Hatch-Waxman Safe Harbor's Scope Likely Headed To High Court

Law360, New York (August 10, 2012, 4:44 PM EDT) -- The U.S. Supreme Court is likely to have the final say on how broadly the Hatch-Waxman Act's safe harbor provision applies, given sharp disagreement among Federal Circuit judges in two recent decisions on the issue, attorneys say.

The Federal Circuit ruled Aug. 3 in Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc. that the safe harbor provision can apply to activities carried out after a drug wins government approval. Under this safe harbor, sale or manufacture of a drug that would otherwise be infringing is deemed not...
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