Case Name: Apotex Inc. v. UCB, Inc., No. 2013-1674, 2014 U.S. App. LEXIS 15670 (Fed. Cir. Aug. 15, 2014) (Circuit Judges Reyna, Wallach, and Hughes presiding; Opinion by Reyna) (Appeal from S.D. Fla., Middlebrooks, J.)
Drug Product and Patent(s)-in-Suit: Univasc® / Uniretic® (moexipril hydrochloride); U.S. Patent No. 6,767,556 (“the ’556 patent”)
Nature of the Case and Issue(s) Presented: Apotex appealed the district court’s finding that the ’556 patent was unenforceable due to inequitable conduct. The ’556 patent describes a method for making moexipril tablets used to treat hypertension. Moexipril, an angiotensin-converting enzyme (“ACE”) inhibitor, is unstable and subject to degradation. The ’556 patent purports to address this problem by reacting moexipril with an alkaline magnesium compound. The district court found that Dr. Bernard Sherman, the sole inventor of the ’556 patent and founder of Apotex, was aware that UCB’s drug Univasc was likely made according to the claimed process but hid that knowledge from the USPTO. Further, the district court found that Dr. Sherman misled an expert to obtain a favorable declaration, withheld key prior art, and submitted the results of experiments that had never, in fact, been performed. The district court had thus found that Dr. Sherman’s acts amounted to material and intentional misconduct, and the Federal Circuit affirmed.
Why UCB Prevailed: The Federal Circuit evaluated whether the district court’s findings relating to materiality and intent were clearly erroneous, and determined they were not. The Federal Circuit found that, first, clear and convincing evidence existed showing Dr. Sherman engaged in material misconduct. Dr. Sherman was an active participant in the prosecution process and wrote the specification of the ’556 patent, omitting key details described in the prior art. The specification also discussed experiments as fact when they had never actually been performed. Further, Dr. Sherman misrepresented the teachings of the prior art in order to overcome the Examiner’s rejections. During its prosecution, the ’556 patent faced three rejections, each premised on the Examiner’s assertion that it would have been obvious to stabilize an ACE inhibitor using the patented method of combining moexipril with an alkaline magnesium compound in light of the prior art. Each time, Dr. Sherman argued that the prior art did not teach a reaction of moexipril and an alkaline magnesium compound, but merely taught combining the two components, without a reaction. As support, Dr. Sherman cited to the Product Monograph and Orange Book listing for Univasc, stating that it consisted of “unreacted but combined” moexipril hydrochloride and magnesium oxide, despite knowing that Univasc was likely manufactured according to the patented process. Additionally, in response to the Examiner’s third rejection, Dr. Sherman submitted the declaration of Dr. Michael Lipp, who stated that the function of a stabilizer is to inhibit reactions and that the stabilizer must be unreacted to perform this function. Thus, a skilled artisan would not have anticipated a reaction to occur between an ACE inhibitor and the alkaline stabilizers disclosed in the prior art. But the Federal Circuit found that Dr. Lipp’s testimony, per Dr. Sherman’s instructions, was limited to documents provided by Apotex; unsurprisingly, these documents would thus have reflected Dr. Sherman’s misrepresentations.
Dr. Sherman’s actions were held to be “but-for material” to the grant of the ’556 patent because it issued only issued after the Examiner was convinced, by Dr. Sherman’s misrepresentations and Dr. Lipp’s declaration, that the prior art taught only “unreacted but combined” compositions. The district court had found that the Examiner would not have allowed the patent to issue had he been aware that Univasc contained moexipril magnesium, an alkaline salt, and was manufactured according to the patented process. The Federal Circuit agreed because Dr. Lipp’s declaration and Dr. Sherman’s misrepresentations were instrumental in swaying the Examiner. Although the Federal Circuit recognized that there is no affirmative duty to disclose suspicions or beliefs about prior art during examination, Dr. Sherman did not advocate a good-faith, reasonable interpretation of the prior art. Instead, he “affirmatively and knowingly misrepresented material facts regarding the prior art.”
Next, the Federal Circuit ruled that there was clear and convincing evidence that Dr. Sherman intended to deceive the USPTO. The court found that during the prosecution of the ’556 patent, Dr. Sherman was aware that his statements about the prior art were at least misleadingly incomplete. Dr. Sherman also drafted the specification, including the details of experiments that he knew had never been performed. Further, Dr. Sherman instructed Apotex’ prosecution counsel to submit an expert declaration based on the same misrepresentations. Apotex stated that Dr. Sherman was simply advocating for his interpretation of the prior art. The Federal Circuit disagreed. The court found that Dr. Sherman did not merely advocate for a particular interpretation of the prior art, but that he had submitted his misrepresentations as if they were fact. Because Dr. Sherman possessed sufficient information to know he was misrepresenting the truth, it was irrelevant that he may have been uncertain of the exact manufacturing process of Univasc or the amount of moexipril magnesium contained in the drug.
