Dead or Alive? Inequitable Conduct / Fraud on the Patent Office (Ethics CLE) Matthew Bernstein
[email protected] Thane Bauz
[email protected] Tawen Chang
[email protected] December 12, 2013
AGENDA • The Good Old Days? •
I.e., Pre‐Therasense
• The Therasense Changes • Post‐Therasense Inequitable Conduct • •
Federal Circuit District Court
• What does the Future Hold?
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The Good Old Days?
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Inequitable Conduct pre‐Therasense • Frequently raised defense, although difficult to win •
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Draconian remedy • Kills entire patent, not just claim, and not just in your litigation • Possibly kills entire patent family Provided a second bite of the apple • Jury trial on noninfringement and invalidity; bench trial on inequitable conduct Allowed you to paint the plaintiff as a bad actor Increased the plaintiff’s costs • Additional discovery and bench trial / good against trolls Keep prosecutors from the litigation team 4
Inequitable Conduct pre‐Therasense • Two elements: intent to deceive and materiality • Finding of inequitable conduct requires clear and convincing evidence that the applicant misrepresented or omitted material information with the specific intent to deceive the PTO
• Court balances proven intent and materiality on a sliding scale: • The more material the omission or misrepresentation, the lower the level of intent required, and vice versa • Where a reference is highly material, gross negligence may be sufficient, in light of the totality of the circumstances • Mere negligence cannot be sufficient
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Inequitable Conduct pre‐Therasense • Multiple materiality tests, mainly based on controlling text of 37 CFR § 1.56 • “Reasonable Examiner” (1977 amendment to Rule 56) • substantial likelihood that a reasonable examiner would consider the reference important in deciding whether to allow the application to issue as a patent
• Prima facie plus (1992 amendment to Rule 56) • Non‐cumulative reference is material if •
It establishes, by itself or in combination, a prima facie case of unpatentability of a claim
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It refutes, or is inconsistent with, a position the applicant takes in opposing an argument of unpatentability relied on by the Office or Asserting an argument of patentability
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Inequitable Conduct pre‐Therasense • Intent to deceive • Can be inferred from indirect circumstantial evidence • Absence of a good faith explanation for conduct may be evidence to support a finding of IC •
But cannot by itself be clear and convincing evidence of intent
• Inference must be the single most reasonable inference able to be drawn from the evidence
• Court views the conduct in light of all the evidence (“totality of the circumstances” • Then the Court must determine whether that conduct in its totality manifests a sufficiently culpable state of mind to warrant a determination that it was inequitable 7
The Therasense Changes
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Therasense ‐ Overview • En Banc Decision Issued on May 25, 2011 • 6 Justices on the opinion • Rader, Newman, Lourie, Linn, Moore, Reyna
• 1 concurring in part and dissenting in part • O'Malley
• 4 dissenting • Bryson, Gajarsa, Dyk, Prost
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Federal Circuit: Consequences of “Low” Intent and “Broad” Materiality Standards • Inequitable conduct charged in most cases •
A “plague”
• Litigation strategy to expand scope of discovery •
Increases costs
Ruinous effect on prosecuting attorney Discourages settlement Distracts from validity & infringement Destroys all claims, taints/destroys all family members • Unsurprisingly, buries Patent Office with references
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Better to disclose than withhold 10
Therasense Redefined Standard for Inequitable Conduct • Materiality: New “but‐for" test • PTO would not have allowed a claim had it been aware of the undisclosed prior art
• Intent to deceive: • Applicant knew of the reference, knew it was material, and made a deliberate decision to withhold it • Specific intent to deceive must be "the single most reasonable inference able to be drawn from the evidence." • Gross negligence or negligence under a “should have known” standard does not satisfy the intent requirement
• Separate requirements: sliding scale eliminated
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Intent "Must prove patentee acted with specific intent to deceive the Patent Office" Standard is "clear and convincing evidence" "The specific intent to deceive must be “the single most reasonable inference able to be drawn from the evidence.” . . . Indeed, the evidence “must be sufficient to require a finding of deceitful intent in the light of all the circumstances.”
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Evidence of intent needs to be clearly more compelling than evidence of no intent
You now need to show careful and selective manipulation of the where, when, and how of disclosure 12
What Does not Satisfy the Intent Requirement • Absence of good faith explanation for withholding a material reference, by itself • “[P]atentee need not offer any good faith explanation unless the accused infringer first proves a threshold level of intent to deceive by clear and convincing evidence.”
• Gross negligence or negligence under a “should have known” standard • "Proving that the applicant knew of a reference, should have known of its materiality, and decided not to submit it to the PTO” 13
Materiality • "This court holds that, as a general matter, the materiality required to establish inequitable conduct is but‐for materiality. When an applicant fails to disclose prior art to the PTO, that prior art is but‐for material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.” •
Rationale: basic fairness
• “Because inequitable conduct renders an entire patent (or even a patent family) unenforceable, as a general rule, this doctrine should only be applied in instances where the patentee’s misconduct resulted in the unfair benefit of receiving an unwarranted claim.” 14
Materiality Exception to “But‐For” Test • 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.” • False affidavit is only an example of an affirmative act of egregious misconduct (but the holding is not so limited)
• What does not qualify under the exception: • mere nondisclosure of prior art references to the PTO • failure to mention prior art references in an affidavit
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Materiality – Evidentiary Standards • Different evidentiary standards for invalidity and inequitable conduct: • Invalidity under §§ 102, 103: clear and convincing evidence • Materiality: preponderance of evidence, giving claims broadest reasonable construction (PTO evidentiary standards) • Consistent with patentability determinations made by the USPTO
• Reference will be material if it would have blocked patent issuance under the PTO's evidentiary standards • If a claim is properly invalidated in district court based on a deliberately withheld reference, then that reference is necessarily material
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Sliding Scale is Dead • District courts should not use a “sliding scale” • Sliding scale: weak showing of intent sufficient based on strong showing of materiality, and vice versa
• Intent and materiality are separate requirements • District court may not infer intent solely from materiality • Court must weigh the evidence of intent to deceive independent of its analysis of materiality
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Inequitable Conduct Post‐ Therasense
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Post‐Therasense Federal Circuit Decisions
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Post‐Therasense Federal Circuit Decisions • • • • • • • • •
American Calcar v. American Honda Cordis v. Boston Scientific Powell v. Home Depot Aventis v. Hospira 1st Media v. Electronic Arts Outside the Box Innovations v. Travel Caddy In re Rosuvastatin Calcium Patent Litigation Novo Nordisk v. Caraco Pharmaceutical Intellect Wireless, Inc. v. HTC Corp. 20
American Calcar v. American Honda • Technology: car navigation systems • Inventors withheld knowledge and information regarding prior art Honda system installed in the Acura 96RL • Pre‐Therasense, D. Ct. found withheld information material • operational details of the 96RL navigation system were same or similar to claimed systems • Jury found that certain of the asserted patents were anticipated by the 96RL system 21
American Calcar v. American Honda • D. Ct. found inequitable conduct – but applied sliding scale for intent • Circumstantial evidence of deceptive intent: • Inventors had operated the 96RL navigation system and developed car manuals in prior business • Patent specifications included description and figure from 96RL manual
• Inference of deceptive intent from inventor’s contradictory, non‐credible testimony • Because withheld information was highly material, less evidence of intent was required to reach a finding of inequitable conduct 22
American Calcar v. American Honda • Two‐tiered review of inequitable conduct determination: • Factual determinations of materiality and intent: clear error • Ultimate decision as to inequitable conduct: abuse of discretion • Federal Circuit Held: • 96RL system material to claims found to be anticipated • Finding of materiality with respect to other patents vacated • Court applied “reasonable examiner” standard • No finding under “but‐for” materiality
• Finding of intent to deceive vacated • Court used sliding scale • No holding that any of the inventors knew withheld information was in fact material and made a deliberate decision to withhold it
• Outcome: Remanded as to non‐anticipated claims 23
Cordis Corp. v. Boston Scientific Corp. • One of the "Stent Wars" cases (balloon‐expandable stents) • Inventor selectively disclosed references cited in EPO search report • Per patent attorney’s advice, inventor reviewed and disclosed reference that was “particularly relevant” standing alone • Inventor did not disclose or review references “particularly relevant” in combination until after patent issued • Inventor did not emphasize references in IDS
• In prior appeal, Fed. Cir. affirmed district court’s finding that one of these references was material
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Cordis v. Boston Scientific • Pre‐Therasense, D. Ct. found no specific intent to deceive • Credited inventor’s explanation for failure to disclose • Intent to deceive was not the “single most reasonable inference”: “[T]he inferences argued by plaintiff are supported by evidence of record and are as reasonable as those inferences argued by defendants."
• Outcome: Affirmed; no clear error or abuse of discretion • Defendant proved threshold level of intent to deceive • Proof was rebutted by inventor’s good faith explanation • Relied on his attorney’s advice on relevance of EPO references • Unaware of withheld references until after patent issued
• Panel deferred to District Court’s credibility determination
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Powell v. Home Depot U.S.A, Inc. • • • • • • •
Appealed in 2010 (pre‐Therasense) Technology: finger‐guards for in‐store radial saws Inventor supplied saws to Home Depot Home Depot sought solution to safety problems Inventor proposed one Home Depot took design to lower priced supplier Inventor sues
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Powell v. Home Depot • Issue: • Inventor filed a Petition to Make Special for expedited review by PTO • Grounds included his obligation to build and supply devices embodying the claims sought
• Inventor did not update his Petition when Home Depot went to other supplier • Application received expedited review
• D. Ct. found intent and materiality, but based in part on balance of equities, no unenforceability
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Powell v. Home Depot • Fed. Cir.: • Failure to inform PTO that circumstances supporting a Petition to Make Special no longer existed: • “obviously fails the but‐for materiality standard” • “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.’”
• Outcome: No inequitable conduct affirmed
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Aventis v. Hospira • Fed. Cir. affirmed invalidity and unenforceability of pharmaceutical patent claims based on selective disclosure of material references • Technology: cancer drug Taxotere, successor to Taxol • Pre‐Therasense, D. Ct. applied but‐for materiality test and made distinct intent and materiality findings • Evidentiary standards reminder (see Therasense): • §§102, 103 invalidity: clear and convincing • Materiality prong of inequitable conduct: preponderance of evidence, giving claims broadest reasonable construction
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Aventis v. Hospira • Materiality • Fed. Cir. upheld invalidity based on withheld references, so they are necessarily material
• Intent • D. Ct. findings not clearly erroneous • Deference to determination that inventor’s explanations for withholding references not credible • D. Ct. did not rely solely on credibility determination to find specific intent • Viewed inventor’s testimony in light of other documentary evidence
• Outcome: Inequitable conduct ruling affirmed
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1st Media, LLC v. Electronic Arts, Inc. • Fed. Cir. reverses inequitable conduct ruling based on failure to disclose • Pre‐Therasense, D. Ct. found inequitable conduct: • Inventor and patent attorney: • withheld material references • knew references were material • failed to provide a credible good faith explanation for nondisclosure of the references • Inference of intent to deceive was appropriate
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1st Media v. Electronic Arts • Held: lack of evidence of deliberate decision to withhold the references • District court did not address whether there was any deliberate decision to withhold • Knowledge of reference and its materiality alone are insufficient after Therasense to show an intent to deceive • “[I]t is not enough to argue carelessness, lack of attention, poor docketing or cross‐referencing, or anything else that might be considered negligent or even grossly negligent.”
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1st Media v. Electronic Arts • Distinguished Aventis Pharma • No evidence of selective disclosure here • “In Aventis Pharma there was affirmative conduct by the applicants showing not only specific awareness of materiality, but careful and selective manipulation of where, when, and how much of the most material information to disclose.”
• Panel did not reach materiality issue • Outcome: Inequitable conduct ruling reversed • But stay tuned . . . Sony Cert. Petition 33
Outside the Box Innovations v. Travel Caddy • Fed. Cir. reverses inequitable conduct ruling on false small entity claim and failure to disclose litigation involving patent (per curiam, with concurrence) • Technology: tool carry cases • Pre‐Therasense, D. Ct. found inequitable conduct • Patentee Travel Caddy failed to disclose litigation involving the parent patent during prosecution of the child application (continuation) • Travel Caddy falsely claimed small entity status and its lower fees
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Outside the Box Innovations v. Travel Caddy • Held: No inequitable conduct based on failure to disclose litigation • No clear and convincing evidence of materiality • Invalidity not at issue in litigation during prosecution of continuation application
• No clear and convincing evidence of a specific intent to deceive the PTO into granting the child patent • District Court inferred deceptive intent solely from the fact of non‐disclosure
• Outcome: Inequitable conduct ruling based on failure to disclose litigation reversed
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Outside the Box Innovations v. Travel Caddy • Inequitable conduct based on allegedly false declaration claiming small entity status • Travel Caddy had fewer than 500 employees • But it had a contract with a distributor that had over 500 employees (when employees of Mexican affiliate are included)
• D. Ct. viewed contract as patent license and distribution agreement for small entity status • D. Ct. found: • Materiality: “false claim of small entity status was undoubtedly material” • Intent to deceive: “[prosecution counsel], an experienced patent attorney, is responsible for being familiar with [small entity] standards.”
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Outside the Box Innovations v. Travel Caddy • Held: No inequitable conduct based on false small entity status declaration • No clear and convincing evidence small entity status was deliberately falsely claimed: • “Where there is no evidence that small entity status was deliberately falsely claimed, a finding of unenforceability is inappropriate.”
• Regulations provide for correction of good faith mistakes in claiming small entity status, by making a deficiency payment • Unenforceability would not be an appropriate remedy
• Note: Court explicitly did not decide whether a false small entity declaration would be an “unmistakably false affidavit”
• Outcome: Inequitable conduct ruling based on false small entity affidavit reversed 37
In re Rosuvastatin Calcium Patent Litigation • 2010 appeal (pre‐Therasense) • Technology: rosuvastatin • Became active ingredient in Crestor (anti‐cholesterol drug)
• Patentee Shionogi’s in‐house patent staff withheld: • Published Bayer and Sandoz patent applications • EPO search report disclosing the Sandoz application
• Four years after issue, Shionogi filed for reissue in order to file IDS disclosing Sandoz and Bayer references • Generic claims rejected over Bayer • Shionogi introduced claims to specific compound rosuvastatin and its salts to secure reissue
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In re Rosuvastatin Calcium Patent Litigation • D. Ct. found no inequitable conduct • Prior art was neither “immaterial” nor “highly material” • No clear and convincing evidence of intent, despite admission of knowledge of duty to disclose Bayer • Testimony of the patent staff involved was credible, and explanations of inexperience, increased workload, and resulting confusion plausible • No in‐house patent staff had legal experience in patents • One staff member departed company before IDS was due • Another believed references had been disclosed
• Deceptive intent not “the single most reasonable inference to be drawn from these circumstances”
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In re Rosuvastatin Calcium Patent Litigation • Fed. Cir.: No inequitable conduct • “[W]e do not disturb the district court’s finding of materiality” • Bayer and Sandoz did not block patentability of claims directed to rosuvastatin, since reissue granted thereover • Agreed with D. Ct. that disclosures were sufficiently similar to claimed rosuvastatin compounds to be material to prosecution • Looser standard than but‐for materiality?
• No clear and convincing evidence of deliberate decision to withhold references from the PTO
• Outcome: No inequitable conduct affirmed
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Novo Nordisk v. Caraco Pharmaceutical • Technology: using a combination of repaglinide with metformin to treat Type II diabetes • Novo scientist (Sturis) submitted declaration showing combination’s synergistic effects, and Novo counsel (Bork) touted declaration as “clear evidence of synergy” • Declaration omitted Sturis’s test protocol and opinion that results did not “prove” synergy in humans
• Pre‐Therasense, D. Ct. found omissions material • Inconsistent with opinions expressed in declaration in support of patentability • “But for” material because examiner withdrew obviousness rejection based solely upon declaration
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Novo Nordisk v. Caraco Pharmaceutical • Fed. Cir. held omission of test protocol and opinion were “troubling” but not “but for” material • Reasonable examiner would have understood that Sturis’s protocol did not prove synergy • Declaration (results “indicated” and “strongly suggest[ed]” synergy) and trial testimony (synergy not affirmatively proven) were consistent • Declaration disclosed all test results, including those obtained through omitted test protocol • Sturis had reasonable explanation for deviation from protocol • Bork’s arguments to PTO tracked qualified nature of Sturis declaration
• Outcome: inequitable conduct finding reversed 42
Intellect Wireless, Inc. v. HTC Corp • Technology: wireless transmission of picture caller ID information • Named inventor Daniel Henderson filed a Rule 131 declaration swearing that his invention was reduced to practice and shown at a meeting • District Court found that Mr. Henderson never reduced the invention to practice • Post‐Therasense, D. Ct. found false affidavit material • Filing false Rule 131 Declaration constituted egregious misconduct • False statements during prosecution of asserted and related patents regarding reduction to practice evidenced intent to deceive
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Intellect Wireless, Inc. v. HTC Corp • Fed. Cir. held District Court did not clearly err • Filing a false declaration to overcome a rejection is affirmative egregious misconduct where application fails to cure • “We note that Therasense in no way modified Rohm & Haas’s holding that the materiality prong of inequitable conduct is met when an applicant files a false affidavit and fails to cure the misconduct.” • Specific intent to deceive was most reasonable inference • “Submission of an affidavit containing fabricated examples of actual reduction to practice in order to overcome a prior art reference raises a strong inference of intent to deceive.”
• Henderson engaged in a “pattern of deceit”
• Outcome: inequitable conduct finding affirmed 44
Federal Circuit Found No Inequitable Conduct in Three Additional Cases • August Technology Corp. v. Camtek, Ltd., 655 F.3d 1278, 1290 (Fed.Cir.(Minn.) Aug 22, 2011) •
Affirmed dismissal of inequitable conduct counterclaim where alleged on‐sale bar prior art would not render the asserted claims obvious in view of the other cited prior art as a matter of law, and therefore not material
• Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d 1344, 1349 (Fed.Cir.(Del.) Sep 04, 2012) •
Affirmed judgment of no inequitable conduct where trial court found inventor’s testimony regarding why test data was not provided until prosecution of continuing application “strained credibility,” but evidence presented was “not sufficient to establish by clear and convincing evidence that [the inventor] acted with an affirmative intent to deceive”
• Network Signatures, Inc. v. State Farm Mut. Auto. Ins. Co., 2013 WL 5312431 (Fed. Cir. Sept. 24, 2013) •
Reversed judgment of inequitable conduct, where trial court found patent owner’s attorney had falsely represented that nonpayment of maintenance fee was “unintentional,” because attorney followed PTO procedure in using PTO’s form petition to revive, and form does not require explanation of reasons for delay 45
Post‐Therasense District Court Decisions
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District Court Decisions • District Courts have found inequitable conduct fewer than 10 out of over 60 cases since Therasense •
Federal Circuit has made it easier for District Court judges to say no inequitable conduct • Or not even let a defendant raise the defense • Motion practice • Plaintiff motions to dismiss or motion for summary judgment • Defendant motions to amend
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District Court Decisions Finding Inequitable Conduct • Worldwide Home Products, Inc. v. Time Inc. (S.D.N.Y. Sept. 30, 2013) •
Selective disclosure of the most relevant prior art – disclosing a low‐resolution image of a prior art clothing hanger while not disclosing a high resolution image or the product itself – established intent to deceive
• Apotex, Inc. v. UCB, Inc. (S.D. Fla. Sept. 6, 2013) •
Affirmative misrepresentations regarding the nature of the prior art and failure to disclose test results contradicting statements made to the PTO were but‐for material and established egregious misconduct.
• Kim Laube & Co. v. Wahl Clipper Corp. (C.D. Cal. July 18, 2013) •
Patentee withheld his own prior art from prosecution counsel and the PTO, where withheld prior art disclosed feature patentee had argued was missing from the prior art, thereby overcoming rejection.
• James Jeffery Caron and Spellbinders Paper Arts Company, LLC v. QuicKutz (D. Ariz. Nov. 13, 2012) •
False affidavit naming inventors and false declaration to overcome rejection constituted egregious misconduct and misleading declarations from third parties established but‐for materiality 48
District Court Decisions Finding Inequitable Conduct • Intellect Wireless, Inc. v. HTC Corp., (N.D. Ill. Sept. 6, 2012), aff’d, 732 F.3d 1339 (Fed. Cir. Oct. 9, 2013) •
False Rule 131 Declaration used to swear behind reference established but‐for materiality
• Network Signatures, Inc. v. State Farm Mut. Auto. Ins. Co., 2012 WL 2357307 (C.D. Cal. June 13, 2012), rev’d, 2013 WL 5312431 (Fed. Cir. Sept. 24, 2013) •
Misstatement in petition to revive established but‐for materiality
• Apotex Inc. v. Cephalon, Inc., 2011 WL 6090696 (E.D. Pa. 2011), aff’d without opinion (Fed. Cir. Apr. 8, 2013) •
Non‐disclosure of invalidating reference and third party’s involvement in supply and testing established but‐for materiality and the non‐disclosure in light of examiner rejections and false statements established intent to deceive
• American Calcar, Inc. v. American Honda Motor Co., Inc., 2012 WL 1328640, (S.D.Cal. Apr 17, 2012) (on remand post‐Therasense) •
Inspiration taken from reference and similarity of subject matter to reference (i.e., figures/text identical or slightly modified from reference) establish but‐for materiality
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Deliberate decision to withhold reference established intent to deceive 49
District Court Decisions • General Electric Company v. Mitsubishi Heavy Industries Ltd., et. al., 3‐10‐cv‐00276 (N.D.Tex. May 28, 2013, Order) (Furgeson, J.) GE submitted one piece of prior art to the PTO, but omitted the entire state of wind industry • No intent found because Mitsubishi was unable to show that GE fully appreciated the materiality and made a deliberate effort to withhold the prior art • District Court said patentees can use attorney‐client privilege to avoid intent findings • District Court said the Federal Circuit tied his hands •
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District Court Decisions • Inequitable conduct as it relates to false affidavits and declarations is still alive • It appears easier to prove an intent to deceive when an individual declares an incorrect statement to be true (i.e., false affidavit/declaration) to the PTO
• Inequitable conduct as it relates to the non‐submission of prior art is difficult to prove and may only be available in the most egregious of scenarios
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The Reality • Typically an accused infringer will only allege inequitable conduct if it has a very strong case •
Some exceptions
• Prosecutors should be more mindful of the accuracy of statements in declarations 52
What Does the Future Hold?
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Backdrop
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Sony Cert Petition to the Supreme Court
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Sony Cert Petition to the Supreme Court • Sony Computer v. 1st Media LLC, Docket No 12‐1086 • Sought review of reversal of inequitable conduct judgment in 1st Media case • Challenged Therasense’s test for intent • Question presented: • “Did the Court of Appeals for the Federal Circuit err in restricting district courts' equitable discretion in evaluating patent unenforceability, contrary to this Court's precedent in Keystone Driller, Hazel‐Atlas, and Precision Instrument, by applying a rigid test that (a) forecloses district courts from considering the entire circumstantial record; and (b) precludes district courts from granting equitable remedies where a patent applicant has violated the PTO's duty of candor?”
• Silent on materiality standard 56
Sony Cert Petition to the Supreme Court • Reasons for the Supreme Court to Take the Case The inequitable conduct doctrine is now too rigid • Federal Circuit now precludes district courts from considering the totality of the circumstances • The Federal Circuit now improperly restricts district court discretion • The Court should grant review to allow inequitable conduct based on all violations of the PTO's duty of candor • Federal Circuit's formula effectively excludes nondisclosure cases altogether • Federal Circuit's formula provides a roadmap to dishonest applicants •
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Sony Cert Petition to the Supreme Court •
On May 13, 2013 the Supreme Court invited the Solicitor General “to file a brief in this case expressing the views of the United States” •
In its September 5, 2013 amicus curiae brief, the U.S. urged the Supreme Court to deny certiorari •
Fed. Cir. should have remanded the District Court’s pre‐Therasense ruling so the District Court could apply the new standard •
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Not a good vehicle to review the Therasense standard •
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Record evidence supported finding of deliberate decision to withhold material information from the PTO Petition presents only half of the Federal Circuit’s new inequitable conduct standard for review – intent without materiality
Sony’s Sept. 10 supplemental brief argued the S.G.’s brief supports cert. •
U.S. admits Fed. Cir. erred; error is a result of inflexible intent framework
• October 15, 2013: Supreme Court denies cert.
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Thank You
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