#hatch-waxman-act

#hatch-waxman-act

The U.S. Supreme Court upheld a broad interpretation of the Hatch-Waxman safe harbor, leaving significant implications for patent law intact.

The Supreme Court's review of Edwards Lifesciences Corp. v. Meril Life Sciences could redefine the Hatch-Waxman Act's safe harbor provision regarding regulatory and commercial activity scope.

Litigation remains a viable strategy for ensuring market exclusivity despite limitations from the Bolar Exemption.

The Federal Circuit's ruling may reshape patent listing practices under Hatch-Waxman, influencing generic drug market access.

The case challenges the suitability of listing device patents in the Orange Book regarding patent claims.

The ruling could define how device patents relate to broader patent strategies for pharmaceuticals.

Hatch-Waxman Act enables patent term extensions to counteract premarket regulatory delays.

The Federal Circuit's decision in Teva v. Amneal could redefine pharmaceutical patent listing requirements under the Hatch-Waxman Act.

The ruling may impact how device patents related to drugs are treated in the FDA's Orange Book.