1. Copyright © 2010 by K&L Gates LLP. All rights reserved. Seven Deadly Sins of University-Industry Collaborations Randy R. Micheletti Presented at the 240 th American Chemical Society National Meeting & Exposition Boston, Massachusetts August 25, 2010

2. 1 Outline 1.Publish and Perish 2.Share Materials & Protocols 3.Ignore IP Ownership Clauses in MTAs & SRAs 4.Unnamed Inventors 5.Going Global…and Losing Priority 6.Failure to Communicate (with Uncle Sam) 7.Multiple Assignments (+ Federal $$) 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

3. 2 Sin #1 Publish and Perish 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

4. 3 Sin # 1: Publish and Perish (§ 102) 35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent. A person shall be entitled to a patent unless— (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

5. 4 Sin #2 Share Materials & Protocols 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

6. 5 Sin #2: Sharing Materials & Protocols 35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent. A person shall be entitled to a patent unless— (a) the invention was known or used by others in this country... before the invention thereof by the applicant for patent, or (b) the invention was... in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

7. 6 Sin #2: Sharing Materials & Protocols Prior Public Use  more than one year before application date  in the U.S.  invention is ready for patenting  embodies the claimed invention Test:  was the purported use accessible to the public?  was the purported use commercially exploited? 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

8. 7 Sin #2: Sharing Materials & Protocols Generally, NO EXPERIMENTAL USE EXCEPTION UNLESS:  testing to see if claimed invention works  AND applicant controls the testing  AND applicant takes steps to maintain secrecy of the testing  AND the invention has not been offered for sale yet See also Madey v. Duke Univ. (Fed. Cir. 2005) (universities do not get special status for experimental use purposes) 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

9. 8 Sin #3 Ignore IP Ownership Clauses in MTAs & SRAs 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

10. 9 Sin #3: Ignore IP Ownership Clauses in MTAs & SRAs  Watch out for ownership of IP clauses  Special warning: Uniform Biological Material Transfer Agreement applies only to university-university material transfers  use Industsry to Non-Profit UBMTA instead  Most of all: READ THEM FIRST! 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

11. 10 Sin #4 Forget Inventors 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

12. 11 Sin #4: Forget Inventors  35 U.S.C. § 256: Can correct inventorship if no deceptive intent  Ethicon v. U.S. Surgical Corp.: defendant identified an unnamed inventor, negotiated a license from him, moved the court to add the unnamed inventor to the patent (§ 256).  Defendant became a licensee, so the court dismissed the infringement suit 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

13. 12 Sin #4: Forget Inventors  Who is an “inventor”??  anyone who “contribute[s] in some significant manner to the conception of the invention”  BJ Svcs Co. v. Halliburton Energy Svcs, Inc.  conception = “the ‘formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.’”  Ethicon  inventorship is determined on a claim-by-claim basis 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

14. 13 Sin #4: Forget Inventors Who is NOT an “inventor”??  someone who merely assists the actual inventor after conception of the claimed invention” (Ethicon)  someone who merely makes a request for others to create (Ethicon)  someone who simply provides the inventor with well- known principles (Stern v. Columbia Univ.:student who performed work on behalf of a professor was not an inventor)  someone who carries out routine tasks of one-skilled in the art (Acromed Corp. v. Sofamor Danke Group: machinist was not an inventor because his contribution to the claimed invention was only routine, ordinary skill in the relevant art) 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

15. 14 Sin #5 Going Global… and Losing Priority 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

16. 15 Sin #5: Going Global…and Losing Priority Edwards Lifesciences v. Cook Biosciences (UK 2009)  Priority claim under Art. 4 PCT requires:  Perfect identity of inventorship  Before filing the international patent application  PCT Applicant must be:  Applicant(s) named in priority application or  Successor in title to priority applicant(s) [ALL OF THEM!]  Retroactive assignments are not effective 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

17. 16 Sin #6 What We Have Here is a Failure to Communicate …With Uncle Sam 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

18. 17 Sin #6: Failure to Communicate (with Uncle Sam) Bayh-Dole Act: Inventions Developed with Federal $$  US Gov’t retains a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world  Patent applicant must notify US Gov’t if it elects to retain title to the patent(s) within 2 years of disclosure to the US Gov’t  US Gov’t can require university to grant a license under certain circumstances 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

19. 18 Sin #6: Failure to Communicate (with Uncle Sam) “Normal” sequence: Project fundedResearchConceptionRTP Disclosure to TT Office Disclosure to Fed Funding Agency 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

20. 19 Sin #6: Failure to Communicate (with Uncle Sam) After Disclosure to TTO  § 202(c):  Contractor must disclose inventions to US Gov’t Agency  Contractor then has 2 years to decide whether to “retain title”  Gov’t “may receive title” if contractor fails to elect  Contractor electing rights in an invention must file patent applications  Gov’t may prosecute patents in jurisdictions where contractor does not elect to retain title 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

21. 20 Sin #6: Failure to Communicate (with Uncle Sam) What about the Inventor(s)?  § 202(d):  If contractor does not elect to retain title, Inventor(s) can request to retain rights in the invention from the Federal Agency 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

22. 21 Sin #7 Multiple Assignments (+ Federal $$) 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

23. 22 Sin #7: Multiple Assignments (+ Federal $$) What happens if Inventor(s) assign rights before federal funds arrive? Stanford v. Roche  On writ of cert to SCOTUS  Main issue: Whether an inventor’s assignment of interest in a future invention trumps the statutory provisions in the Bayh-Dole Act 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

24. 23 Sin #7: Multiple Assignments (+ Federal $$) Basic Facts  Stanford sent Holodniy (a researcher) to develop a PCR method at Cetus.  Holodniy-Stanford Employment Agreement  “I agree to assign”  Holodniy signed CDA with Cetus  “I hereby assign”  Holodniy developed method while at Cetus, with the help of several Cetus scientists  Stanford then received federal funds to further develop the technology 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

25. 24 Sin #7: Multiple Assignments (+ Federal $$) Basic Facts (cont.)  Holodniy/Stanford filed patent application, also naming several Cetus scientists as co-inventors  Roche bought Cetus and all of its IP interests  Stanford and Roche tried to negotiate a license  Stanford sued Roche for infringement when talks broke down 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

26. 25 Sin #7: Multiple Assignments (+ Federal $$) Roche’s Ownership Defense  Holodniy assigned his future rights to Cetus  Holodniy-Stanford contract was merely a promise to assign  All this happened before Stanford got federal funds, so there was nothing left for Stanford to “elect” under Bayh-Dole; Cetus already owned title  Federal Circuit agreed 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

27. 26 Sin #7: Multiple Assignments (+ Federal $$) Stanford’s Rebuttal  If Fed Cir is right, any inventor could undermine all of Bayh-Dole and its underlying purpose by simply signing an “I hereby assign” type Employment Agreement  Or by assigning to a third party before contractor (ie, the inventor’s employer) needs to elect under the B-D Act 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

28. 27 Sin #7: Multiple Assignments (+ Federal $$) Bayh-Dole Act: Inventions Developed with Federal $$  US Gov’t retains a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world  Patent applicant must notify US Gov’t if it elects to retain title to the patent(s) within 2 years of disclosure to the US Gov’t  US Gov’t can require university to grant a license under certain circumstances 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010

29. 28 THANK YOU! Randy R. Micheletti Attorney K&L Gates LLP 70 West Madison Street Suite 3100 Chicago, IL 60602-4207 (312) 781-7231 randy.micheletti@klgates.com www.klgates.com 240 th ACS National Meeting & Exposition Boston, MA August 25, 2010