Hatch-Waxman declaratory judgments

The Drug Price Competition and Patent Term Restoration Act 1984 (commonly referred to as ‘Hatch-Waxman’) attempts to strike a balance between the interests of innovative drug manufacturers and generic manufacturers. As part of this balance, an innovator alerts the public and generic competitors as to which patents it believes cover its Food and Drug Administration (FDA)-approved drug product or methods of the product’s use by listing the patents in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the ‘Orange Book’). While an innovator may list several patents in the Orange Book, it may not assert all patents against the generic manufacturer (eg, if it concludes that the generic’s product does not infringe certain patents). This can lead to uncertainty for generics, since nothing in Hatch-Waxman will stop an innovator from later asserting those same patents against the generic’s product after market launch. As a result, generics often seek a declaratory judgment that an unasserted patent is invalid or not infringed, and recent Supreme Court and Court of Appeals for the Federal Circuit decisions have given more strength and structure to declaratory judgment actions in the area of Hatch-Waxman.

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