Therasense

  • Therasense En Banc (Fed. Cir. 05/25/11):
    • Rewrites and restricts inequitable conduct doctrine. See Energy Heating (Fed. Cir. 05/04/18) (aff’g inequitable conduct where applicant failed to disclose 61 pre-critical date fracking jobs using patented system generating $1.8MM in revenue and applicant was aware of on-sale bar); Transweb (Fed. Cir. 02/10/16) (aff’g judgment of inequitable conduct for delayed disclosure followed by deceptive assertion by inventor and in-house attorney, in response to rejection of all claims for obviousness over third party’s public-use of samples, that applicant had received the samples under confidentiality agreement); Calcar (Fed. Cir. 09/26/14) (aff’g judgment of inequitable conduct under Therasense; applicant withheld owner’s manual and photographs his company possessed of prior art system he disclosed to PTO as being prior art, and which disclosed supposedly novel feature); Apotex (Fed. Cir. 08/15/14) (aff’g inequitable conduct judgment based on series of misstatements and failures to disclose); Aventis Pharma (Fed. Cir. 04/09/12) (aff’g inequitable conduct judgment, applying Therasense; invention derived from withheld reference); Santarus (Fed. Cir. 09/04/12) (aff’g no deceptive intent despite trial judge comment that applicant’s explanation for non-disclosure “strained credibility”); 1st Media (Fed. Cir. 09/13/12) (rev’g bench trial finding of deliberate decision to withhold with deceptive intent, despite adverse credibility finding and presumed knowledge of materiality); Novo Nordisk (Fed. Cir. 06/18/13) (rev’g bench-trial judgment of inequitable conduct, no clear and convincing evidence of “but for” materiality of information omitted from declaration submitted to PTO); Network Signatures (Fed. Cir. 09/24/13) (2-1) (rev’g inequitable conduct Summ. J.; checking “unintentional” box on late-maintenance-fee form not shown to be with deceptive intent, despite intentional decision to abandon); Ohio Willow Wood I (Fed. Cir. 11/15/13) (rev’g Summ. J. of no inequitable conduct; finding genuine disputes of material fact re materiality and intent); Ohio Willow Wood II (Fed. Cir. 02/19/16) (aff’g judgment (on remand) of inequitable conduct: withheld evidence corroborating public use where patent owner successfully argued to Board that there was no corroborating evidence.).
    • New Inequitable Conduct Doctrine:
      • Specific Intent (Conscious Decision) To Deceive PTO: “must prove that the patentee acted with the specific intent to deceive the PTO;” if non-disclosure: “that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it;” i.e., made a “conscious decision not to disclose them in order to deceive the PTO.” See Energy Heating (Fed. Cir. 05/04/18) (aff’g inequitable conduct where applicant failed to disclose 61 pre-critical date sales and had no contemporaneous records to support asserted belief that the sales were experimental); Intercontinental Great Brands (Fed. Cir. 09/07/17) (Fed. Cir. 09/07/17) (aff’g Summ. J. of no intent where patent owner failed to note that language in reference likely was a misprint; “the intent requirement is demanding.”); Regeneron (Fed. Cir. 07/27/17) (2-1) (aff’g inequitable conduct; “an inference of intent to deceive is appropriate where the applicant engages in ‘a pattern of lack of candor,’ including where the applicant repeatedly makes factual representations ‘contrary to the true information he had in his possession”), en banc review denied (Fed. Cir. 12/26/17) (Newman, J., dissenting op.) (litigation misconduct cannot extinguish property right); Everlight Elecs. (Fed. Cir. 01/04/18) (non-precedential) (aff’g denial of inequitable conduct; no reversible error in district court’s finding that “a mere showing that documents should have been submitted to the USPTO but have been lost” does not show specific intent).
        • Deceitful intent not proven by (1) showing “should have known” of materiality, (2) lack of evidence of good faith, or (3) where another reasonable inference exists.
      • Materiality Generally But-For: “as a general matter, the materiality required … is but-for materiality … [i.e.,] if the PTO would not have allowed a claim had it been aware of the undisclosed prior art,” applying broadest reasonable construction and preponderance of evidence standard. See Regeneron (Fed. Cir. 07/27/17) (2-1) (aff’g inequitable conduct; apply broadest reasonable construction and preponderance of evidence standard to determine materiality; “Determining but-for materiality requires that the court place itself in the shoes of a [reasonable] patent examiner and determine whether, had the reference(s) been before the examiner at the time, the claims of the patent would have still issued.”); Calcar (Fed. Cir. 09/26/14); U.S. Water Services (Fed. Cir. 12/15/16) (aff’g Summ. J. of no materiality of withheld materials from litigation).{Implies it must be an issued claim}
        • Exception Where Affirmative, Egregious Misconduct: “When the patentee has engaged in affirmative acts of egregious misconduct, such as the filing of an unmistakably false affidavit, the misconduct is material.” Exception does not apply to omission of information. See Intellect Wireless (Fed. Cir. 10/09/13) (aff’g inequitable conduct judgment; “the materiality prong of inequitable conduct is met when an applicant files a false affidavit and fails to cure the misconduct” by expressly identifying the misrepresentation and stating the correct facts, openly).
        • PTO R. 56 Materiality Test Does Not Apply
      • No Sliding Scale: intent and materiality are not balanced.
    • Policy Reasons For The Change: “While honesty at the PTO is essential, low standards for intent and materiality have inadvertently led to many unintended consequences, among them, increased adjudication cost and complexity, reduced likelihood of settlement, burdened courts, strained PTO resources, increased PTO backlog, and impaired patent quality. This court now tightens the standards for finding both intent and materiality in order to redirect a doctrine that has been overused to the detriment of the public.”
  • Needs To Be Material To At Least One Issued Claim: “Inequitable conduct regarding any single claim renders the entire patent unenforceable.” Therasense (Fed. Cir. 05/25/11) (en banc); Regeneron (Fed. Cir. 07/27/17) (2-1); but see Calcar (Fed. Cir. 06/27/11) (“On remand, the district court should determine whether the PTO would not have granted the Search patents but for Calcar’s failure to disclose the 96RL information.”)
  • Cumulative References Are Not Material: Regeneron (Fed. Cir. 07/27/17) (2-1) (aff’g inequitable conduct based on withholding of four but-for-material references; “a reference is not but-for material, however, if it is merely cumulative. A reference is cumulative when it ‘teaches no more than what a reasonable examiner would consider to be taught by the prior art already before the PTO.’”)
  • Deception Re Petition To Make Special Does Not Meet But For Test: Failing to update PTO that circumstances justifying petition to make special no longer exist are not inequitable conduct, even with deceptive intent, because it “obviously fails the but-for materiality standard and is not the type of unequivocal act, ‘such as the filing of an unmistakably false affidavit,’ that would rise to the level of ‘affirmative egregious misconduct.’” Powell (Fed. Cir. 11/14/11).
  • Deceptive Declaration That Failure To Pay Maintenace Fee Was Unintentional Meets But For Test: “Statements critical to the ‘survival of the patent’—even though they do not, strictly speaking, bear on patentability— also can be material within the meaning of Therasense.” In re Rembrandt Tech. (Fed. Cir. 08/15/18) (aff’g exceptional case finding, in part due to prior patent owner’s inequitable conduct in filing false declaration that failure to pay maintenance fees was unintentional). Allegation that delay in payment was unintentional was material because “the PTO would not have revived the patents if it had known that Paradyne consciously allowed them to expire.” Id. (aff’g intent to deceive finding in part based on other misdeeds by same actors). Cf. Network Signatures (Fed. Cir. 09/24/13) (2-1) (rev’g inequitable conduct Summ. J.; checking “unintentional” box on late-maintenance-fee form not shown to be with deceptive intent, despite intentional decision to abandon).
  • Adverse Inference Of Deceptive Intent May Be Imposed As Sanction For Litigation Misconduct: As a sanction for litigation misconduct, part of which “obfuscated its prosecution misconduct,” a court may infer that the withholding of but-for-material references was with an intent to deceive the Patent Office. Regeneron (Fed. Cir. 07/27/17) (2-1) (Plaintiff repeatedly “chose tactics over substance” and used “sword and shield tactics to protect [the patent attorneys’] thoughts regarding disclosure of the Withheld References to the PTO.” Plaintiff’s litigation misconduct included refusing to break down infringement contentions element by element; asserting that no terms required construction; producing on eve of deposition of outside prosecution counsel a previously withheld (as privileged) memo. written by that attorney; making seriously incorrect argument that the memo. was not privileged so did not waive privilege; in response to court order to produce all related materials, providing incomplete materials without describing its own filter for selecting materials to provide; submitting trial affidavits of direct testimony from witnesses for whom it had withheld as privileged multiple documents on same subjects as privileged; withholding non-privileged documents as privileged, etc.), en banc review denied (Fed. Cir. 12/26/17) (Newman, J., dissenting op.) (litigation misconduct cannot extinguish property right).
  • AIA: Supplemental Examination May Cure Inequitable Conduct Not Already Pled With Particularity: Patent owner may institute to correct any error affecting patentability in original prosecution, but will not immunize patentability from inequitable conduct already pled with particularity in a civil action. 35 U.S.C. § 257 (AIA) (“A patent owner may request supplemental examination of a patent in the Office to consider, reconsider, or correct information believed to be relevant to the patent ….”).
  • TIPS: