Tuesday, May 13, 2014

Lupin, Teva and Others Win Judgment over Anti-Inflammatory Drug

Case Filed: May 05, 2013

Case Closed: May 08, 2014

Court: Virginia Eastern District Court

Judge: Arenda L. Wright Allen

Case Summary:

G.D. Searle and Pfizer jointly filed a suit alleging patent infringement of U.S RES44048 by defendants Lupin, Teva, Mylan, Watson and Apotex. The lawsuit concerned filing of abbreviated new drug applications (ANDAs) with the U.S Food and Drug Administration (FDA) seeking approvals to market generic versions of Pfizer's Celebrex® drug product to treat rheumatoid arthritis and osteoarthritis, prior to expiration of the '048 patent and related period of exclusivity.


The patent involved in this suit is: RE44048 entitled ‘4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-YL]benzenesulfonamide for the treatment of inflammation or an inflammation-associated disorder,’ duly issued to G.D. Searle on May 05, 2013 and expired[i] on Nov 30, 2013. The patent describes a class of pyrazolyl benzenesulfonamide compounds, compositions and methods for treating inflammation and inflammation-associated disorders.

As in complaint:

Pfizer filed this suit on the day the patent office issued the '048 patent and has a pediatric exclusivity that expires by Dec 02, 2015. Defendants intend to market generic versions of Pfizer's Celebrex® drug product beginning on or about May 30, 2014, which is prior to the expiration of the '048 patent. One or more claims of the '048 patent cover use of the pyrazolyl benzenesulfonamide compounds disclosed to treat each of the indications in Pfizer's Celebrex® label.

Defendants’ notice letters referring to the ANDAs (nos. 202240, 76-898, 78-857, 200562 and 204197) stated the claims 1-17 of the patent-in-suit as invalid, unenforceable and/or will not be infringed by the commercial manufacture of their ANDA products.

The complaint stated that the act of infringement will cause plaintiffs to suffer irreparable harm (even in case of later judicial determination) and sought preliminary injunction to prevent irreparable and irreversible harm.

ANDA holder:

G.D. Searle currently holds[ii] an approved new drug application, no. 20-998, for celecoxib capsules, 50, 100, 200and 400mg dosage strengths, which it sells under the registered name Celebrex® (source: Patent Marker). As stated in Pfizer's FDA approved label for Celebrex®, the drug is indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea.

Final Judgment:

The Court found that the '048 patent is invalid for obviousness-type double patenting. Accordingly, the Court granted in part the Joint Motion for Summary Judgment filed by defendants and denied plaintiffs' Motion for Summary Judgment. In line with court’s opinion and order, final judgment was entered in favor of defendants.


The case has now been appealed by G.D. Searle and Pfizer on May 09 challenging court’s decision favoring Lupin, Teva, Mylan, Watson and Apotex.

See 2:13-cv-00121 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] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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