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Archived updates for Wednesday, August 17, 2005

Inventors' Incorrect Claim Construction Shows Lack of Deceptive Intent for Unenforcability

In Warner-Lambert Company, et al. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. August 11, 2005), the court affirmed denial of summary judgment of unenforceability based upon the inventor's lack of intent to deceive. In this case, the court noted that Claim 16, at least on its face, appeared to read on much of the Vasotec® formulation:

However, after hearing all the evidence and, specifically, the testimony of Dr. Murthy and Dr. Harris, the trial court concluded that the inventors acted with subjective good faith in not disclosing Vasotec®. The court found that they did not disclose Vasotec® because, at the time of filing for the ’450 patent, they simply did not think it had any relevance to their application. In other words, they did not appreciate its materiality. See Molins, 48 F.3d at 1178 (holding that the patentee must be aware of both the reference and its materiality).

They knew Vasotec® contained sodium bicarbonate, but they did not know how sodium bicarbonate functioned in Vasotec® or that the "alkali or alkaline earth metal carbonate" recited in claim 16 included bicarbonate. Bench Trial Opinion, 2004 WL 1498162, at *11-12 (finding Dr. Murthy and Dr. Harris "completely credible" witnesses). We cannot say that the district court committed clear error in assessing the credibility of these witnesses and finding an absence of deceitful intent.

Teva argues that, even assuming the Warner-Lambert scientists did not know how to stabilize Vasotec®, the patentees still committed inequitable conduct because claims 16 and 17 nevertheless read on Vasotec®. This, according to Teva, is because the claims simply require "contacting" an ACE inhibitor with a metal carbonate and a saccharide. Teva also points out that the originally filed claims were not limited to carbonates, but merely referred to "alkali and alkaline earth metal salts," and that this court’s decision in Schwarz Pharma construed "carbonate" to include "bicarbonate."

The problem with this argument is that the district court, after hearing testimony and making credibility determinations, found that the Warner-Lambert scientists did not use sodium bicarbonate for anything other than adjusting the pH of quinapril during the stage one investigations, and that their subsequent failure to disclose Vasotec® was the result of their good-faith belief that Vasotec® did not relate to their claimed invention. Id. at *12.

Dr. Murthy specifically testified to the fact that he did not think claims 16 or 17 included sodium bicarbonate:

Because I took ["[a] suitable amount of an alkali or alkaline earth metal salt"] to mean mostly carbonates because those are the ones that worked. There was no bicarbonate that has worked for us in our efforts to stabilize the product, so we did not have any bicarbonate in mind.
. . . .
We do not--we did not have in mind sodium bicarbonate, otherwise we would have been very specific about it. Because our experiments with sodium bicarbonate did not help us in the stabilizing of quinapril. So we didn’t --at least I did not have in mind sodium bicarbonate and to prevent cyclization of quinapril.

In short, based on the testimony presented at trial, the court concluded that the Warner-Lambert inventors were concerned only with carbonate ions, had no intention of claiming bicarbonates, and consequently had no intent to deceive the PTO in not disclosing Vasotec®. Id.

In keeping within our role as an appellate court of review, we cannot say that the district court committed clear error in making these findings. See Anderson v. Bessemer City, 470 U.S. 564, 575 (1985) ("[W]hen a trial judge’s finding is based on his decision to credit the testimony of one of two or more witnesses, each of whom has told a coherent and facially plausible story that is not contradicted by extrinsic evidence, that finding, if not internally inconsistent, can virtually never be clear error."); LNP Eng’g Plastics, Inc. v. Miller Waste, Inc., 275 F.3d 1347, 1361 (Fed. Cir. 2001) ("[T]he district court’s determination on intent in this case depends heavily on the assessment of witness testimony at trial. This court may not reassess, and indeed is incapable of reassessing, witness credibility and motive issues on review.").

. . . [T]he district court’s findings do not suggest that the patentees were "intimately familiar" with Vasotec® or knew of its potential relevance to the PTO. On the contrary, the evidence, particularly with respect to Warner-Lambert’s abandonment of Vasotec® after the failed pH studies, suggests that the patentees had only limited familiarity with the Vasotec® formulation. This is not surprising considering that Merck maintained its sodium bicarbonate stabilization process as a trade secret. Perhaps most importantly though, unlike the situation in Critikon, Warner-Lambert, through Dr. Murthy and Dr. Harris, offered a plausible, good faith explanation for why Vasotec® was not cited to the PTO. Accordingly, given the district court’s view of the evidence, we do not think the facts of this case necessarily require a finding of intent to deceive.

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