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Generic Drugs Not Misbranded Under Lanham Act, Seventh Circuit Rules

 

A recent decision by the Seventh Circuit caught the notice of our Illinois trademark infringement litigators. Schering-Plough Healthcare Products Inc. v. Schwarz Pharma, Inc. et al, Nos. 09-1438, 09-1462, 09-1601 (7th Cir. Oct. 29, 2009) is a dispute between the original maker of a laxative whose patent has expired and the companies that now manufacture a generic version. Schering, the original patent holder, sued four companies for claiming that the drug’s active ingredient is not available over the counter, when Schering does manufacture an over-the-counter version. The trial court in the case dismissed Schering’s complaint, a decision the Seventh Circuit upholds here.

The laxative in question was originally sold as the prescription drug MiraLAX. After its patent expired, the four defendants were authorized to sell generic prescription versions, either as GlycoLax or under the chemical name polyethylene glycol 3350. All four defendants’ drugs have labels stating that the active ingredients in their drugs are sold only by prescription. This is a requirement of the federal Food, Drug and Cosmetics Act, but it is no longer entirely true. After the generic versions were approved, Schering won approval for an over-the-counter version of MiraLAX. It brought a trademark lawsuit against the defendants, claiming their labeling makes false and misleading statements that misrepresent the nature of their own and Schering’s products, and constitute misbranding under the FD&C Act.

Importantly, the FDA is conducting its own investigation into whether the generic drugs are now misbranded. Simultaneous sales of the same active ingredient in generic and over-the-counter versions violates federal law, which the FDA is also trying to resolve. The Seventh Circuit noted that the FDA may resolve Schering’s lawsuit by finding that the generic drugs may no longer be sold, or that their labels are not false and misleading under the FD&C Act. In either case, the court wrote, it would rather defer that decision to the FDA. This was also the decision of the trial court in the case, which dismissed Schering’s case without prejudice, suggesting that the company re-file after the FDA’s decision, if necessary. Schering appealed, asking for a judgment in its favor rather than a trial. The defendants cross-appealed, arguing that the case should have been dismissed with prejudice.

The Seventh started by noting that a dismissal without prejudice is appealable unless the defect leading to it is immediately curable. It then turned to the merits of Schering’s claim. Letters from FDA regulators the company cited are irrelevant, the court said, because they did not determine the final outcome of the agency’s review. It also dismissed Schering’s argument that the generic drugs were misbranded under the FD&C Act because their labels say “prescription only,” noting that prescription drugs are required to carry this warning. And it noted that federal courts have previously resolved conflicts between FDA labeling requirements and intellectual property law, including in SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharmaceuticals, Inc., 211 F.3d 21 (2d Cir. 2000).

Schering has been “coy” about what kind of labeling it would find sufficient on the generic drugs, the court wrote, leaving suggested wording out of its briefs entirely and agreeing with suggested wording only under pressure at oral arguments. That reticence, the court wrote, made it believe this is not a matter that “can be resolved intelligently without a decision by the FDA.” Because it has more experience with how consumers interact with drug labeling, the court said, the FDA should decide on proper labeling before a Lanham Act claim is filed. Thus, the Seventh Circuit upheld the trial court’s decision to dismiss Schering’s claim in anticipation of the FDA’s ruling. For the same reason, however, it also upheld the district court’s decision to dismiss without prejudice — so Schering can re-file its claim, if necessary, in the future.


DiTommaso Lubin Austermuehle has more than 20 years of experience helping businesses of all sizes in commercial litigation, including Lanham Act claims and trade libel or product disparagement claims. Our Chicago trademark infringement attorneys represent businesses seeking to stop unfair trademark infringement or false statements by a competitor, as well as those defending themselves against trademark infringement lawsuits. We are proud of our strong record of results in trademark cases, which includes wins against corporations and in cases involving international law. Based in Chicago and Oak Brook, Ill., near Naperville, Wheaton and Aurora we practice in state and federal courts in Illinois, Indiana, Wisconsin and around the United States.

If your business is caught up in make-or-break trademark litigation, you should speak to the experienced Aurora, Ill. trademark lawyers at DiTommaso Lubin Austermuehle today. To set up a consultation, you can call us toll-free at 1-877-990-4990 or contact us online.