JOINT RESEARCH AGREEMENTSAND THE CREATE ACTDISCLAIMER: THIS PRESENTATION HAS BEEN PREPARED FOR GENERAL INFORMATION PURPOSES ONLY TO PERMIT YOU TO LEARN MORE ABOUT OUR FIRM, OUR SERVICES AND THE EXPERIENCE OF OUR ATTORNEYS. THE INFORMATION PRESENTED IS NOT LEGAL ADVICE, IS NOT TO BE ACTED ON AS SUCH, MAY NOT BE CURRENT AND IS SUBJECT TO CHANGE WITHOUT NOTICE.

Jonathan M. Blanchard, Ph.D.W. John Keyes, Ph.D. © 2015 Blanchard & Associates, Chicago

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

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Types of prior art post-AIA3

(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

102(a)(2) art4

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!

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

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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. XCompany B files U.S. Appl. No. YA + B file U.S. Appl. No. Z, claiming subject matter

from joint research efforts. X and Y qualify as prior art to Z.

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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

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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?

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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.

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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.

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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)

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Types of Joint Research Agreements

Non-Disclosure Agreements Material Transfer Agreements Licenses Cooperative Research And Development

Agreements (CRADAs) Sponsored Research Agreements Research Collaborations

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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

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“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

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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

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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”

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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].”

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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

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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

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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…..

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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

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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

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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.

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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

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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 rejectionDivisional applications to separate non-obvious claims from rejected claimsAmend rejected claims to overcome rejection

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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

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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

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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

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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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