Court Opinion

ID: 799880
Source: CourtListenerOpinion
Date Created: 2012-05-15 19:46:49+00
Date Added: 2024-06-11T11:10:34.052129
License: Public Domain

NOTE: This order is nonprecedential

United States Court of Appeals
for the Federal Circuit

SANOFI-SYNTHELABO, SANOFI-SYNTHELABO,
INC. AND BRISTOL-MYERS SQUIBB SANOFI
PHARMACEUTICALS HOLDING PARTNERSHIP,
Plaintiffs-Appellees,

V.

APOTEX INC. AND APOTEX CORP.,
Defendants-Appellants.

2012-1383

Appeal from the United States District Court for the
S0uthern District of New York in case n0. 02-CV-2255,
Judge Sidney H. Stein.

ON MOTION

Bef0re NEWMAN, Circuit Judge.
O R D E R

Apotex Inc. and Apotex Corp. (Apotex) move to sum-
marily reverse the decision of the United States District
Court for the Southern District of New York denying their
motion to modify an injunction pursuant to Rule 60(b)(6)

 

SANOFI-SYNTHELABO V. APOTEX INC. 2

of the Federal Rules of Civil Procedure. Sanofi-
Synthelabo et al. oppose. Apotex replies.

This appeal arises out of a Hatch-Waxman dispute
regarding clopidogre1 bisulfate tablets, sold by Sanofi
under the brand name Plavix®. In June 2007, after
finding the patent in suit was not invalid and not unen-
forceable, the district court issued an injunction_prohibit-
ing Apotex “from engaging in the commercial
manufacture, use, offer to sell or sale within the United
States, or importation into the United States of drug
products as claimed in U.S. Patent No. 4,84'7,265, until
the expiration of U.S. Patent No. 4,847,265 and of any
period of pediatric exclusivity that may be granted."

On April 9, 2012, Apotex submitted an application
with the Food and Drug Administration (FDA) for ap~
proval to participate in its "Pre-Launch Activities Irnpor-
tation Request” (PLAIR) program, which pe`rmits drug
manufacturers to import and warehouse finished drugs
where an application for drug approval is pending and
where the import and warehousing will expedite the
commercial launch of the drug once the FDA approves the
application

On May 3, 2012, Apotex moved the district court to
modify the injunction in order to allow Apotex to partici-
pate in the PLAIR program once approved by the FDA.
In opposing the motion, Sanofi argued that bringing the
motion five years after the date the injunction was first
entered was unreasonable and inexcusable given Apotex’s
familiarity with the PI..AIR program and the terms of the
injunction On May 10, 2012, the district court denied
that motion, Apotex appealed.

Apotex seeks summary reversal to allow Apotex to
join other generic manufacturers in the PLAIR program
once the pediatric exclusivity period expires on May 17,

3 SANOFI-SYNTHELABO V. APOTEX INC.

2012. However, summary disposition of a case is only
appropriate “when the position of one party is so clearly
correct as a matter of law that no substantial question
regarding the outcome of the appeal exists." Joshua v.
Um`ted Stotes, 17 F.3d 378, 380 (Fed. Cir. 1994).

Under these circumstances, this court cannot agree
that summary reversal is appropriate, for it is not clear
that the district court abused its discretion in denying the
motion, See Motarese v. LeFevre, 801 F.Zd 98, 106-07 (Zd
Cir. 1986) (reviewing a district court’s denial of a motion
brought pursuant to Rule 60(b)(6) for abuse of discretion).
Among other things, there is at least a substantial ques-
tion as to whether the motion to modify the injunction
was brought “within a reasonable time." Fed. R. Civ. P.
60(c)(1).

Accordingly,
IT Is ORDERED THAT:

The motion is denied.

FoR THE CoURT

mw 15 mm /S/Jan Horbaiy
Date J an Horbaly
Clerk
cc: Robert B. Breisblatt, Esq.
Robert L. Baechtold, Esq. LED
U.S. COUR`.IF':fJF APPEN.S FUF|

819 wersnair.~.ic\ncurr

|“|AY 15 2012
JAN HUHBALY
CLEHK