United States District Court, E.D. North Carolina, Western Division
TERRENCE W. BOYLE UNITED STATES DISTRICT JUDGE
cause comes before the Court on plaintiffs motion to stay
these proceedings with respect to its claims relating to U.S.
Patent No. 6, 486, 150. The appropriate responses and replies
have been filed and a hearing was held on the matter before
the undersigned on May 10, 2017, at Raleigh, North Carolina.
In this posture, the motion is ripe for adjudication and, for
the reasons discussed below, it is granted.
action arose following defendant's filing of an
Abbreviated New Drug Application (ANDA) seeking FDA approval
to market a generic version of plaintiff s antibiotic drug
Invanz® (ertapenem for injection). Plaintiff (Merck)
filed this action alleging patent infringement; at this
stage, the litigation concerns only plaintiffs U.S. Patent
No. 6, 486, 150 ('150) and No. 5, 952, 323 ('323).
Defendant (Savior) has stipulated that its generic ertapenem
product will infringe plaintiffs asserted claims in the
'323 patent, but challenges the validity of the '323
patent. Savior challenges both the validity and the alleged
infringement of the ' 150 patent.
filed a separate action in the United States District Court
for the District of Delaware against another company seeking
to market a generic form of Invanz®. That matter has
proceeded through trial and judgment was entered on October
24, 2016. The Delaware court held that all of the asserted
claims related to '323 patent were infringed by the
defendant, but that asserted claims related to the '150
patent were invalid for obviousness. Merck Sharp &
Dohme Corp. v. HospiraInc., No. CV 14-915-RGA, 2016 WL
8231143, at *23 (D. Del. Oct. 7, 2016). That decision is
currently on appeal in the United States Court of Appeals for
the Federal Circuit, with oral argument set for the August 7,
now seeks to stay this action to await a decision by the
Federal Circuit on its appeal of the District of
Delaware's holding that its '150 patent claims were
invalid for obviousness. Savior opposes a stay, and asks this
Court to set a schedule in this case which would allow it to
render a final decision by October 30, 2017.
district court has inherent authority to manage its docket,
which includes the authority to stay litigation pending the
outcome of a decision by a court of appeals on an issue which
would affect or control the outcome in a case before it.
See, e.g., Xerox Corp. v. 3Com Corp., 69 F.Supp.2d
404, 406 (W.D.N.Y.1999). When determining whether to stay
proceedings, a court considers "(1) whether a stay would
unduly prejudice or present a clear tactical disadvantage to
the non-moving party; (2) whether a stay will simplify the
issues in question and trial of the case; and (3) whether
discovery is complete and whether a trial date has been
set." Id., see also Murata Mach. USA v. Daifuku
Co., 830 F.3d 1357, 1361 (Fed. Cir. 2016).
second and third factors clearly weigh in favor of entering a
stay in this case. A ruling by the Federal Circuit on the
validity of the '150 patent claims will plainly simplify
the issues in this case, as Merck has asserted that if the
Delaware court's decision on invalidity is affirmed there
will be no need for a Markman hearing or trial in this case
on its claims related to the '150 patent. Further, as
Merck has argued, if the Federal Circuit reverses the
District of Delaware's judgment, its opinion could
provide valuable guidance for construction of at least one
claim that is at issue in this case. The period for discovery
in this case has closed, but no trial date has been set.
primary opposition to a stay is based on perceived prejudice.
Specifically, Savior asserts that it will be prejudiced by a
stay in any scenario other than one in which the Delaware
court's decision is affirmed in full and such opinion is
issued prior the FDA's approval of Savior's ANDA. The
' 150 patent expires on November 15, 2017; Savior hopes
with a judgment of invalidity to be able to enter the generic
Invanz® market prior to the expiration of the patent.
Savior's argument related to prejudice might be more
compelling if it did not rely on speculative circumstances.
First, because the '323 patent expired on May 15, 2017,
it appears that Savior may not enter the market with a
Invanz® generic prior to the expiration of the six month
pediatric exclusivity period, which ends on November 15,
2017. Second, Savior has not yet gained tentative approval
from the FDA on its ANDA, and thus does not know whether it
would be in a position to enter the market on filing of an
order in this Court should it find in Savior's favor.
these reasons, the Court in its discretion holds that the
factors to be considered weigh decidedly in favor of a stay
of these proceedings as to the '150 patent.
Merck's motion to stay [DE 62] is GRANTED. This action is
hereby STAYED with respect to all claims concerning
plaintiffs ' 150 patent. The parties are ORDERED to
notify the Court within ten days of any substantive rulings
by the Federal Circuit in Merck Sharp & Dohme Corp.
v. Hospira Inc., No. 2017-1115. Further, in light of
representations made in the papers and during argument as to
the effect of the expiration of the '323 patent on May
15, 2017, Savior is DIRECTED to notify the Court within ten
(10) days of the date of entry of this order as to whether it
intends to proceed on its motion for summary judgment. [DE
67]. In light of the ...