Life Sciences Advisory Bulletin
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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