{"id":1668,"date":"2017-07-28T11:48:07","date_gmt":"2017-07-28T15:48:07","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=1668"},"modified":"2017-07-28T11:48:07","modified_gmt":"2017-07-28T15:48:07","slug":"karmas-a-sanction-for-litigation-misconduct-results-in-finding-of-intent-to-deceive-the-uspto","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=1668","title":{"rendered":"Karma’s a ^$#*! – Sanction for Litigation Misconduct Results in Finding of Intent to Deceive the USPTO"},"content":{"rendered":"

In\u00a0Regeneron Pharmaceuticals, Inc. v. Merus N.V.<\/a>, [2016-1346] (July 27, 2017), the Federal Circuit affirmed final judgment that \u00a0U.S. Patent No. 8,502,018 (which related to using large DNA\u00a0vectors to target and modify endogenous genes and chromosomal\u00a0loci in eukaryotic cells) unenforceable\u00a0because of Regeneron\u2019s inequitable conduct during prosecution.<\/p>\n

Merus argued that Regeneron\u2019s patent\u00a0prosecutors withheld four references from the USPTO during prosecution. \u00a0The references were cited in a third-party\u00a0submission in related U.S. patent prosecution and in
\nEuropean opposition briefs, were but-for material, and\u00a0were withheld by Regeneron with the specific intent to\u00a0deceive the PTO. \u00a0Regeneron argues, however, that the\u00a0references were not but-for material, that they were\u00a0cumulative of references the PTO actually relied on\u00a0during prosecution, and that Regeneron did not have any\u00a0specific intent to deceive the PTO.<\/p>\n

During prosecution,\u00a0Regeneron asserted that it had developed a commercial\u00a0embodiment of the claimed mouse with surprising
\nresults. \u00a0However, it was undisputed that that assertion was false;\u00a0Regeneron had not developed any such mouse\u00a0at the time. \u00a0Regeneron’s application was allowed. \u00a0However, just before allowance, a third party made a submission of prior art in the parent case. This prior art was not disclosed in the ‘018 patent, but once the \u2019018\u00a0patent had been allowed, the art was disclosed\u00a0in every related application\u00a0having the same specification and similar claims.<\/p>\n

The Federal Circuit acknowledged that\u00a0the materiality required to establish\u00a0inequitable conduct is but-for materiality, and said that\u00a0In determining the materiality\u00a0of a reference, the court applies the preponderance of the\u00a0evidence standard and gives claims their broadest reasonable\u00a0construction. \u00a0The Federal Circuit added that\u00a0a reference is not but-for material, however, if it is\u00a0merely cumulative, i.e., when it \u201cteaches\u00a0no more than what a reasonable examiner would consider\u00a0to be taught by the prior art already before the PTO.\u201d<\/p>\n

In addition to proving the materiality of the withheld references, a challenger\u00a0must prove that the patentee\u00a0acted with the specific intent to deceive the PTO. \u00a0Evidence of intent to deceive should be weighed independently of the materiality analysis. Proving that the applicant knew of a reference,\u00a0should have known of its materiality, and decided\u00a0not to submit it to the PTO does not prove specific intent\u00a0to deceive, rather\u00a0clear and\u00a0convincing evidence must show that the applicant made a\u00a0deliberate decision<\/em> to withhold a known material reference.<\/p>\n

Direct evidence of intent is not required, and\u00a0an inference of intent to deceive can be made where the\u00a0applicant engages in \u201ca pattern of lack of candor,\u201d such as repeatedly makes factual representations\u00a0\u201ccontrary to the true information he had in his\u00a0possession.\u201d<\/p>\n

Applying the broadest reasonable interpretation to the claims, the Federal Circuit concluded that the district court properly found that the withheld references were but-for material separately and in combination. \u00a0As to specific intent to withhold, the Federal Circuit approved the district court’s drawing an adverse inference\u00a0of specific intent from Regeneron’s litigation conduct, which the Federal Circuit described as “beset with\u00a0troubling misconduct.” \u00a0This misconduct included:<\/p>\n