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March 30, 2007

Actual Controversy

Generic drug maker Teva took on Novartis for its Famvir® herpes drug by filing an ANDA with the FDA. Teva figured facing five patents, but Novartis only sued for infringing one. So Teva sought declaratory judgment "to obtain patent certainty" on the other four. The district court dismissed, but, in light of the Supreme Court MedImmune ruling last November, and the CAFC's Sandisk ruling a few days ago, the CAFC (06-1181) remanded, telling the district court to take the case. Any "actual controversy" now lays the tarmac for takeoff of a declaratory judgment filing.

In concurring opinion, Judge Friedman put the last nail in the coffin of the old, higher standard, required for seeking declaratory judgment.

In these unusual circumstances, where the Supreme Court went out of its way to state its disagreement with our “reasonable apprehension of imminent suit” test, which was not an issue in the case before it, it appears incumbent on us to stop using that test and hereafter to apply the general declaratory judgment standards that the Supreme Court applied in Medimmune.

Posted by Patent Hawk at March 30, 2007 11:50 AM | Declaratory Judgment

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