and the Duty to Disclose

Tonya Drake March 2, 2010 Inequitable conduct

Defense to infringement – A finding of inequitable conduct will render a patent unenforceable – Claims may still be valid, but be unenforceable

2 Inequitable conduct allegations

Percentage of cases including an allegation of inequitable conduct 45.00% 40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% 2000 2001 2002 2003 2004 2005 2006 2007 2008

Inequitable Conduct litigation “has become an absolute plague.” – Dickson Indus. (Fed. Cir. 2009)

Source: Christian E. Mammen, Controlling the “Plague”: Reforming The Doctrine of Inequitable Conduct, Berkeley Technology Law Journal, 2009

3 Federal Circuit decisions

18 16 14 Inequitable Conduct 12 10 No Inequitable Conduct 8 6 Finding Vacated 4 (remanded to district Number of decisions Number 2 court) 0

1 4 7 2000 200 2002 2003 200 2005 2006 200 2008

Source: Christian E. Mammen, Controlling the “Plague”: Reforming The Doctrine of Inequitable Conduct, Berkeley Technology Law Journal, 2009

4 Inequitable conduct and the duty to disclose

Breach of the duty to disclose is the foundation of many inequitable conduct allegations Rule 56 sets out the duty to disclose

5 Rule 56 – the duty to disclose

Who? – Each individual associated with the filing and prosecution of a What? – Material information - information a reasonable examiner would consider important Why? – Examination is more effective when the examiner is aware of and evaluates all information material to

6 Two part test – materiality and intent

Requires proof of: 1) an affirmative misrepresentation of material fact, failure to disclose material information, or submission of false material information 2) by that act intended to deceive the patent office

7 Balancing of materiality and intent

Equitable balancing of materiality and intent – “when balanced against high materiality, the showing of intent can be proportionally less” Bristol-Meyers Squibb Co. (Fed. Cir. 2003) Was conduct was so culpable that the patent should be held unenforceable?

8 Materiality

Reasonable examiner standard – What would a reasonable examiner consider important in deciding whether to allow the application? Rule 56 standard – Establishes a prima facie case of unpatentability or – Refutes, or is inconsistent with positions taken by the applicant Not cumulative

9 Examples of possibly material information

Highly relevant Information that contradicts statements to the patent office Information of prior sales Co-pending applications Rejections of substantially similar claims References and office actions from related applications Related litigation information

10 Intent to deceive

Evidence must show intent to deceive – Gross negligence alone is not sufficient – Intent to withhold a reference is not sufficient However, intent to deceive may be proven by circumstantial evidence Good faith should be considered

11 Dayco v. Total Containment – 2003

Overview: A contrary decision of another examiner can be material even when included in an office action in a co-pending application in a separate family – The office action was from an application with no priority relationship to the patent in suit – The applicant had not disclosed either the co-pendency or the adverse office action

12 McKesson v. Bridge Medical – 2007

Overview: An office action in a substantively related (not by priority) co-pending application can be material – Examiner was aware of the fact of the co-pendent prosecution, but was not specifically notified of the office action BUT - the district court characterized the prosecuting attorney’s testimony as “not credible,” contradicted by the evidence, and undermined by his own prior testimony

13 Larson v. Aluminart -2009

Overview: Actions from related co- pending applications can be material even when co-pendency has been disclosed and the office actions discuss only cumulative art

14 Larson v. Aluminart

15 Larson: Materiality

Why were the 3rd and 4th office actions material? – Not simply “boilerplate reiterations of previous rejections” – The 3rd Office Action was the first to convey a specific explanation about a reference – Later withdraw of 3rd rejection did not change materiality

16 Larson - Guidance on intent

Instructed the district court to "take into account any evidence of good faith, which militates against a finding of deceptive intent" Directed the district court to consider that the patentee had disclosed the co-pending application and the 1st and 2nd office actions

17 Larson - Summary

Office actions from related, co-pending applications can be material to prosecution even where: – the fact of the co-pendency has been disclosed, and – the office actions discuss only cumulative art Notifying the examiner of related prosecution and disclosing earlier documents from that related prosecution evinces good faith

18 Practice Tips

Doubts about whether information, including office actions, should be disclosed should be resolved in favor of disclosure If applications are co-pending, notify the examiner of their co-pendency – However, merely disclosing the existence of co-pending applications or related proceedings is not necessarily sufficient Keep close track of ongoing prosecution in US and foreign counterparts – Consider citing references and office actions from related cases

19 Therasense v. Becton, Dickinson - 2010

Overview: statements made to the European Patent Office during a proceeding involving the European counterpart of another patent family were material

20 Therasense v. Becton, Dickinson

‘382 Patent EPO Counterpart Inventors Common

“optionally, but ‘551 Patent preferably” Revocation Proceeding

21 Therasense

The statements made to the EPO were material – The statements made to the EPO contradicted the statements made to the USPTO The attorney read the EPO decision and “knew or should have known that the withheld information would have been highly material to the [USPTO] examiner” Federal Circuit affirmed findings of both materiality and intent

22 Therasense - inequitable conduct should be rare

Although the court affirmed the finding of inequitable conduct, it noted that such a finding should be “rare” Judge Linn, Dissent: “…the individuals subjectively believed that the withheld information was immaterial when they withheld it”

23 Practice Tips

Be particularly vigilant when submitting affidavits – Carefully review relevant documents and publications to ensure that any affidavit is complete and accurate Keep close track of continuations, divisionals, and foreign counterparts – Do not take inconsistent positions in different jurisdictions – Consider centralized prosecution of patent families

24 Can you disclose too much?

Over citation can also result in allegations of inequitable conduct Burying a material reference is unlikely to satisfy the intent prong

25 Guidance for prosecutors

Resolve doubts in favor of disclosure Set up a standard procedure Don’t rely on the procedure to avoid citing art Consider consolidating or having someone responsible for distribution of information Only file patent applications in jurisdictions of value

26 Thank You

Tonya Drake Associate Fish & Richardson P.C.

Special Thanks To Frank Gerratana and Proshanto Mukherji for their help preparing this presentation