Novo Nordisk A/s v. SANOFI-AVENTIS U.S. LLC and SANOFI-AVENTIS DEUTSCHLAND GMBH

NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2008-1225
NOVO NORDISK A/S,
Plaintiff-Appellant,
v.
SANOFI-AVENTIS U.S. LLC
and SANOFI-AVENTIS DEUTSCHLAND GMBH,
Defendants-Appellees,
and
SANOFI-AVENTIS,
Defendant.
David B. Tulchin, Sullivan & Cromwell, LLP, of New York, New York, argued
for plaintiff-appellant. With him on the brief were Marc De Leeuw and James T.
Williams.
Paul H. Berghoff, McDonnell Boehnen Hulbert & Berghoff, LLP, of Chicago,
Illinois, argued for defendants-appellees. With him on the brief were David M.
Frischkorn, Curt J. Whitenack, and Eric R. Moran.
Appealed from: United States District Court for the District of New Jersey
Judge Mary L. Cooper

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NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2008-1225
NOVO NORDISK A/S,
Plaintiff-Appellant,
v.
SANOFI-AVENTIS U.S. LLC
and SANOFI-AVENTIS DEUTSCHLAND GMBH,
Defendants-Appellees,
and
SANOFI-AVENTIS,
Defendant.
Appeal from the United States District Court for the District of New Jersey in case no.
07-CV-3206, Judge Mary L. Cooper.
__________________________
DECIDED: July 30, 2008
__________________________
Before LOURIE, BRYSON, and PROST, Circuit Judges.
PROST, Circuit Judge.
Plaintiff-Appellant Novo Nordisk A/S (“Novo”) sued Defendants-Appellees Sanofi-
Aventis U.S. LLC, Sanofi-Aventis, and Sanofi-Aventis Deutschland GmbH (collectively
“Sanofi”), alleging that Sanofi’s SoloStar product infringes one or more claims of Novo’s
U.S. Patent No. 7,241,278 (the “’278 patent”). Novo then filed a motion to preliminarily
enjoin Sanofi “from making, using, selling, offering to sell, and/or importing SoloStar in

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the United States.” The United States District Court for the District of New Jersey
denied Novo’s request for a preliminary injunction, Novo Nordisk A/S v. Sanofi-Aventis
U.S. LLC, 3:07-CV-3206, slip op. (D.N.J. Feb. 19, 2008) (“Injunction Order”), and Novo
appealed. Having jurisdiction pursuant to 28 U.S.C. §§ 1292(c)(1) and 1295(a)(1), we
affirm.
DISCUSSION
In order to obtain a preliminary injunction, a patentee must show: “(1) reasonable
likelihood of success on the merits; (2) irreparable harm; (3) that the balance of
hardships tips in its favor; and (4) the impact of the injunction on the public interest.”
Jack Guttman, Inc. v. Kopykake Enters., 302 F.3d 1352, 1356 (Fed. Cir. 2002). The
denial of a preliminary injunction pursuant to 35 U.S.C. § 283 is within a district court’s
discretion. Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997).
We will reverse such a decision only when an appellant demonstrates that the “factors
relied on by the district court [were] clearly erroneous” and “that a denial of the
preliminary relief sought would amount to an abuse of the court’s discretion upon
reversal of an erroneous finding.” New Eng. Braiding Co. v. A.W. Chesterton Co., 970
F.2d 878, 882 (Fed. Cir. 1992).
In this case, the district court denied the preliminary injunction because the
patentee failed to show a reasonable likelihood of success on the merits. Injunction
Order at 38. The court concluded, “Novo has not shown that Sanofi’s asserted defense
that SoloStar does not infringe the ’278 patent because it lacks direct gearing and a
non-rotatable piston rod, lacks substantial merit.” Id. The district court reasoned that
Sanofi “raised substantial questions regarding whether the specification read as a whole
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suggests that the very character of the invention requires direct gearing and a non-
rotatable piston rod to be part of every embodiment.” Id. at 35. These substantial
questions included:
whether (1) the embodiments of the invention set forth in the specification
as “the invention” constitute the invention itself despite claim language that
could be interpreted more broadly, (2) the specification expressly
disclaims injection pens with rotating piston rods or gearing other than
direct gearing, (3) the specification suggests the need to narrowly
construe the claims because it distinguishes prior art or clearly expresses
an intention to limit the invention’s structure, and (4) Novo’s amendment of
the ’278 patent’s claims to import language from the DCA Application
affects this Court’s use of the specification, which was not amended, in
construing such claims (i.e., whether the Court should ignore the
specification and assume that Novo abandoned the gearbox in favor of the
clutch mechanism when it amended its claims to import claims from the
DCA Application).
Id. at 36. The district court ultimately found that these substantial questions precluded a
finding that Novo has a likelihood of success on the merits and, accordingly, denied
Novo’s motion for a preliminary injunction. Id. at 38, 40.
Novo appeals, arguing that the district court erred in interpreting the claims to
require a gearbox and non-rotating piston rod. Novo asserts that the district court’s
claim construction is legal error because the claim language is clear, the specification
contains no disclaimer, the prosecution history makes clear that Novo abandoned these
requirements, and the doctrine of claim differentiation supports Novo’s proposed
construction. In response, Sanofi asserts that the specification mandates that the
claimed injection device include a gearbox and non-rotatable piston rod. Sanofi also
argues that the specification barely refers to a “clutch,” which Novo asserts is the crucial
component of its independent claims. Further, Sanofi contends that the injection device
described by the ’278 patent could not function without the gearbox and non-rotatable
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piston rod. Accordingly, Sanofi asserts that the district court correctly construed the
claims.
After reviewing the intrinsic record, we cannot conclude that the district court
abused its discretion. The district court found that a question exists regarding whether
“the very character of the invention requires direct gearing and a non-rotatable piston
rod,” id. at 35, a finding which, at this stage of the proceedings and on this record, we
do not view to be clearly erroneous. Although Novo argues that the claims do not
explicitly include the terms “gearbox” or “non-rotatable piston rod,” Sanofi notes that the
specification is directed to an invention that appears to center on the “gearbox” and
“non-rotatable piston rod” components. In light of this apparent conflict between the
specification and the claims, the district court appropriately exercised its discretion in
concluding that Novo has not established a likelihood of success on the merits.
Moreover, notwithstanding Novo’s arguments to the contrary, we read the district
court’s opinion as generally addressing whether Sanofi raised “substantial questions,”
rather than specifically articulating a claim construction. While it is true that many of the
substantial questions identified by the district court would ultimately be analyzed in the
context of construing the claims, some might more appropriately be analyzed in the
context of validity (i.e., written description and enablement). See, e.g., Tate Access
Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357, 1372 (Fed. Cir. 2002)
(“[W]here claim language is clear we must accord it full breadth even if the result is a
claim that is clearly invalid.”). At the preliminary injunction stage, however, it is
irrelevant whether this case presents greater issues of claim construction or validity—
the existence of one or both of these issues is sufficient to justify the district court’s
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2008-1225 5
decision to deny a preliminary injunction. As this court previously explained in a similar
situation:
Cases such as this one, in which predecessor applications or patents
were drawn to narrow claims and in which the claims in the successor
application are arguably broader than the invention described in the
specification, present difficult questions of both claim construction and
validity. Where the applicant expressly and unambiguously states his
intention to claim broadly, the claim construction issue is easier and the
question becomes one of validity—whether the specification supports the
full breadth of the new claims. On the other hand, where—as in this
case—the patentee has not been explicit about the scope of the new
claims, the case can pose interdependent problems of both claim
construction and validity.
Saunders Group, Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1335-36 (Fed. Cir. 2007).
CONCLUSION
The record is sufficient to support the district court’s finding that Novo has not
shown a likelihood of success on the merits. Accordingly, we conclude that the district
court did not abuse its discretion in denying Novo’s motion for a preliminary injunction.

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