United States Court of Appeals for the Federal Circuit
06-1021, -1022, -1034
ABBOTT LABORATORIES
and CENTRAL GLASS COMPANY, LTD.,
Plaintiffs-Appellants,
v.
BAXTER PHARMACEUTICAL PRODUCTS, INC.
and BAXTER HEALTHCARE CORP.,
Defendants-Cross Appellants.
R. Mark McCareins, Winston & Strawn LLP, of Chicago, Illinois, argued for
plaintiffs-appellants. With him on the brief were Edward L. Foote, Raymond C. Perkins,
Peggy M. Balesteri, James F. Herbison, and Timothy M. Schaum.
Constantine L. Trela, Jr., Sidley Austin LLP, of Chicago, Illinois, argued for
defendants-cross appellants. With him on the brief were David T. Pritikin, William H.
Baumgartner, Jr., and Russell E. Cass. Of counsel on the brief was Thomas S. Borecki,
Baxter Healthcare Corporation, of Deerfield, Illinois. Of counsel was Marc A. Cavan,
Sidley Austin LLP, of Chicago, Illinois.
Appealed from: United States District Court for the Northern District of Illinois
Judge Ronald A. Guzman
United States Court of Appeals for the Federal Circuit
06-1021, -1022, -1034
ABBOTT LABORATORIES
and CENTRAL GLASS COMPANY, LTD.,
Plaintiffs-Appellants,
v.
BAXTER PHARMACEUTICAL PRODUCTS, INC.
and BAXTER HEALTHCARE CORP.,
Defendants-Cross
Appellants.
__________________________
DECIDED: November 9, 2006
__________________________
Before BRYSON, Circuit Judge, ARCHER, Senior Circuit Judge, and GAJARSA, Circuit
Judge.
GAJARSA, Circuit Judge.
Plaintiffs Abbott Laboratories and Central Glass Company (collectively “Abbott”)
appeal from a judgment of noninfringement of
U.S. Patent No. 5,990,176 (“the ’176
patent”) by the United States District Court for the Northern District of Illinois.
Defendants Baxter Pharmaceutical Products, Inc. and Baxter Healthcare Corp.
(collectively “Baxter”) cross-appeal the district court’s determination that the asserted
claims are valid and its refusal to find unenforceability due to inequitable conduct. This
is our second hearing of this case; following our first, we reversed the district court’s
claim construction and remanded for trial. Abbott Labs. v. Baxter Pharm. Prods., Inc.,
334 F.3d 1274 (Fed. Cir. 2003). The district court conducted a bench trial, then further
construed the claims at issue and found them valid and enforceable but not infringed.
Abbott Labs v. Baxter Pharm. Prods., Inc., No. 01-CV-1867 (N.D. Ill. Sept. 26, 2005).
This appeal timely followed.
Because we hold the asserted claims of the ’176 patent to be anticipated by the
disclosure in
U.S. Patent No. 5,684,211 (“the ’211 patent”), we reverse the district
court’s validity judgment.
I. BACKGROUND
A. The technology
Sevoflurane is a fast-acting, highly effective inhalation anesthetic. However, pure
sevoflurane has a serious problem, unknown at the time of its invention and original
shipment: it degrades in the presence of Lewis acids. Lewis acids are essentially
defined as any species with an empty electron orbit leading to electron affinity and are
common enough that avoiding exposure of sevoflurane to Lewis acids is quite difficult.
Among the products of the degradation reaction is hydrofluoric acid, which is highly
dangerous if inhaled. ’176 patent col.1 ll.52-57. The original containers in which Abbott
shipped its product had Lewis acids exposed on their interiors. The hydrofluoric acid
thus produced etched the containers’ glass surfaces, exposing even more Lewis acids,
resulting in a vicious-cycle cascading reaction that seriously compromised Abbott’s
product while on the shelf and forced a recall.
After investigating the cause of the degradation, Abbott discovered the source of
the problem. It also found a solution: water mixed in with sevoflurane will bind to and
deactivate Lewis acids, protecting the sevoflurane from the degradation reaction.
06-1021, -1022, -1034 2
A deliberate addition of water to sevoflurane ran counter to the conventional wisdom at
the time: previously, Abbott had sought to minimize its product’s water content. Abbott
filed a patent application on the degradation-preventing combination of water or other
“Lewis acid inhibitors” with sevoflurane, which issued as the ’176 patent at issue here.
B. Prior proceedings
Baxter sought to ship its own sevoflurane product. On January 26, 2001, it filed
an amended Abbreviated New Drug Application (“ANDA”) with the Food and Drug
Administration (“FDA”) covering its own sevoflurane product. Baxter filed with the FDA
a certification of noninfringement and invalidity of the ’176 patent pursuant to
21 U.S.C.
§ 355(j)(2)(A)(vii)(IV) (commonly known as a “paragraph IV certification”), which created
the cause of action giving rise to this suit under
35 U.S.C. § 271(e)(2).
There are multiple product and method claims at issue. Claim 1 of the ’176
patent is representative:
An anesthetic composition comprising: a quantity of sevoflurane; and a
Lewis acid inhibitor in an amount effective to prevent degradation by a
Lewis acid of said quantity of sevoflurane, said Lewis acid inhibitor
selected from the group consisting of water, butylated hydroxytoluene,
methylparaben, propylparaben, propofol, and thymol.
’176 patent col.11 ll.21-29. The other claims at issue speak to using water specifically,
methods of combining sevoflurane and Lewis acid inhibitors to produce the above-
mentioned composition, or both.
Id. at cols.11-12.
This case came before us for the first time when we reviewed the district court’s
construction of the phrase “amount effective to prevent degradation” to require at least
131 parts per million (“ppm”) of water and its consequent summary judgment of
noninfringement. Abbott,
334 F.3d at 1277. We disagreed with that construction, noting
that “an effective amount of any given Lewis acid inhibitor will vary according to the
06-1021, -1022, -1034 3
conditions to which sevoflurane is subjected,” making construction referencing particular
ranges of water content inappropriate.
Id. at 1278. We vacated the district court’s
summary judgment and remanded.
Id. at 1283. On remand, the district court
conducted a bench trial. It determined that the term “to prevent degradation” had been
left unconstrued, Abbott, No. 01-CV-1867, slip op. at 7, and concluded that “sevoflurane
is degraded if it contains degradants in amounts greater than 300 ppm.” Id. at 16. It
found Abbott’s literal infringement evidence to be unpersuasive, id. at 27, and Abbott’s
doctrine of equivalents argument to be barred by prosecution history estoppel, id. at 31.
It addressed Baxter’s claim that the patent was unenforceable due to inequitable
conduct, but declined to so hold. Id. at 48.
Baxter made two distinct invalidity arguments. It first argued that since some lots
of the pre-recall sevoflurane sold by Abbott had not degraded, there had been a prior
sale which would bar the patent. The district court found insufficient evidence that those
lots had actually been exposed to Lewis acids, making a finding that they had contained
water “in an amount effective to prevent degradation” unsupportable. Id. at 44. Baxter’s
second argument was that the ’211 patent disclosed a composition of water-saturated
sevoflurane that met all the limitations of the asserted claims. Id. at 37-39. The district
court noted some of our holdings finding anticipation even where, as here, there was no
knowledge at the time of the relevant properties of the prior art. Id. at 40-41 (citing Atlas
Powder Co. v. IRECO, Inc.,
190 F.3d 1342, 1348-49 (Fed. Cir. 1999); SmithKline
Beecham Corp. v. Apotex Corp.,
403 F.3d 1331, 1343-44 (Fed. Cir. 2005); Schering
Corp. v. Geneva Pharms., Inc.,
339 F.3d 1373, 1378-80 (Fed. Cir. 2003)). However, it
concluded that the ’211 patent did not anticipate. Id. at 43. That decision was based on
06-1021, -1022, -1034 4
its reading of our decision in Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., in
which we noted that “[n]ewly discovered results of known processes directed to the
same purpose are not patentable because such results are inherent.” Id. at 42 (quoting
246 F.3d 1368, 1376 (Fed. Cir. 2001) (emphasis added by district court)). It concluded
that since the ’211 patent disclosed an “intermediate step” in the manufacture of
sevoflurane, “the patent’s purpose was not to produce sevoflurane in its final useable
form,” in distinction to the purpose of the ’176 patent, which “involves a final step in
production.” Id. at 42. The district court reasoned that since the patents’ purposes were
different, the Bristol-Myers Squibb distinction foreclosed a finding of anticipation. Id. at
42-43.
All of these rulings by the district court are before us via either Abbott’s appeal or
Baxter’s cross-appeal. Abbott challenges the claim construction, arguing that the
intrinsic evidence of the ’176 patent permits more than 4,000 ppm of impurities before
the sevoflurane may be considered “degraded.” Abbott also challenges the district
court’s findings on literal and doctrine of equivalents infringement. Baxter challenges
enforceability and validity, the latter in light of both the ’211 patent and the alleged prior
sale. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(1).
II. DISCUSSION
A. Standard of review
Patent claims are presumed to be valid,
35 U.S.C. § 282, and the party seeking
to show invalidity must prove facts supporting invalidity by clear and convincing
evidence. N. Am. Vaccine, Inc. v. Am. Cyanamid Co.,
7 F.3d 1371, 1379 (Fed. Cir.
1993). Since this case comes to us from a trial without jury, we review the district
06-1021, -1022, -1034 5
court’s findings of fact for clear error and its legal conclusions de novo. Panduit Corp. v.
Dennison Mfg. Co.,
810 F.2d 1561, 1565 (Fed. Cir. 1987).
B. The ’211 patent
The ’211 patent was applied for in 1995 and awarded to Kawai et al. in
November 1997. Appellant Central Glass Co. is the assignee. The parties do not
dispute that the ’211 patent predates the ’176 patent for the purposes of
35 U.S.C.
§ 102, and the facts about what the ’211 patent teaches are in relevant part undisputed.
It discloses a technique for purifying sevoflurane for “use[] as a pharmaceutical and
particularly as an inhalation anesthetic,” ’211 patent abstract, which involves the
addition of water. If the steps of its Illustration 1, Table 2 are practiced, the result will be
sevoflurane that is saturated with water, unable to absorb any more moisture.
Saturation implies that the sevoflurane contains an amount of water sufficient to prevent
it from degrading due to Lewis acids.
At the time, however, knowledge of the beneficial nature of a water-sevoflurane
mix was wholly lacking in the art. The district court describes the matter succinctly:
[P]rior to [the ’176 patent] invention no one had any idea that Lewis acids
had the potential to degrade sevoflurane. Further, no one was aware of
the stabilizing effect water would have to prevent Lewis acid degradation.
In fact, water was considered an impurity and was removed from
sevoflurane to the extent possible during the manufacturing process that
included the teachings of the ’211 patent.
Abbott, No. 01-CV-1867, slip op. at 39. Thus, the ’211 patent discloses a particular
composition and claims a process for making that composition, but does not teach the
advantageous feature of that composition whose discovery led to the patent in suit.
06-1021, -1022, -1034 6
C. Unknown properties and anticipation
Our cases have consistently held that a reference may anticipate even when the
relevant properties of the thing disclosed were not appreciated at the time. The classic
case on this point is Titanium Metals Corp. v. Banner,
778 F.2d 775 (Fed. Cir. 1985). In
Titanium Metals, the applicants sought patent protection on an alloy with previously
unknown corrosion resistance and workability properties.
Id. at 776. The prior art
reference was an article by two Russian scientists that disclosed in a few data points on
its graphs an alloy falling within the scope of the claims of the patent in suit.
Id. at 776-
77. There was no sign that the Russian authors or anyone else had understood the
later-discovered features of the alloy thus described.
Id. at 780-81. Despite the fact
that “the applicants for patent had discovered or invented and disclosed knowledge
which is not to be found in the reference,” we held that the Russian article anticipated
the asserted patent claims.
Id. at 782. The Titanium Metals rule has been repeatedly
confirmed and applied by this court. See, e.g., In re Crish,
393 F.3d 1253, 1258-59
(Fed. Cir. 2004) (citing cases; holding asserted claims covering a gene’s nucleotide
sequence anticipated where the gene, though not its particular sequence, was already
known to the art); In re Cruciferous Sprout Litig.,
301 F.3d 1343, 1349-50 (Fed. Cir.
2002) (inventor’s recognition of substances that render broccoli and cauliflower
particularly healthy does not permit patent on identifying broccoli seeds or preparing
broccoli as a food product); Atlas Powder,
190 F.3d at 1347-1350 (holding asserted
claims covering air mixed into an explosive composition anticipated by prior art that
necessarily also contained air as claimed, even though benefits of the air were not
recognized). Indeed, the rule did not originate with Titanium Metals. See Ansonia
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Brass & Copper Co. v. Elec. Supply Co.,
144 U.S. 11, 18 (1892) (“[T]he application of
an old process or machine to a similar or analogous subject, with no change in the
manner of application and no result substantially distinct in its nature, will not sustain a
patent even if the new form of result had not before been contemplated.”); In re
Pearson,
494 F.2d 1399, 1403 (C.C.P.A. 1974) (inventor’s recognition that prior-art
compound inhibited defects in peanut plants did not suffice to grant patent protection on
that compound); In re Benner,
174 F.2d 938, 942 (C.C.P.A. 1949) (“[N]o provision has
been made in the patent statutes for granting a patent upon an old product based solely
upon discovery of a new use for such product.”).
The general principle that a newly-discovered property of the prior art cannot
support a patent on that same art is not avoided if the patentee explicitly claims that
property. “[A] prior art reference may anticipate without disclosing a feature of the
claimed invention if that missing characteristic is necessarily present, or inherent, in the
single anticipating reference.” Schering,
339 F.3d at 1377 (citing Continental Can Co. v.
Monsanto Co.,
948 F.2d 1264, 1268 (Fed. Cir. 1991)). “[I]nherent anticipation does not
require that a person of ordinary skill in the art at the time would have recognized the
inherent disclosure.”
Id. (citing Cruciferous Sprout,
301 F.3d at 1351).
Abbott’s objection here is merely that at the time of the ’211 patent, nobody knew
that the water-saturated sevoflurane that patent disclosed had the property of resisting
the Lewis acid degradation reaction. Just as in Titanium Metals, that lack of knowledge
is wholly irrelevant to the question of whether the ’176 patent claims something “new”
over the disclosure of the ’211 patent; the claimed property of resistance to degradation
is found inherently in the disclosure. Since the ’211 patent discloses sevoflurane
06-1021, -1022, -1034 8
saturated with water – i.e., unable to absorb any additional water to further protect it
from the degradation reaction – it anticipates the claims of the ’176 patent. This is true
under any definition of the term “prevent degradation” that the claims might reasonably
bear, so we need not construe that phrase with numerical exactitude in order to reach
our decision.
The district court nonetheless found the patent valid due to the purpose-based
distinction we drew in Bristol-Myers Squibb. Abbott, No. 01-CV-1867, slip op. at 42-43
(citing
246 F.3d at 1376). As a threshold matter, we note that that distinction is
applicable only to process claims. Bristol-Myers Squibb states that “new uses of known
processes may be patentable,” citing in support the definition of “process” found at
35
U.S.C. § 100(b).
246 F.3d at 1376. The case does not speak to composition claims;
the district court therefore committed legal error by applying it to sustain the validity of
those claims of the ’176 patent that cover a mixture of sevoflurane and water. As to the
’176 patent’s process claims, we agree that Bristol-Myers Squibb needs to be
considered, but we disagree with the concept that the processes described in the ’176
patent are not “directed to the same purpose,”
id., under the meaning of Bristol-Myers
Squibb. Both the ’211 and the ’176 patents disclose methods which help to ensure that
sevoflurane will be of high purity at the time it is administered to patients. The ’211
patent discloses a method of achieving that end by adding water and then distilling the
solution, which results in removing impurities from the sevoflurane, while the ’176 patent
accomplishes the same objective by merely adding water, which results in safeguarding
the sevoflurane against impurities generated by the presence of Lewis acids. All of the
steps of the ’176 patent are thus disclosed in the ’211 patent in furtherance of the same
06-1021, -1022, -1034 9
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. We hold today, as we did in Bristol-Myers Squibb, that “the claimed process
here is not directed to a new use; it is the same use.” Id.; see also Catalina Mktg. Int’l,
Inc. v. Coolsavings.com, Inc.,
289 F.3d 801, 809-10 (Fed. Cir. 2002) (explaining that an
inventor may not obtain a patent on a process having the same steps as a prior art
process, in which the new process merely identifies a new, advantageous property of
the prior art process).
We also do not find it material that the district court found the anticipating
method in the ’211 patent to be “an intermediate step” in the manufacture of
sevoflurane. Abbott, No. 01-CV-1867, slip op. at 42. The product of that method was
an anesthetic sevoflurane composition with sufficient water to prevent Lewis acid
degradation—exactly what is claimed by the ’176 patent. Commercial finality is not
claimed.
III. CONCLUSION
For the reasons given above, we reverse the district court’s judgment that the
asserted claims of the ’176 patent are valid. Since all asserted claims are invalid, we do
not reach questions of infringement or inequitable conduct.
REVERSED.
No costs.
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