Iovate supplement patent ruled invalid
This article was originally published in The Tan Sheet
Executive SummarySupplements made by Bio-Engineered Supplements & Nutrition Inc. did not infringe a patent on a certain formulation of a ketoacid and an amino acid to enhance muscle performance, a federal appellate court says. Iovate Health Sciences appealed a summary judgment order by a U.S. district court in Texas, which had declared Iovate's patent invalid as anticipated by prior advertising. In a Nov. 19 1decision, the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's decision, finding Iovate's patent on the ketoacid/amino acid supplement anticipated by earlier ads for TwinLab Mass Fuel and Weider's VICTORY Professional Protein products
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.