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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #2
Share Materials & Protocols
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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?
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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)
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #3
Ignore IP Ownership Clauses in MTAs & SRAs
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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!
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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)
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #5
Going Global… and Losing Priority
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #6: Failure to Communicate (with Uncle Sam)
“Normal” sequence:
Projec
t fun
ded
Resea
rch
Conce
ption
RTP
Disclos
ure
to
TT Offic
e
Disclos
ure
to F
ed
Fundin
g Age
ncy
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #6: Failure to Communicate (with Uncle Sam)
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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #7
Multiple Assignments (+ Federal $$)
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #7: Multiple Assignments (+ Federal $$)
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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #7: Multiple Assignments (+ Federal $$)
Basic FactsStanford sent Holodniy (a researcher) to develop a PCR method at Cetus.Holodniy-Stanford Employment Agreement “I agree to assign”Holodniy signed CDA with Cetus “I hereby assign”Holodniy developed method while at Cetus, with the help of several Cetus scientistsStanford then received federal funds to further develop the technology
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #7: Multiple Assignments (+ Federal $$)
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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #7: Multiple Assignments (+ Federal $$)
Roche’s Ownership DefenseHolodniy assigned his future rights to CetusHolodniy-Stanford contract was merely a promise to assignAll this happened before Stanford got federal funds, so there was nothing left for Stanford to “elect” under Bayh-Dole; Cetus already owned titleFederal Circuit agreed
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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Sin #7: Multiple Assignments (+ Federal $$)
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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010
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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
www.klgates.com
240th ACS National Meeting & Exposition • Boston, MA • August 25, 2010