High Court Sides With Generic Drug Makers

The U.S. Supreme Court ruled last week that generic drug companies should be allowed to challenge the way brand-name manufacturers describe their patents to FDA. In a unanimous decision, the justices said Caraco Pharmaceutical Laboratories, a unit of India’s Sun Pharmaceutical Industries, may take legal action to force Denmark’s Novo Nordisk to narrow the description of its patent for repaglinide. This compound is marketed as the diabetes drug Prandin. Caraco had argued that Novo’s patent was too broad and therefore prevented any generics competition. The justices agreed, overturning an earlier ruling by the U.S. Court of Appeals for the Federal Circuit. Justice Elena Kagan, who wrote the high court’s opinion, noted that FDA requires brand-name manufacturers to submit “use codes,” which describe the scope of their patents. The agency doesn’t verify the accuracy of companies’ submissions. But Kagan said generics manufacturers may use a provision in the Hatch-Waxman Act “to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using the drug in question.” The Generic Pharmaceutical Association, an industry group, calls the ruling a win for generics competition and consumers.