1. Protect Your Patents from Inequitable Conduct Charges July 22, 2010

2. 2 Your Presenters

3. 3 Background Each individual "associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the [U.S. Patent and Trademark ] Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability." 37 C.F.R. 1.56. Common breaches include: –failure to submit material prior art known by the applicant; –rejections of substantially similar claims and references and office actions from related applications; –misstatements of fact, including misstatements in affidavits concerning patentability; and –Misrepresentation of inventorship. Inequitable conduct is a remedy for a breach of this duty of candor and good faith. Thus, inequitable conduct is a defense against patent infringement that even in the instance that a patent is valid and infringed, if found, renders the asserted patented unenforceable.

4. 4 Background, continued Finding of inequitable conduct 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. Nobody here intends to commit inequitable conduct. Approximately 40% of all patent lawsuits include an inequitable conduct pleading 1. 1 C. E. Mammen, Controlling the “Plague”: Reforming The Doctrine of Inequitable Conduct, Berkeley Technology Law Journal, 2009

5. 5 Background, continued Materiality and intent are balanced. Thus, our focus is on: 1.identifying potentially material information and 2.minimizing the likelihood that one could argue an intent from the circumstances surrounding prosecution and the potentially material information.

6. 6 Policies Contract review policy –Federal Funds –Private Contracts –Gifts / Endowments / Planned Giving –Confidentiality / Material Transfers Research and invention policy –Notebook policy –Publication policy Invention Disclosure –Process / procedure, generally –Intake –Interviews –Disclosure “incentive” program Equity Review –Process / Procedure, generally –Funding source determination, process / procedure –Inventorship determination, process / procedure –Dispute resolutions Election of Title –Federally-funded inventions –Privately-funded inventions –Mixed-funding inventions –Joint inventions Inter-Institutional Agreements –Assignment Policy

7. 7 Tension between publication and patenting Academic mission: –Pursuit of academic freedom and dissemination of information through publication and presentation of research results. –Attribution. –Authorship conventions. Patent process: –A tradeoff of a limited monopoly for the dissemination of novel and non-obvious inventions through the patent process. –Disclosure. –Inventorship determinations.

8. 8 Disclosure Analysis: Duty of Disclosure Consider Obvious Sources of Material Information –Papers –Presentations –Grant applications Consider Less-Obvious Sources of Material Information –Posters –Abstracts –Online publications –Non-disclosure agreements –Consulting agreements –Open thesis defense –Department/campus seminars

9. 9 Disclosure Analysis: Duty of Disclosure, Continued Consider implications of collaboration –Intra-institutional Familiarity of each faculty member to patent process Departmental calendars –Inter-institutional Inter-institutional agreement –Corporate collaboration Research agreement(s) –Master-research agreement? Familiarity of corporate entity with patent process

10. 10 Disclosure Analysis: Duty of Disclosure, Continued Consider implications funding sources and implications of invention title. –Federally-funded inventions  Grants and publications –Privately-funded inventions  Public disclosures, consulting arrangements, potential offers for sale –Mixed-funding inventions  Combination of above –Inter-institutional or multi-funded inventions  Coordinating all of the above with another institution and/or multiple corporations

11. 11 Disclosure Analysis: Inventorship Inventorship is a legal determination of who conceived of the subject matter claimed in patent application. Under U.S. case law, an inventor is the one with "intellectual domination 2 " "[T]he threshold question" of inventorship is" who conceived the invention". Generally, conception is "the complete performance of the mental part of the inventive act", and "the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is thereafter to be applied in practice…" 3 2 Morse v. Porter, 155 USPQ 280, 283 (Bd. Pat. Inter. 1965) 3 Townsend v. Smith, 36 F.2d 292, 295, 4 USPQ 269, 271 (CCPA 1930)

12. 12 Disclosure Analysis: Inventorship, continued Disclosure analysis –Review disclosure using knowledge of faculty members, generally, and knowledge gained from above analysis. –Consider relative status of co-authors. –Consider source of disclosure materials. Ph.D. thesis  Advisor or other students co- inventors? Academic Publication  Author = inventor? Presentation  Presenter = inventor?

13. 13 Patent Preparation: Inventorship Patent Drafting Analysis –Analyze/discuss initial inventorship listed on disclosure. Discuss authorship vs. inventorship. Discuss inventorship vs. ownership (exclude intra-institutional, inter-institutional, corporate collaboration agreements from meeting). Attempt to determine relative contributions prior to commencement of the drafting process. –Conduct updated inventorship analysis upon conversion of a provisional/preparation of a continuation or divisional.

14. 14 Patent Preparation: Duty of Disclosure Identify and secure copies of all prior-art materials as early as possible. Attempt to date all un-dated publications (e.g., abstracts, posters, public disclosures, etc.). Prepare IDS with contemporaneously with application preparation (even provisional applications).

15. 15 Patent Preparation: Priority Claims Priority claims bring early filing priorities and: –Funding questions. –Inventorship questions. –Disclosure questions. –Prior-art implications.

16. 16 Patent Preparation: Enablement and Written Description 35 U.S.C. § 112, first paragraph, contains a written description requirement that is separate from the enablement requirement. 4 An application must include a description with as much specificity as possible disclosing what the inventors believe to be the invention. –Only inventors can make this determination. –Specifically request inventors consider whether a draft of the application meets this requirement. 4 Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (Fed. Cir. 2010)

17. 17 Patent Prosecution: Duty of Disclosure Failure to disclose a contrary decision of another examiner can be a material omission even when included in an office action in a co-pending application with no priority relationship (Dayco). Failure to disclose an Office Action in a substantively- related, co-pending application with no priority relationship can be a material omission even if the examiner has actual knowledge of the Office Action (McKesson). Failure to disclose Office Actions from related, co-pending applications can be a material omission even when the existence of the co-pending application has been disclosed and the Office Actions cites potentially cumulative prior art (Larson).

18. 18 Patent Prosecutions: 1.131 Declarations to Disqualify Prior Art Stick to the facts. Evidence conception. Evidence diligence. –Inventor diligence. –TTO diligence. –Attorney diligence. Note, reasonable backlog of unrelated cases which were taken up in substantially chronological order and carried out expeditiously by patent attorney insures to the benefit of the inventor under MPEP 2138.06.

19. 19 Patent Prosecutions: 1.132 Declarations to Disqualify Prior Art Provide objective evidence supporting facts. Qualify opinions as "based upon my/our knowledge…" or state "I/we believe…" or "To my/our knowledge…" Provide copy of inventor's CV.

20. 20 Thank you! Any Questions?