Opinion ID: 211331
Heading Depth: 2
Heading Rank: 3

Heading: Intent to Deceive the PTO

Text: Even if an omission is found to be material, the omission must also be found to have been made with the intent to deceive. “Materiality does not presume intent, which is a separate and essential component of inequitable conduct.” GFI, Inc. v. Franklin, Corp., 265 F.3d 1268, 1274 (Fed. Cir. 2001) (quoting Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 552 (Fed. Cir. 1990)). To find an intent to deceive, “the involved conduct, viewed in light of all the evidence, including evidence of good faith, must indicate sufficient culpability to require a finding of intent to deceive.” Paragon Podiatry Lab., Inc. v. KLM Labs., Inc., 984 F.2d 1182, 1189 (Fed. Cir. 1993) (quoting Kingsdown Med. Consultants Ltd. v. Hollister, Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc)). “Intent need not be shown by direct evidence, but may be inferred from the totality of the evidence.” Digital Control, 437 F.3d at 1319. However, “[i]n the summary judgment context, all inferences must be made in favor of the nonmovant; thus, it is often improper to determine at summary judgment that a patentee made intentional misstatements or omissions to the PTO.” Id. at 1317. On summary judgment, to create a genuine issue of material fact, Aventis was required to state specific facts supporting a plausible justification or excuse for its failure to disclose material information. Paragon Podiatry, 984 F.2d at 1191. Here, the district court did not find direct evidence of intent to deceive, but found that the “facts and circumstances surrounding the failure to disclose the dose differential 05-1513 10 . . . supports a strong inference of intent by Aventis to deceive the PTO.” Aventis Opinion, 390 F. Supp. 2d at 951-52. Aventis contends that the district court erred in finding an intent to deceive on summary judgment by denying Dr. Uzan an opportunity to testify in person, ignoring evidence negating intent, misconstruing deposition testimony, and drawing factual inferences adverse to Aventis. Because Aventis has met its burden of setting forth a plausible justification for its failure to disclose material information, deciding all inferences in favor of Aventis, we hold that the district court erred in finding intent to deceive on summary judgment. For example, the district court found it irrelevant whether comparison at different doses was reasonable. Id. at 951. On appeal, Teva also advocates this position, arguing that the relevant inquiry is whether there was an intent to deceive in failing to disclose the 60 mg dosage amount of the prior art product. We disagree. The reasonableness of the comparison between different dosages is relevant to determining whether the failure to disclose that the comparison was made using 60 mg EP 40,144 data was made with an intent to deceive. Because there exist genuine issues of material fact as to the reasonableness of the comparisons made by Aventis,3 we must draw an inference for purposes of summary judgment that it was reasonable to compare the 40 mg Debrie half-life with the 60 mg EP 40,144 half-life. Accepting that inference, the district court was required to determine whether Aventis still intended to deceive by withholding the dosages at which the comparisons were made. 3 For example, Aventis argues the comparison was reasonable because: 1) it reflects the preferred dosage level for therapeutic reasons; 2) the 60 mg dosage level was not preferred because it caused bleeding in some patients; and 3) the 40 mg dosage level was more reliable because it had been confirmed in a separate study. 05-1513 11 Aventis maintains that Dr. Uzan had a reasonable belief that he informed the examiner that his half-life comparison was made at different doses and that he could not have intended to deceive because he disclosed the data based on 60 mg. Aventis further explains that Dr. Uzan had no reason to make a prospective statement about what would be possible using a lower dose based on a comparison at the same dose, because he could and did directly make that point by comparing the 60 mg EP 40,144 LMWH data against the 40 mg Debrie LMWH data. Aventis also points out that the district court did not even reference, let alone draw reasonable inferences from the fact that Dr. Uzan submitted the half-life data for 60 mg of Debrie LMWH, which would allow the examiner to compare the data from equal doses. Although the district court did not reference all of Aventis’s arguments, it ultimately concluded that the facts supported a strong inference of intent to deceive. The district court’s inference was reasonable—by failing to disclose that the EP 40,144 data was at a 60 mg dose, Aventis may have been painting the rosiest picture possible as to the half-life improvement of its claimed compounds in an attempt to deceive the examiner.4 Appellees contend that this is only reasonable inference to draw from the facts presented. However, there is another reasonable inference—namely, as Aventis argues, if the comparison between different doses was reasonable, the failure to disclose may have been due purely to inadvertence. Based on the facts presented by Aventis, these are not “insupportable, [or] specious . . . explanations or excuses.” Paragon Podiatry, 4 Even the disclosure of the 60 mg Debrie data might ultimately militate a finding of intent to deceive because it implies that Dr. Uzan was aware that the 60 mg data was relevant to the comparison, but did not specifically tell the examiner why. 05-1513 12 984 F.2d at 1190. Neither are Aventis’s contentions merely “[c]onclusory allegations and attorney arguments.” Ferring v. Barr, 437 F.3d 1181, 1193 (Fed. Cir. 2006). Aventis presents declarations from the inventor, the declarant, and an expert witness stating facts supporting a “plausible justification” for its material omission. Paragon Podiatry, 984 F.2d at 1191. Therefore, a finding of intent was inappropriate on summary judgment.