In BayerPharma AG v. Watson Laboratories, Inc., [2016-2169] (November 1, 2017), the Federal Circuit reversed the district court’s holding that claims 9 and 11 of U.S. Patent No. 8,613,950 would not have been obvious.

The district court rejected each of Watson’s arguments.  It found a person of ordinary skill in the art would not have been motivated to create an orally disintegrating tablet (“ODT”) formulation of vardenafil and would not have used mannitol and sorbitol as excipients.  It found the prior art taught away from formulating vardenafil ODT as immediate-release.  The district court also addressed Bayer’s objective evidence of nonobviousness and found it supported its conclusion that Watson failed to prove by clear and convincing evidence that claims 9 and 11 would have been obvious.

The district court determined that Watson failed to meet its burden of proving by clear and convincing evidence that there would have been a motivation to formulate vardenafil as an ODT formulation largely on the court’s finding the testimony of Bayer’s expert, Dr. Wicks, more persuasive than the testimony of Watson’s expert, Dr. Jacobs.  The Federal Circuit said that the clear error in the district court fact finding that there was no motivation to formulate ED drugs in ODTs, is that it concluded that the record did not contain an indication that ED drugs would be good candidates for ODT formulations.  The Federal Circuit noted that the district court’s opinion did not discuss any of the references that Watson cited to show that ED drugs would be good candidates for ODT formulations.

It is well within the district court’s discretion to credit one expert’s competing testimony over another.  The Federal Circuit said it must give due regard to the trial court’s opportunity to judge the witnesses’ credibility.  However, a district court cannot, through a credibility determination, ignore the wealth of evidence, especially as in this case where the expert did not even address it.

The Federal Circuit also faulted the district court’s focus on the fact that no ODT ED drug had gained FDA approval as of ’950 patent’s priority date.  The Federal Circuit said that  the motivation to combine inquiry is not limited to what products are forthcoming or currently available on the market.  The Federal Circuit said that any motivation, “whether articulated in the references themselves or supported by evidence of the knowledge of a skilled artisan, is sufficient.

The Federal Circuit was left with the definite and firm conviction that the district court clearly erred when it found there would not have been a motivation to formulate vardenafil ODT.

The district court also found a person of ordinary skill in the art would not have been motivated to use mannitol and sorbitol in an ODT formulation, again finding Dr. Wicks’ testimony on this limitation more credible than Dr. Jacobs’.  The Federal Circuit did not question the district court’s credibility determinations.  However, the district court’s analysis for the sorbitol and mannitol limitation focused on the commercial availability of products while failing to address relevant prior art.  Upon consideration of the entire record and under a proper analysis, they concluded that the district court clearly erred in finding a person of ordinary skill in the art would not have been motivated to formulate an ODT with sorbitol and mannitol.

Finally, the Federal Circuit rejected the district court’s determination that vardenafil’s expected bitter taste taught away from an oral formulation.  The Federal Circuit noted that a reference teaches away when it suggests that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant.  The Federal Circuit said that the district court did not find that a person of ordinary skill in the art would have believed vardenafil’s expected bitter taste and increased bioavailability would have likely rendered an immediate-release formulation unproductive, but instead focused on whether a person of ordinary skill in the art would have pursued other alternatives.  The Federal Circuit said that the teaching away inquiry does not focus on whether a person of ordinary skill in the art would have merely favored one disclosed option over another disclosed option.  In assessing whether prior art teaches away, that better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes.

Weighing all four Graham factors, the Federal Circuit concluded that claims 9 and 11 of the ’950 patent would have been obvious.  The repeated suggestion in the prior art to make an ODT formulation of an ED drug and the suggestion to use the combination of sorbitol and mannitol as excipients were strong evidence of a motivation to make the claimed combination.