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Therasense v. Therasense v. Becton Dickinson Becton Dickinson

and Bayerand BayerJohn M. WhealanJohn M. Whealan

Associate Dean for IP LawAssociate Dean for IP Law

George Washington Law George Washington Law SchoolSchool

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How did we get here?How did we get here?

‘‘551 patent (U.S. Patent No. 5,820,551)551 patent (U.S. Patent No. 5,820,551) technology involves disposable blood glucose technology involves disposable blood glucose

test stripstest strips claim feature – no membrane is required for claim feature – no membrane is required for

the sensor when blood is testedthe sensor when blood is tested Therasense sued BD and Bayer for patent Therasense sued BD and Bayer for patent

infringement of the ‘551 patentinfringement of the ‘551 patent BD and B asserted, inter alia, thatBD and B asserted, inter alia, that

‘‘551 patent was invalid as obvious551 patent was invalid as obvious ‘‘551 patent was unenforceable due to IC551 patent was unenforceable due to IC

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How did we get here?How did we get here?

DCTDCT Found patent invalid as obviousFound patent invalid as obvious Found inequitable conduct (IC)Found inequitable conduct (IC)

Federal CircuitFederal Circuit Affirmed on obviousnessAffirmed on obviousness Affirmed on ICAffirmed on IC

J. Linn – strong dissent on ICJ. Linn – strong dissent on IC

Therasense filed a petition for en Therasense filed a petition for en banc reviewbanc review

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Federal Circuit granted en Federal Circuit granted en banc reviewbanc review

1. Should the materiality-intent-balancing framework for inequitable 1. Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?conduct be modified or replaced?

2. If so, how? In particular, should the standard be tied directly to fraud 2. If so, how? In particular, should the standard be tied directly to fraud or unclean hands? See Precision Instrument Mfg. Co. v. Auto. Maint. or unclean hands? See Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945); Hazel-Atlas Glass Co. v. Hartford- Empire Mach. Co., 324 U.S. 806 (1945); Hazel-Atlas Glass Co. v. Hartford- Empire Co., 322 U.S. 238 (1944), overruled on other grounds by Standard Oil Co. Co., 322 U.S. 238 (1944), overruled on other grounds by Standard Oil Co. v. United States, 429 U.S. 17 (1976); Keystone Driller Co. v. Gen. v. United States, 429 U.S. 17 (1976); Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933). If so, what is the appropriate Excavator Co., 290 U.S. 240 (1933). If so, what is the appropriate standard for fraud or unclean hands?standard for fraud or unclean hands?

3. What is the proper standard for materiality? What role should the 3. What is the proper standard for materiality? What role should the United States Patent and Trademark Office’s rules play in defining United States Patent and Trademark Office’s rules play in defining materiality? Should a finding of materiality require that but for the materiality? Should a finding of materiality require that but for the alleged misconduct, one or more claims would not have issued?alleged misconduct, one or more claims would not have issued?

4. Under what circumstances is it proper to infer intent from materiality? 4. Under what circumstances is it proper to infer intent from materiality? See Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 See Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc).(Fed. Cir. 1988) (en banc).

5. Should the balancing inquiry (balancing materiality and intent) be 5. Should the balancing inquiry (balancing materiality and intent) be abandoned?abandoned?

6. Whether the standards for materiality and intent in other federal 6. Whether the standards for materiality and intent in other federal agency contexts or at common law shed light on the appropriate agency contexts or at common law shed light on the appropriate standards to be applied in the patent context.standards to be applied in the patent context.

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Therasense outside counsel Therasense outside counsel

legal teamlegal team Rohit K. SinglaRohit K. Singla

Peter A. DetrePeter A. DetreJeffrey I. WeinbergerJeffrey I. WeinbergerMUNGER, TOLLES & OLSON LLPMUNGER, TOLLES & OLSON LLP

Jeffrey A. LamkenJeffrey A. LamkenMichael G. Pattillo Jr.Michael G. Pattillo Jr.MOLOLAMKEN LLPMOLOLAMKEN LLP

John M. WhealanJohn M. Whealan

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Therasense Opening Therasense Opening BriefBrief

I. Courts May Render a Patent Unenforceable for I. Courts May Render a Patent Unenforceable for Inequitable Conduct Only Where the Patent Was Inequitable Conduct Only Where the Patent Was Procured Through Conduct Tantamount to fraudProcured Through Conduct Tantamount to fraud A. Supreme Court Precedent Recognizes Inequitable A. Supreme Court Precedent Recognizes Inequitable

Conduct Only in Cases of Egregious, Fraud-Like Conduct Only in Cases of Egregious, Fraud-Like Conduct Conduct

B. Trademark and Copyright Impose Similarly B. Trademark and Copyright Impose Similarly Exacting RequirementsExacting Requirements

C. Congress Adopted the “Unenforceability” Defense C. Congress Adopted the “Unenforceability” Defense Against the Backdrop of a “Fraudulent Procurement” Against the Backdrop of a “Fraudulent Procurement” Standard Standard

D. Unclean-Hands Principles Support a Fraud-Based D. Unclean-Hands Principles Support a Fraud-Based Limit Where, as Here, Important Property Rights Are Limit Where, as Here, Important Property Rights Are at Stakeat Stake

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Therasense Opening Therasense Opening BriefBrief

II. Under This Court’s En Banc Precedent, II. Under This Court’s En Banc Precedent, Inequitable Conduct Requires a Showing Inequitable Conduct Requires a Showing That the Patentee Acted With Specific That the Patentee Acted With Specific Intent To Deceive the PTO into Granting Intent To Deceive the PTO into Granting the Patent the Patent A. This Court Should Reinvigorate Kingsdown’s A. This Court Should Reinvigorate Kingsdown’s

Requirement of Specific Intent To Deceive the Requirement of Specific Intent To Deceive the PTO PTO

B. Supreme Court Precedent Supports B. Supreme Court Precedent Supports Kingsdown’s “Intent To Deceive” StandardKingsdown’s “Intent To Deceive” Standard

C. Kingsdown’s Intent Standard Is Consistent C. Kingsdown’s Intent Standard Is Consistent With Other Areas of Intellectual Property LawWith Other Areas of Intellectual Property Law

D. Sound Policy Considerations Support the D. Sound Policy Considerations Support the Kingsdown StandardKingsdown Standard

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Therasense Opening Therasense Opening BriefBrief

III. A Patent Should Be Unenforceable III. A Patent Should Be Unenforceable for Inequitable Conduct Only Where for Inequitable Conduct Only Where the Patent Would Not Have Issued the Patent Would Not Have Issued Absent the Misconduct Absent the Misconduct A. Supreme Court Precedent Requires But-A. Supreme Court Precedent Requires But-

For CausationFor Causation B. But-For Causation Is Required in B. But-For Causation Is Required in

Related ContextsRelated Contexts C. Courts Should Not Render Valuable C. Courts Should Not Render Valuable

Patents Unenforceable Based on Violations Patents Unenforceable Based on Violations of PTO Rules Where Causation Is Unprovedof PTO Rules Where Causation Is Unproved

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Therasense Opening Therasense Opening BriefBrief

IV. The Court Should Eliminate IV. The Court Should Eliminate Sliding-Scale Balancing Because It Sliding-Scale Balancing Because It Dilutes Both the Intent and Dilutes Both the Intent and Materiality RequirementsMateriality Requirements

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Therasense Opening Therasense Opening BriefBrief

V. This Case Illustrates Why This Court V. This Case Illustrates Why This Court Must Revitalize Inequitable Conduct Must Revitalize Inequitable Conduct Standards Standards A. The Panel Opinion Improperly A. The Panel Opinion Improperly

Substitutes Materiality for Proof of Intent Substitutes Materiality for Proof of Intent Under a Diluted Standard Under a Diluted Standard

B. Pope and Sanghera’s Interpretation of B. Pope and Sanghera’s Interpretation of Dost’s Arguments Was at Least Reasonable Dost’s Arguments Was at Least Reasonable

C. The Panel Decision Abrogates the Rule C. The Panel Decision Abrogates the Rule That Lawyer-Argument Is Not MaterialThat Lawyer-Argument Is Not Material

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Amicus BriefsAmicus Briefs GovernmentGovernment 1.1. Brief for the United States Brief for the United States

Bar OrganizationsBar Organizations2.2. American Bar AssociationAmerican Bar Association3.3. Federal Circuit BarFederal Circuit Bar4.4. American Intellectual Property Law Association American Intellectual Property Law Association 5.5. Houston Intellectual Property Law AssociationHouston Intellectual Property Law Association6.6. San Diego Intellectual Property Law AssociationSan Diego Intellectual Property Law Association7.7. Washington State Patent Law AssociationWashington State Patent Law Association8.8. Intellectual Property Law Association of ChicagoIntellectual Property Law Association of Chicago9.9. Conejo Valley Bar AssociationConejo Valley Bar Association10.10. Boston Patent Law AssociationBoston Patent Law Association

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Amicus BriefsAmicus Briefs Public Interest OrganizationsPublic Interest Organizations

11.11. Washington Legal FoundationWashington Legal Foundation12.12. Intellectual Property Owners AssociationIntellectual Property Owners Association13.13. Biotechnology Industry OrganizationBiotechnology Industry Organization14.14. International Intellectual Property InstituteInternational Intellectual Property Institute

AcademicsAcademics15.15. Seven Intellectual Property Law Professors Seven Intellectual Property Law Professors 16.16. University of Kentucky Intellectual Property Law SocietyUniversity of Kentucky Intellectual Property Law Society17.17. Professor David HricikProfessor David Hricik

LawyersLawyers18.18. 22 Patent Prosecution Firms and Practitioners22 Patent Prosecution Firms and Practitioners19.19. 43 Patent Practitioners Employed by Eli Lilly and 43 Patent Practitioners Employed by Eli Lilly and CompanyCompany20.20. Patterson Thuente Christensen Pedersen, P.A.Patterson Thuente Christensen Pedersen, P.A.

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Amicus BriefsAmicus Briefs CorporationsCorporations

21.21. Eisai Co., Ltd. and Eisai Inc.Eisai Co., Ltd. and Eisai Inc.22.22. Sanofi-Aventis and Microsoft CorporationSanofi-Aventis and Microsoft Corporation23.23. Ecore International, Inc.Ecore International, Inc.24.24. SAP America, Inc.SAP America, Inc.25.25. Johnson & Johnson and The Procter & Gamble Johnson & Johnson and The Procter & Gamble CompanyCompany26.26. Verizon Communications Inc.Verizon Communications Inc.27.27. Dolby Laboratories, Inc. Dolby Laboratories, Inc. 28.28. Ole K. Nilssen and Geo Foundation, Ltd. Ole K. Nilssen and Geo Foundation, Ltd. 29.29. Apotex, Inc.Apotex, Inc.30.30. Acacia Research Corporation and 1st Media, Acacia Research Corporation and 1st Media, LLCLLC

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Amicus BriefsAmicus Briefs

Amici Supporting AppelleesAmici Supporting Appellees31.31. Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals USA, Inc., Cisco Systems, Inc. and Generic Cisco Systems, Inc. and Generic Pharmaceutical AssociationPharmaceutical Association32.32. Intel CorporationIntel Corporation33.33. University of Akron School of Law, University of Akron School of Law, Center for Intellectual Property Law Center for Intellectual Property Law and Technologyand Technology34.34. Association of Citizens for Patent Association of Citizens for Patent Protection in the Public InterestProtection in the Public Interest

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Opposition BriefsOpposition Briefs

Bayer and BD each filed briefs in Bayer and BD each filed briefs in oppositionopposition

However, it is interesting what However, it is interesting what issues:issues: (i) they agree with us on, and(i) they agree with us on, and (ii) where they disagree(ii) where they disagree

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Therasense Reply BriefTherasense Reply Brief

The parties - and most amici - agree The parties - and most amici - agree on the following:on the following: Kingsdown’s Specific-Intent-To-Deceive Kingsdown’s Specific-Intent-To-Deceive

Standard Should GovernStandard Should Govern ““Reasonable examiner” standard for Reasonable examiner” standard for

materiality should be abandonedmateriality should be abandoned ““Materiality-Intent Balancing” Should Materiality-Intent Balancing” Should

Be Abandoned or ReformedBe Abandoned or Reformed

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Therasense Reply BriefTherasense Reply Brief

Disagreements:Disagreements: 1. Test for materaility1. Test for materaility

Fraud-like “but for”, orFraud-like “but for”, or PTO Rule 56PTO Rule 56

2. Parties disagree on the merits2. Parties disagree on the merits

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Therasense Reply BriefTherasense Reply Brief

Inequitable Conduct Should Require Causation Inequitable Conduct Should Require Causation A. Causation Is Required for Fraud and Unclean A. Causation Is Required for Fraud and Unclean

HandsHands 1. The Foundational Supreme Court Cases Require Fraud 1. The Foundational Supreme Court Cases Require Fraud

or Fraud-Like Conduct or Fraud-Like Conduct 2. “Unclean Hands” Requires But-For Causation Where 2. “Unclean Hands” Requires But-For Causation Where

Important Rights Will Be InvalidatedImportant Rights Will Be Invalidated B. But-For Causation Is Required in Related B. But-For Causation Is Required in Related

ContextsContexts C. The Proposal To Adopt Rule 56 Is Contrary to C. The Proposal To Adopt Rule 56 Is Contrary to

Law Law D. Defendants’ Policy Arguments Lack MeritD. Defendants’ Policy Arguments Lack Merit

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Therasense Reply BriefTherasense Reply Brief

The Finding of Inequitable Conduct The Finding of Inequitable Conduct by the DCT here Must Be Reversedby the DCT here Must Be Reversed A. The District Court’s Use of an A. The District Court’s Use of an

Erroneous Standard Precludes Erroneous Standard Precludes AffirmanceAffirmance

B. The Evidence of Intent To Deceive B. The Evidence of Intent To Deceive Falls ShortFalls Short

C. Materiality Was AbsentC. Materiality Was Absent

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En banc oral argumentEn banc oral argument

Tuesday, Nov. 9, 2010Tuesday, Nov. 9, 2010 http://www.cafc.uscourts.gov/oral-http://www.cafc.uscourts.gov/oral-

argument-recordings/all/argument-recordings/all/therasense.htmltherasense.html

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Questions?Questions?

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Thank you…..Thank you…..

Contact information:Contact information: 202-994-2195202-994-2195 jwhealan@law.gwu.edujwhealan@law.gwu.edu