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Archived updates for Wednesday, February 08, 2006

A Lesson in Laboratory Notebook Keeping

In Medichem, S.A. v. Rolabo, S.L. (Fed. Cir. February 3, 2004), the parties disputed whether or not there was adequate corroboration of the inventors’ testimony that Medichem had actually reduced to practice the process of the claimed invention before Rolabo’s effective filing date. The court considered three principal pieces of potentially corroborative evidence -- the NMR spectra, the notebooks of Medichem’s inventors, and the notebook of non-inventor Casas -- to conclude that cooberation was absent:

We note at the outset that the problem with the dated NMR data is that at most they corroborate that the inventors were in possession of the chemical
loratadine as of that date; they do not, in themselves, adequately corroborate
the claimed process, as they do not establish whether the sample that was
analyzed was actually produced by that process. If this case dealt with a claim
to a composition of matter, rather than to a process, the NMR evidence might
very well take on a different relevance in this regard. As far as the
corroborative value of the inventors’ notebooks is concerned, they were not
witnessed, and they do not provide an "independent" source of authority on the
issue of reduction to practice. Hence, they have minimum corroborative value.

It is clear to this court, therefore, that Medichem’s claim of
corroboration stands or falls with the modicum of additional corroborative value
that can properly be assigned to non-inventor Casas’ notebook. However, Casas
did not testify regarding the notebook or the genuineness of its contents. In
addition, although Casas’ notebook was dated, it was neither signed nor
witnessed, and inventor Rodriguez testified that she and Casas had made entries
in each others’ notebooks. Rodriguez characterized these occasions as not out of
the ordinary. As a result, the district court was clearly reliant on the
inventor to help to identify the author of specific entries made in Casas’
notebook, because in a reduction to practice inquiry, only those passages of the
unsigned, unwitnessed notebooks authored by non-inventor Casas could possess
significant corroborative value. In addition, without testimony from Casas, the
court lacked any non-inventor testimony regarding the genuineness of the
notebook’s contents.

We also note that Medichem admitted fraudulently backdating
certain documents relating to a purported 1995 reduction to practice. Even
though the backdating of the 1995 documents was unrelated to the critical pages
in Casas’ notebook, which purport to establish a reduction to practice in 1996,
the district court found that the credibility of the Medichem inventors was
accordingly diminished.

Where a laboratory notebook authored by a non-inventor is offered into
evidence pursuant to authentication by an inventor, where the author of the
notebook has not testified at trial or otherwise attested to its authenticity,
and where the notebook has not been signed or witnessed and has not been
maintained in reasonable accordance with good laboratory practices sufficient to
reasonably ensure its genuineness under the circumstances, then the
corroborative value of the notebook is minimal. Given the facts of this case,
Casas’ notebook should therefore not be accorded much corroborative value. In
view of the minimal corroborative value of the inventors’ notebooks and the
limited value of the NMR spectrum, we conclude that the evidence, evaluated as a
whole under the rule of reason, is insufficient as a matter of law to
corroborate Medichem’s reduction to practice.

The district court did not specifically address corroboration in its
obviousness inquiry, a fact that might, in some circumstances, hamper our
ability to conduct clear error review. Here, however, the facts of the case
admit of only one conclusion as a matter of law, and we therefore decide the
case without remanding to the district court for an explanation of why it
implicitly found corroboration to be present. We hold that corroboration is
absent and that the district court therefore erred in reaching its legal
conclusion that Medichem had reduced its invention to practice in the spring of
1996. Accordingly, we reverse the district court’s award of priority to

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