Transcript Therasense v. Becton Dickinson and Bayer

Therasense v.
Becton Dickinson and
Bayer
John M. Whealan
Associate Dean for IP Law
George Washington Law School
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How did we get here?
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‘551 patent (U.S. Patent No. 5,820,551)
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technology involves disposable blood glucose test strips
claim feature – no membrane is required for the sensor when
blood is tested
Therasense sued BD and Bayer for patent infringement
of the ‘551 patent
BD and B asserted, inter alia, that
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‘551 patent was invalid as obvious
‘551 patent was unenforceable due to IC
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How did we get here?
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DCT
Found patent invalid as obvious
 Found inequitable conduct (IC)
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Federal Circuit
Affirmed on obviousness
 Affirmed on IC
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J. Linn – strong dissent on IC
Therasense filed a petition for en banc review
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Federal Circuit granted en banc
review
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1. Should the materiality-intent-balancing framework for inequitable conduct be modified or
replaced?
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. 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. 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 standard for fraud or unclean hands?
3. What is the proper standard for materiality? What role should the United States Patent and
Trademark Office’s rules play in defining materiality? Should a finding of materiality require that
but for the alleged misconduct, one or more claims would not have issued?
4. Under what circumstances is it proper to infer intent from materiality? See Kingsdown Med.
Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc).
5. Should the balancing inquiry (balancing materiality and intent) be abandoned?
6. Whether the standards for materiality and intent in other federal agency contexts or at
common law shed light on the appropriate standards to be applied in the patent context.
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Therasense outside counsel
legal team
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Rohit K. Singla
Peter A. Detre
Jeffrey I. Weinberger
MUNGER, TOLLES & OLSON LLP
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Jeffrey A. Lamken
Michael G. Pattillo Jr.
MOLOLAMKEN LLP
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John M. Whealan
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Therasense Opening Brief
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I. Courts May Render a Patent Unenforceable for
Inequitable Conduct Only Where the Patent Was
Procured Through Conduct Tantamount to fraud
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A. Supreme Court Precedent Recognizes Inequitable
Conduct Only in Cases of Egregious, Fraud-Like Conduct
B. Trademark and Copyright Impose Similarly Exacting
Requirements
C. Congress Adopted the “Unenforceability” Defense
Against the Backdrop of a “Fraudulent Procurement”
Standard
D. Unclean-Hands Principles Support a Fraud-Based Limit
Where, as Here, Important Property Rights Are at Stake
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Therasense Opening Brief
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II. Under This Court’s En Banc Precedent, Inequitable
Conduct Requires a Showing That the Patentee Acted
With Specific Intent To Deceive the PTO into
Granting the Patent
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A. This Court Should Reinvigorate Kingsdown’s
Requirement of Specific Intent To Deceive the PTO
B. Supreme Court Precedent Supports Kingsdown’s “Intent
To Deceive” Standard
C. Kingsdown’s Intent Standard Is Consistent With Other
Areas of Intellectual Property Law
D. Sound Policy Considerations Support the Kingsdown
Standard
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Therasense Opening Brief
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III. A Patent Should Be Unenforceable for
Inequitable Conduct Only Where the Patent
Would Not Have Issued Absent the Misconduct
A. Supreme Court Precedent Requires But-For
Causation
 B. But-For Causation Is Required in Related
Contexts
 C. Courts Should Not Render Valuable Patents
Unenforceable Based on Violations of PTO Rules
Where Causation Is Unproved
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Therasense Opening Brief
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IV. The Court Should Eliminate Sliding-Scale
Balancing Because It Dilutes Both the Intent
and Materiality Requirements
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Therasense Opening Brief
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V. This Case Illustrates Why This Court Must
Revitalize Inequitable Conduct Standards
A. The Panel Opinion Improperly Substitutes
Materiality for Proof of Intent Under a Diluted
Standard
 B. Pope and Sanghera’s Interpretation of Dost’s
Arguments Was at Least Reasonable
 C. The Panel Decision Abrogates the Rule That
Lawyer-Argument Is Not Material
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Amicus Briefs
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Government
1.
Brief for the United States
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Bar Organizations
2.
American Bar Association
3.
Federal Circuit Bar
4.
American Intellectual Property Law Association
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Houston Intellectual Property Law Association
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San Diego Intellectual Property Law Association
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Washington State Patent Law Association
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Intellectual Property Law Association of Chicago
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Conejo Valley Bar Association
10. Boston Patent Law Association
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Amicus Briefs
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Public Interest Organizations
11. Washington Legal Foundation
12. Intellectual Property Owners Association
13. Biotechnology Industry Organization
14. International Intellectual Property Institute
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Academics
15. Seven Intellectual Property Law Professors
16. University of Kentucky Intellectual Property Law Society
17. Professor David Hricik
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Lawyers
18. 22 Patent Prosecution Firms and Practitioners
19. 43 Patent Practitioners Employed by Eli Lilly and Company
20. Patterson Thuente Christensen Pedersen, P.A.
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Amicus Briefs
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Corporations
21. Eisai Co., Ltd. and Eisai Inc.
22. Sanofi-Aventis and Microsoft Corporation
23. Ecore International, Inc.
24. SAP America, Inc.
25. Johnson & Johnson and The Procter & Gamble Company
26. Verizon Communications Inc.
27. Dolby Laboratories, Inc.
28. Ole K. Nilssen and Geo Foundation, Ltd.
29. Apotex, Inc.
30. Acacia Research Corporation and 1st Media, LLC
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Amicus Briefs
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Amici Supporting Appellees
31. Teva Pharmaceuticals USA, Inc., Cisco
Systems, Inc. and Generic Pharmaceutical
Association
32. Intel Corporation
33. University of Akron School of Law, Center
for Intellectual Property Law and Technology
34. Association of Citizens for Patent Protection
in the Public Interest
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Opposition Briefs
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Bayer and BD each filed briefs in opposition
However, it is interesting what issues:
(i) they agree with us on, and
 (ii) where they disagree
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Therasense Reply Brief
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The parties - and most amici - agree on the
following:
Kingsdown’s Specific-Intent-To-Deceive Standard
Should Govern
 “Reasonable examiner” standard for materiality
should be abandoned
 “Materiality-Intent Balancing” Should Be
Abandoned or Reformed
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Therasense Reply Brief
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Disagreements:
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1. Test for materaility
Fraud-like “but for”, or
 PTO Rule 56
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2. Parties disagree on the merits
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Therasense Reply Brief
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Inequitable Conduct Should Require Causation
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A. Causation Is Required for Fraud and Unclean Hands
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1. The Foundational Supreme Court Cases Require Fraud or FraudLike Conduct
2. “Unclean Hands” Requires But-For Causation Where Important
Rights Will Be Invalidated
B. But-For Causation Is Required in Related Contexts
C. The Proposal To Adopt Rule 56 Is Contrary to Law
D. Defendants’ Policy Arguments Lack Merit
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Therasense Reply Brief
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The Finding of Inequitable Conduct by the
DCT here Must Be Reversed
A. The District Court’s Use of an Erroneous
Standard Precludes Affirmance
 B. The Evidence of Intent To Deceive Falls Short
 C. Materiality Was Absent
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En banc oral argument
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Tuesday, Nov. 9, 2010
http://www.cafc.uscourts.gov/oral-argumentrecordings/all/therasense.html
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Questions?
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Thank you…..
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Contact information:
202-994-2195
 [email protected]
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