Seven Deadly Sins of
University-Industry Collaborations
Randy R. Micheletti
Presented at the 240th American Chemical Society National Meeting & Exposition
Boston, Massachusetts
August 25, 2010
Copyright © 2010 by K&L Gates LLP. All rights reserved.
Outline
1.
2.
3.
4.
5.
6.
7.
Publish and Perish
Share Materials & Protocols
Ignore IP Ownership Clauses in MTAs & SRAs
Unnamed Inventors
Going Global…and Losing Priority
Failure to Communicate (with Uncle Sam)
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 & 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
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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 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)
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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 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!
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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 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
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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
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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 wellknown 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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Sin #6: Failure to Communicate (with Uncle Sam)
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“Normal” sequence:
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Sin #6: Failure to Communicate (with Uncle Sam)
After Disclosure to TTO Æ § 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
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Sin #6: Failure to Communicate (with Uncle Sam)
What about the Inventor(s)? Æ § 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. 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
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Sin #7: Multiple Assignments (+ Federal $$)
Basic Facts
Stanford sent Holodniy (a researcher) to develop a
PCR method at Cetus.
Holodniy-Stanford Employment Agreement Æ “I
agree to assign”
Holodniy signed CDA with Cetus Æ “I hereby assign”
Holodniy developed method while at Cetus, with the
help of several Cetus scientists
Stanford then received federal funds to further
develop the technology
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Sin #7: Multiple Assignments (+ Federal $$)
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
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Sin #7: Multiple Assignments (+ Federal $$)
Roche’s Ownership Defense
Holodniy assigned his future rights to Cetus
Holodniy-Stanford contract was merely a promise to
assign
All this happened before Stanford got federal funds,
so there was nothing left for Stanford to “elect” under
Bayh-Dole; Cetus already owned title
Federal Circuit agreed
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Sin #7: Multiple Assignments (+ Federal $$)
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
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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
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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
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