By Donald Zuhn --
In an
appeal from a District Court judgment of validity and noninfringement, the
Federal Circuit reversed the District Court's finding of validity, holding the asserted
claims in U.S. Patent No. 5,990,176 to be anticipated by the
disclosure in U.S. Patent No. 5,684,211.
The '176
patent relates to degradation-resistant compositions of the inhalation
anesthetic sevoflurane and processes for preventing the degradation of
sevoflurane. Abbott Laboratories
(Abbott), an assignee of the '176 patent, had discovered that its sevoflurane
product was being degraded by Lewis acids located on the interior of the containers in
which the sevoflurane was being shipped. This degradation reaction yielded hydrofluoric acid, which is highly
dangerous if inhaled. Abbott also
discovered that sevoflurane could be protected from degradation by mixing the
sevoflurane with water, which would bind to and deactivate the Lewis acids. Neither the degradation of sevoflurane by
Lewis acids nor the protective effects of water were known in the art at the
time of the '176 invention.
Seeking to
ship their own sevoflurane product, Baxter Pharmaceutical Products, Inc. and
Baxter Healthcare Corp. (Baxter) filed a certification of noninfringement and
invalidity of the '176 patent with the FDA, giving rise to the suit with
Abbott. Before the District Court,
Baxter argued, inter alia, that the '211 patent disclosed a composition of
water-saturated sevoflurane that met all of the limitations of the asserted
claims of the '176 patent, and therefore, anticipated the '176 patent. The District Court, however, determined that
because the purpose of the '211 patent was not to produce sevoflurane in its
final useable form, the purposes of the '211 and '176 patents were different,
and therefore, under Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., the
'211 patent did not anticipate the '176 patent. 246 F.3d 1368 (Fed. Cir. 2001) ("Newly discovered results of known
processes directed to the same purpose are not patentable because such results
are inherent.").
In
rejecting the District Court's application of Bristol-Myers Squibb, the Federal
Circuit noted that the purpose-based distinction set forth in that case
"is applicable only to process claims [and] does not speak to composition
claims." The Federal Circuit,
therefore, determined that the District Court erred by applying Bristol-Myers
Squibb to sustain the validity of the composition claims in the '176
patent. With respect to the process
claims in the '176 patent, the Federal Circuit disagreed with the District
Court's determination that the processes of the '211 and '176 patents were not
directed to the same purpose, finding that "[a]ll of the steps of the '176
patent are disclosed in the '211 patent in furtherance of the same
purpose: the delivery of safe, effective sevoflurane anesthetic. All that is contributed by the method claims
of the '176 patent is the recognition of a new property of the prior art
process."
The Federal
Circuit also rejected Abbott's argument that at the time of the '211 patent,
nobody knew that the water-saturated sevoflurane composition disclosed in the
'211 patent could resist Lewis acid degradation, stating that "[o]ur cases
have consistently held that a reference may anticipate even when the relevant
properties of the thing disclosed were not appreciated at the time." Noting that the "lack of knowledge
[regarding the property of degradation resistance] is wholly irrelevant to the
question of whether the '176 patent claims something 'new' over the disclosure
of the '211 patent," and finding that the claimed property was inherently
present in the '211 patent, the Federal Circuit determined that the '211
patent's disclosure of water-saturated sevoflurane anticipated the claims of
the '176 patent. The Federal Circuit,
therefore, reversed the District Court's finding of validity.
Abbott Laboratories v. Baxter Pharmaceutical Products, Inc. (Fed. Cir. 2006)
Panel: Circuit Judge Bryson, Senior Circuit Judge Archer, and Circuit Judge Gajarsa
Opinion by Circuit Judge Gajarsa
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