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In recent years, the topic of gene patents has generated significant debate among medical researchers, biotechnology companies, academics, policymakers, and patent lawyers. The controversy implicates a wide range of legal and policy questions, including whether human genes should be patentable, and whether such patents stimulate or stifle innovation. In Association for Molecular Pathology v. Myriad Genetics, a high-profile case recently before the United States Court of Appeals for the Federal Circuit, a divided panel of the court addressed these questions. Before reaching the merits of the case, however, the court had to decide whether the plaintiffs had standing to sue the patent owner for declaratory relief. Although scholars and other commentators have discussed at length the substantive issues raised by the Myriad case, little has been said about this crucial procedural question.

This Essay explores the question of standing in the Myriad case, specifically, and in patent declaratory judgment actions more generally. In Myriad, the Federal Circuit concluded that only one of the twenty plaintiffs had standing to sue. While this was sufficient for the case to proceed, this Essay critically examines the Federal Circuit's approach to standing in Myriad. The Essay argues that the court misinterpreted and misapplied Supreme Court precedent, thus adopting a formalistic and overly narrow test for standing. The Essay urges the Supreme Court, if presented with the opportunity, to grant certiorari in Myriad to reconfirm its holding in MedImmune v. Genentech that standing in patent declaratory judgment actions must be analyzed under the all the circumstances test, not according to bright line rules. Finally, the Essay concludes by underscoring the importance of declaratory judgment actions to our patent system. The Supreme Court consistently has adopted legal standards that facilitate patent declaratory relief actions because of the public benefit afforded when bad patents are invalidated. The Federal Circuit, too, should consider its obligation to the public when deciding the justiciability of patent declaratory judgment actions.



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