSilver and Gold with varying usage levels. To learn more about Max-Insight, click here.

* 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.

No comments:

Post a Comment