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Past vs. Present:
The Importance of Tense in Patent Application Examples
Federal Circuit Questions Example's Validity
in "Hoffman LaRoche, Inc. v. Promega"
By Jane
E.R. Potter, Ph.D. and Gargi Talukder, Ph.D. (DWT Summer
Associate)
[July 2003]
Early this
spring, in Hoffman
LaRoche, Inc. v. Promega, the Court of Appeals for
the Federal Circuit reviewed a district court opinion on the
validity of an issued patent. The full court opinion can be
found in Hoffman LaRoche, Inc. v. Promega, 323 F.3d
1354 (C.A.F.C., 2003). The Court found that drafting an Example
in the past tense, when the experimental work had not been performed
as written, could be construed as inequitable conduct. Under
some circumstances, inequitable conduct can render a patent
unenforceable and even result in a monetary award against the
patent owner. The Court remanded the case to the district court
to determine if the incidents of inequitable conduct sustained
by the Federal Circuit on appeal justified finding the patent
at issue unenforceable.
Contents
of a Patent Application
This advisory
bulletin addresses one aspect of the decision: the importance of
accurately drafting the Examples in a patent application. The required
contents of a patent application are described in 37 C.F.R. §
1.71, and they include the Specification, Title, Abstract, Summary,
Drawings (if appropriate to the invention), and Claims. A patent
application need not have an Examples section. However, most patents
in the life sciences, biotechnology, and pharmaceutical areas include
one or more Examples. Often the Examples are written in a manner
similar to the “Materials and Methods” section of a
scientific publication. Recently issued patents including Examples
sections are 6,054,121;
6,251,594;
and 6,414,130.
Examples
in a Patent Application
The Examples
serve at least two purposes. First, they can provide the details
of how experiments were performed, supporting data the applicant
may rely on for utility usefulness and enablement operability
of the claimed invention. Second, they can provide an outline
of experiments that may be performed in the future.
Examples disclosing
experiments that have been performed as described are written in
the past tense. In contrast, the second type of Example is generally
referred to as a “prophetic” or “paper”
example, and is written in the present or future tense. If these
“prophetic” experiments subsequently are performed as
described in the patent application, the inventors can file the
experimental data during prosecution of the patent application.
Often this data is submitted in the form of a Declaration under
37
C.F.R. § 1.131 or 1.132, and the Patent Examiner
will consider it in allowing the claims. Examples usually will not,
and in fact should not, combine tenses, unless it is to illustrate
variations in how an experiment could be performed.
Manual
of Patent Examining Procedure
For interpreting
the language in the Examples, Patent Examiners refer to the Manual
of Patent Examining Procedure (MPEP). In a section entitled
“Simulated or Predicted Test Results or Prophetic Examples,”
the MPEP clearly distinguishes between prophetic and working
examples. “Simulated or predicted test results and prophetical
examples (paper examples) are permitted in patent applications.
Working examples correspond to work actually performed and may describe
tests which have actually been conducted and results that were achieved.
Paper examples should not be represented as work actually done.”
“Paper examples should not be described in the past tense.”
MPEP
§ 608.01(p)(II), August 2001.
Past
vs. Present Tense
Hoffman
LaRoche, Inc. v. Promega emphasizes that any Example written
in the past tense is a signal that the experiment was
actually performed in the way the Example is written. More specifically,
this means that any Example written in the past tense must have
been performed in the order in which the steps are written.
After Hoffman
LaRoche, Inc. v. Promega, hypothetical Examples are still
acceptable, but, as indicated in the MPEP, and by the Court,
they must be written “prophetically,” meaning in
the present tense. The present tense is a signal to the Examiner
that the protocol may not have been performed, but that it nonetheless
portrays a sequence of steps and materials for conducting the
experiment. Any Example written in the past tense must have
data supporting the implicit assertion that all steps of the
Example were performed in the order and way that they were written.
If substantial evidence does not exist to support that the Example
was performed as written, this misrepresentation has the potential
for rendering the patent unenforceable.
Dos
and Don’ts
The Hoffman LaRoche, Inc. v. Promega case provides
some guidelines for attorneys and patent agents to keep in mind
when drafting the Examples section of a patent application,
and for scientists when providing information to the attorney
or agent:
Attorneys
and agents
- Do
use the present tense for prophetic Examples and the past
tense for Examples that were performed in the way they were
written
- Don’t
mix tenses within a single Example. If an Example is a prophetic
example, use the present tense throughout. If the Example
was performed, stay with the past tense. Mixing tenses can
lead to confusion about whether the experiments were performed
as written, and this can be construed against the applicant.
Scientists
- Do
use particular care when assembling protocols for use as Examples.
Tell the person preparing the application which protocols
were actually performed. Distinguish these from the protocols
for future experiments.
- Don’t
use the past tense when combining protocols. Combinations
of protocols often do represent the best way of performing
an experiment, but if the steps of the resulting experiment
were not performed as written by the time the patent application
is filed, the Example cannot be written in the past tense.
It must be written in the present tense to signal to the Examiner
that it is a prophetic Example.
Attorneys,
agents and scientists
- Do
discuss future plans for further experimentation, and in the
patent application, include one or more examples that track
methods the way the scientist plans to perform them. Once
the patent application is filed, inventors should let the
attorney know when the experiments have been conducted. Experimental
data may be helpful during prosecution of the patent application
and can be presented to the Examiner after the application
is filed. For example, the data may help overcome prior art
cited against the application, or may support utility or enablement
of the invention as claimed.
For further guidance or to seek specific information, please contact
DWT's Life Science attorneys. With offices from coast to coast,
DWT Life Science attorneys combine their experience in diverse practice
areas with industry knowledge to help you reach your business goals.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Jane E.R. Potter,
Ph.D. (biotechnology), Seattle, (206) 628-7650, janepotter@dwt.com
David H. Deits (medical
devices), Seattle, (206) 628-7631, davedeits@dwt.com
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 only be given in response to inquiries
regarding particular situations.
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