United States District Court, D. Delaware
ICEUTICA PTY LTD, and EGALET U.S. INC., Plaintiffs,
NOVITIUM PHARMA LLC, Defendant.
F. CONNOLLY, UNITED STATES DISTRICT JUDGE.
Wilmington, this 23rd day of September 2019, having reviewed
Defendant Novitium Pharma LLC's Motion for Leave to File
an Amended Answer and Counterclaims (D.I. 75) and the related
briefing (D.I. 76, D.I. 88, D.I. 91), IT IS HEREBY
ORDERED that Defendant's motion is
DENIED for the following reasons.
iCeutica Pty Ltd and Egalet U.S. Inc. initiated this
Hatch-Waxman action on April 20, 2018, accusing Defendant of
infringing United States Patent Nos. 9, 526, 734 (the
"#734 patent"), 9, 649, 318 (the "#318
patent"), and 9, 808, 468 (the "#468 patent").
D.I. 1 at ¶ 1. The asserted patents cover
Plaintiffs' VIVLODEX® brand Meloxicam 5mg and 10 mg
capsules for the management of osteoarthritis pain.
Id. Defendant has submitted an Abbreviated New Drug
Application ("ANDA") "for approval to market
[its own] Meloxicam capsules, 5mg and 10 mg, before the
expiration of the" asserted patents. D.I. 76 at 1.
deadline for leave to amend pleadings in this case was
February 1, 2019. D.I. 31 at ¶ 2. Defendant filed the
instant motion on May 7, 2019. See D.I. 75. A
two-day bench trial is scheduled to begin on February 18,
2019. D.I. 31 at ¶ 18.
Rule of Civil Procedure 15 governs amendments to the
pleadings generally, providing that "[t]he court should
freely give leave [to amend] when justice so requires."
See FED. R. Civ. P. 15(a)(2). When a party moves to
amend past the date set by the scheduling order, Federal Rule
of Civil Procedure 16(b) also applies. See FED. R.
Civ. P. 16(b)(4); see also E. Minerals & Chems. Co.
v. Mohan, 225 F.3d 330, 340 (3d Cir. 2000). In pertinent
part, Rule 16(b) provides: "A schedule may be modified
only for good cause and with the judge's consent."
Fed.R.Civ.P. 16(b)(4). "Good cause is present when the
schedule cannot be met despite the moving party's
diligence." Meda Pharm. Inc. v. Teva Pharm. USA,
Inc., 2016 WL 6693113, at *1 (D. Del. Nov. 14, 2016).
"In contrast to Rule 15(a), the good cause standard
under Rule 16(b) hinges on diligence of the movant, and not
on prejudice to the non-moving party." S. Track
& Pump, Inc. v. Terex Corp., 722 F.Supp.2d 509, 521
(D. Del. 2010) (quotation marks and citation omitted).
movant meets its burden under Rule 16(b)(4) to show that good
cause exists, the court may then consider whether it should
grant leave to amend under Rule 15(a)(2). See
Intellectual Ventures I LLC v. Toshiba Corp., 2016 WL
4690384, at *1 (D. Del. Sept. 7, 2016). "The Third
Circuit has adopted a liberal policy favoring the amendment
of pleadings to ensure that claims are decided on the merits
rather than on technicalities." S. Track &
Pump, 722 F.Supp.2d at 520 (citing Dole v. Arco
Chem. Co., 921 F.2d 484, 487 (3d Cir. 1990)). Absent a
showing of undue delay, bad faith, dilatory motive,
prejudice, or futility, leave to amend under Rule 15 should
generally be permitted. Id. (citing Foman v.
Davis, 371 U.S. 178, 182(1962)).
requests leave to amend its answer and counterclaims, seeking
to assert that the asserted patents are invalid as indefinite
under 35 U.S.C. § 112(b). D.I. 76 at 1; see
also D.I. 75, Ex. A, Proposed Amended Answer at
¶¶ 129-134, Proposed Amended Counterclaims at
¶¶ 42-56. Because Defendant filed its request after
the February 1, 2019 deadline to amend pleadings,
see D.I. 31 at ¶ 2, Defendant must satisfy the
good cause requirement of Rule 16(b), see FED. R.
Civ. P. 16(b)(4). Defendant argues that it satisfies the good
cause requirement because Plaintiff did not inform it of
Plaintiffs' actual interpretation of the disputed claim
terms until the March 19, 2019 Markman
hearing. D.I. 16 at 10. In particular,
Defendant contends that Plaintiffs' responses to the
Court's questions first alerted Defendant to
Plaintiffs' position that the disputed claim terms
"refer to 'particles' that vaguely
'include meloxicam, ' ... such that the
measurements of median particle size could involve
measurement of both meloxicam and various amounts of other
things." Id. at 10-11 (emphasis in original).
disagree and find that Defendant has not demonstrated
diligence in asserting its new invalidity defenses and
counterclaims such that good cause exists to extend the
Scheduling Order's February 1, 2019 deadline for pleading
amendments. Although Defendant contends that it was not aware
of the "full extent to which [Plaintiffs']
interpretation of the claim terms is a moving target"
until the Markman hearing, see D.I. 75 at
10, and that Plaintiffs' intention to pursue this
interpretation was not "crystalized" until
Plaintiffs' April 3, 2019 written discovery responses,
see Id . at 2, a review of the record informs me
otherwise. Plaintiffs' opening claim construction brief,
served on December 13, 2018, see D.I. 32, discusses
how "particle size measurements can be, and in fact are,
made on meloxicam particles in the presence of
excipients." D.I. 46 at 13. An expert declaration served
by Plaintiffs the same day recited: "A person of
ordinary skill in the art would ... understand the particle
size measurements described in the '734 parent are not
necessarily generated from an 'excipient free'
population of meloxicam particles." D.I. 47, Ex. 4 at
¶ 35. Moreover, Plaintiffs' reply brief, although
served three days after the deadline to amend pleadings,
makes clear Plaintiffs' position that
"meloxicam" did not "mean 'pure, ' or
'solely, ' meloxicam" and "that excipients
can exist on the meloxicam structure and therefore be a part
of the meloxicam particle." D.I. 46 at 42-43.
are correct that Plaintiffs' claim construction briefs
did not recite the same words Plaintiffs used at the
Markman hearing to describe their position-
i.e., that the amount of meloxicam present in a
"meloxicam particle" could be "substantial,
" "minute, " "predominant, " or
“de minimis” among other adjectives.
See D.I. 91 at 2. But Plaintiffs' position,
however presented, was not offered for the first time at that
March 19, 2019 hearing. In Defendant's claim construction
sur-reply brief, which was served on February 25, 2019,
see D.I. 45, Defendant itself attributed to
Plaintiffs the very position Defendant now contends it
learned for the first time at the Markman hearing:
Under [Plaintiffs'] construction, the pharmaceutical
composition need not contain 5 mg of meloxicam, so long as
the "meloxicam particles"-which can comprise an
indefinitely high percent of excipients-have a collective
total mass of 5 mg. That means that, under Plaintiffs'
construction, the "5 mg of meloxicam" limitation
would be met by a composition containing nowhere near 5 mg of
the active ingredient (e.g. a composition that contains
0.0005 mg of the active ingredient would meet that