The document discusses joint research agreements (JRAs) and how they can be used to overcome prior art rejections under the CREATE Act. It explains that the CREATE Act allows commonly owned secret prior art or prior art from different owners involved in a JRA to be disqualified. The summary discusses requirements for invoking the CREATE Act during patent prosecution to overcome rejections and potential issues like double patenting rejections that could result.

1. JOINT RESEARCH
AGREEMENTS
AND THE CREATE ACT
DISCLAIMER: THIS PRESENTATION HAS BEEN PREPARED FOR
GENERAL INFORMATION PURPOSES ONLY TO PERMIT YOU TO
LEARN MORE ABOUT OUR FIRM, OUR SERVICES AND THE
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BE CURRENT AND IS SUBJECT TO CHANGE WITHOUT NOTICE.
Jonathan M. Blanchard, Ph.D.
W. John Keyes, Ph.D. © 2015 Blanchard & Associates, Chicago

2. JOINT RESEARCH AGREEMENTS AND
THE CREATE ACT
 Types of prior art – “traditional” vs. “secret”
 CREATE Act
 New AIA provisions
 CREATE Act in Patent Prosecution
 Alternatives to the CREATE Act
2

3. Types of prior art post-AIA
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 (1) the claimed invention was patented, described
in a printed publication, or in public use, on sale,
or otherwise available to the public before the
effective filing date of the claimed invention; or
 (2) the claimed invention was described in a
patent issued under section 151, or in an
application for patent published or deemed
published under section 122 (b), in which the
patent or application, as the case may be, names
another inventor and was effectively filed before
the effective filing date of the claimed invention

4. 102(a)(2) art
4
 Prior filed patent applications and patents with
different inventive entities (102(a)(2)), which
would be disclosed to the general public but for
delays at the PTO
 Patent applications filed by different inventive
entities working in the same lab or for the same
company qualify as 102(a)(2) art.
 Inventors A + B + C file US Application No. X.
 Inventors A + B + D file App. No. Y. Same lab but
different inventive entity, then X is art!

5. A SAFE HARBOR
 102(b)(2) DISCLOSURES APPEARING IN
APPLICATIONS AND PATENTS.—A disclosure shall
not be prior art to a claimed invention under
subsection (a)(2) if— […]
 (C) the subject matter disclosed and the claimed
invention, not later than the effective filing date of
the claimed invention, were owned by the same
person or subject to an obligation of assignment
to the same person.
Congress provided a Safe Harbor for Commonly
Owned Secret Prior Art
5

6. WHAT ABOUT DIFFERENT OWNERS?
 102(b)(2)(C) only applies to “in house” prior art
 Not commonly owned information is not covered
by the safe harbor provision
 A problem for shared research projects:
Company A files U.S. Appl. No. X
Company B files U.S. Appl. No. Y
A + B file U.S. Appl. No. Z, claiming subject matter
from joint research efforts. X and Y qualify as prior
art to Z.
6

7. Cooperative Research and Technology Enhancement
Act of 2004 (CREATE Act), i.e. pre-AIA 103(c)(2)
 CREATE Act’ introduces 103(c)(2), a procedure to
disqualify that which arises out of a joint research
agreement (JRA)
 The CREATE Act expands the safe harbor
provisions to cover non-commonly owned 102(a)
(2) cited against patent application(s) arising from
research collaborations between different entities
7

8. Original requirements for the CREATE Act
 The claimed invention was made by or on behalf of parties to
a written joint research agreement that was in effect on or
before the claimed invention was made
 The claimed invention was made as a result of activities
undertaken within the scope of the joint research agreement
 The application for patent for the claimed invention discloses
or is amended to disclose the names of the parties to the
joint research agreement
Problem: how does one define the invention before it is made?
8

9. Post-AIA requirements for the CREATE Act
 The subject matter disclosed was developed and
the claimed invention was made by, or on behalf
of, 1 or more parties to a joint research agreement
that was in effect on or before the effective filing
date of the claimed invention
JRA no longer needs to be in place before the
invention is made. Instead, the parties to the JRA
can adapt the scope of the agreement to suit the
needs of the patent application –no more, no less.
9

10. Even better than before!
MPEP § 2156
“The CREATE Act provisions only apply to
obviousness rejections and not to anticipation
rejections”
The AIA provisions render a reference not available
under either obviousness or anticipation.
10

11. Benefits of the CREATE Act
 Promotes collaborative research and exchange of
information among collaborating researchers and
different entities
 Protects IP derived from collaborations from art
created by the entities themselves
 Less likely to cause inequitable conduct based on
omission to disclose “prior art” (caveat)
11

12. Types of Joint Research Agreements
 Non-Disclosure Agreements
 Material Transfer Agreements
 Licenses
 Cooperative Research And Development
Agreements (CRADAs)
 Sponsored Research Agreements
 Research Collaborations
12

13. BEWARE!
 Even if one is not interested in a JRA, it should be
clear from the outset of a collaboration whether a
contract is not a JRA
 One party to the joint research agreement may file
applications drawn to obvious improvements to
the discoveries of the research by unilaterally
invoking the Act. For example, a party may invoke
the Act based on a contract not initially
contemplated by the parties to be a JRA
13

14. “Joint Research Agreement”
 A written contract, grant, or cooperative
agreement entered into by two or more persons
or entities
 for the performance of experimental,
developmental, or research work in the field of the
claimed invention
14

15. Non-Disclosure Agreements (NDAs)
 Commonly used to convey confidential
information, for example a disclosure or patent
application, to a potential licensee
 Binds recipient of “Information” to hold in
confidence until the information is made public by
disclosing party
15

16. NDA as a JRA
Company A and Company B execute an NDA. Company A files
patent application to a protein and discloses the protein to
Company B pursuant to the NDA
Company B files a patent application to an obvious
improvement, e.g. the glycosylated or pegylated protein
Company B’s patent application is rejected as obvious over
Company A’s patent application
Company B invokes the Act by claiming that the NDA is a JRA
under the CREATE Act, potentially obtaining a “blocking patent”
16

17. This Is Not A JRA
“This NDA is not a joint research agreement under
the CREATE Act and the receiving party shall not
invoke the CREATE Act during patent examination to
overcome prior art rejections.”
Alternative approach: preserve the option of a JRA
“In the event that the receiving party invokes the
CREATE Act, all patents that arise from this NDA will
be jointly owned by the Company A and Company B
[or royalty arrangement instead].”
17

18. Material Transfer Agreements (MTAs)
Usually, MTAs govern the transfer of “research materials”
between two different entities, when the recipient wishes to
conduct research on the research materials
Example MTAs can be used for new materials samples,
reagents, software code, antibodies, seeds, cell lines, vectors,
spores, plasmids
The research materials may be transferred between two
universities, two industries, a university and a company
18

19. MTA as JRA
 Parties A and B and execute an MTA. A sends
GMO seeds to B
 B files a patent application based on discoveries
they made with the seeds
 B’s application gets rejected based on an
application by A claiming the GMO seeds.
 Company invokes the CREATE Act arguing that the
MTA regulating the transfer of the seeds is a JRA
under the Act
19

20. Preserving the option of a JRA
“In the event that B invokes the CREATE Act to overcome any
prior art rejection, all patents obtained by B by asserting that
this MTA is a joint research agreement will be jointly owned.”
Or
Co-owned patents may be difficult to enforce, so the following
may be better:
“B owns patent, but parties to the MTA agree to share
royalties/proceedings.”
BUT…..
20

21. Invoking the CREATE Act in
Patent Prosecution
To overcome a rejection by invoking the joint research
agreement provisions of the CREATE Act, applicant must:
1. Provide a signed statement regarding the JRA;
and
2. Amend the specification* to disclose the names of the
parties to the JRA (see 37 CFR 1.71(g) and 1.77(b)(4))
*Unless the specification discloses the required information
21

22. The Price of Invoking the Benefits of
the CREATE Act
 If a patent applicant invokes the CREATE Act to overcome an
obviousness rejection based on a prior patent or application,
the Examiner is (very) likely to reject the claims again based
on “obviousness type double patenting”
 Obviousness type double patenting is a doctrine that
prevents anyone from getting more than one patent on the
same invention by obtaining claims not patentably distinct
from the reference claim(s)
 Rejection can be overcome by a terminal disclaimer, normally
easy to do even if the rejection is improper
22

23. Double Patenting Rejection: MPEP
804
Congress recognized that the CREATE Act would result in
situations in which there would be double patenting rejections
between applications not owned by the same party. (see H.R.
Rep. No. 108-425, at 5-6 (2003))
 37 CFR 1.321(d)(3) sets out the requirements for a terminal
disclaimer directed to applications not owned by the same
party.
23

24. 37 CFR 1.321(d)(3)
 Include a provision waiving the right to separately enforce
any patent granted on that application [...] and the patent or
[...] granted on the application which formed the basis for the
double patenting,
and
 that any patent granted on that application [...] shall be
enforceable only for and during such period that said patent
and the patent [...] which formed the basis for the double
patenting are not separately enforced
24

25. CAVEAT I
 PROBLEM: Can you count on the owners of the cited
application or patent to abide by the requirements of 37 CFR
1.321(d)(3)?
 Are they contractually bound to enforce their patent(s) with
the one claiming the benefit of the CREATE Act? This
provision should be part of the JRA
 Alternative approaches:
Argue against the rejection
Divisional applications to separate
non-obvious claims from rejected claims
Amend rejected claims to overcome rejection
25

26. CAVEAT II
 Art that is disqualified under 102(c) should nonetheless be
disclosed to the PTO.
 MPEP § 724: It matters not whether the "material"
information [is the other party’s to the JRA] trade secret, or is
proprietary material [..]. The obligation is the same; it must
be disclosed if "material to patentability" as defined in 37 CFR
1.56(b)
 Make sure the other party is contractually bound to disclose
such references
26

27. No JRA?
 Company A and Company B undertake a joint research
project. No JRA is executed
 Company A and Company B each file their respective
application. Company A files first, failing to list any inventors
from Company B
 Patent Office rejects B’s application as being obvious in view
of A’s earlier filing (that was not published at the time of B’s
filing)
 “Derivation proceeding” approach possible as an alternative
to battling inventorship in court
27

28. Derivation Proceeding
 Company B believes that Company A has neglected to include
B, (one of) the true inventor(s) of the claimed subject matter,
in its application
 Company B files a second application directed to that portion
of the subject matter invented by B
 Thereafter, Company B files a petition to institute a
“derivation proceeding” before the PTAB to establish that (i)
inventor A named in an Company A’s application derived the
claimed invention from B, and (ii) the earlier application by
Company A claiming the subject matter invented by B was
filed without authorization
28

29. Derivation Proceeding
 Inventorship can now be corrected at the PTO –quicker, less
expensive, and subject to a lower standard of proof than in
court.
 No longer required that the error was made without
deceptive intent:
35 U.S.C. 116(c)
[…] (c) CORRECTION OF ERRORS IN APPLICATION.--Whenever
through error a person is named in an application for patent
as the inventor, or through an error an inventor is not named
in an application, [and such error arose without any
deceptive intention on his part], the Director may permit the
application to be amended accordingly, under such terms as
he prescribes.
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