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New CREATE Act Affects Inventions and Patent
Applications Arising from Research Collaborations
By Jane
E.R. Potter, Ph.D.
[February 2005]
Teams of scientists and research physicians at universities,
medical centers, research institutes and companies work together
to discover better ways to treat and prevent disease. These
teams collaborate on experiments and exchange ideas, materials,
and research results with each other. Until recently, such sharing
had the potential to affect the patentability of inventions
resulting from such work, especially if one party to the collaboration
filed a patent application or developed an invention, and another
party was not named as an inventor in the patent application.
In order to address this issue, and to recognize and encourage
the sharing of confidential information by collaborating research
groups, the Patent Act has been amended by the Cooperative Research
and Technology Enhancement Act of 2004 (CREATE). The Create
Act (S. 2192) was cleared for the President’s signature
on Nov. 20, 2004, and became Public Law 108-453 on Dec. 10,
2004.
CREATE amends a section of the patent statute (title 35 United
States Code) that deals generally with printed publications
and other public information that can defeat patentability of
an invention. Section 103(c) of 35 U.S.C is amended to recognize
that an invention can arise from the combined contributions
of people at more than one institution. To accomplish this,
two new paragraphs have been added to Section 103(c). The first
paragraph of Section 103(c) is similar to the entire prior Section
103(c) and reads as follows:
(c) (1) Subject matter developed by another person, which
qualifies as prior art only under one or more of subsections
(e), (f), and (g) of section 102 of this title, shall not
preclude patentability under this section where the subject
matter and the claimed invention were, at the time the claimed
invention was made, owned by the same person or subject to
an obligation of assignment to the same person.
For the complete text of 35 U.S.C. § 102 (e), (f) and
(g), please refer to http://www.uspto.gov/web/offices/pac/mpep/consolidated_laws.pdf
(page 21). Briefly, for the purposes of this discussion, sections
102 (e), (f) and (g) provide situations under which a patent
may not be obtained. These sections relate specifically to inventions,
patents, and patent applications of someone other than the inventor
of the subject matter on which a patent is sought (“another
person”). Thus, under the new Act a prior patent, patent
application, or invention of “another person” may
no longer qualify as “prior art” for the purposes
of defeating claims in a patent application, if the prior patent,
patent application, or invention by “another person”
falls within the Act’s definition of a “joint research
agreement.” This is explained in more detail below.
Inventions made pursuant to a Joint Research Agreement
Generally, new paragraph 2, sections (A), (B), and (C) of 103(c),
expands on “subject matter developed by another person”
and “owned by the same person or subject to an obligation
of assignment to the same person.” Paragraph 2 provides
three requirements for inventions developed under research collaborations.
Section (A) of this paragraph states that the claimed invention
must be made by or on behalf of parties to a joint research
agreement that was in effect on or
before the date the claimed invention was made. Section
(B) states that the claimed invention must be made as a result
of activities undertaken within the
scope of the joint research agreement. Section (C) states
that the patent application for the claimed invention has to
disclose, or be amended to disclose, the names
of the parties to the joint research agreement.
Definition of Joint Research Agreement
New paragraph (3) of 103(c) states that for the purposes of
paragraph (2), the term “joint research agreement”
means “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.”
Applying the new Section 103(c) to research programs
In practical terms, 35 U.S.C. § 103(c) now defines what
is meant by “the same person” for the purposes of
determining patentability. Anyone involved in preparing and
executing Joint Research Agreements should become familiar with
these definitions and timeframes, to ensure that a Joint Research
Agreement meets the requirements of the Act. Parties to a Joint
Research Agreement can now share information with each other,
without the risk that a patent application filed on the basis
of such disclosure could affect the patentability of an invention
arising from the collaborative research. The statute also specifies
that the Joint Research Agreement has to be in effect on
or before the date that the invention was made. Thus, technology
managers or others who are charged with overseeing research
agreements and processing invention disclosures should be aware
of ongoing collaborations between their employees and scientists
at other institutes. Such collaborations should be formalized
as soon as possible after initiation, so that the effective
date of the Joint Research Agreement will not be subsequent
to the date of any invention under the collaboration.
Scientist participation
Institutes vary in terms of who has responsibility for managing
research collaborations and invention disclosure processing,
and sometimes these responsibilities are split among departments.
Regardless of internal department arrangements, scientists should
keep their technology manager, project leader, or other designated
supervisor aware of collaborations with other institutes. Such
collaborations often begin informally, and the technology manager
or project leader first learns of them upon receipt of an invention
disclosure or a manuscript for publication. At the early stages,
the collaboration may only involve transfer of materials, gene
sequences, proteins, cell lines, or the like, but if the transfer
leads to sharing of research results or data that might become
the subject of a patent application, it is important to establish
the collaboration as defined under the new law so that it meets
the definition of a Joint Research Agreement. Attention to this
during the early stages of research can avoid potential problems
that might arise later when transferred material or ideas lead
to an invention, but the research project is not covered by
a Joint Research Agreement.
Writing the patent application
Finally, section 103(c) now specifies that any patent application
arising from the invention must disclose the names of the parties
to the Joint Research Agreement. To meet this requirement, the
person responsible for preparing the patent application, such
as an in-house patent attorney or agent, or outside patent counsel,
should be informed of the Joint Research Agreement and the names
of the parties. Thus, scientists should keep the technology
manager, project leader, or other designated supervisor informed
of any ongoing or new collaborations, or transfer of materials
to or from another institute or company, so that this information
can be considered when the patent application is prepared and
prosecuted. Under the law, the patent application can be amended
to add the names of the parties, so if this information is not
disclosed to the attorney or agent when the application is first
filed, it should be provided as soon as possible.
Effective date
Regarding the effective date, the text of S. 2192 states, “The
amendments made by this Act shall apply to any patent granted
on or after the date of the enactment of this Act.” However,
the amendments made by the Act do not affect final decisions
of a court or by the U.S. Patent and Trademark Office where
the decisions were rendered before the date of enactment of
the Act. The Act also states that the amendments “shall
not affect the right of any party in any action pending before
the United States Patent and Trademark Office or a court on
the date of the enactment of this Act to have that party’s
rights determined on the basis of the provisions of title 35,
United States Code, in effect on the day before the date of
enactment of this Act.”
The full text of Public Law 108-453 can be found at http://www.dwt.com/pdfs/PL108-453.pdf.
For further information, please contact:
This Life Sciences Advisory Bulletin is a publication of the
Life Sciences Group of Davis Wright Tremaine LLP. Our purpose
in publishing this Advisory Bulletin is to inform our clients
and friends of developments in life sciences law. It is not
intended, nor should it be used, as a substitute for specific
legal advice as legal counsel may be given only in response
to inquiries regarding particular situations.
Copyright © 2005,
Davis Wright Tremaine LLP.
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