The doctrines of patent exhaustion, or first sale, and of patent misuse are generally considered only affirmative defenses to patent infringement claims. However, under MedImmune, Inc. v. Genentech, Inc. , 549 U.S. 118 (2007), where patent misuse caused or threatened injury to an entity, that entity may assert misuse as an independent claim. Moreover, several recent precedents indicate that patent exhaustion or first sale may also be affirmative claims.
MedImmune, which had been paying royalties under a license agreement, sought declaratory judgment that the patent was invalid and unenforceable so that no royalties are due. Genentech answered that there was no case or controversy because MedImmune was paying royalties, had therefore not infringed Genentech’s patents, and Genentech was not threatening suit. The Supreme Court held that a declaratory judgment action was proper, and MedImmune “was not required, insofar as Article III is concerned, to break or terminate its 1997 license agreement before seeking a declaratory judgment in federal court that the underlying patent is invalid, unenforceable, or not infringed.” The crucial factors are whether the dispute is “definite and concrete, touching the legal relations of parties having adverse interests” and “real and substantial,” such that it will permit “specific relief through a decree of a conclusive character.“
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