Proving and Avoiding Inequitable Conduct in Patent ...media.straffordpub.com/products/proving-and-avoiding...Proving and Avoiding Inequitable Conduct in Patent Prosecution and Litigation

Proving and Avoiding Inequitable Conduct in Patent Prosecution and Litigation Leveraging Court Treatment Post-Therasense and the AIA’s Answer to Inequitable Conduct Issues

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THURSDAY, JANUARY 8, 2015

Presenting a live 90-minute webinar with interactive Q&A

Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Jennifer M.K. Rogers, Partner, Shumaker & Sieffert, St. Paul, Minn.

Margaret J. Sampson, Partner, Vinson & Elkins, Palo Alto, Calif.

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The Post-Therasense Inequitable Conduct Battles Continue

January 8, 2015

Tom Irving

Jennifer M. K. Rogers ‎ Margaret Sampson

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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), SHUMAKER SIEFFERT, and VINSON & ELKINS LLP, 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), SHUMAKER SIEFFERT, or VINSON & ELKINS LLP. 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 Rule changing the standard of materiality, presently suspended indefinitely. 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

8

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.

9

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.

10

DUTY OF DISCLOSURE ACKNOWLEDGED IN DECLARATIONS

• USPTO Notice, 1327 OG 112 (Feb. 12, 2008) – The United States Patent and Trademark Office (Office) will

no longer accept as complying with 37 CFR 1.63(b)(3) an oath or declaration that does not acknowledge a duty to disclose information material to patentability as defined in 37 CFR 1.56. All oaths or declarations filed on or after June 1, 2008, will be required to include the language expressly set forth in 37 CFR 1.63, including that in 37 CFR 1.63(b)(3). This notice applies to oaths or declarations filed in all nonprovisional patent applications, including reissue applications.

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HOW LONG DOES DUTY LAST?

• Through issuance (unless put it back it reexam/IPR/PGR or reissue).

• But 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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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): 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)

STANDARDS FOR INTENT AND MATERIALITY

– 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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Therasense: WHAT EXACTLY HAPPENED? • During Abbott’s U.S. prosecution (13 years), argued:

– the “[o]ptionally, but preferably” language [of the prior art patent] was “mere ‘patent phraseology’ that did not convey a clear meaning.”

– prior art patent taught “that active electrodes designed for use with whole blood require a protective membrane.”

– “There is no teaching or suggestion of unprotected active electrodes for use with whole blood specimens in this patent or the other prior art of record in this application.”

• Meanwhile, to the EPO, Abbott argued that the “[o]ptionally, but preferably” language [of the prior art patent] was “unequivocally clear,” and “the EPO documents clearly explained that membranes were merely preferred for live blood… and that a membrane was not necessary for testing whole blood in vitro.”

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Therasense: WHAT EXACTLY HAPPENED?

• Federal Circuit: Affirmed judgment of inequitable conduct.

– Abbott failed to disclose statements made to the European Patent Office (“EPO”) during a revocation proceeding of the European counterpart to the prior art patent.

– Statements made to the EPO were “highly material” because they contradicted representations made to the U.S. PTO regarding the disclosure of the prior art patent.

– “To deprive an examiner of the EPO statements-statements directly contrary to Abbott's representations to the PTO-on the grounds that they were not material would be to eviscerate the duty of disclosure. Moreover, if this could be regarded as a close case, which it is not, we have repeatedly emphasized that the duty of disclosure requires that the material in question be submitted to the examiner rather than withheld by the applicant.”

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Therasense: REVIEW OF CASES CITED BY FEDERAL CIRCUIT

• Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806

(1945)

– the equitable maxim that ‘he who comes into equity must come with clean

hands.’…necessarily gives wide range to the equity court's use of discretion in

refusing to aid the unclean litigant. It is ‘not bound by formula or restrained by

any limitation that tends to trammel the free and just exercise of discretion.’”

quoting Keystone Driller

– “public policy against the assertion and enforcement of patent claims infected

with fraud and perjury”

– Knowing purchase of “perjured” application and failure to disclose perjury to

Patent Office -> not the “standard of conduct requisite to the maintenance of

this suit in equity.” 21


• Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944), overruled

on other grounds by Standard Oil Co. v. United States, 429 U.S. 17 (1976)

– “Every element of the fraud here disclosed demands the exercise of the historic

power of equity to set aside fraudulently begotten judgments. This is not simply a

case of a judgment obtained with the aid of a witness who, on the basis of after-

discovered evidence, is believed possibly to have been guilty of perjury. Here,

even if we consider nothing but Hartford's sworn admissions, we find a

deliberately planned and carefully executed scheme to defraud not only the

Patent Office but the Circuit Court of Appeals.”

– “The total effect of all this fraud, practiced both on the Patent Office and the

courts, calls for nothing less than a complete denial of relief to Hartford for the

claimed infringement of the patent thereby procured and enforced.”

22


• Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc)

– Court noted that it did not discuss materiality because of its decision on intent.

– “Whether the intent element of inequitable conduct is present cannot always be inferred from a pattern of conduct that may be described as gross negligence. That conduct must be sufficient to require a finding of deceitful intent in the light of all the circumstances. We are not convinced that deceitful intent was present in Kingsdown's negligent filing of its continuation application or, in fact, that its conduct even rises to a level that would warrant the description ‘gross negligence.’”

– “Kingsdown's counsel may have been careless, but it was clearly erroneous to base a finding of intent to deceive on that fact alone.”

– “It is not possible to counter the “I didn't know” excuse with a “should have known” accountability approach when faced with a pure error, which by definition is done unintentionally.”

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Therasense: DR. SANGHERA: DECLARATION TRIGGERED DUTY

• “Once Dr. Sanghera disclosed the inconsistent EPO information to Attorney Pope,

he ordinarily would have done all that Rule 56 required. A specific Rule 56 proviso

stated that “[i]ndividuals other than the attorney, agent or inventor may comply

with this section by disclosing information to the attorney, agent or inventor.” Dr.

Sanghera did so.”

• “The problem is that he then made direct representations to the PTO-

representations that were materially misleading by omission. He did not have to

take this extra step. Having done so, he was obligated to avoid intentional

deception. His sworn statements to the PTO about the meaning of the “optionally,

but preferably” sentence were known by him to be inconsistent with his own

company's statements to the EPO-statements he had himself helped craft. … In

sum, given the fact that Dr. Sanghera made a positive submission to the PTO, he

was himself duty-bound to avoid making an intentionally misleading submission,

whether or not he told Attorney Pope about the inconsistency.

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REMAND: Therasense, Inc. v. Becton, Dickinson and Co., 2012 WL 1038715 (N.D.Cal. Mar. 27, 2012)

• Patents procured through inequitable conduct.

– Withheld EPO Briefs Were But–For Material

• “the examiner would not have finally allowed the ′551 patent had the EPO briefs been submitted. The evidence is clear and convincing on this point[.]”

• “the representations…would have been proven false by the EPO

briefs.”

– Knew of Materiality • “The evidence is clear and convincing that Dr. Sanghera and Attorney

Pope knew the content of the EPO briefs and knew that the EPO briefs, standing alone, would so seriously undermine their submission that the examiner would have reverted to unpatentability.”

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• Did Pope and Sanghera intend to deceive the USPTO? – “three elements together are enough to establish a threshold case of

specific intent to defraud: (i) actual knowledge of the withheld item, (ii) actual knowledge of its materiality (using the but-for standard), and (iii) a deliberate decision to withhold it.”

– then “consider whether, in combination and viewed in light of all the trial evidence, specific intent to deceive is clear and convincing.” • This is the point where explanations (or lack of) is considered.

– Sanghera and Pope knew of the EPO briefs, they knew that the EPO

briefs were material (using the but-for standard), they made a conscious decision to withhold, and intent to deceive is the single most reasonable inference.

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REMAND: Therasense, Inc. v. Becton, Dickinson and Co., 2012 WL 1038715 (N.D.Cal. Mar. 27, 2012)

MOVE TO “SINGLE MOST REASONABLE INFERENCE” STARTED PRE-THERASENSE

Lazare Kaplan Intern., Inc. v. Photoscribe Technologies, Inc., 628 F.3d 1359 (Fed. Cir. 2010)

LINN, Lourie, Friedman

No inequitable conduct

“mistake or exercise of poor judgment … does not support an inference of intent to deceive.”

Ring Plus, Inc. v. Cingular Wireless Corp., 614 F.3d 1354 (Fed. Cir. 2010)

MOORE, Lourie, Gajarsa


If multiple reasonable inferences, error to overlook one in favor of another equally reasonable inference.

Cancer Research Technology Ltd. v. Barr Laboratories, Inc., 625 F.3d 724 (Fed.Cir. 2010)

LOURIE, Newman, Prost)(Prost dissenting


• Without direct evidence of intent to deceive, then intent to deceive satisfied if it is the "only reasonable inference.”

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http://office.microsoft.com/en-us/images/MC900440407.aspx

http://office.microsoft.com/en-us/images/MC900440407.aspx

“SINGLE MOST REASONABLE INFERENCE”

• Ring Plus, Inc. v. Cingular Wireless Corp., 614 F.3d 1354 (Fed. Cir.

2010)(MOORE, Lourie, Gajarsa)

– Basis for inequitable conduct allegation: misrepresentation of two

references in both the Background of the Invention and in an amendment.

• Background: identified references and stated “there is no algorithm or software

proposed for operating the telephone system.

• Amendment: claimed system different from references because it “only

generates [a] message when the phone line between the caller and the

recipient is not busy.”

– DC: references disclose software-based algorithms and playing a sound

presentation only when the recipient line is not busy. -> material

misrepresentations. Single most reasonable inference was intent to

deceive.

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“SINGLE MOST REASONABLE INFERENCE”

• Ring Plus (con’t)

– FC:

• “Any inference of deceptive intent must be ‘the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard.’ Star Scientific, 537 F.3d at 1366.”

• “Whenever evidence proffered to show either materiality or intent is susceptible of multiple reasonable inferences, a district court clearly errs in overlooking one inference in favor of another equally reasonable inference.” [quoting Scanner Techs.]

• “Mr. Schaap's testimony gives rise to the inference that applicants believed that Strietzel and Sleevi did not disclose software for operating a telephone system. Based on the evidence of record, this inference is as reasonable as the court's inference of deceptive intent, particularly in view of the references' ambiguity as to operating software. Thus, the district court clearly erred in finding clear and convincing evidence of deceptive intent.”

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A NON-FRAUDULENT REASON FOR NON-DISCLOSURE?

• Cancer Research Technology Ltd. v. Barr Laboratories, Inc., 625 F.3d 724 (Fed.Cir. 2010)

– FC: Reversed judgment of inequitable conduct.

• “an equally reasonable inference to draw from the

evidence is that Stevens viewed publication of all the data as important to his career as a scientist but did not appreciate their potential importance to the patentability of the tetrazine derivatives patent claims.”

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CASES WHERE COURT FOUND INEQUITABLE CONDUCT BUT MIGHT HAVE COME OUT DIFFERENTLY IF

“ONLY REASONABLE INFERENCE” APPLIED

• Cargill, Inc. v. Canbra Foods (Fed. Cir. 2007): Patentee argued nondisclosed test results not comparable.

• Pharmacia Corp. v. Par Pharmaceutical, Inc. (Fed. Cir. 2005): Patentee argued mistake in verb tense was accidental, and declarant had good faith belief in statements made in declaration even though not based on actual tests.

• Bristol-Myers Squibb v. Rhône-Poulenc Rorer (Fed. Cir. 2003)‎: Attorney testified believed nondisclosed article was irrelevant.

• Aventis v. Amphastar (Fed. Cir. 2008). Patentee explained why comparison at different dosages reasonable.

• Taltech Ltd. v. Esquel Enterprises Ltd. (Fed. Cir. 2010). Gajarsa, dissenting: “district court drew an inference of bad faith despite an equally plausible, and likely more reasonable, inference of good faith.”

• Onstar, LLC v. Micral, Inc. (N.D.Ohio April 7, 2010). Patentee “believed that citing to the ‘389 application in the ‘663 Rule 47(b) Petition was sufficient to disclose the material information to the Patent Office.”

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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

• Disclosure of prior art reference “buried” in an IDS; good faith explanation

• Compliance with standard PTO procedure for delayed payment, though delay may not have been unintentional

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Inequitable Conduct

• Withholding material information

• Concealing third party’s involvement in claimed invention

• Submission of false declaration

• Affirmative misrepresentations of prior art and test results

FEDERAL CIRCUIT: INEQUITABLE CONDUCT POST-THERASENSE

Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012)

PROST, Linn, Dyk Affirmed inequitable conduct

Withheld references material

No credible explanation why disclosed to FDA but not PTO

Apotex Inc. v. Cephalon, Inc., 2011 WL 6090696 (E.D. Pa. 2011), aff’d without opinion (Fed. Cir. April 8, 2013)

PER CURIAM (Rader, Lourie, O’Malley

Affirmed inequitable conduct

Concealed supplier’s involvement in claimed invention

No alternative explanation why told PTO it modified Lafon’s modafinil when it did not.

Intellect Wireless, Inc. v. HTC Corp., 732 F.3d 1339 (Fed. Cir. 2013)

MOORE, Prost, O’Malley


Submission of false declaration = affirmative egregious misconduct

Pattern of conduct showed intent to deceive: similar false statements in related patents; never notified examiner of error in the declaration or attempted to correct it.

Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333 (Fed. Cir. 2013)

REYNA, Bryson, Dyk Reversed SJ of no inequitable conduct

Failure to disclose material information = 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.”

Query whether decided same way if claims subject to AIA §102 (secret sale not prior art)

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FEDERAL CIRCUIT: INEQUITABLE CONDUCT POST-THERASENSE (con’t)

Apotex, Inc. v. UCB, Inc., 763 F.3d 1354 (Fed. Cir. 2014)

REYNA, Wallach, and Hughes


Affirmative misrepresentations of prior art and test results

Pattern of conduct showed intent to deceive.

American Calcar, Inc. v. American Honda Motor Co., Inc., 768 F.3d 1185 (Fed. Cir. 2014)

PROST, Wallach Dissent - Newman


Failure to disclose material information

“Mr. Obradovich deliberately decided to withhold the information from the PTO.”

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DISTRICT COURT: INEQUITABLE CONDUCT POST-THERASENSE

Worldwide Home Prods., Inc. v. Time, Inc., 1:11-cv-03633 (S.D.N.Y. Sept. 30, 2013)(SUMMARY JUDGMENT)

Swain Misrepresentation about prior art was basis for overcoming prior art rejection (“but for” materiality)

Defendants’ counsel alerted applicant of inaccurate description prior to the Notice of Allowance, but applicant did not correct ->specific intent to deceive is single most reasonable inference

Ohio Willow Wood Co. v. Alps South LLC, 2:04-cv-1223 (S.D.Ohio Sept. 24, 2014)

Frost Withheld material information and did not correct misrepresentation

“the most reasonable inference to be drawn from the evidence is that OWW acted with deceptive intent in misrepresenting the existence of evidence corroborating the [expert] testimony.”

Graphics Properties Holdings, Inc. v. Google, Inc., 2014 WL 6629021 (D.Del. Nov. 20, 2014)

Stark Withheld a Federal Circuit decision on the disclosure of a parent patent specification

“undisputed that the examiner was not given actual notice of the Federal Circuit's subsequent decision.” Therefore, the court allowed amendment of the complaint to allege inequitable conduct.

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FEDERAL CIRCUIT: NO INEQUITABLE CONDUCT POST-THERASENSE

Network Signature, Inc. v. State Farm Mut. Auto. Ins. Co., 731 F. 3d 1239 (Fed. Cir. 2013)

NEWMAN, Dissent - Clevenger

Reversed SJ of inequitable conduct

Use of PTO form to pay maintenance fee despite intentional decision to abandon

Patent owner acted promptly upon learning of commercial interest and standard form does not require explanation

1st Media, LLC v. Electronic Arts, Inc., 694 F. 3d 1367 (Fed. Cir. 2012)

LINN, Wallach, Rader

Reversed SJ of inequitable conduct

Withholding 3 material references from related prosecution

No intent - no evidence of deliberate decision to withhold references

Cordis Corp. v. Boston Scientific Corp., 658 F.3d 1347 (Fed. Cir. 2011)

GAJARSA, Bryson, Mayer

Affirmed – no inequitable conduct

Initially failed to disclose prior art; disclosed later without emphasis

intent to deceive was not the single most reasonable inference

Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285 (Fed. Cir. 2012)

PER CURIAM, Newman, Prost, O’Malley Concurring-in-part/dissenting-in-part - Newman

Reversed inequitable conduct finding

Failure to disclose litigation of related patent; incorrect claim of “small entity” status

Validity not at issue in litigation at the time; good faith mistake on small entity status; no evidence of deceptive intent

AstraZeneca v. Aurobindo Pharma Ltd., 703 F. 3d 511 (Fed. Cir. 2012)

No inequitable conduct affirmed

Failure to disclose prior art references; disclosed upon discovery in reissue

No deceptive intent, only genuine mistakes that did not negate patentability

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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.

POST-THERASENSE: Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012)

Inequitable conduct upheld

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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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POST-THERASENSE: 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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• 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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• 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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POST-THERASENSE: 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.’

42



• 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.”

43



• 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

– 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.”

44

POST-THERASENSE: Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333 (Fed. Cir. 2013)

Fact issue precluded summary judgment of no inequitable conduct

• On Remand at the District Court: 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.”

45

POST-THERASENSE: Ohio Willow Wood Co. v. Alps South, LLC, 2014 WL 4775374 (S.D. Ohio Sept. 24, 2014)

Unenforceable for inequitable conduct

• 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.”

46

POST-THERASENSE: Apotex, Inc. v. UCB, Inc.,

763 F.3d 1354 (Fed. Cir. 2014) Inequitable conduct upheld

• 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.”

47

POST-THERASENSE: Apotex, Inc. v. UCB, Inc.,


• 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.”

48

POST-THERASENSE: American Calcar, Inc. v. American Honda Motor Co., Inc.,


• 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.

49

POST-THERASENSE: American Calcar, Inc. v. American Honda Motor Co., Inc.,


• 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.

50

POST-THERASENSE: Worldwide Home Prods., Inc. v. Time, Inc.,

1:11-cv-03633 (S.D.N.Y. Sept. 30, 2013) Unenforceable for inequitable conduct

• 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.”

51

POST-THERASENSE: Worldwide Home Prods., Inc. v. Time, Inc.,

1:11-cv-03633 (S.D.N.Y. Sept. 30, 2013) Unenforceable for Inequitable conduct

• 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. June 4, 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.

52

POST-THERASENSE: 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 alleges 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.

53


Motion to Amend Complaint to assert Inequitable Conduct Granted

• 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.”

54


Motion to Amend Complaint to assert Inequitable Conduct Granted

• 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 for 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.’”

55

POST-THERASENSE: Network Signatures, Inc. v. State Farm Mut. Auto. Ins. Co.,

731 F. 3d 1239 (Fed. Cir. 2013) Reversed MSJ of inequitable conduct

• 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.”

56

POST-THERASENSE: 1st Media, LLC v. Electronic Arts, Inc.,

694 F. 3d 1367 (Fed. Cir. 2012) Reversed MSJ of inequitable conduct

• 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.

57

POST-THERASENSE: Cordis Corp. v. Boston Scientific Corp., 658 F.3d 1347 (Fed. Cir. 2011) No inequitable conduct upheld

• 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.”

58

POST-THERASENSE: Outside the Box Innovations, LLC v. Travel Caddy, Inc.,

695 F.3d 1285 (Fed. Cir. 2012) Inequitable conduct reversed

• 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.”

59

POST-THERASENSE: Outside the Box Innovations, LLC v. Travel Caddy, Inc.,

695 F.3d 1285 (Fed. Cir. 2012) Inequitable conduct reversed

https://a.next.westlaw.com/Link/Document/FullText?findType=L&pubNum=1000547&cite=37CFRS1.28&originatingDoc=I30f3e52703f411e2b11ea85d0b248d27&refType=LQ&originationContext=document&transitionType=DocumentItem&contextData=(sc.Keycite)




• 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.”

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POST-THERASENSE: In re Rosuvastatin Calcium Patent Litigation,

AstraZeneca v. Aurobindo Pharma Ltd, 703 F. 3d 511 (Fed. Cir. 2012) No inequitable conduct upheld

• 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

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• 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 there from 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])

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• 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.

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• §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

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• 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?

65

• § 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

66

SUPPLEMENTAL EXAMINATION STATS SO FAR

Source: http://www.uspto.gov/aia_implementation/statistics.jsp 67

Supp Exam Stats from USPTO Annual Report (as of Sept. 30, 2014)

Supp Exam Stats from USPTO Annual Report (as of Sept. 30, 2014)

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? Why?

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)

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• New 35 U.S.C. §288: – Whenever, without deceptive intention, a claim of a

patent is invalid, an action may be maintained for the infringement of a claim of the patent which may be valid.

• Although not invalid, remaining patent claims may nonetheless be

unenforceable based upon the inequitable conduct of an “unclean litigant.” Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806, 814-15 (1945). -> ????

AIA REMOVED “WITHOUT DECEPTIVE INTENTION” FROM 35 U.S.C.

71

• Therasense is binding precedent.

• Probably most practitioners won’t change Rule 56 disclosure practices very much for now.

WHAT SHOULD A PRACTITIONER DO?

72

• 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

73

• 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

74

• 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?


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• 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)


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• 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)


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CONSIDERATIONS FOR DRAFTING AND PROSECUTING CLAIMS THAT WILL WITHSTAND IPR/PGR ATTACK

• Strong patentability positions during drafting and prosecution.

– Supporting declarations

• Consider Therasense

• Declarations need to be as solid as possible. PTAB has found that defective

declarations relied on for patentability during prosecution can form an

independent basis for instituting an IPR.

– K-40 Electronics, LLC v. Escort, Inc., IPR2013-00203, Paper 6 (PTAB Aug. 29, 2013)

• Board reviewed a § 1.131 declaration from the prosecution, found it deficient, and

reapplied the prior art the declaration had antedated, instituting the IPR.

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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,…”

79

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

[email protected]

Jennifer M. K. Rogers

[email protected]

Margaret Sampson

[email protected]

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