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FDAnews Drug Daily Bulletin
Sept. 6, 2012 | Vol. 9 No. 175
High Court Likely to Keep ‘Safe Harbor’ Broad, Aiding Generics, Biosimilars
The country’s highest court is likely to mull Hatch-Waxman’s safe-harbor provision now that the U.S. Court of Appeals for the Federal Circuit has issued contradictory rulings on when the law allows drugmakers to use others’ patents without fear of infringement. And all indications point to the Supreme Court keeping the safe harbor broad, a legal expert says. This decision would be a win for generic and biosimilars makers, which could see their industries stunted if the court finds the safe harbor provision only applies during the premarket approval phase.
Washington Drug Letter
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