Considered or not • The Burden Never Changes • Clear and Convincing

Sciele Pharma Inc. v. Lupin Ltd., [2012-1228] (July 2, 2012)[MOORE, Lourie Proust] The Federal Circuit vacated a preliminary injunction against Lupin's launch of a generic version of Fortamet that Sciele alleged Lupin infringed U.S. Patent No. 6,866,866.
DISCUSSION: The '866 patent issued with claims that the Examiner found problematic, and the applicant cancelled.  The district court granted a preliminary injunction, which the Federal Circuit reversed and remanded because the district court didn't even consider obviousness.  On remand the district considered obviousness but since all of the art was considered by the USPTO found that Lupin had not overcome the deference due a qualified government agency presumed to have done its job.  Both parties argued that the burden of proving invalidity was changed by the facts of the case, and the Federal Circuit found that both parties were wrong, and that the burden of proof never changes.  The Federal Circuit noted that "clear and convincing evidence" already reflected the burden of overcoming the presumption of overcoming the deference that is due a qualified government agency presumed to have done its job.  The court said "whether a reference was previously considered by the PTO, the burden of proof is the same: clear and convincing evidence of invalidity.  There is no heightened burden when a reference has been previously considered, and no lessened burden when there is a reference that has not been considered.