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

Patent Attorney David FazzolareBy: 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 Pharmaceutical’s and denied GlaxoSmithKline’s petition for certiorari of the Federal Circuit’s decision in Classen v. GlaxoSmithKine. Whereas the Federal Circuit panel sitting en banc in Classen held that the safe harbor applies only to pre-approval activities, a different panel of the Federal Circuit sitting en banc more recently held in Momenta that the safe harbor applies to certain post-approval activities, such as quality control batch testing to comply with FDA regulations. The safe harbor is codified in 35 U.S.C. 271(e) (1), which provides that “it shall not be an act of infringement to make, use, offer to sell or sell … a patented invention … solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.”

The Supreme Court’s refusal to grant certiorari in the Momenta case arguably means that the High Court is willing to accept that certain post-approval activities are protected under the safe harbor. The Court’s failure to opine on the issue, however, leaves interested stakeholders wondering exactly what types of post-approval activities are protected under the safe harbor. Given the divergence of opinions held by existing Federal Circuit justices, and the unresolved conflict between the Momenta and GlaxoSmithKline holdings, the Supreme Court will likely have another opportunity to clarify the types of post-approval activities that are protected under the safe harbor. In the meantime, industry stakeholders contemplating conducting post-approval activities that might infringe a patent would be well-advised to avoid extending the safe harbor beyond the facts of Momenta until the Supreme Court confirms that the safe harbor has indeed become a safe ocean.

To learn more about this topic, please contact David Fazzolare.

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