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1 (U.S. Constitution Article1, Section 8, Clause 8) Patent Laws Federal Regulations 5 (MPEP: Manual of Patent Examining Procedures), Patent Procedures & related guides Bayh-Dole Act - 35 USC & 37 CFR Cooperative Research and Technology Enhancement (CREATE) Act of USC (USPTO) (USPTO)

2 (Discovery) (Trial) (Antitrust Law)- Title 15 USC (Misuse law) (JRA) Non-Exclusive License Agreement Exclusive License Agreement Joint Research & Development Agreement 2

3 Bayh-Dole CREATE 1.2 1) 2) 3) 4) 5) 6) 7) 8) 9) 1.3 1) AUTM2007Anual Meeting 2) JUNBA 3) 3

4 / / / /1 2007/ /3 AUTM2007 Annual Meeting /4 4

5 (U.S. Constitution Article1, Section 8, Clause 8) "To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writing and discoveries" 2.2 Patent Laws 35 Title 35 United States Code Patents (United States Code : USC) Federal Regulations 37 Title 37 Code of Federal Regulations - Patents, Trademarks, and Copyrights 37 (USPTO) (MPEP: Manual of Patent Examining Procedures), Patent Procedures & related guides ( ) 5

6 ) Utility Application 35 USC 101 Design Application 35 USC 161 Plant Application 35 USC 171 2) Provisional Application Ordinary Application Divisional Application Continuation Application Continuation-in-part Application Substitute Application Reissue Application (First to invent system) First to file system (First to invent system) (Inventor) (Applicant) (Inventor) (Assignee) (Provisional Application) 35 USC 111(b) 1 6

7 Information Disclosure Statement (IDS) U.S.C. 122(b) ) (Specification) (Abstract) 2) (Drawings) 3) (Declaration) 4) (35 USC 41 37CFR ) 5) 6) USPTO Virginia Alexandria USTPO 1) (EFS) 2) FAX 3) USPS 4) 5) (Patentable Subject Matter )- 35 U.S.C. 101 (process) (machine) (manufacture) 7

8 (composition of matter) 2) "Anything under the sun that is made by man" 2 3) "Not Patentable" (algorithm) (physical phenomena) (laws of nature) mathematical formula (abstract idea) RCE) / 8

9 3.2.2 (Utility) - 35 U.S.C ) (Specific) 2) (Substantial) 3) (Credible) (Novelty) - 35 U.S.C ) (prior art) / 2) 1 3) (Anticipation) - 35 U.S.C. 102(a)(e)(g) Statutory Bar - 35 U.S.C. 102(b)(c)(d) (Nonobviousness) - 35 U.S.C ) ) 9

10 3.2.5 (Disclosure Requirement) - 35 U.S.C ) (Written Description) 2) (Enablement) 3) (Best Mode) Office action (Rejection) (Objection) 2 (RCE) (RCE) 35 USC 132 (CPA) (CPA) 2003 RCE (Restriction Requirement) (Divisional Application) - 35 USC

11 3.2.9 (BPAI) - 35 USC (Interference) - 35 USC (Notice of Allowance) (Issue Fee Payment) (Patent Term) ($900) 7 ($2,300) 11 ($3,800) (Reissue Application) - 35 USC (Reexamination) - 35 USC 302 1) 11

12 2) (Ex Partes Reexamination) - 35 USC 302 USPTO USPTO USTPO BPAI BPAI CAFC (Inter Partes Reexamination) - 35 USC USTPO USPTO USTPO 1 (BPAI) BPAI CAFC 12

13 4 4.1 Bayh-Dole Act - 35 USC & 37 CFR Bayh-Dole Act 1980 University and Small Business Patent Procedures Act Council on Governmental Relations (COGR) Bayh-Dole Act ) 2) 3) 4) 5) 6) (march in right) 7) 4.2 Cooperative Research and Technology Enhancement (CREATE) Act of USC CREATE Act CREATE Act 2 13

14 4.2.2CREATE Act (JRA) (Joint Research Agreement: JRA) 1) Collaboration Agreement 2) NDA 3) Sponsored Research Agreement 4) Licenses Agreement 5) Material Transfer Agreement) 6) (Visitor/Visiting Faculty Agreement) 7) (Inter-institutional Agreement) 8) ) 2) 3) 4) ) 2) 3) 4) Council on Governmental Relations (COGR) CREATE Act 14

15 (USPTO) 1) 2) 3) 4) 5) 6) Troll 5.2 (USPTO) ) 1 1 2) ) IDS IDS ) (First-to-file) 2) (Redefinition of prior art) 3) (Assignee filing) 4) (Elimination of best mode) 5) (The duty of candor and good faith) 6) (Inequitable conduct) 7) (Publishing of application) 8) (Inter partes reexamination) 15

16 9) (Opposition proceedings) 10) (Third party prior art submission) 11) (Prior use rights) 12) 271(f) (Elimination of 35 USC 271(f)) 13) (Willful infringement) 14) (Injunction) 15) (Venue) 16) USPTO 16

17 ) 2) 3) 18 4) 5) ) Final office action (RCE) 7) 1 8) 9) 10) 17

18 Discovery ) (Dossier Access System) ) Patent Prosecution Highway :Pilot) )

19 ) 2) 3) / 4) 5) ) 2) 3) 4) 5) ) 2) 3) (Literal infringement) 4) (Doctrine of equivalent) 19

20 5) ) (US Supreme Court) (Court of Appeal for Federal Circuit) (Federal Circuit) Washington DC (District Court) ) (International Trade Commission: ITC) ITC ITC 1 ITC BPAI(Board of Patent Appeals & Interference) ) 2) 3) 4) 5) 6) 7) 20

21 Supreme court CAFC District court ITC

22 7.2.2 US$3 million US$5 million ) 2) (Willful Infringement) ) (Permanent Injunction) (Preliminary Injunction) 2) 3) 1 2 4) ) 2) 22

23 ) 2) 3) 4) 5) 6) ) (Negotiation) 2) (Arbitration) 3) (Mediation) 4) (Litigation) ) 2) 3) ) 2) 3) 4) 5) 6) (Complaint) (ITC) (Reply) 23

24 (invalid) (equitable conduct) latches 7.4 (Discovery) ) (Interrogation) 2) 3) 4) (Deposition) 5)

25 ) 2) 3) 4) 5) ) 2) 3) 4) 5) (Trial) (Jury) (Opening statement)

26 Yes/No Yes/No (Appeal) (CAFC)) ,800 (2005 ) ) 3.6% 2) ITC 40% 3) 70% 26

27 ) 68 2) 51 3) Federal Circuit US$ 3 million US$ 5 million 1 1 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 27

28 8 8.1 (Antitrust Law)- Title 15 USC ) (Joint conduct) Sherman Act 1 Clayton Act 3 M&A Clayton Act 7 2) (Unilateral conduct) Sherman Act 2 3) FTC Act ) 2) 3) 4) 5) ) 2) (DOJ) : 3) (Sherman Act 6a) ) (DOJ) (FTC) DOJ FTC : 2) 3) 28

29 4) 5) 8.2 (Misuse law) ) 2) 35 USC 271(d) ) 2) 3) 4) (Export Administration Regulation: EAR, 15 CFR 730) 1) 2) PR USC 184 (foreign filing license) 6 29

30

31 Bayh-Dole CREATE Bayh-Dole CREATE

32 (1) (Lab notebooks) 32

33 (2) (1) (2) (3) (4) 9.3 (JRA) (Masuda, Funai, Eifert & Mitchell, Ltd.) 33

34 9.3.1 (Non-Exclusive License Agreement) (Exclusive License Agreement) (Masuda, Funai, Eifert & Mitchell, Ltd.) 34

35 11 (Case law) 35

36 1) 9) 10) 13) 1) "AUTM Technology Transfer Practice Manual 3 rd Edition, Volume2, Chapter1, Section1", Mark Crowell, January ) "Beginning and Advanced Topics of Current Interest in Patent Law/ 2007 AUTM Annual Meeting" Nabeela R Macmillian, Trevor Mee, David L Parker, March ) "The CREATE Act- A Double-Edged Swords / 2007 AUTM Annual Meeting" Elizabeth B Carlson, March ) "Patent Reform / 2007 AUTM Annual Meeting" Margaret J. Sampson, March ) " " & Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, October ) " / 3 4 " & Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, March ) "JSPS-SF / " Tomotaka Homma, February ) " JSPS-SF / (1)" Tomotaka Homma, February ) " JSPS-SF / (2)" Tomotaka Homma, February ) " ", December ) " ", June ) " ", June ) " " John G Smith,, February 2006 ****************************************************************************** Masuda, Funai, Eifert & Mitchell, Ltd. Chicago, Illinois , USA 36

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