Antitrust Law Daily Wrap Up, FALSE ADVERTISING—DNJ: Generic Drug Maker’s False Marking Counterclaims Dismissed , (Jan 22, 2013)

By Jody Coultas, J.D.

Generic drug manufacturer Novel Laboratories, Inc. could not state Lanham Act and New Jersey unfair competition claims against pharmaceutical company Braintree Laboratories, Inc. for allegedly falsely marking a its colonic purgative formula product with a patent number, according to the federal district court in Trenton, New Jersey (Braintree Laboratories, Inc. v. Novel Laboratories, Inc., January 18, 2013, Sheridan, P.).

Braintree filed a New Drug Application with the Food and Drug Administration for SUPREP Bowel Prep Kit, a reduced volume colonic purgative formulation. The inventors of SUPREP were granted U.S. Patent No. 6,946,149 (the ’149 patent). During the clinical trials, the U.S. Patent and Trademark Office issued a reexamination certificate amending the claims of the ’149 patent. The FDA approved the application for SUPREP and was listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (the Orange Book).

After Novel filed an Abbreviated New Drug Application for a generic version of SUPREP, Braintree filed infringement claims. In its counterclaims, Novel alleged that Braintree violated the Lanham Act, New Jersey Consumer Fraud Act, and the false marking section of the America Invents Act.

The false marking and unfair competition counterclaims were beyond the Hatch-Waxman Act criteria for quick patent dispute adjudication, according to the court. Each of the counterclaims were based on Braintree’s alleged false marking of SUPREP with the ’149 patent and false listing of the ’149 patent in the Orange Book. The Hatch-Waxman Act provides an aggressive trial procedure for patent infringement and invalidity claims. The counterclaims did not comport with those available under the Hatch-Waxman Act for improper listing of a patent in the Orange Book.

Even if the false marking claim fell under the counterclaims available under the Hatch-Waxman Act, the court would have dismissed the claims for failure to prove SUPREP was falsely marked. To state a claim for false marking, Novel needed to show that that Braintree marked an unpatented product and intended to deceive the public. However, the court concluded that SUPREP was covered by the ‘149 patent.

The court also concluded that Novel could not have stated Lanham Act or New Jersey Consumer Fraud Act claims against Braintree. Both statutes required Novel to show that Braintree made commercial statements that were either literally false or true but deceptive. Because the court awarded Braintree summary judgment on its infringement claims, Novel could not prove either element or show that Braintree acted in bad faith.

The case is No. 11-1341 (PGS).

Attorneys: Keith J. Miller (Robinson, Wettre & Miller LLC) for Braintree Laboratories, Inc. Hillel Ira Parness (Robins Kaplan Miller & Ciresi LLP) for Novel Laboratories, Inc.

Companies: Braintree Laboratories, Inc.; Novel Laboratories, Inc.

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