Pfizer brings Patent Infringement Suit against Wockhardt to Block Generic Version of Lyrica

Plaintiffs: Pfizer, Inc., Northwestern University, Warner-Lambert Company LLC, PF Prism CV

Defendants: Wockhardt Limited, Wockhardt USA, LLC 

Case Number: 1:13-cv-00143

Date Filed: January 25, 2013

Court: Delaware District Court

Patent-in-Suit: US6197819

The patent US6197819 involved in this suit is currently assigned[*] to Northwestern University (source: Maxval’s Assignment Database). The patent entitled Gamma Amino Butyric Acid Analogs and Optical Isomers was issued on March 06, 2001 and expires[†] on March 06, 2018. The patent describes compound of the formula ##STR1## wherein R.sub.1 is a straight or branched alkyl group having from 1 to 6 carbon atoms, phenyl, or cycloalkyl having from 3 to 6 carbon atoms; R.sub.2 is hydrogen or methyl; and R.sub.3 is hydrogen, methyl or carboxyl; which is useful in the treatment of seizure disorders. 

The Parties:

Pfizer is a research-based, global biopharmaceutical company. The company's diversified global healthcare portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products.

Northwestern University (NU) is a private research university.

Warner-Lambert Company LLC operates in three segments: pharmaceutical products, consumer health care products, and confectionery products. It operates as a subsidiary of Pfizer Inc.

Wockhardt is a pharmaceutical and biotechnology company engaged in the pharmaceutical business. The Company together with its subsidiaries is engaged in the business of manufacture and marketing of pharmaceutical products.

As in complaint:

Defendant with the Abbreviated New Drug Application (ANDA) No. 204258 seeks approval of FDA to generic version of Pfizer’s pharmaceutical product Lyrica®, a pregabalin oral solution containing 20 mg/ml of pregabalin, which is covered by the patent-in-suit. 

Pfizer (PF Prism) is the current holder[‡] of the New Drug Application (NDA) no. 22488 for Lyrica, (source: Patent Marker) (see Fig. 1) with active ingredient as pregabalin that is approved by FDA on January 04, 2010. Lyrica is used to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles. It is also indicated to treat partial onset seizures in adults with epilepsy who take 1 or more drugs for seizures.

 Other Case(s) Filed:

Pfizer has filed nearly 150 cases and a few are listed below:

Defendants	Case Number	Date Filed	Status
Roxane Laboratories	2:12-cv-00593	07/03/2012	Closed
Mylan Pharmaceuticals	1:12-cv-00106	06/26/2012	Closed
Sandoz	3:12-cv-03880	06/25/2012	Closed
Watson Laboratories	0:12-cv-61268	06/26/2012	Closed
Anchen Pharmaceuticals	2:12-cv-05535	06/26/2012	Closed
Zydus Pharmaceuticals	1:12-cv-00818	06/22/2012	Pending
Wockhardt	1:12-cv-00817	06/22/2012	Pending

Table information sourced from Maxval’s Litigation Database. 

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[*] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

[†] 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.

[‡] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.