Laboratory Notebooks and Recordkeeping Under the AIA

1. Laboratory Notebooks and Recordkeeping Under the AIA David Albagli AIPLA Mid-Winter Institute IP Practice in Japan Committee Pre-Meeting Seminar Tampa, FL January 29, 2013

2. Disclaimer These materials are public information and have been prepared solely for educational purposes to contribute to the understanding of American intellectual property law. These materials reflect only the personal views of the 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. Thus, the authors and Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. cannot be bound either philosophically or as representatives of their 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 authors or Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. 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.

3. Reasons to Witness under Current Law • Under current patent law (pre-AIA law), the date of invention is relevant to: • Antedating a prior art reference during prosecution or during litigation • Establishing priority to an invention in an interference • Proving inventorship (proving “who,” not “when”) • Inventor testimony alone is insufficient • Primary evidence: corroborated documentation of invention • Other forms of evidence: apply a “rule of reason” to entire evidentiary record

4. Background: Corroborating Evidence • Conception must be proven by corroborating evidence – Coleman v. Dines, 754, F.2d 353 (Fed. Cir. 1985); an actual reduction to practice must be proven by corroborating evidence • Witnessing of laboratory notebooks is considered a reliable way to corroborate a date of conception if it becomes necessary in an interference proceeding - §§ 135, 291 • FY 2011: 536,604 applications filed; 64 interferences declared • Credibility of evidence is enhanced by a contemporaneous record that someone other than an inventor received and understood that recorded activities took place by a certain date • Related records may also be used: supply of reagents, requests for analysis, data, periodic reports, etc. • Evidentiary weight is strongly affected by timely, signed records of the inventor • Signed lab notebooks constitute a “best practice”

5. Reasons to Witness under New AIA Law • Under the new patent law (AIA law), the date of invention is not relevant to: • Antedating a prior art reference during prosecution or during litigation – prior art is defined relative to the filing date of the application • However, under the AIA, “who” and “when” are still relevant under some circumstances • Establishing priority to an invention in an interference – some applications that claim inventive activity after March 16, 2013 will be subject to interferences • Removing references from the prior art (prior art exceptions) • Proving inventorship (proving “who,” not “when”) • Derivation proceedings and prior user rights

6. Documenting Inventive Activity Under the AIA Witnessing notebooks and/or diligent recordkeeping will be relevant to: • Interferences in transition (mixed law) applications • Establishing prior art exceptions (grace period exceptions) under AIA §§ 102(b)(1) and (b)(2) • Establishing inventorship • Derivation proceedings • Prior User Rights (AIA § 273)

7. A. Interferences in the Transition to AIA • Claims in an application filed on or after March 16, 2013 that is subject to the AIA can also be subject to an interference if: • that application also ever contained a claim that has an effective filing date before March 16, 2013, or • any parent application ever contained such a claim • The following patent families, for example, may yield such a situation: • Pre-AIA provisional application and AIA non-provisional • Pre-AIA priority application and AIA PCT application • Pre-AIA non-provisional and AIA CIP application

8. A. Transition Application Examples Old Law USNP C JP Mixed Law? 371 D JP PCT (US) Mixed Law? 371 PCT (US) D CIP JP Mixed Law? JP USNP USNP C New Law JP 16 March 2013 Period in which inventive activity after March 16, 2013, may be subject to an interference

9. A. First-to-Invent Transition • The provisions of §§ 102(g), 135, and 291 of Title 35 in effect on March 15, 2013, shall apply to each claim in an application for patent, and any patent issued thereon, for which amendments made by this section also apply, if such application or patent contains or contained at any time – • A claim having an effective filing date before March 16, 2013, or • A specific reference under §§ 120, 121 or 365(c) of Title 35 to any patent or patent that contains or contained at any time such a claim • Leahy-Smith AIA, Pub. L. No. 112-29,§ 3(n)(2), 125 Stat. 284, 293 (2011)

10. B. Prior Art Exceptions • Disclosures made 1 year or less before effective filing date – §102(b)(1) • Inventor or one who obtained subject matter disclosed directly or indirectly from inventor or a joint inventor • Disclosures appearing in applications and patents – § 102(b)(2) • Disclosure obtained directly or indirectly from the inventor or joint inventor • Subject matter disclosed and claimed invention were owned by same person or subject to assignment to same person

11. B. Prior Art Exceptions • To establish an exception under AIA § 102(b), patent applicants must submit a declaration • Declaration* “must identify and provide the date of earlier disclosure of the subject matter . . . and provide a satisfactory showing that the inventor . . . is the inventor of the subject matter of the earlier disclosure” • Should keep records about • Public disclosures (oral presentations, meetings, public use, etc.) • Transfers of information to third parties • Especially transfers under collaborative research agreements • Typically, such information is not found in inventors’ notebooks • Nonetheless, notebooks would provide supporting evidence * Language from proposed rules, final rules will be published in February 2013

12. B. Prior Art Exceptions • 102(b)(1)(A) Excluding disclosures by inventor • Internal records • 102(b)(1)(A) Excluding disclosures by non-inventor who obtained subject matter from inventor • Internal records plus evidence that communication to non-inventor was enabling • 102(b)(1)(B) Excluding disclosures by third parties who obtained subject matter from inventor, directly or indirectly • Records of inventive activity, scope and content of public and nonpublic disclosures, audience/recipient

13. C. Establishing Inventorship • Assignee/ownership • Common ownership/obligation to assign establishes exception to prior art • AIA § 102(b)(2)(c) • Common ownership under joint research agreement – establishes exception to prior art • AIA § 102(c) • §§ 120, 121, 365(c) benefit claims – at least one inventor must be in common

14. D. Derivation Proceedings • Petition must be filed within the one-year period beginning on the date of the first publication of a claim to an invention that is the same or substantially the same (i.e., patentably indistinct) as the earlier application’s claim to the allegedly derived invention (§ 42.403) • Derivation requires both (1) earlier conception by the party alleging derivation (2) communication of the conception

15. D. Derivation Proceedings • By requiring demonstration of derivation, the rules necessarily require a showing of earlier conception as well as corroboration of that earlier conception and communication (§ 42.405(c)) • Courts may look to precedential case law decided allegations of derivation under 35 U.S.C. § 102(f) • “The showing of communication must be corroborated” (§ 42.405(c)) • Witnessing may be particularly advisable when working in a collaborative arrangement with an individual/entity outside the company

16. E. Prior User Rights • AIA § 273 repeals the previous law and provides*: • (a) IN GENERAL—A person shall be entitled to a defense under section 282(b) with respect to any subject matter consisting of a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process, that would otherwise infringe a claimed invention being asserted against the person if— • such person, acting in good faith, commercially used the subject matter in the United States . . .; and • Such commercial use occurred at least 1 year before the earlier of either • The effective filing date of the claimed invention; or • The date on which the claimed invention was disclosed to the public * Additional limitations and exceptions apply to the defense

17. Summary: Documenting Inventions Under the AIA Witnessing notebooks and/or diligent recordkeeping will be relevant to: • Interferences in transition (mixed law) applications • Establishing prior art exceptions (grace period exceptions) under AIA §§ 102(b)(1) and (b)(2) • Establishing inventorship • Derivation proceedings • Prior User Rights (AIA § 273)

18. ご清聴有り難うございました！　Thanks for your attention! David Albagli Patent Attorney Finnegan, Henderson, Farabow, Garrett, & Dunner LLP Shiroyama Trust Tower, 33F 3-1, Toranomon 4-chome Minato-ku, Tokyo, Japan 105-6033 +81-3-3431-6943 +1-650-387-7274 (mobile) david.albagli@finnegan.com

19. AIA 35 U.S.C. § 102 §102 Conditions for patentability (a) NOVELTY; PRIOR ART. A person shall be entitled to a patent unless— (1) the claimed invention was *patented, *described in a printed publication, or *in public use, *on sale, or *otherwise available to the public before the effective filing date of the claimed invention; or (2) the claimed invention was *described in a patent issued under section 151, *or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

20. AIA 35 U.S.C. § 102 • These exceptions define what is not prior art: • §102 (b) EXCEPTIONS. (1) Disclosures made 1 year or less before the effective filing date of the claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor (2) Disclosures appearing in applications and patents under subsection (a)(2) if: (A) obtained directly or indirectly from the inventor or a joint inventor; (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter directly or indirectly from the inventor or joint inventor; or (C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.