Bayer Pharma AG v. Watson Laboratories, Inc.
In Bayer, the Federal Circuit held that a patent should have been found to be obvious over nine prior art references supporting a motivation to create the claimed invention, notwithstanding expert testimony that the claims were non-obvious.
Bayer is the owner of a patent directed to an oral dissolving tablet formulation of the erectile dysfunction drug vardenafil. Watson filed an abbreviated new drug application seeking approval to market its own generic form of ODT vardenafil. Bayer sued.
Before the district court, Watson presented evidence that vardenafil and ODT formulations of drugs were known in the art. Watson relied on nine prior art references that purported to show ED drugs would be good candidates for ODT formulations, to support its motivation to combine the drug and dosage form. Bayer responded the combination would not have been obvious because no ODT forms of ED drugs previously existed on the market. Bayer also presented expert testimony and two prior art references tending to show that ODTs were not considered particularly applicable to ED drugs. The district court found in favor of Bayer, holding that the record did not contain an indication that ED drugs would be good candidates for ODT formulations. Watson appealed.
The Federal Circuit reversed the district court’s finding of non-obviousness. The district court’s conclusion that ED drugs were not good candidates for ODT formulations was contradicted by Watson’s nine prior art references. While the district court was entitled to credit one expert’s testimony over another, the amount of credit given to Bayer’s expert over the weight of the prior art references relied on by Watson was clearly erroneous.
The district court erred by crediting an expert’s conclusion of non-obviousness over the clear weight of prior art references showing a motivation to combine a known compound in a known formulation.
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