Sanofi-Aventis U.S. LLC et al v. Mylan N.V. et al
Filing
60
ORDER GRANTING DEFENDANTS' MOTION FOR EXPEDITED SCHEDULING CONFERENCE 45 AND MOTION TO EXPEDITE 46 . Rule 26 Meeting to be held by 12/18/2017, Rule 26 Meeting Report due by 12/22/2017, Scheduling Conference set for 1/3/2018 10:00 AM in Clarksburg District Judge Courtroom, 2nd Floor before Senior Judge Irene M. Keeley, Discovery due by 1/10/2018. Signed by Senior Judge Irene M. Keeley on 12/13/2017. (kd)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
SANOFI-AVENTIS U.S. LLC,
SANOFI-AVENTIS DEUTSCHLAND GMBH,
and SANOFI WINTHROP INDUSTRIE,
Plaintiffs,
v.
//
CIVIL ACTION NO. 1:17CV181
(Judge Keeley)
MYLAN N.V., MYLAN GMBH,
MYLAN INC., and MYLAN
PHARMACEUTICALS INC.,
Defendants.
ORDER GRANTING DEFENDANTS’ MOTION FOR EXPEDITED SCHEDULING
CONFERENCE [DKT. NO. 45] AND MOTION TO EXPEDITE [DKT. NO. 46]
The
plaintiffs,
Sanofi-Aventis
U.S.
LLC,
Sanofi-Aventis
Deutschland GmbH, and Sanofi Winthrop Industrie (collectively,
“Sanofi”), commenced this second-filed Hatch-Waxman case on October
26, 2017, by filing a complaint against the defendants, Mylan N.V.,
Mylan
GmbH,
Mylan
Inc.,
and
Mylan
Pharmaceuticals
Inc.
(collectively, “Mylan”) (Dkt. No. 1). On November 1, 2017, the
Court entered its First Order and Notice Regarding Discovery and
Scheduling (“First Order”), setting a scheduling conference in this
case for January 23, 2018 (Dkt. No. 21).
On November 22, 2017, however, Mylan moved for an expedited
“scheduling conference for January 3, 2018 or at the Court’s
earliest convenience” (Dkt. No. 45). In support, Mylan avers that,
on March 23, 2020, the insulin product at issue in this case will
transition from being subject to approval under the Hatch-Waxman
SANOFI V. MYLAN
1:17CV181
ORDER GRANTING DEFENDANTS’ MOTION FOR EXPEDITED SCHEDULING
CONFERENCE [DKT. NO. 45] AND MOTION TO EXPEDITE [DKT. NO. 46]
Act
to
being
Competition
subject
and
to
Innovation
approval
Act
under
the
(“BPCIA”).
Biologics
Id.
at
1.
Price
If
an
Abbreviated New Drug Application (“ANDA”) for a biological product
is not approved by this date, the Food and Drug Administration
(“FDA”) will not approve the ANDA. The applicant will instead be
required to seek approval under the BPCIA regulatory approval
process (Dkt. No. 45-1 at 8). Accordingly, Mylan insists that an
accelerated schedule is necessary “to obtain final regulatory
approval before March 23, 2020" (Dkt. No. 45 at 2).
Sanofi opposes Mylan’s motion, asserting that “the BPCIA
transition date is irrelevant to this case because the 30-month
stay will expire prior to the BPCIA transition date.” Given that
“the FDA will have full authority to approve the pending drug
application prior to the transition date,” Sanofi contends that
“this lawsuit presents no impediment to FDA approval” (Dkt. No. 57
at 2). Despite its opposition, Sanofi notes that it will defer “to
the Court’s schedule and availability, as Sanofi will be prepared
to participate in a scheduling conference whenever the Court deems
appropriate.” Id.
After reviewing the parties’ arguments, and without otherwise
deciding how the BPCIA transition date should affect the schedule
2
SANOFI V. MYLAN
1:17CV181
ORDER GRANTING DEFENDANTS’ MOTION FOR EXPEDITED SCHEDULING
CONFERENCE [DKT. NO. 45] AND MOTION TO EXPEDITE [DKT. NO. 46]
or posture of this case,1 the Court finds that good cause supports
Mylan’s
request
for
an
expedited
scheduling
conference.
An
expedited scheduling conference will permit the Court to hear
argument on Sanofi’s motion to stay and determine at the earliest
possible time whether the looming BPCIA transition date affects
this
litigation.
Therefore,
the
Court
GRANTS
Mylan’s
Motion
Requesting an Expedited Scheduling Conference (Dkt. No. 45), as
well as its Motion to Expedite Defendants’ Motion Requesting an
Expedited Scheduling Conference (Dkt. No. 46).
The Court thus AMENDS the dates and deadlines set forth in its
First Order as follows:
INITIAL PLANNING MEETING:
REPORT FILING DATE:
SCHEDULING CONFERENCE DATE:
SCHEDULING CONFERENCE TIME:
INITIAL DISCOVERY DISCLOSURES
DUE DATE:
1.
December 18,
December 22,
January 3,
10:00
2017
2017
2018
A.M.
January 10, 2018
INITIAL PLANNING MEETING: Pursuant to Fed. R. Civ. P. 16
and 26(f) and LR 16.01(b), parties to this action shall meet in
person or by telephone on or before December 18, 2017. At this
1
The BPCIA transition date may also affect the resolution of
Sanofi’s pending motion to stay this case in favor of the firstfiled case in the District of New Jersey (Dkt. No. 41).
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SANOFI V. MYLAN
1:17CV181
ORDER GRANTING DEFENDANTS’ MOTION FOR EXPEDITED SCHEDULING
CONFERENCE [DKT. NO. 45] AND MOTION TO EXPEDITE [DKT. NO. 46]
meeting, they shall discuss all matters required by Fed. R. Civ. P.
16 and 26(f) and LR 16.01(b). The parties shall also consider the
benefits of early mediation and advise in their report whether they
wish the Court to schedule the matter for early mediation.
2.
MEETING REPORT AND PROPOSED DISCOVERY PLAN: Pursuant to
Fed. R. Civ. P. 26(f) and LR 16.01(c), the parties shall submit a
written report on the results of the initial discovery meeting on
or before December 22, 2017. This report shall include the parties’
report on those matters set forth in LR 16.01(b) and (c) and the
parties’ discovery plan as required by Fed. R. Civ. P. 26(f). The
parties’ report on their meeting shall be considered by this Court
as advisory only. Parties and counsel are subject to sanctions as
set forth in LR 37.01 for failure to participate in good faith in
the development and submission of a meeting report and proposed
discovery plan.
3.
SCHEDULING CONFERENCE/SCHEDULING ORDER: Upon receipt of
the meeting report and proposed discovery plan, the undersigned
District Judge WILL CONDUCT a scheduling conference on January 3,
2018, at 10:00 A.M., in the Clarksburg District Courtroom, Second
Floor. See Fed. R. Civ. P. 16(b) and LR 16.01(d). (Please note that
the Court conducts scheduling conferences in all cases.) The
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SANOFI V. MYLAN
1:17CV181
ORDER GRANTING DEFENDANTS’ MOTION FOR EXPEDITED SCHEDULING
CONFERENCE [DKT. NO. 45] AND MOTION TO EXPEDITE [DKT. NO. 46]
scheduling conference may be by telephone. If counsel elect to
proceed by telephone, the Court directs lead counsel for the
plaintiff to arrange the conference call and provide dial-in
information
to
all
parties
and
the
Court,
by
email
to
candace_levitsky@wvnd.uscourts.gov, no later than December 27,
2017. If counsel elect to appear in person, counsel shall notify
the Court, by email to candace_levitsky@wvnd.uscourts.gov, no later
than December 27, 2017. The Court notifies the parties that any
pending
motions
in
the
case
that
are
fully
briefed
WILL
BE
ADDRESSED at the scheduling conference.
4.
INITIAL DISCOVERY DISCLOSURES: Pursuant to LR 26.01(a),
each party shall provide to every other party the initial discovery
disclosures required under Fed. R. Civ. P. 26(a)(1) on or before
January 10, 2018.
The Court directs the Clerk to transmit copies of this Order
to counsel of record.
DATED: December 13, 2017.
/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE
5
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