seven deadly sins of university-industry collaborations randy r. micheletti

Copyright © 2010 by K&L Gates LLP. All rights reserved.

Seven Deadly Sins ofUniversity-Industry Collaborations

Randy R. Micheletti

Presented at the 240th American Chemical Society National Meeting & ExpositionBoston, MassachusettsAugust 25, 2010

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Outline

1. Publish and Perish2. Share Materials & Protocols 3. Ignore IP Ownership Clauses in MTAs & SRAs4. Unnamed Inventors5. Going Global…and Losing Priority6. Failure to Communicate (with Uncle Sam)7. Multiple Assignments (+ Federal $$)

240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010

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Sin #1

Publish and Perish


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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


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Sin #2

Share Materials & Protocols


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Sin #2: Sharing Materials & Protocols35 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


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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?


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Sin #2: Sharing Materials & Protocols

Generally, NO EXPERIMENTAL USE EXCEPTIONUNLESS:

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

yetSee also Madey v. Duke Univ. (Fed. Cir. 2005) (universities do not get special status for experimental use purposes)


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Sin #3

Ignore IP Ownership Clauses in MTAs & SRAs


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Sin #3: Ignore IP Ownership Clauses in MTAs & SRAs

Watch out for ownership of IP clausesSpecial 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!


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Sin #4

Forget Inventors


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Sin #4: Forget Inventors

35 U.S.C. § 256: Can correct inventorship if no deceptive intentEthicon 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


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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


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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)


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Sin #5

Going Global… and Losing Priority


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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


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Sin #6

What We Have Here is a Failure to Communicate

…With Uncle Sam


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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


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“Normal” sequence:

Projec

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Resea

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Conce

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RTP

Disclos

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TT Offic

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Disclos

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After Disclosure to TTO § 202(c):Contractor must disclose inventions to US Gov’t AgencyContractor then has 2 years to decide whether to “retain title”

Gov’t “may receive title” if contractor fails to electContractor electing rights in an invention must file patent applications

Gov’t may prosecute patents in jurisdictions where contractor does not elect to retain title


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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


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Sin #7

Multiple Assignments (+ Federal $$)


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Sin #7: Multiple Assignments (+ Federal $$)

What happens if Inventor(s) assign rights before federal funds arrive? Stanford v. RocheOn writ of cert to SCOTUSMain issue: Whether an inventor’s assignment of interest in a future invention trumps the statutory provisions in the Bayh-Dole Act


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Basic FactsStanford 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 scientistsStanford then received federal funds to further develop the technology


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Basic Facts (cont.)Holodniy/Stanford filed patent application, also naming several Cetus scientists as co-inventorsRoche bought Cetus and all of its IP interestsStanford and Roche tried to negotiate a licenseStanford sued Roche for infringement when talks broke down


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Roche’s Ownership DefenseHolodniy assigned his future rights to CetusHolodniy-Stanford contract was merely a promise to assignAll this happened before Stanford got federal funds, so there was nothing left for Stanford to “elect” under Bayh-Dole; Cetus already owned titleFederal Circuit agreed


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Stanford’s RebuttalIf 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


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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


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THANK YOU!

Randy R. MichelettiAttorney

K&L Gates LLP

70 West Madison StreetSuite 3100

Chicago, IL 60602-4207

(312) 781-7231

[email protected]

www.klgates.com


seven deadly sins of university-industry collaborations randy r. micheletti

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