proving and avoiding inequitable conduct in patent...
TRANSCRIPT
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Presenting a live 90-minute webinar with interactive Q&A
Proving and Avoiding Inequitable Conduct
in Patent Prosecution and Litigation Leveraging Court Treatment Post-Therasense and the AIA's Answer to Inequitable Conduct Issues
Today’s faculty features:
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
TUESDAY, JANUARY 31, 2017
Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Amanda K. Murphy, Ph.D., Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Margaret J. Sampson, Partner, Baker Botts, Austin, Tex.
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Disclaimer These materials are public information and have been prepared solely for
educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law and practice. These materials reflect only the personal views of the joint authors and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. And not all views expressed herein are subscribed to by each joint author. Thus, the joint authors, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), and BAKER BOTTS, cannot be bound either philosophically or as representatives of various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the joint authors, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), or BAKER BOTTS. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
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The AIA deals only indirectly with inequitable conduct through the new supplemental examination procedure. USPTO Proposed Rules changing the standard of materiality to be consistent with Therasense recently revived. For now, the main guide for U.S. Patent practitioners on inequitable conduct remains case law, and, in particular, the en banc Federal Circuit decision in Therasense and its progeny.
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DUTY OF DISCLOSURE
• Everyone involved in drafting and prosecuting US patent application owes a duty of disclosure to the USPTO
– 37 C.F.R. §1.56: Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability[.]
– M.P.E.P. §2000
Intent to
deceive
material
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WHO HAS A RULE 56 DUTY?
• Individuals associated with the filing or prosecution of a patent application are: – Inventors
– attorney or agent and
– every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, with the assignee or with anyone to whom there is an obligation to assign the application.
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INCLUDING DECLARANTS!
• 37 C.F.R. §1.66 or §1.68 – Everything in declaration or oath is true.
• 37 C.F.R. §1.63(b) – (1) Identify the application; – (2) Declarant has reviewed and understands the
contents of the application, including the claims,
– (3) acknowledges the duty to disclose to the Office all information known to the person to be material to patentability as defined in §1.56.
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HOW LONG DOES DUTY LAST?
• Through issuance (unless back before USPTO via reexam/IPR/PGR or reissue).
• But perhaps not during patent term extension - See Schering Corp.
v. Mylan Pharmaceuticals, Inc., Slip Copy, 2011 WL 1885709 (D.N.J. May 17, 2011) (unpublished)
– “in view of the specific allegations at issue in this motion, the Court
does not interpret the duty of candor and good faith identified in §1.765 to require the disclosure of potentially invalidating prior art relating to the '721 patent. The Court therefore concludes that the Schering's alleged failure to disclose such information during the term extension proceedings would not support a finding of inequitable conduct[.]”
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BEYOND ISSUANCE? POSSIBLY
• 3D Medical Imaging Systems, LLC v. Visage Imaging, Inc., 2:14-cv-00267 (N.D. Ga. Jan. 11, 2017)
– Patent expired Jan. 16, 2013, for failure to pay maintenance fee.
– New owner petitioned PTO to reinstate for “unintentional delay.”
– PTO granted petition and reinstated patent.
– But the new owner did not know the non-payment was unintentional.
– DC: Certification was inequitable conduct.
• “[S]ubmitted petition without any idea whether certification was true.” • Misrepresentation, “but for” material, specific intent to deceive because
certified without any knowledge of the truth.
• See also, Ulead Sys., Inc. v. Lex Comput. & Mgmt. Corp., 351 F.3d 1139, 1144 (Fed. Cir. 2003); Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223, 1231 (Fed. Cir. 2007)
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IF PROSECUTION IS RE-OPENED
• Post-grant proceedings such as ex parte reexamination, inter partes review, and post-grant review -> the duty of disclosure applies.
• Inequitable conduct is not a ground upon which an IPR or PGR petition may challenge issued claims. – But that means no estoppel in the district court on the issue of
inequitable conduct. 35 U.S.C. §315(e)/ §325(e).
• Since the duty of disclosure applies during the IPR/PGR
proceeding, an omission or misrepresentation discovered in the course of the IPR/PGR, or in a declaration submitted in an IPR/PGR, could be raised in the context of an allegation of inequitable conduct in subsequent district court litigation.
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IC RAISED BASED ON IPR
• PPC Broadband, Inc. v. Corning Optical Communications RF, LLC, F. Supp.3d__ (N.D.N.Y. June 16, 2016)
– Corning raised an inequitable conduct defense based on
PPC’s alleged failure to disclose an IPR institution decision in co-pending reexams on related patents.
– The district court granted PPC’s motion for summary judgment of no inequitable conduct because “Corning's allegations of PPC's inequitable conduct fall far below the heightened standard articulated in Therasense.”
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DUTY OF CANDOR BEFORE PTAB
• 37 C.F.R. § 42.11(a): Duty of candor. Parties and individuals involved in the proceeding have a duty of candor and good faith to the Office during the course of a proceeding.
• 37 C.F.R. § 42.12 Sanctions. – (a) The Board may impose a sanction against a party for misconduct,
including: • (1) Failure to comply with an applicable rule or order in the proceeding; • (2) Advancing a misleading or frivolous argument or request for relief; • (3) Misrepresentation of a fact; • (4) Engaging in dilatory tactics; • (5) Abuse of discovery; • (6) Abuse of process; or • (7) Any other improper use of the proceeding, including actions that
harass or cause unnecessary delay or an unnecessary increase in the cost of the proceeding.
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PTAB SANCTIONS
• Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc., IPR2015-00826, Paper 39 (P.T.A.B. Dec. 6, 2016)
– District court infringement lawsuit dismissed without prejudice for
lack of personal jurisdiction over AGL.
– AGL filed IPR petition; terminated prior to FWD for failure to identify RPI (AGL Resources).
– AGL filed second IPR petition, included AGL Resources as RPI.
– Prior to FWD, AMS Corp. merged with AGL Resources, which became wholly owned subsidiary of The Southern Co.
– PTAB FWD that instituted claims unpatentable.
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PTAB SANCTIONS
• IPR2015-00826 (con’t)
– Patent Owner asserted that all RPIs had not been identified.
– PTAB ordered AGL to file updated mandatory notice.
– Patent Owner requested rehearing and sanctions, including costs and fees.
– PTAB denied rehearing but granted costs and fees associated with request for rehearing. • “the Board specifically found that AGLR is a real party in interest, and it
follows that the merged entity is also a real party in interest.”
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PTAB SANCTIONS
• IPR2015-00826 (con’t)
– PTAB: • “The merger with AMS Corp. has meaningful effects that impose
an obligation on Petitioner to apprise the Board that Southern Gas Company is a real party in interest. Petitioner’s failure to file timely the updated mandatory notice is especially significant in light of the central nature that the issue of AGLR’s status as a real party in interest played in the related IPR.”
• “Petitioner cannot have it both ways, identifying The Southern Company as a real party in interest (even ‘out of an abundance of caution’) to ensure compliance with 35 U.S.C. § 312(b), while simultaneously maintaining that it is not a real party in interest to evade the obligations of 37 C.F.R. § 42.8(a)(3).”
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PRE-THERASENSE STANDARDS FOR
“MATERIALITY”
• Objective “but for” standard (misrepresentation was so material that the patent should not have issued).
• Subjective “but for” test (misrepresentation actually caused the examiner to approve the patent application when he would not otherwise have done so).
• “But it may have” standard (misrepresentation may have influenced the parent examiner in the course of prosecution).
• “Reasonable examiner” standard.
• Rule 56 (amended in 1992): information is material if not cumulative and establishes prima facie case of unpatentability or is inconsistent with a position taken by the applicant during prosecution.
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• Evolving Standards
– 70’s and 80’s: Gross negligence
– 1988: “sufficient culpability” – Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867,
876 (Fed. Cir. 1988) (en banc)
– Early 2000’s: “knew or should have known materiality”
• Bristol-Myers Squibb Co. v. Rhône-Poulenc Rorer, Inc., 326 F.3d 1226, 1229 (Fed. Cir. 2003)
• “[W]here withheld information is material and the patentee knew or should have know [sic] of that materiality, he or she can expect to have great difficulty in establishing subjective good faith sufficient to overcome an inference of intent to mislead.”
PRE-THERASENSE STANDARDS FOR “INTENT TO DECEIVE”
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Clear and convincing evidence of materiality and intent must be shown before patentee has any burden to show no inequitable conduct.
•Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008), cert. denied (2009)
•“Courts must ensure that an accused infringer asserting inequitable conduct has met his burden on materiality and deceptive intent with clear and convincing evidence before exercising its discretion on whether to render a patent unenforceable.”
MATERIALITY AND INTENT MUST BE SHOWN
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Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc)
– Abbott’s statements in US prosecution found to be inconsistent with statements made to the EPO.
– Statements made to the EPO found to be not disclosed to USPTO examiner.
– District court: Unenforceable for inequitable conduct. • Withheld information was material, and “neither Pope nor Dr. Sanghera
provided a credible explanation for failing to submit the EPO documents to the PTO”
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Therasense: STANDARD FOR MATERIALITY
• Therasense Majority (6-5) on Rehearing En Banc: – “but for” materiality = if the PTO would not have allowed a claim
had it been aware of the undisclosed prior art.
– “affirmative egregious misconduct” exception = no “but-for” materiality but it would otherwise be unjust to allow the patentee to enforce the patent. Example: filing of an unmistakably false affidavit. Does not include mere nondisclosure of prior art references.
– That majority was lost when Judge Rader departed.
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Therasense: STANDARD FOR INTENT
• Therasense Majority on Rehearing En Banc:
– specific intent to deceive = single most reasonable inference that one with a Rule 56 duty "knew of the reference, knew that it was material, and made a deliberate decision to withhold it.” No more “should have known” standard for intent (no disagreement from dissent or concurring opinions). Absence of a good faith explanation for failure to disclose a material reference (which was the case in Therasense) does not, by itself, constitute intent to deceive.
– Explicitly forbade inferring intent solely from materiality and abandoned the “sliding scale”. (No disagreement in the dissenting or concurring opinions).
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INEQUITABLE CONDUCT: POST-THERASENSE
No Inequitable Conduct • Failure to disclose prior art references
was a mistake that was corrected upon discovery • AstraZeneca v. Aurobindo Pharma Ltd, 703 F. 3d
511 (Fed. Cir. 2012)
• Disclosure of prior art reference
“buried” in an IDS; good faith explanation • Cordis Corp. v. Boston Scientific Corp., 658 F.3d
1347 (Fed. Cir. 2011)
• Compliance with standard PTO
procedure for delayed payment, though delay may not have been unintentional • Network Signatures, Inc. v. State Farm Mut.
Auto. Ins. Co., 731 F. 3d 1239 (Fed. Cir. 2013)
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Inequitable Conduct
• Withholding material information – Aventis Pharma S.A. v. Hospira, Inc., 675
F.3d 1324 (Fed. Cir. 2012)
• Concealing third party’s involvement in
claimed invention – Apotex Inc. v. Cephalon, Inc., 2011 WL
6090696 (E.D. Pa. 2011), aff’d w/o op. (Fed. Cir. April 8, 2013)
• Submission of false declaration
– Intellect Wireless, Inc. v. HTC Corp., 732 F.3d 1339 (Fed. Cir. 2013)
• Affirmative misrepresentations of prior
art and test results – Apotex, Inc. v. UCB, Inc., 763 F.3d 1354
(Fed. Cir. 2014)
POST-THERASENSE CASES FINDING INEQUITABLE CONDUCT
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• District court: Inequitable conduct. – References were material to patentability and the inventor intentionally withheld
them with the intent to deceive the USPTO.
• Sanofi’s appeal: – Inventor explained why he did not disclose the references, so intent to deceive
was not the single most reasonable inference. • Inventor testified he believed failed experiments did not have to be disclosed.
– References were not material to patentability because they were duplicative of references before the PTO.
• Federal Circuit: Affirmed. – Withheld references were material.
– Inventor testimony as to why did not disclose references (experimental failures) was found “not credible.”
– Inventor made sure reference disclosed in an article and gave to FDA, but failed to disclose to the PTO.
– Specific intent to deceive.
Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012)
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• District Court: Inequitable conduct.
– Cephalon RE′516 patent for modafinil (Provigil®)
– Cephalon never disclosed to the PTO about Lafon’s small particle
modafinil (Batch 003) :
• (1) Lafon was the manufacturer of Batch 003;
• (2) Lafon measured the particle size of that batch prior to providing
it to Cephalon (would have demonstrated derivation);
• (3) Lafon manufactured and tested several modafinil API batches
and tablet lots that fell within the claim limitations; or
• (4) that the two companies, Lafon and Cephalon, had both supply
and license agreements (would have established anticipation and
on-sale bar).
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Apotex Inc. v. Cephalon, Inc., 2011 WL 6090696 (E.D. Pa. 2011), aff’d w/o op. (Fed. Cir. April 8, 2013)
• Materiality: Established by finding of invalidity based on Lafon.
– “Cephalon failed to disclose to the PTO any of the information relating to Lafon's substantial role in Cephalon's claimed invention. Had the PTO been aware of this information, it would not have allowed the patent to issue.”
• Intent: Established by concealment and misrepresentations
– “the complete concealment of another company's extensive involvement in the product which is the subject of the claimed invention definitively establishes Cephalon's deception by clear and convincing evidence.”
– Affirmative misrepresentation: told PTO it modified Lafon’s modafinil when it did not.
• In response to obviousness rejections, “Cephalon asserted that the prior art and studies on that art would not have motivated one of ordinary skill in the art to modify or manipulate the particle size of the drug substance like Cephalon's inventors had done. … This response not only served to further conceal Lafon's role . . . but was an affirmative misrepresentation . . . . Without a logical explanation for making such misrepresentations . . . Cephalon made those unsupported claims with the intention of convincing the patent examiner to change his mind and issue the patent.”
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Apotex Inc. v. Cephalon, Inc. (con’t)
• Intent (con’t) – concern over Lafon's “confidential” information “does not explain
Cephalon's decision to omit any mention of Lafon's role in its application.”
– No alternative explanation for these misrepresentations and omissions.
• “given the unmistakable importance of the Lafon information, the
inexplicable concealment of that information from the PTO, even after the examiner's obviousness challenge unequivocally alerted Cephalon to its importance, as well as the direct misrepresentations made by Cephalon to the PTO, the only reasonable inference to be drawn is that Cephalon made a deliberate choice to deceive the PTO . . . and justifies rendering the patent unenforceable.”
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Apotex Inc. v. Cephalon, Inc. (con’t)
• District Court: Unenforceable for inequitable conduct. – Materiality: declaration containing false statements
• Said actually reduced to practice but never did • affirmative egregious misconduct
– Intent: inventor had specific intent to deceive the PTO. • “pattern of false and misleading statements during prosecution of related
patents” • Inventor’s “explanations for the misrepresentations during prosecution of
the asserted patents were not credible.”
• Intellect’s appeal: misrepresentations were corrected and no
specific intent to deceive.
• Federal Circuit: affirmed
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Intellect Wireless, Inc. v. HTC Corp., 732 F.3d 1339 (Fed. Cir. 2013)
• Federal Circuit: Materiality
– Cited Rohm & Haas Co. v. Crystal Chem. Co., 722 F.2d 1556, 1572 (Fed. Cir. 1983): must “expressly advise the PTO of [the misrepresentation’s] existence, stating specifically wherein it resides…what the actual facts are” and the applicant must “take the necessary action . . . openly. It does not suffice that one knowing of misrepresentations in an application or in its prosecution merely supplies the examiner with accurate facts without calling his attention to the untrue or misleading assertions sought to be overcome, leaving him to formulate his own conclusions.”
– In this case, “[a]t best, the revised declaration obfuscated the truth.”
• “the declaration nowhere expressly stated the actual facts, which are that ‘neither [Mr. Henderson] nor Intellect Wireless actually reduced to practice’ the inventions claimed in the asserted patents. …Nowhere did the declaration openly advise the PTO of Mr. Henderson’s misrepresentations”
– “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. Therasense expressly cited Rohm & Haas with approval and made clear that filing a false affidavit is exactly the sort of ‘affirmative act[] of egregious misconduct’ that renders the misconduct ‘material.’”
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Intellect Wireless, Inc. v. HTC Corp. (con’t)
• Federal Circuit: Intent – “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. See Rohm & Haas, 722 F.2d at 1571. Further, Mr. Henderson engaged in a pattern of deceit, which makes the inference stronger.”
– “the district court’s finding of intent could be affirmed based on the content of the two declarations. The completely false statements in a first declaration were followed by a replacement declaration that, rather than expressly admitting the earlier falsity, dances around the truth.”
– “Thus, the district court did not clearly err in concluding that specific intent to deceive the PTO was the most reasonable inference from Mr. Henderson’s conduct. The district court also did not err when it decided not to credit Mr. Henderson’s explanations for the repeated submission of false affidavits…. The pattern of deceit supports the court’s finding that Mr. Henderson’s explanations for making false statements during prosecution of the asserted patents are not credible.”
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Intellect Wireless, Inc. v. HTC Corp. (con’t)
• District Court: Unenforceable for inequitable conduct.
– Misrepresentations • Dr. Sherman was aware that Univasc was made according to his claimed process,
concealed this knowledge from the PTO, and misrepresented the nature of Univasc and the prior art.
• Withheld relevant prior art and submitted results of experiments that he never conducted (written in past tense).
– Materiality • “Examiner adopted Dr. Sherman’s repeated misrepresentations verbatim and would not
have allowed the claims had he been aware that Univasc contained moexipril magnesium.”
• Falsification of examples alone not sufficiently material, it nonetheless added to the materiality determination when viewed in conjunction with other misrepresentations and omissions.
• Egregious misconduct – “Dr. Sherman abused the patent system by targeting a competitor’s existing and widely available product and seeking to obtain a patent on it through lies and deception for the purpose of suing that competitor.”
– Intent: • “single most reasonable inference that could be drawn from the evidence was that
Dr. Sherman intended to deceive the PTO.”
33
Apotex, Inc. v. UCB, Inc.,
763 F.3d 1354 (Fed. Cir. 2014)
• Federal Circuit: Affirmed
– No abuse of discretion
– Materiality: • Dr. Sherman responsible. • Affirmative misrepresentations of material facts. • “but-for” materiality: “rejections were based on the very same
prior art that is the subject of Dr. Sherman’s misrepresentations.”
– Intent: • Deceptive intent is “single most reasonable inference” • “[Dr. Sherman] knew enough to recognize that he was crossing the
line from legitimate advocacy to genuine misrepresentation of material facts.”
34
Apotex, Inc. v. UCB, Inc. (con’t)
• Alleged inequitable conduct of OWW counsel: – failing to list all inventors on the patent application; – withholding disclosure of prior art; and – affirmative misrepresentations about prior art and deposition
testimony.
• District Court: Summary judgment of no inequitable conduct.
• Federal Circuit: Reversed and remanded (fact issue precluded
summary judgment of no inequitable conduct) – Failure to disclose material information “tantamount” to submitting a
false affidavit. – “OWW withheld various pieces of material information and had no
reasonable explanation for the several misrepresentations it made to the PTO.”
35
Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333 (Fed. Cir. 2013), on remand, 2:04–cv–1223 (S.D. Ohio Sept 24, 2014), on appeal,
813 F.3d 1350 (Fed. Cir. 2016)
• DC: unenforceable for inequitable conduct. – OWW withheld or misrepresented “but-for” material information – “misrepresentations about corroborating evidence”
• Misrepresentations were intentional. – OWW employee’s explanations not credible: “It is inconceivable that the
OWW employee responsible for its patent litigation did not have access to confidential information that could cause the Court to invalidate one of OWW’s most important patents simply because he did not sign the Protective Order. That testimony is particularly not credible in this instance because the material at issue was not marked ‘Confidential’ or ‘Confidential – Attorney’s Eyes Only.’”
– “In allowing Mr. Gayan [OWW’s attorney] to repeatedly argue (on OWW’s behalf) that Mr. Comtesse was confused and isolated in his position that the pre-critical date SSGL did not allow gel bleed-through, when in fact other individuals shared and corroborated that position, OWW went beyond any good faith defense the Protective Order provides.”
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Ohio Willow Wood Co. v. Alps South, LLC, on remand 2014 WL 4775374 (S.D. Ohio Sept. 24, 2014)
Ohio Willow Wood Co. v. Alps South, LLC, on second appeal
• FC: affirmed the finding of inequitable conduct with respect to the withholding of material information in the second reexamination:
– Evidence known to, but withheld by, Mr. Colvin, was “but for” material to
patentability in the second reexamination. • OWW argued to the Board on appeal that Mr. Comtesse’s declaration lacked corroboration and
was unreliable. • “OWW’s counsel knew that if the BPAI accepted Mr. Comtesse’s account of the prior art SSGL,
then the ’237 patent would not have emerged from the second reexamination.”
– Colvin's act of withholding the letters was the product of deceptive intent.
• The withheld evidence corroborating Mr. Comtesse’s testimony supported an inference of intent to deceive.
• “he understood that he could have given his reexamination counsel the Scalise letters at any point but …he chose not to do so.”
– Because Mr. Colvin knew of the misrepresentations from OWW’s
reexamination counsel and failed to correct them, and OWW was unable to offer a reasonable explanation for Mr. Colvin’s conduct, the most reasonable inference to be drawn was an intent to deceive the USPTO.
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• Inequitable conduct allegation: – Co-inventor and Calcar’s founder, Mr. Obradovich, “disclosed the existence of
the 1996 Acura RL (‘96RL’) navigation system, [but] he intentionally did not disclose additional information [owner’s manual and photographs] that would have led the PTO to deny the patent” application.
• District Court: unenforceable for inequitable conduct.
– “but-for” material: “it would have been obvious to a person of ordinary skill in the art to include different information in the 96RL navigation system.”
– Intent: “Mr. Obradovich knew the information was material [and] the single reasonable inference …was that Mr. Obradovich deliberately decided to withhold the information from the PTO.”
– “expressly rejected Calcar’s suggestion that it would have been equally reasonable for the district court to infer that Mr. Obradovich’s actions were merely negligent or grossly negligent.”
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American Calcar, Inc. v. American Honda Motor Co., Inc.,
768 F.3d 1185 (Fed. Cir. 2014)
• Federal Circuit: Affirmed. – “affirm the district court’s determination that the undisclosed
operational details of the 96RL navigation system are material to the patentability of the ’465 and ’795 patents.”
– “Partial disclosure of material information about the prior art to the PTO cannot absolve a patentee of intent if the disclosure is intentionally selective.”
– District court did not abuse discretion.
• Newman dissented because materials at issue were
provided to the PTO during reexamination, and patentability was confirmed.
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American Calcar, Inc. v. American Honda Motor Co., Inc. (con’t)
• Inequitable conduct allegation: Patent counsel
knowingly provided false information about the prior
art to the examiner. – Submitted low-resolution photo rather than physical
sample of prior art; could not tell from photo that hangers
had claimed feature.
• Before patent allowed, defendant sent patent
counsel high-resolution photograph of prior art
hanger and suggested disclosure to the PTO.
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Worldwide Home Prods., Inc. v. Time, Inc.,
1:11-cv-03633 (S.D.N.Y. Sept. 30, 2013), 74 F. Supp. 3d 626 (S.D.N.Y. 2015), appeal dismissed, 626 Fed.Appx. 1009 (Fed. Cir. Dec. 16, 2015)
• Summary judgment of inequitable conduct granted
• Materiality: “It cannot reasonably be argued that the Merrick Hangers would not have been material to the PTO's decision on the Application, because it is undisputed that the Merrick Reference depicted the Merrick Hangers and the patent examiner initially rejected the Application on the basis of the Merrick Reference.”
• Intent: “the only reasonable inference to be drawn from the undisputed facts is that [the
attorney] intended to deceive the PTO examiner about a reference he knew was material and that he in fact did so.”
– “he filed the Amended Application which distinguished the Application from the Merrick
Reference on the basis of non-abutment of the cascade hooks of the hangers portrayed in the Merrick Reference. It is also undisputed that the top and bottom surfaces of the cascade hook members of the Merrick Hangers do in fact abut when nested, and that Mr. Sonnabend had Merrick Hangers in his possession at the time he spoke to the PTO examiner.”
– “His sophistry concerning the logic underlying his behavior is completely inconsistent with that behavior and is thus insufficient, in light of the compelling circumstantial evidence that he provided false information to the examiner, to frame a genuine issue of material fact regarding his intent to deceive the examiner.”
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Worldwide Home Prods., Inc. v. Time, Inc. (con’t)
Worldwide Home Prods., Inc. v. Time, Inc. (con’t)
• Found the attorney jointly and severally liable with client for $800K. – “Mr. Sonnabend prosecuted this litigation very
aggressively and ignored numerous opportunities to withdraw plaintiff’s claims …His conduct was vexatious and in bad faith and is a proper predicate for the imposition of sanctions pursuant to 28 U.S.C. section 1927.”
42
Transweb, LLC v. 3M Innovative Properties Co., 812 F.3d 1295 (Fed. Cir. 2016)
• Examiner initially allowed all claims. • When 3M notified the examiner of one of the TransWeb
samples that it had on hand, the examiner rejected all claims as obvious over that disclosure and the Angadjivand patent.
• 3M asserted that the TransWeb samples were only received after signing of a confidentiality agreement and thus were not prior art.
• Then examiner allowed claims.
• DC: Patents unenforceable for inequitable conduct. – But-for materiality: examiner would not have allowed the claims if
the samples had been properly disclosed as prior art. – 3M inventor and in-house attorney had specific intent to deceive.
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Transweb, LLC v. 3M Innovative Properties Co. (con’t)
• FC: Affirmed.
– 3M generally and inventor particularly “were very much aware of the
samples TransWeb was distributing at the expo.”
– There was a coordinated plan to gather information from TransWeb at the
expo and inventor attended the expo.
– “evidence shows that [inventor] knew …that it was plasma-fluorinated
material.”
– Another company sent samples received from TransWeb to 3M inventor,
identifying them as being plasma-fluorinated.
44
Transweb, LLC v. 3M Innovative Properties Co. (con’t)
• FC: Affirmed.
– In-house attorney “undertook an intentional scheme to paper over the potentially prior art nature of the Racal-received samples.” • Sent letter to try and get admission that the Racal-received samples were
covered by a confidentiality agreement, “even though this point was itself dubious.”
• Submitted this letter to the PTO “as definitive proof that the TransWeb samples were not prior art[.]”
– In-house attorney “waited several years between learning of the potential
TransWeb prior art and informing the patent office.” • “waited until the last possible moment, when a notice of allowance had already
been mailed, to submit the TransWeb material in a request for continued prosecution.”
45
Regeneron Pharmaceuticals, Inc. v. Merus B.V., 144 F.Supp.3d 530 (S.D.N.Y. Nov. 2, 2015), appeal filed, December 18, 2015, no decision yet
• To overcome a rejection during prosecution, Regeneron amended claims by inserting “an endogenous” and represented to the PTO that a commercial embodiment of the invention, the VelocImmune mice performed unexpectedly better than mice with disabled endogenous loci.
• Regeneron’s counsel told the examiner that the VelocImmune mouse was created only by virtue of VelociGene & VelociMouse technologies, although Regeneron had been unable to make it.
• Counsel made a representation that the VelocImmune mouse had the ability to preserve DNA of endogenous mouse immunoglobulin locus as among its benefits over prior art mice even though a prior art reference Zou disclosed the same inventive feature in 1994.
• In infringement litigation, Merus argued unenforceability for inequitable conduct because the VelocImmune mouse did not exist when the application was filed.
46
Regeneron Pharmaceuticals, Inc. v. Merus B.V. (con’t)
• DC: Regeneron engaged in inequitable conduct.
– Four withheld references were material; each could suggest or teach a person of ordinary skill in the art to come up with creation of chimeric mice as claimed.
– Opposition briefs submitted during the European proceedings material because they would have provided the examiner with a basis for obviousness rejection in view of the withheld references.
– Regeneron had similar claims in the same patent family rejected in view of the withheld references.
– One withheld reference was actually used by Regeneron itself to oppose against a similar European patent owned by a third party.
– Regeneron engaged in affirmative egregious misconduct in representing that (1) the invented assay for modification of allele does not require a part of the sequence information, (2) Regeneron had made the LTVEC having a homology arm to the mouse genome with the 5’ end, and (3) the created VelocImmune mouse had unexpected superior features than prior art models.
– Inference of intent to deceive based on Regeneron’s egregious litigation tactics.
47
• District court granted Google’s motion for leave to amend their answer to add a defense of unenforceability due to GPH's inequitable conduct.
• Silicon Graphics, Inc. v. ATI Techs., Inc., 2007 WL 5614112, at *6–7 (W.D. Wis. Oct. 15, 2007) – construed “scan conversion” in U.S. Pat. No. 6,650,327 to mean “a process that specifies which pixels of the display screen belong to which primitives on an entirely floating point basis.”
• Federal Circuit affirmed in Silicon Graphics, Inc. v. ATI Techs., Inc., 607 F.3d 784, 791–92 (Fed. Cir. 2010): specification did not disclose or support scan conversion in any format except floating point.
• Patent at issue is a continuation of the ′327 patent.
48
Graphics Properties Holdings, Inc. v. Google, Inc., 2014 WL 6629021 (D.Del. Nov. 20, 2014)
Motion to Amend Complaint to assert inequitable conduct granted
• Google alleged that GPH and its attorneys withheld the Federal Circuit Order with the intent to deceive the PTO during the prosecution of the continuation.
– Application claimed a “scan converter being configured to scan convert data received at the input, at least a portion of the data received at the input being in floating point format.”
– Had the PTO known about the Federal Circuit Order, it would have concluded (i) the claims lacked written description support, or (ii) the claims were not entitled to the priority date of the ′327 patent (June 16, 1998) but rather could claim priority only to the effective filing date of their application (January 11, 2011), which would have led the PTO to consider an expanded range of prior art systems and publications (dated after June 16, 1998 but before January 11, 2011), which would in turn
have then compelled the PTO to reject the claims.
49
Graphics Properties Holdings, Inc. v. Google, Inc. (con’t)
• GPH argued amendment futile because it provided the examiner with notice of the District Court Order.
• District Court: “undisputed that the examiner was not given actual notice of the Federal Circuit's subsequent decision.” – According to Google, Federal Circuit Order contains “adverse
statements not contained in the District Court Order.”
50
Graphics Properties Holdings, Inc. v. Google, Inc. (con’t)
POST-THERASENSE CASES FINDING NO INEQUITABLE CONDUCT
51
• District Court: Granted summary judgment of inequitable conduct: – Owner’s standard practice not to pay maintenance fees if no commercial interest at
7.5 years; – Intentionally abandoned; – Learned of commercial interest and petitioned for late payment of maintenance fees,
stating the delay was “unintentional” without setting forth the details of how the delay occurred;
– Material and Intentional.
• Federal Circuit: Reversed and remanded:
– No requirement for explanation on standard form; – Mr Karasek acted promptly; – “Mr. Karasek's compliance with the standard PTO procedure for delayed payment, using the
PTO form for delayed payment, does not provide clear and convincing evidence of withholding of material information with the intent to deceive the Director. On matters unrelated to the substantive criteria of patentability, but within the authority of the Director, ‘it is almost surely preferable for a reviewing court not to involve itself in the minutiae of Patent Office proceedings and to second-guess the Patent Office on procedural issues at every turn.’”
52
Network Signatures, Inc. v. State Farm Mut. Auto. Ins. Co.,
731 F. 3d 1239 (Fed. Cir. 2013)
• District Court: inequitable conduct (decision before Therasense). – Inventor and attorney withheld 3 material references and information
about PTO rejections in 2 related prosecutions. – Following pre-Therasense precedent, district court did not discuss or
consider whether any deliberate decision was made to withhold the references from the PTO.
• Federal Circuit: Reversed (decision after Therasense)
– Intent: No evidence of deliberate decision to withhold references. – “Knowledge of the reference and knowledge of materiality alone are
insufficient after Therasense to show an intent to deceive. Moreover, it 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.”
53
1st Media, LLC v. Electronic Arts, Inc.,
694 F. 3d 1367 (Fed. Cir. 2012)
• District Court: not unenforceable for inequitable conduct.
– Patentees failed to disclose prior art reference, and when finally did disclose,
buried it.
– BUT, concluded that intent to deceive was not the single most reasonable
inference.
• Federal Circuit: Affirmed based on Therasense standard (“specific intent to deceive is the single most reasonable inference”).
– Patentee relied on communication from attorney; once found out about
importance of prior art reference, disclosed it (albeit without emphasis).
– Threshold level of intent to deceive met, but that proof rebutted by
good faith explanation.
54
Cordis Corp. v. Boston Scientific Corp., 658 F.3d 1347 (Fed. Cir. 2011)
• District Court: unenforceable for inequitable conduct.
– Failure to disclose litigation of related patent • “although only infringement of the ‘992 patent had been placed at issue, ‘it was
clear that the issue of validity would likely arise in the litigation.’ The court inferred deceptive intent from the fact of non-disclosure[.]”
– Incorrect claim of “small entity” status • Travel Caddy met criteria for small entity, but could not claim status because of
commercial arrangement with large entity.
• “Travel Caddy's false claim of small entity status was undoubtedly material,” and intent to deceive found because “Nelson, an experienced patent attorney, is responsible for being familiar with such standards. Under these circumstances, the Court finds that an inference of Travel Caddy's intent to deceive the PTO has been established.”
55
Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285 (Fed. Cir. 2012)
• Federal Circuit: Reversed.
– Failure to disclose litigation not material • “there was no citation of prior art, nor any pleading of invalidity or unpatentability
in the ′992 complaint as it existed during pendency of the ′104 application.”
• “There was no evidence on which to base an inference of deceptive intent.”
– Small entity status • “no evidence that small entity status was deliberately falsely claimed.”
• “37 C.F.R. § 1.28 provides that good faith mistakes can be remedied by making a deficiency payment.”
56
Outside the Box Innovations, LLC v. Travel Caddy, Inc. (con’t)
• District Court: Not unenforceable for inequitable conduct. – Case involved Crestor ® (rosuvastatin).
– Two in-house patent staff did not disclose prior art references.
– Patentee filed reissue application as soon as discovered error.
• Federal Circuit: Affirmed. – Reference compounds were sufficiently similar in structure to warrant
citation, even though they did not negate the patentability of rosuvastatin.
– No deceptive intent: “no more than a string of mishaps, mistakes, misapprehensions and misjudgments on the part of inexperienced and overworked individuals.”
– “‘equally plausible’ that Mr. Shibata believed the requirements of the United States patent prosecution had been met.”
57
In re Rosuvastatin Calcium Patent Litigation,
AstraZeneca v. Aurobindo Pharma Ltd, 703 F. 3d 511 (Fed. Cir. 2012)
• PPC Broadband, Inc. v. Corning Optical Communications RF, LLC, __F. Supp.3d__ (N.D.N.Y. June 16, 2016) • PPC sued for infringement. • Before trial, Corning preserved an inequitable conduct defense. • Jury trial: willful infringement. • PPC motion for SJ on Corning’s inequitable conduct defense.
• Nov. 2013, Corning sought ex parte reexams. • May 2014, Corning filed IPR on a different patent (same references as
in ex parte reexams). • PTAB instituted, but then vacated for Corning’s failure to name all RPI’s. • Corning: PPC’s failure to disclose IPR institution decision in co-pending
reexams on related patents was inequitable conduct.
POST-DAYCO/MCKESSON
58
• PPC (con’t) • PPC counsel testified that knew of institition decision but did not
consider it material • DC: SJ granted.
• “Corning's allegations of PPC's inequitable conduct fall far below the heightened standard articulated in Therasense.”
• “reasonable inferences other than deception can be drawn from Sullivan's non-disclosure, namely, his opinion that the 446 IPR decision was cumulative of other record evidence in the reexaminations.”
• Testimony indicated examiners aware of IPR decision anyway. • “PPC, however, need not provide the court with a good faith explanation
of its conduct absent a showing by clear and convincing evidence that it intended to deceive the PTO, and Corning has failed to make such a showing.”
• Decision to institute not shown to be “but for” material. • Cumulative
POST-DAYCO/MCKESSON (con’t)
59
IDSs and IC
• Masimo Corp. v. Philips Electronic North Am. Corp., C.A. No. 09-80-LPS (D. Del. 2016), Stipulation of Dismissal with Prejudice by Masimo Corp., entered November 14, 2016
– Masimo alleged infringement of ‘222, ‘984, and ‘074
patents.
– Jury: ‘222 and ‘984 patents valid and infringed; $466M damages.
– DC: No inequitable conduct.
60
TIMELINE
• May 8, 2007, ‘984 patent issued.
• Feb. 3, 2009, Masimo sued Philips.
• Sept. 5, 2012, Philips filed ex parte reexam request of ‘984 patent and several other Masimo patents.
• May 6, 2014, Reexam certificate issued.
61
PROCEDURE ESTABLISHED FOR DISCLOSURE
• Masimo and counsel established procedure to disclose litigation documents to PTO.
• Masimo CEO and named inventor instructed counsel to “submit everything.”
• Protective Order in litigation.
• Associate go-between for lit and pros teams.
62
ALLEGATION
• April 15, 2014, Philips filed letter with court alleging that Masimo did not inform examiner of Judge Thynge’s rejection of proposed claim constructions that were same as those Masimo relied upon to overcome the Examiner’s rejections.
– Basis of allegation: Masimo failed to submit March 31,
2014 SJ Order adopting Judge Thynge’s April 2, 2013 R&R and its claim construction.
– But letter did not cite the SJ order.
63
DC DECISION
• DC: Philips failed to meet burden to prove omission was deliberate decision to withhold a known material reference.
– Counsel “had set up a system of disclosure aimed at providing
the PTO with all relevant district court orders by filing IDSs in the …reexaminations.”
– “the ‘single most reasonable inference’ is that this was the result of timing and circumstances of the reexamination process rather than any deceitful intent[.]”
– Masimo submitted an IDS that included the R&R on April 29, 2013.
64
DC DECISION (con’t)
– Failed to show SJ order was “known material reference.”
• “all testified that they did not know the Court's SJ Order of March 31, 2014 had adopted a claim construction (to which there was no objection) from the R&R that was arguably contrary to a position they had advanced during the '984 Reexam until after they had formed the belief the reexam record was closed. Kesler and Grover did not learn of the SJ Order until May 7, 2014. (Tr. at 180-81, 327-28) While Jensen knew that the SJ Order issued, he was aware of only the general outcome of the ruling.”
65
DC DECISION (con’t)
• “At most, the evidence gives rise to ‘multiple reasonable inferences,' including that Kesler, Grover, and Jensen were acting in good faith to disclose all that they could to the PTO. … ‘[W]hen there are multiple reasonable inferences that may be drawn, intent to deceive cannot be found.' Therasense, 649 F .3d at 1290-91. At bottom, what matters is not whether the Masimo attorneys were correct on the law, but what the evidence shows they credibly believed. Even if Kesler, Grover, and Jensen were technically wrong about what post-NIRC disclosures were permissible under the MPEP (a dispute the Court need not resolve), what is decisive here is that they believed no such disclosures were possible. The emails and testimony presented at trial all give rise to a strong inference that Kesler, Grover, and Jensen believed they were disclosing everything they could to the PTO through the available mechanisms.”
66
NO MISREPRESENTATION
• “Philips further alleges that Masimo's attorneys made a misrepresentation to the PTO by failing to correct a statement Masimo made to the PTO in a response to an office action, a statement that in Philips' view became false the moment Judge Thynge issued her R&R on April 2, 2013. One fundamental flaw in Philips' theory is that the claim construction positions Masimo advocated throughout prosecution and reexamination of the '984 patent were arguments, not factual statements. ‘While the law prohibits genuine misrepresentations of material fact, a prosecuting attorney is free to present argument in favor of patentability without fear of committing inequitable conduct.’ Rothman v. Target Corp., 556 F.3d 1310, 1328-29 (Fed. Cir. 2009).”
67
IC IN PI CONTEXT
• Fresenius Kabi USA, LLC v. Fera Pharms., LLC, 2:15-cv-03654 (D. NJ Sept. 20, 2016)
– Fresenius’ 3 patents describe lyophilized levothyroxine.
– Grandfathered version of levothyroxine available since 1969; not
approved by FDA.
– 2010 Fresenius filed NDA on a more stable formulation; FDA approved Fresenius’ NDA June 24, 2011. • Formulation: levothyroxine, buffer, bulking agent (mannitol) • Lower amount of mannitol unexpectedly increased stability.
– Fera filed ANDA and Fresenius sued.
68
IC IN PI CONTEXT (con’t)
• Fresenius (con’t)
– Fera: Fresenius concealed information that the grandfathered previously
marketed compositions were as stable as the claimed formulations.
• Application showed tables of results of stability testing.
• Specification states: “[s]urprisingly, the stability of levothyroxine in lyophilized
formulations containing dibasic sodium phosphate instead of tribasic sodium
phosphate was found to decrease with an increase in the ratio of mannitol to
levothyroxine in the formulation.” (emphasis in original)
• But no comparison provided between the dibasic and tribasic sodium phosphate
formulations.
• Alleges Fresenius never submitted stability tests for tribasic sodium formulations.
69
IC IN PI CONTEXT (con’t)
• Fresenius (con’t)
– DC: Rejected • “no substantial evidence of misrepresentation, or intentional
withholding of material information from the patent examiner.”
– Examiner knew some of the prior art taught a tribasic
formulation.
– “the relevant apples-to-apples comparison, as presented to and understood by the examiner, was between dibasic formulations containing different proportions of mannitol.”
– Note: also held “single most reasonable inference test” applies in motion to dismiss – motion to dismiss denied.
70
REVIVED PROPOSED RULES
71
• 81 Fed. Reg. 74,987 (Oct. 28, 2016), “Revision of the Materiality to Patentability Standard for the Duty To Disclose Information in Patent Applications” (Comment period closed Dec. 27, 2016).
– § 1.56 Duty to disclose information material to patentability.
• (a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability under the but-for materiality standard as defined in paragraph (b) of this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application.
USPTO PROPOSED RULE CHANGE
72
• § 1.56 Duty to disclose information material to patentability (con’t) – (a) …. There is no duty to submit information which is not material to the
patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b) through (d) and 1.98. However, no patent will be granted on an application in connection with which affirmative egregious misconduct was engaged in, fraud on the Office was practiced or attempted, or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:
• (1) Prior art cited in search reports of a foreign patent office in a counterpart
application, and
• (2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.
USPTO PROPOSED RULE CHANGE
73
• § 1.56 Duty to disclose information material to patentability (con’t) – (b) Information is but-for material to patentability if the Office would
not allow a claim if the Office were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction consistent with the specification.
USPTO PROPOSED RULE CHANGE
74
• § 1.555 Information material to patentability in ex parte reexamination and inter partes reexamination proceedings.
– (a) A patent by its very nature is affected with a public interest. The public interest is best
served, and the most effective reexamination occurs when, at the time a reexamination proceeding is being conducted, the Office is aware of and evaluates the teachings of all information material to patentability in a reexamination proceeding. Each individual associated with the patent owner in a reexamination proceeding has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability in a reexamination proceeding under the but-for materiality standard as defined in paragraph (b) of this section. The individuals who have a duty to disclose to the Office all information known to them to be material to patentability in a reexamination proceeding are the patent owner, each attorney or agent who represents the patent owner, and every other individual who is substantively involved on behalf of the patent owner in a reexamination proceeding. The duty to disclose the information exists with respect to each claim pending in the reexamination proceeding until the claim is cancelled. Information material to the patentability of a cancelled claim need not be submitted if the information is not material to patentability of any claim remaining under consideration in the reexamination proceeding.
USPTO PROPOSED RULE CHANGE
75
• § 1.555 Information material to patentability in ex parte reexamination and inter partes reexamination proceedings (con’t)
– (a)…. The duty to disclose all information known to be material to patentability in a reexamination proceeding is deemed to be satisfied if all information known to be material to patentability of any claim in the patent after issuance of the reexamination certificate was cited by the Office or submitted to the Office in an information disclosure statement. However, the duties of candor, good faith, and disclosure have not been complied with if affirmative egregious misconduct was engaged in, any fraud on the Office was practiced or attempted, or the duty of disclosure was violated through bad faith or intentional misconduct by, or on behalf of, the patent owner in the reexamination proceeding. Any information disclosure statement must be filed with the items listed in § 1.98(a) as applied to individuals associated with the patent owner in a reexamination proceeding and should be filed within two months of the date of the order for reexamination or as soon thereafter as possible.
USPTO PROPOSED RULE CHANGE
76
• § 1.555 Information material to patentability in ex
parte reexamination and inter partes
reexamination proceedings (con’t)
– (b) Information is but-for material to patentability if, for
any matter proper for consideration in reexamination,
the Office would not find a claim patentable if the
Office were aware of the information, applying the
preponderance of the evidence standard and giving the
claim its broadest reasonable construction consistent
with the specification.
USPTO PROPOSED RULE CHANGE
77
78
NO CHANGE TO 37 C.F.R. §1.105(a)(1)
• Note, no change to 37 C.F.R. §1.105(a)(1):
–“In the course of examining or treating a matter in a pending or abandoned application filed under 35 U.S.C. 111 or 371 (including a reissue application), in a patent, or in a reexamination proceeding, the examiner or other Office employee may require the submission, from individuals identified under § 1.56(c), or any assignee, of such information as may be reasonably necessary to properly examine or treat the matter,…”
SUPPLEMENTAL EXAMINATION
79
• IN GENERAL.—A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of the patent. The making of a request under subsection (a), or the absence thereof, shall not be relevant to enforceability of the patent under section 282. [§257(c)(1), 125 STAT. 326]
• Is this a holy grail of a pre-lit purge of inequitable conduct under a “but-for” materiality standard?
SUPPLEMENTAL EXAMINATION: BASIS OF SNQP REMOVED AS BASIS FOR ALLEGATION OF INEQUITABLE CONDUCT: THE EFFECT
80
• Allows submission of prior art in your own patents
• Restrictions:
– Does not apply against allegations already raised in district court or
ANDA notice para. IV before date of filing request (§257(c)(2)(A)), or
– Shall not apply to any defenses raised in ITC litigation/district court litigation unless SE and any reexam ordered therefrom is finished before the date on which the action is brought (§257(c)(2)(B)). • Patent owners: think very carefully about the timing of any effort at
supplemental examination if there is a desire to enforce the patent in the foreseeable future. A reexamination may need to be appealed to get the patent out. Thus, it may mean delaying any effort to enforce the patent for one or more years.
SUPPLEMENTAL EXAMINATION (“shall apply to any patent issued before, on, or after [Sept. 16, 2012]”)
81
• New §257(a): “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[.]”
– Prior art? – Inconsistent positions? – Errors? – Therasense: Rule 56?
SUPPLEMENTAL EXAMINATION (“shall apply to any patent issued before, on, or after [Sept. 16, 2012]”)
Importantly, uses term “relevant” not “material.” Request does not
mean admission of materiality. 82
• §257(f): Nothing in this section shall be construed—
– (1) to preclude the imposition of sanctions based upon criminal or antitrust laws …;
– (2) to limit the authority of the Director to investigate issues of possible misconduct and impose sanctions for misconduct in connection with matters or proceedings before the Office; or
– (3) to limit the authority of the Director to promulgate regulations under chapter 3 relating to sanctions for misconduct by representatives practicing before the Office.
SUPPLEMENTAL EXAMINATION: HEADING SOUTH
83
• Fraud exception [§257(e)]
– (e) FRAUD.—If the Director becomes aware, during the course of a supplemental examination or reexamination proceeding …, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental examination…the Director shall also refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate.
SUPPLEMENTAL EXAMINATION: THE SOUTH POLE?
84
• § 1.605 Request cannot have more than 12 items believed to be relevant to the patent. – May file more than one supplemental examination request at a time.
• § 1.610(b) A request for supplemental examination must include:
• (5) A separate, detailed explanation of the relevance and manner of applying each item of information to each claim of the patent for which supplemental examination is requested.
• §1.620
– (e) No interviews. – (f) No amendments.
SUPPLEMENTAL EXAMINATION FINAL RULES
85
SUPP EXAM STATS FROM USPTO 2016 ANNUAL REPORT
43
53
45
33 35
30
20
25
30
35
40
45
50
55
FY2014 FY2015 FY2016
Filed Granted
Source: https://www.uspto.gov/sites/default/files/documents/USPTOFY16PAR.pdf
Of interest, only 1 case indicated as having related litigation.
86
SUPP EXAM STATS FROM USPTO 2016 ANNUAL REPORT
SNQ found, 73, 66%
SNQ not found, 38, 34%
FY2014-FY2016
Source: https://www.uspto.gov/sites/default/files/documents/USPTOFY16PAR.pdf 87
SUPP EXAM STATS FROM USPTO 2016 ANNUAL REPORT
Chemical, 34, 24%
Electrical, 74, 52%
Mechanical, 32, 23%
Design, 2, 1%
SE Petitions Filed
Source: https://www.uspto.gov/sites/default/files/documents/USPTOFY16PAR.pdf 88
AIA REISSUE AMENDMENT
▪ Another purge opportunity? Amendment to §§251, 253:
– Whenever any patent is , through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent…. [SEC. 20(d) and (e), 125 STAT. 333-334].
– Biggest implication – no pre-filing “due diligence” is needed to assess whether any “deceptive intent” was involved in the “error” on which the reissue under § 251 is based or whether any “deceptive intent” was involved in a claim being disclaimed under §253???
– Would one use a combination of Reissue and Supplemental Examination to insulate
reissued claims from allegation of inequitable conduct? Or just reissue?
Note: 37 CFR 1.16(e) Basic fee for filing each application for the reissue of a patent is $330! (with small entity reduction available)
89
• Therasense is binding precedent.
• Probably most practitioners won’t change Rule 56 disclosure practices very much for now.
WHAT SHOULD A PRACTITIONER DO?
90
• Are subjective evaluations presented as fact? Are assertions supported by science? – Purdue Pharma L.P. v. Endo Pharms., Inc., 438 F.3d 1123
(Fed. Cir. 2006)
• Do they know of any prior art?
• Do they have any articles or publications on the
subject matter of the invention? – Bristol-Myers Squibb Co. v. Rhône-Poulenc Rorer, Inc., 326
F.3d 1226 (Fed. Cir. 2003)
QUESTIONS TO ASK INVENTORS: ANSWERS HAVE INEQUITABLE CONDUCT IMPLICATIONS
91
• Were all the experiments described performed as described?
– Hoffmann-LaRoche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003)
– Novo Nordisk Pharmaceuticals, Inc. v. Bio-Technology General Corp., 424 F.3d
1347 (Fed. Cir. 2005)
– Pharmacia Corp. v. Par Pharmaceutical, Inc., 417 F.3d 1369 (Fed. Cir. 2005)
– Apotex, Inc. v. UCB, Inc., 763 F.3d 1354 (Fed. Cir. 2014)
• Are there experiments and/or experiment details that were not included in the specification?
– Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc., 525 F.3d 1334 (Fed. Cir.
2008)
MORE QUESTIONS TO ASK INVENTORS: ANSWERS HAVE INEQUITABLE CONDUCT IMPLICATIONS
92
• Are there undisclosed data? – Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359 (Fed. Cir.
2007)
• Are the data being relied upon to establish patentability?
MORE QUESTIONS TO ASK INVENTORS: ANSWERS HAVE INEQUITABLE CONDUCT IMPLICATIONS
93
• Is there information in the files of those having a Rule 56 duty that is inconsistent with those data submitted? Arguments made?
– Monsanto Co. v. Bayer Bioscience N.V., 514 F.3d 1229 (Fed. Cir. 2008)
– Ferring B.V. v. Barr Labs., Inc., 437 F.3d 1181 (Fed. Cir. 2006)
MORE QUESTIONS TO ASK INVENTORS: ANSWERS HAVE INEQUITABLE CONDUCT IMPLICATIONS
94
• Do they know of any related applications? Office Actions in any related applications? related patents? any litigation on the related patents?
– McKesson Information Solutions, Inc. v. Bridge Medical, Inc., 487
F.3d 897 (Fed. Cir. 2007)
– Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223 (Fed. Cir. 2007)
– Leviton Mfg. Co., Inc. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed. Cir. 2010)
– Masimo Corp. v. Philips Electronic North Am. Corp., C.A. No. 09-80-LPS (D. Del. 2016)
MORE QUESTIONS TO ASK INVENTORS: ANSWERS HAVE INEQUITABLE CONDUCT IMPLICATIONS
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DON’T LIE TO THE COURT
• Tesco Corp. v. Weatherford Int’l, Inc., NO. H-08-2531 (S. D. Tex. Aug. 25, 2014)
– Did not lose the patent, but lost the chance to enforce it.
– “Tesco’s counsel affirmatively misrepresented to the Court during trial the statements of key witnesses regarding important evidence disclosed only during trial.”
– Case (filed in 2008!) dismissed with prejudice.
– Possibly invalidating marketing brochure introduced during testimony at trial.
– Counsel told court that he spoke to person who made the image in the brochure who said it was not the invention.
– But that person was not the creator of the brochure.
– “Such misrepresentations irrevocably poisoned these proceedings[.]”
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Thank you!
Tom Irving
Margaret Sampson
Amanda Murphy, Ph.D.
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