By Donald Zuhn --
In an appeal from a District Court judgment invalidating
more than two hundred claims in three Invitrogen patents as being anticipated
under § 102(g)(2), the Federal Circuit vacated the District Court's invalidity
judgment and remanded the case for further proceedings, holding that the
District Court misapplied the law of appreciation when determining the date of
conception for researchers at Columbia University. The Federal Circuit, however, affirmed the
District Court's rulings on enablement, written description, and infringement.
The patents at issue relate to a genetically modified
version of the enzyme reverse transcriptase, which has use in the field of
molecular biology. Naturally-occurring
(or unmodified) reverse transcriptase possesses both DNA polymerase and RNase H activities, the former permitting the enzyme to
synthesize a DNA copy (cDNA) of a messenger RNA (mRNA) template, and the latter permitting the enzyme to degrade the mRNA
template following cDNA synthesis. In
contrast, the modified enzyme lacks RNase H activity, and therefore, is unable
to degrade the mRNA template following cDNA synthesis, allowing researchers to
reuse the mRNA template to create additional cDNA copies.
While neither party disputed the District Court's
determination that Invitrogen had reduced a modified reverse transcriptase
lacking RNase H activity to practice in January of 1987, Invitrogen did find
fault with the lower court's ruling that Drs. Stephen Goff and Naoko Tanese,
two researchers at Columbia University, had conceived of such an enzyme before
Invitrogen had reduced the enzyme to practice. Drs. Goff and Tanese had begun their work in 1984 by preparing a panel
of bacterial mutants having modified reverse transcriptase genes. The panel included two mutants that the
Columbia University researchers would later show possess modified reverse
transcriptase lacking RNase H activity. However, due to limitations in the assays that Drs. Goff and Tanese were
using to measure RNase H activity, they were unable to conclusively establish
that any of the mutants possessed modified reverse transcriptase lacking RNase
H activity at the time the mutant panel was prepared. In March of 1987, Drs. Goff and Tanese used a
new assay that they had developed to finally establish that two of the mutants
from their panel possessed the modified enzyme. They were also able to correlate the results obtained with their new
assay with their late 1986 sequencing analysis of the mutants.
Following a series of pre-trial motions regarding the
issues of conception, enablement, written description, and infringement, the
District Court determined, inter alia, that Drs. Goff and Tanese (a) had
conceived of a genetically modified reverse transcriptase lacking RNase H
activity either in December of 1984 when they had isolated mutants possessing
modified reverse transcriptase, or in January of 1986 when they had sequenced
the reverse transcriptase genes in these mutants; (b) had actually reduced
their invention to practice in March of 1987 when they established that two
mutants from their panel possessed modified reverse transcriptase; and (c) were
diligent in reducing their invention to practice, and did not abandon, conceal,
or suppress it. However, despite these
rulings, the District Court refused to find that the work of Drs. Goff and
Tanese anticipated Invitrogen's patents under § 102(g)(2), arguing that
anticipation posed factual questions requiring resolution on a claim by claim
basis.
Stating that conception "require[s] more than
unrecognized accidental creation," and instead "requires that the
inventor appreciate that which he has invented," the Federal Circuit found
that the District Court erred by establishing Drs. Goff and Tanese's conception
before January of 1987 and granting partial summary judgment for Clontech. Relying on decisions of its predecessor
Court, which "require some connection between the physical result (the
invention) and the belief (by the inventor)," the Federal Circuit
determined that the record was inconsistent with the District Court's notion
that Drs. Goff and Tanese set out to create a modified reverse transcriptase or
appreciated in 1984 that their mutant panel contained two mutants possessing
modified reverse transcriptase. Rather,
the Federal Circuit believed that this case "fit[] squarely within the
unrecognized, accidental duplication cases."
However, while the Federal Circuit determined that the
evidence excluded both dates of conception proposed by the District Court, the
Federal Circuit also found that Dr. Goff's deposition testimony precluded it
from finding that the District Court abused its discretion in refusing to grant
partial summary judgment for Invitrogen on the issue of conception. In particular, Dr. Goff had testified that he
had formed a suspicion in late 1986, based on his difficulties analyzing the
mutants, that two of the mutants possessed modified reverse transcriptase
lacking RNase H activity. Because a reasonable
fact-finder presented with Dr. Goff's testimony could conclude that the
evidence preceding the researchers' March 1987 testing might suffice, under the
applicable standard, to corroborate Dr. Goff's suspicions about the two
mutants, the Federal Circuit vacated the District Court's invalidity judgment
and remanded the case for further proceedings.
Invitrogen Corp. v. Clontech Lab., Inc. (Fed. Cir. 2005)
Panel: Chief Judge Michel and Circuit Judges Rader and Gajarsa
Opinion by Circuit Judge Gajarsa
This article was originally published on Patently-O on November 20, 2005.
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