United States District Court, N.D. Illinois, Eastern Division
September 27, 2004.
ABBOTT LABORATORIES, an Illinois Corporation, and CENTRAL GLASS COMPANY LTD., a Japanese Corporation, Plaintiffs,
BAXTER PHARMACEUTICAL PRODUCTS, INC., a Delaware Corporation, and BAXTER HEALTHCARE CORP., a Delaware Corporation, Defendants.
The opinion of the court was delivered by: RONALD GUZMAN, District Judge
MEMORANDUM OPINION AND ORDER
Plaintiffs Abbott Laboratories and Central Glass Company Ltd.
have moved in limine to bar the introduction by Defendants Baxter
Pharmaceutical Products, Inc. and Baxter Healthcare Corp. of any
evidence of defendants' alleged ability or inability to produce a
product with a water level not more than 130 parts per million
("ppm") because of commercial impracticability. For the reasons
provided in this Memorandum Opinion and Order, the Court grants
Plaintiffs' motion in limine to bar any evidence of defendants'
ability or inability to manufacture generic sevoflurane with a
water content of not more than 130 ppm.
Sevoflurane is a fluorine-based inhalation anesthetic first
developed by Baxter in the mid-1960's. It is used as a general
anesthesia for patients undergoing surgery. The original patent on sevoflurane has long since expired, and due to
a complicated licensing agreement, Abbott Laboratories is the
sole seller of sevoflurane in the United States until December
2005. Abbott has several patents for inhibiting degradation of
liquid sevoflurane by Lewis acids, which can result in harmful
by-products. In order to prevent degradation, Abbott determined
that a Lewis acid inhibitor (one of which is water) could be
added to the sevoflurane. Abbott's U.S. Patent No. 5,990, 176
("the '176 patent") teaches that to stop degradation, an
effective stabilizing amount of Lewis acid inhibitor must be
added to the sevoflurane.
This complaint arises out of an Abbreviated New Drug
Application ("ANDA") filed by Baxter in June 2000 seeking
approval to sell generic sevoflurane with a water level of not
more than 130 ppm in aluminum containers lined with an
epoxyphenolic liner. In its ANDA, Baxter made a paragraph IV
certification that its generic sevoflurane does not infringe the
'176 patent. Abbott filed suit alleging infringement of the '176
patent under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2). The
Court granted Baxter's motion for summary judgment, limiting the
meaning of "effective amount" to amounts greater than 130 ppm due
to a disclosure made by Abbott during patent prosecution that
sevoflurane was sold at a level of 131 ppm more than one year
prior to filing it patent application. Abbott Labs. v. Baxter
Pharm. Prods., No. 01 C 1867, 2002 WL 449007 at *6 (N.D. Ill.
Mar. 22, 2002), vacated and remanded by Abbott Labs. v. Baxter
Pharm. Prods., Inc., 334 F.3d 1274 (Fed. Cir. 2003). The Federal
Circuit vacated and remanded the case, disagreeing with the
Court's decision restricting effective amounts to those above 130
ppm and interpreting the scope of claims 1 and 6 of the '176
patent "to a single Lewis acid inhibitor selected from the
recited Markush group, and present in an amount effective to prevent degradation of sevoflurane by Lewis acids."
Abbott Labs., 334 F.3d at 1281.
Baxter's ANDA submission and paragraph IV certification that
its proposed generic sevoflurane product does not infringe the
'176 patent creates an artificial act of infringement under
35 U.S.C. § 271(e)(2). See Eli Lilly & Co. v. Medtronic, Inc.,
496 U.S. 661, 678 (1990) (noting that submission of an ANDA creates a
"highly artificial act of infringement");
35 U.S.C. § 271(e)(2)(A) ("It shall be an act of infringement to submit . . .
an [abbreviated new drug] application under [21 U.S.C. § 355(j)]
. . . for a drug claimed in a patent or the use of which is
claimed in a patent . . . if the purpose of such submission is to
obtain approval . . . to engage in the commercial manufacture,
use, or sale of a drug . . . claimed in a patent or the use of
which is claimed in a patent before the expiration of such
Plaintiffs and defendants agree that infringement in this case
is based upon the limitation supplied in defendants' ANDA that
sevoflurane will have a water content of 130 ppm or less. (See
Pls.' Reply Baxter's Resp. Mot. Limine (1) at 2 ("the
determination of literal infringement rests on whether Baxter's
amended ANDA with 130 ppm water level infringes the '176
patent."); Baxter's Sur-Reply Mem. Opp'n Pls.' Mot. Limine (I) at
1 ("Because this is a Hatch-Waxman Case, infringement is judged
based on the description of Baxter's proposed sevoflurane product
in Baxter's ANDA.").) The issue raised in the instant motion in
limine and memorandum in support is whether Baxter may provide
evidence of an ability or inability to produce a product with a
water level not more than the 130 ppm limitation imposed by their ANDA.
Baxter responds that no evidence will be submitted on an
inability to produce a produce with a water level of not more
than 130 ppm, but that defendants will introduce evidence that
they do in fact have the ability to produce generic sevoflurane
at levels below 130 ppm. Baxter has misconstrued Abbott's motion
in limine in which Abbott requests that the Court bar Baxter from
introducing any evidence of an inability or ability to produce
generic sevoflurane with a water level of not more than 130 ppm.
(See Pls.' Mot. Limine (1) at n. 1 (arguing that "[a] water
level below 130 ppm has no bearing on [infringement]" and
quoting Baxter's Proposed Finding of Fact 2 on non-infringement
which states that "sevoflurane can be made with little or no
water and still meet the specification set forth in Baxter's
ANDA").) This motion turns on whether Baxter's ability or
inability to produce generic sevoflurane at a water content of
less than 130 ppm is relevant to the issue of infringement.
Federal Rule of Evidence 401 defines relevant evidence as
"evidence having any tendency to make the existence of any fact
that is of consequence to the determination of the action more
probable or less probable than it would be without the evidence."
Fed.R. Evid. 401. Baxter's ability or inability to manufacture
generic sevoflurane with a water content of not more than 130 ppm
is not relevant in this case. Baxter contends that it will not
even offer any such evidence on its inability. (Baxter's Resp.
Pls. Mot. Limine (I) at 1.) Whether Baxter has the ability to
produce generic sevoflurane with a water level of not more than
130 ppm is also not relevant in this case. As noted above, an
action brought under § 271(e) constitutes an artificial act of
infringement. In this case, infringement will be determined at
the 130 ppm limitation noted in Baxter's ANDA. Baxter argues that their ANDA specifies sevoflurane having not
more than 130 ppm of water and that infringement then involves
sevoflurane with 130 ppm of water or less. Baxer's reasoning is
misguided. Patent infringement in such a scenario is defined by
the specification in the ANDA itself. See Abbott Labs. v.
TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002) (noting
that "an ANDA specification defining a proposed generic drug in a
manner that directly addresses the issue of infringement will
control the infringement inquiry.") The ANDA specification in
this case defines Baxter's sevoflurane product with a water
content of not more than 130 ppm, which directly addresses the
issue of infringement, as the '176 patent teaches the use of
water as a Lewis acid inhibitor. The product that Baxter actually
manufactures is not an issue in this case. The act of
infringement is defined by the ANDA itself, and if a 130 ppm
water content is effective as a Lewis acid inhibitor, it is
irrelevant whether Baxter could produce sevoflurane with a water
content of 100 ppm, 65 ppm, or even 0 ppm.
Under literal infringement or under the doctrine of
equivalents, the ultimate issue must be addressed with regard to
a 130 ppm water content. As noted by the Federal Circuit, to
prove infringement "Abbott must show a species selected from the
members of the recited Markush group [i.e., water] is present
in Baxter's sevoflurane composition in an amount effective to
function as a Lewis acid inhibitor." Abbott Labs.,
334 F.3d at 1283 (emphasis added). Literal infringement then turns on whether
a water content of 130 ppm, as specified in its ANDA, is
effective as a Lewis acid inhibitor. Baxter's theories of
non-infringement do not alter this viewpoint. First, Baxter
contends that a person of ordinary skill in the art would not be
able to determine this "effective" amount beforehand because
effectiveness is dependent on the "particular circumstances" of
the sevoflurane at issue. Next, Baxter contends that its proposed
sevoflurane product does in fact degrade when it is exposed to
Lewis acids, and that the water content must therefore not be
effective. Finally, Baxter argues that Abbott made statements to
the FDA indicating that a water content of 130 ppm is not
effective to prevent degradation. None of these theories of
literal infringement require any evidence that Baxter could
produce generic sevoflurane with a water content below 130 ppm.
Under the doctrine of equivalents the same holds true, and the
130 ppm specification from Baxter's ANDA will be the water
content that is considered by the Court.
Baxter also mistook Abbott's request to bar evidence of
Baxter's ability or inability to produce generic sevoflurane with
a water level of not more than 130 ppm with a request to bar
any evidence of a water level below 130 ppm. Indeed, some
evidence regarding a water level below the 130 ppm limitation
outlined in Baxter's ANDA may be relevant. For example, evidence
of water content that falls below the ANDA limitation of 130 ppm
may establish effective lower limits of water required to inhibit
Lewis acids in Baxter's proposed lined container. Abbott's own
expert reported testing results on a sample of Baxter's
sevoflurane having a water content of 60 ppm. (Baxter's Sur-Reply
Mem. Opp'n Pls.' Mot. Limine (1) at 2.) Ultimately, of course,
infringement will be determined at a water level of 130 ppm, per
Baxter's ANDA, but barring any evidence of a lower water
concentration is not warranted in this case.
This Court grants Plaintiffs' Motion in Limine (I). Baxter is
barred from introducing any testimony on its ability or inability
to produce a product with a water level of not more than 130 ppm,
per its ANDA. CONCLUSION
For the foregoing reasons, the Court grants Abbott's motion in
limine to bar the introduction by Baxter of any evidence of its
alleged ability or inability to produce a generic sevoflurane
with a water level of not more than 130 ppm [doc. no. 161].
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