Fed Circuit: ‘Safe Harbor’ Provision Is Broad: Amphastar, Momenta Dispute

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A 2–1 final federal appeals court decision that lifts an injunction barring Watson Pharmaceuticals and Amphastar from selling a generic version of Sanofi’s blockbuster blood-thinner Lovenox hinged on an expansive interpretation of Hatch-Waxman’s “safe harbor” provision — a move that could have wide-ranging implications for all patent holders, warns Momenta Pharmaceuticals, which lost its appeal.

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