Tuesday, February 07, 2006

MediChem v. Rolabo

In MediChem v. Rolabo, 2006 U.S. App. LEXIS 2653, the CAFC delves into chemistry related to the synthesis of loratidine (CLARITIN). In claims directed to a McMurry reaction, MediChem required a tertiary amine, but Rolabo did not, so one had a species (MediChem) falling within a genus (Rolabo). Rolabo had an earlier effective filing date, but MediChem was trying to establish an earlier reduction to practice, to prevail under 102(g).

Of interference-in-fact issues, the CAFC cited to Lilly, 334 F.3d 1264.

There are some interesting issue preclusion (collateral estoppel) issues because of a parallel proceeding before the BPAI. 65 USPQ2d 1942.

There are also some interesting issues about the evidentiary use of laboratory notebooks.

For starters, the CAFC made clear that evidence within a notebook (unlike testimony) did NOT have to be corroborated:

For purposes of conceptual clarity, as well as clarity of language,
it should be noted that no similar condition of "corroboration" is imposed on an
inventor's notebook, or indeed on any documentary or physical evidence, as a
condition for its serving as evidence of reduction to practice. See, e.g.,
Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577-78 (Fed. Cir. 1996) (explaining
that "this court does not require corroboration where a party seeks to prove
conception through the use of physical exhibits because the trier of fact can
conclude for itself what documents show, aided by testimony as to what the exhibit
would mean to one skilled in the art"
); Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993) ("Only the inventor's testimony requires corroboration before it
can be considered.").

Relevant to proposed evidence of an NMR spectrum, the CAFC noted that the NMR spectrum might have different value for a product claim than a process claim:

When an inventor claims a process for making a chemical compound
rather than the compound itself, it is the successful reduction to practice of the
process that must be corroborated, and not merely the successful production of
the compound per se. Thus, spectral evidence that might be sufficient per
se to corroborate a claim directed to the product will generally not be
sufficient to corroborate a claim directed to the process, in the absence of some
evidence to corroborate that the product was produced via that process.

Of the facts of the case:

This court now turns to consider the corroborative value of the
three principal pieces of potentially corroborative evidence: the NMR
spectra, the notebooks of Medichem's inventors, and the notebook of non-inventor
Casas. 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

Of the noninventor Casas:

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. n10 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
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.

The real moral to the MediChem story: if you need the content of a noninventor's notebooks to make your case, be sure to have the noninventor testify. As the CAFC said:

Indeed, in Chen v. Bouchard, this court affirmed the decision of the Board of Patent Appeals and Interferences to exclude as inadmissible hearsay a non-inventor's notebooks, which had been offered to corroborate reduction to practice where, as in the instant case, the non-inventor did not testify. 347 F.3d 1299, 1308 (Fed. Cir. 2003).


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