Florida Breckenridge, Inc. v. Solvay Pharmaceuticals

Florida Breckenridge, Inc. (plaintiff) manufactured and marketed a menopause hormone drug, Menogen, claiming it was the generic equivalent of Estratest, which was manufactured by Solvay Pharmaceuticals (defendant). Neither Breckenridge nor Solvay had obtained Food and Drug Administration (FDA) approval to market its drug though each erroneously claimed different numerous exemptions under the Drug Efficacy Study Implementation (DESI) program and GRASE-exemption. Solvay notified Breckenridge that it believed that Menogen infringed Estratest’s trade dress and falsely advertised that Menogen was the generic equivalent of Estratest. Breckenridge filed suit for a declaratory judgment that their marketing of Menogen did not infringe Estratest’s trade dress or constitute false advertising under the Lanham Act, a federal law that provides a claim against a competitor for false advertising when it may result in consumer confusion. Solvay counterclaimed for trade-dress infringement and false advertising under the Lanham Act. After discovery, the district court granted summary judgment for Breckenridge on both claims after finding no likelihood of confusion and that a lesser standard of equivalence applied because both drugs were allowed on the market without FDA approval. Solvay appealed, and when the FDA filed an amicus curiae brief contending that neither drug was legally on the market and the appellate court asked the parties to submit supplemental briefs addressing whether Lanham-Act relief is available for drugs sold in violation of FDA rules and regulations, Solvay moved to dismiss the appeal and Breckenridge did not oppose the motion.