Infringing Present Activity Needed For Declaratory Judgment
Client Alert | 1 min read | 07.23.07
In Benitec v Nucleonics (July 20, 2007) a Federal Circuit panel affirms a district court’s dismissal of Nucleonics’ counterclaims for lack of jurisdiction under the Declaratory Judgment Act. Benitec brought suit for patent infringement against Nucleonics for activities directed to developing and submitting information to the U.S. Food and Drug Administration (“FDA”) for eventually filing of a new drug application. Nucleonics filed counterclaims seeking a declaratory judgment for invalidity and unenforceability. Subsequently, the Supreme Court decided Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), which read expansively on the statutory “pharmaceutical research exception.” Benitec moved to dismiss its complaint without prejudice on the basis that Nucleonics activities in the aftermath of Merck no longer constituted patent infringement. Nonetheless, Nucleonics sought a declaratory judgment on its counterclaims. The district court granted Benitec’s motion, but dismissed Nucleonics’ counterclaims for lack of jurisdiction.
Citing the Supreme Court’s recent decision in MedImmune, the Federal Circuit panel states that the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. In addition, the panel states that the case or controversy must be present at all stages of the litigation. Finding that Nucleonics failed to meet its burden of showing that it was presently engaged in any activity that could subject it to a claim of infringement by Benitec, or that its future plans met the immediacy and reality requirement of MedImmune that is necessary to support a justiciable controversy, the panel affirms the District court’s decision.
Insights
Client Alert | 7 min read | 06.26.26
Federal Roundup: Updates for PBMs and Medicare Advantage Organizations
In June 2026, federal regulators and lawmakers continued their efforts to improve drug affordability through targeted reforms. These recent developments will primarily impact pharmaceutical manufacturers, managed care organizations, and pharmacy benefit managers (PBM) serving Medicare Part D program members. PBMs, Medicare Advantage organizations, and Part D sponsors should monitor these changes in the interest of maintaining compliance and providing input on regulatory proposals that may influence their business operations or compensation structures in the future.
Client Alert | 4 min read | 06.25.26
Twin Executive Orders Seek to Spur Quantum Leap in Technology and Cybersecurity
Client Alert | 7 min read | 06.24.26
Client Alert | 3 min read | 06.24.26
