The US Court of Appeals for the Federal Circuit reversed a finding of non-obviousness, concluding that the district court clearly erred in relying on selective expert testimony, rather than a totality of the evidence, in finding that a skilled artisan would not have been motivated to make the claimed combination. Bayer Pharma AG v. Watson Laboratories, Inc., Case No. 16-2169 (Fed. Cir., Nov. 1, 2017) (Moore, J).

Bayer is the owner of a US patent directed to an oral dissolving tablet (ODT) formulation of the erectile dysfunction (ED) drug vardenafil (Staxyn). Watson filed an abbreviated new drug application seeking US Food and Drug Administration (FDA) approval to market its own generic form of Staxyn. Bayer sued for patent infringement. During the district court proceeding, Watson alleged that the claims were obvious based on several prior art references teaching that ED drugs would be good candidates for ODT formulations. Watson argued that one of ordinary skill in the art would have been motivated to formulate an ODT version of vardenafil based on these prior art disclosures. In response, Bayer argued that the claims at issue were non-obvious, relying on expert testimony and publications showing that ODT formulations were rare and generally inapplicable in the field of ED pharmaceutical technology.

The district court agreed with Bayer, finding the claims non-obvious. The district court’s finding rested largely on the testimony of Bayer’s expert, who testified that Bayer’s competitors had not developed ODT formulations of ED drugs before the patent’s priority date and that a person of skill would not consider ED drugs to be good candidates for ODT formulations. Watson appealed.

The Federal Circuit reversed the district court’s finding of non-obviousness. First, the Court found that the district court clearly erred by selectively considering Bayer’s expert testimony over the totality of evidence supporting Watson’s position, which not only established that ED drugs were viable candidates for ODT formulations but also provided express suggestion to develop such formulations. Second, the Court found that the fact that no ODT versions of ED drugs had been approved by the FDA did “not negate an otherwise apparent motivation to formulate [the patented ODT] product.” Third, the Court found that while the district court was free to find that ODT vardenafil would be less favorable than a delayed-release formulation given its bitter taste and increased bioavailability, the district court erred when it elevated these findings to a teaching away. Instead, the Court found that ODT vardenafil would still have been productive, and absent a showing that the prior art “was somehow so flawed that there was no reason to upgrade it,” the record as a whole did not lead one of ordinary skill in the art away from the patented formulation.   

Practice Note: An expert’s conclusion of non-obviousness is one of many factors that a Court will consider in its factual determination of obviousness. It is important to ensure that an expert addresses the totality of the evidence.