High Court Sides With Generic Drugmakers In Patent Case.

The Wall Street Journal  (4/18, Kendall, Subscription Publication) reports that the Supreme Court ruled on Tuesday that generic drug companies may file certain legal counterclaims against grand-drug firms as a way to get cheaper drugs to market. In an opinion written by Justice Elena Kagan, the court ruled unanimously that generic-drug makers may challenge the way brand-name drugmakers describe patents to the Food and Drug Administration, thus overturning an appellate court ruling that generic drugmakers cannot bring such legal claims.

        The AP  (4/18) explains, "The Supreme Court says the makers of a name brand drug may have to correct a patent that could hinder the approval of a generic drug." On Tuesday, "the high court on Tuesday agreed with a court decision that forced Novo Nordisk A/S to correct the patent for repaglinide, which is marketed as the diabetes drug Prandin." The AP says that "generic drug maker Caraco Pharmaceutical Laboratories, Ltd., wants to make a generic version" but "Novo had its patent description revised and made broader, which blocks Caraco's generic application."

        "The decision gives generic companies what they say is an important tool to prevent brand-name drugmakers from abusing the Food and Drug Administration approval process to thwart competition," Bloomberg News  (4/18, Stohr) reports. "In a concurring opinion, Justice Sonia Sotomayor called on Congress or the FDA to fix a system that forces generic-drug makers to engage in 'expensive and time-consuming litigation' to challenge an overly broad use code." Additionally, "Sotomayor faulted the FDA for its 'opacity in describing what is required of brand manufacturers' and suggested the agency should evaluate the accuracy of use codes on its own."

        Reuters  (4/18, Frankel) quotes Supreme Court Justice Elena Kagan, who said, "The law, however, was 'not altogether free of ambiguity.'" Kagan wrote, "We think that the 'not any' construction does not appear in the relevant counterclaim provision because Congress did not mean what Novo wishes it had," and added, "And we think that is so because Congress meant (as it usually does) for the provision it enacted to fit within the statutory scheme -- here, by facilitating the approval of non-infringing generic drugs."

        Also covering the story are the San Francisco Chronicle  (4/18, D2, Stohr), Reuters  (4/18, Yukhananov, Vicini), and MedPage Today  (4/18, Gever).