SCOTUS Fails to Clear the Murky Hatch-Waxman Act Safe Harbor Waters

By: David Fazzolare Uncertainty over the extent to which the Hatch-Waxman Act’s safe harbor applies to post-approval activities remains as the Supreme Court declined to grant certiorari in two prominent cases involving the safe harbor this year. In particular, the Court both denied Momenta’s petition for certiorari of the Federal Circuit’s decision in Momenta v. Amphastar …

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The Biologics Price Competition and Innovation Act of 2009 May Fail to Sufficiently Incentivize Development of Biosimilars

By: David A. Fazzolare The Biologics Price Competition and Innovation Act of 2009 (the “Biosimilars Act”) was enacted in 2010 as part of the Patient Protection and Affordable Care Act. The Biosimilars Act gives biosimilar manufacturers an abbreviated market approval pathway akin to the abbreviated approval pathway for generic drugs under the Hatch-Waxman Act. I …

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