he described the processing of APP into AΣv by enzymes. Mullan did
not actually make the mice described and claimed in his patent. Mullan
did not disclose looking for ATF-betaAPP as a proxy for Aσv.
In addition to the patents-in-suit, plaintiffs own a patent by the same
inventors covering the brain-homogenate method for testing for
ATF-betaAPP disclosed in the specifications of the patents-in-suit. That
patent has not been asserted against Mayo because Mayo tests its mice
directly for as is now the industry standard.
A "party moving for summary judgment bears the burden of identifying
the evidence that demonstrates the absence of a disputed material fact
and establishes that the moving party is entitled to judgment as a matter
of law." See Seal-Flex, Inc. v. Athletic Track And Court Constr.,
98 F.3d 1318, 1321 (Fed.Cir. 1996) (citation omitted). "A patent is
presumed to be valid, see 35 U.S.C. § 282, and this presumption only
can be overcome by clear and convincing evidence to the contrary."
Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed.Cir. 2000).
An invention is invalid as anticipated if it "was described in a patent
granted on an application for patent by another filed in the United
States before the invention thereof by the applicant for patent. . . ."
35 U.S.C. § 102 (e). The prior-art patent must disclose each and
every limitation of the claimed invention, must be enabling, and must
describe the claimed invention sufficiently to have placed it in
possession of a person of ordinary skill in the art. Ibid.
Though each limitation of the asserted claim must be disclosed in the
prior-art patent, the prior-art patent need not duplicate the claim word
for word. It is sufficient that the claimed limitation is "inherent" in
the relevant reference. In re Donahue, 766 F.2d 531, 533 (Fed.Cir.
1985). The invention disclosed in the prior-art patent need not have been
built or practiced, so long as it is described sufficiently to enable
others to build or practice it. Atlas Powder Co. v. E.I. du Pont De
Nemours & Co., 750 F.2d 1569, 1576 (Fed.Cir. 1984).
Plaintiffs concede that the Mullan patent, filed in 1992, is prior art
to the patents-in-suit. Plaintiffs contend, however, that the Mullan
patent does not anticipate the asserted claims because the Mullan patent
does not disclose, explicitly or inherently, the transgenic mice
processing the APP polypeptide to ATF-betaAPP in a sufficient amount to be
detectable in a brain homogenate.*fn1 The Court disagrees. The mice
claimed in the patents-in-suit are merely a subset of the mice described
in Mullan. Some of the mice made using the process disclosed in Mullan
(which is essentially the same process disclosed in the patents-in-suit)
would inevitably have detectable levels of ATF-betaAPP. Were Plaintiffs
to contend otherwise, their own patents would not be enabled. Mullan
therefore inherently includes the limitation of the final "wherein"
clauses of the asserted claims.
Plaintiffs' arguments to the contrary do not persuade the Court.
First, plaintiffs argue that all mice created from the Mullan disclosure
would have to process the APP polypeptide to ATF-betaAPP in order for
Mullan to anticipate the last "wherein" clauses of the asserted claims.
Plaintiffs cite Glaxo, Inc. v. Navapharm Ltd., 52 F.3d 1043 (Fed.Cir.
1995), to support their position. In Glaxo, Inc., Glaxo
chemists discovered ranitidine in 1976 and began making preparations for
manufacturing and selling the compound as an antiulcer drug. Glaxo, Inc.
v. Novopharm Ltd., 830 F. Supp. 871, 873 (E.D.N.C. 1993). In 1977, Glaxo
filed an application for a United States Patent covering all rantidine
compounds of a specified general formula, including ranitidine
hydrochlorides, a salt of ranitidine that Glaxo had discovered about a
month earlier. That application resulted in the `658 patent. The `658
patent disclosed the method, called Example 36, for making rantidine
From 1977 to 1980, Glaxo tested procedures for the production of
rantidine hydrochloride. The procedure set out in Example 32 was not used
in any of this work. Glaxo used a similar process it called Process 3A,
and then later a more efficient process it called Process 3B. In 1980, a
batch of rantidine hydrochloride prepared using Process 3B produced
crystals that were different from the previously produced by Glaxo. Glaxo
determined that there were two crystal forms of rantidine hydrochloride.
It called the 1980 variety Form 2 and the earlier variety Form 1. Glaxo
eventually decided to proceed with the commercial development of Form 2
rather than Form 1. and modified Process 3B so that it regularly produced
Form 2. Ibid. It then applied for and obtained the `431 patent covering
Form 2. Id. at 874. It asserted the `431 patent against Novopharm.
As a defense to infringement, Novopharm argued that the `431 patent was
inherently anticipated by Glaxo's earlier `658 patent, which disclosed
the Example 32 method for making rantidine hydrochloride. Ibid. At
trial, Novopharm contended that, practiced as written, the product of
Example 32 was always Form 2. Four chemists testified for Novopharm that
they had repeatedly followed the Example 32 procedure and always achieved
Form 2. Id. at 875. Three chemists for Glaxo, on the other hand,
testified that they had repeatedly followed Example 32 and always
achieved Form 1. Ibid.
The district court found that the proper practice of Example 32
resulted at times in the exclusive production of Form 1 and at times in
the exclusive production of Form 2. From this the court concluded that
Novopharm had failed to carry its burden of proving inherence by clear
and convincing evidence. According to the court, Form 2 could only have
been inherent in Example 32 if Example 32 had invariably produced Form 2
as opposed to Form 1. Ibid. The Federal Circuit affirmed. Glaxo, Inc. v.
Novopharm, Ltd., 52 F.3d at 1047-48.
The present case differs significantly in two respects from the Glaxo,
Inc. case. First, here, the patents-in-suit do not disclose a new way of
making the patented mice, finely tuned to produce only mice that process
the APP polypeptide such that ATF-beta APP will be detectable in a brain
homogenate. To the contrary, the patents-in-suit disclose the same
procedure — the only relevant difference is that they claim only a
portion of the results. In the Glaxo, Inc., on the other hand, the patent
disclosed a new method designed to produce Form 2. Moreover, the
disclosure in the prior-art patent indicated that only Form 1 had been
achieved, meaning no rantidine hydrochloride in Form 2 had been
Second, in the present case, a predictable percentage of mice produced
according to Mullan (and the patents-in-suit) will inevitably process the
APP polypeptide to ATF-beta APP in amounts detectable in a brain
homogenate. In Glaxo, Inc., on the other hand, there was nothing
inevitable about the production of Form 2 from the Example 32 method,
which apparently was a very general instruction. Sometimes
Example 32 produced only Form 1. Sometimes Example 32 produced only Form
2. The results seemed to vary according to how the process was carried
out, not according to statistical probabilities. In other words, the
practice of Example 32 probably varied in small ways that would
unpredictably lead to either Form 1 or Form 2 rantidine hydrochloride.
These differences distinguish the present case from Glaxo, Inc. Here,
Mullan's disclosure would produce some mice that process the APP
polypeptide to ATF betaAPP in detectable amounts, just as the disclosures
in the patents-in-suit produce some mice that process the APP polypeptide
to ATF beta-APP in detectable amounts. Were the facts of Glaxo, Inc.
parallel to the instant facts, (1) Example 32 would produce a predictable
percentage of Form 2 rantidine hydrochloride regardless of who was
practicing the procedure, and (2) the `431 patent (the patent there at
issue) would not have disclosed a new process for predictably achieving
only Form 2, but instead would have disclosed the same Example 32 while
claiming only the Form 2 product.
In addition to the Glaxo, Inc. opinions, plaintiffs also cite Finnigan
Corp. v. United States Int'l Trade Comm'n, 180 F.3d 1354, 1365 (Fed.Cir.
1999). From Finnigan Corp. Plaintiffs quote the following language:
"Inherency . . . may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given
set of circumstances is not sufficient." But Plaintiffs omit the
remainder of the passage. In whole, the passage reads:
Inherency, however, may not be established by
probabilities or possibilities. The mere fact that a
certain thing may result form a given set of
circumstances is not sufficient. If, however, the
disclosure is sufficient to show that the natural
result flowing from the operation as taught would
result in the performance of the questioned function,
it seems to be well settled that the disclosure should
be regarded as sufficient.
Finnigan Corp., 180 F.3d at 1365 (quoting In re Oelrich, 666 F.2d 578,
581 (Cust. & Pat.App. 1981)). As an initial matter, the Mullan patent
meets the above definition of inherency. Mice that produce ATF-betaAPP in
detectable amounts are a natural result flowing from the practice taught
by Mullan, just as they are a natural result flowing from the
(essentially identical) process taught by the patents-in-suit.
In addition, the present case is distinguishable from Finnigan on its
facts. In Finnigan, the issue was whether a priorart article inherently
disclosed nonresonance ejection in a quadruple ion trap. At trial, the
author of the article was equivocal as to whether the diagrams in his
article showed nonresonance ejection or selective ejection. The Federal
Circuit held that "[t]he mere possibility that Figure 2 might be
understood by one of skill in the art to disclose nonresonnance ejection
is insufficient to show that it is inherently disclosed therein." Id. at
1366. The present case does not fit the Finnigan model. Here, there is no
ambiguity in the Mullan patent such that the Court must determine whether
it would have taught one skilled in the art to make the covered mouse.
Rather, here, the parties agree that if one skilled in the art were to
follow Mullan, he or she would produce some mice that would process an
APP polypeptide having the Swedish to ATF-betaAPP in a sufficient amount
to be detectable in a brain homogenate.
Plaintiffs also point to MEHL/Biophile Int'l Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed.Cir. 1999). There, the Federal Circuit found
that a prior-art manual that taught how to use a laser to remove tattaos
did not inherently disclose a method
of removing hair using a laser because an operator of the tatoo-removing
laser could use it without necessarily aligning the laser "substantially
vertical over a hair follidc opening." Again, the present case is
distinguishable because using the Mullan disclosure (or the disclosures
in the patents-in-suit) to make numerous mice as intended, would
inevitably lead to some mice with the characteristics claimed in the
patents-in-suit. The mice would not be an accident, but rather a
Plaintiffs argue that one could practice Mullan and still not infringe
the claims of the patents-in-suit. According to plaintiffs, the claims at
issue implicitly require that a successful mouse — that is, a mouse
with detectable amounts of ATF-betaAPP — be identified as such. An
untested mouse, according to plaintiffs' logic, could not infringe the
patents-in-suit, even if that mouse processed an APP polypeptide having
the Swedish to ATF-betaAPP in a sufficient amount to be detectable in a
brain homogenate. The Court disagrees with this position. The asserted
claims do not require testing of the covered mouse. They require only
that the mouse have claimed characteristics.
For the foregoing reasons, the Court holds that the Mullan patent
anticipates the asserted claims of the patents-in-suit. Defendant's
motion for summary judgment is GRANTED. The clerk shall close the file.
IT IS SO ORDERED.