Hatch-Waxman Safe Harbor Murky After High Court Rejection

Law360, New York (January 14, 2013, 10:09 PM EST) -- The U.S. Supreme Court decided Monday to not hear a case over the scope of the Hatch-Waxman Act safe harbor that protects allegedly infringing conduct involving pharmaceutical patents, leaving uncertain whether the law applies to activities that take place after a drug receives government approval, attorneys say.

The safe harbor holds that otherwise-infringing conduct is legal if it is done under the requirements of federal drug laws. The justices rejected GlaxoSmithKline PLC's appeal of a Federal Circuit decision that the provision applies only to activities that...
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