Generic-Drug Makers Win at High Court on Brand-Name Patents
Source: Bloomberg
The U.S. Supreme Court boosted generic-drug makers in seeking federal approval for treatments, saying they can argue in court that their brand-name rivals overstated the reach of their patents in regulatory filings.
The justices today unanimously sided with Caraco Pharmaceutical Laboratories Inc., a generic-drug company trying to sell a lower-cost version of Novo Nordisk AS’s Prandin diabetes drug.
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. It overturns a lower-court ruling that a 2010 Morgan Stanley research report said would have let brand-name companies delay generic versions of select drugs.
Detroit-based Caraco and its Mumbai-based parent company, Sun Pharmaceutical Industries Ltd. (SUNP), contend that Novo improperly extended its monopoly over Prandin until 2018 by misrepresenting to the FDA the reach of one of its patents. Novo is based in Bagsvaerd, Denmark.
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