clear and convincing standard : CAFC Alert

Presumption of validity attaches to all issued patents, even incorrectly issued patents

Andrew Melick | July 5, 2012

Sciele Pharma Inc. v. Lupin Ltd.

July 2, 2012

Panel: Lourie, Prost, Moore.  Opinion by Moore

Summary

Shionogi (new name for Sciele Pharma) obtained US Patent No. 6,866,866 (“the ‘866 patent”) which included broader claims that were intended to be cancelled in favor of narrower claims in response to a rejection.  Shionogi brought suit against Lupin for infringement of the ‘866 patent including claims that were to be cancelled.  Lupin began selling the alleged infringing product and Shionogi moved for a preliminary injunction.  The District Court granted Shionogi’s request for preliminary injunction and Lupin appealed.  On appeal, the CAFC stated that even though the ‘866 patent issued with the incorrect claims, the ‘866 patent nonetheless had a presumption of validity and that the clear and convincing evidentiary standard applied for invalidating the patent.  The CAFC also stated that there is not a heightened standard just because references were considered by the PTO.  With the proper clear and convincing evidentiary standard applied to the ‘866 patent, the CAFC stated that Lupin has raised a substantial question of invalidity, and thus, the preliminary injunction is vacated.


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