United States District Court, D. Delaware
MALLINCKRODT IP UNLIMITED COMPANY, MALLINCKRODT HOSPITAL PRODUCTS INC., and SCR PHARMATOP Plaintiffs,
B. BRAUN MEDICAL INC., Defendant. MALLINCKRODT IP UNLIMITED COMPANY AND MALLINCKRODT HOSPITAL PRODUCTS INC., Plaintiff,
B. BRAUN MEDICAL INC., Defendant.
HONORABLE LEONARD P. STARK UNITED STATES DISTRICT JUDGE
reviewed various motions filed by the parties in these
matters, and all associated filings, IT IS HEREBY ORDERED
Pharmatop L.P.'s ("New Pharmatop") Motion to
Substitute Party (C.A. No. 17- 365 D.I. 46) is GRANTED. The
relief requested is entirely consistent with Federal Rule of
Civil Procedure 25(c). No. substantive rights are affected:
if original plaintiff "SCR Pharmatop" properly
"enjoyed" an automatic 30-month stay of FDA
approval, then New Pharmatop, as a proper transferee, does as
well; if SCR Pharmatop did not enjoy such a stay, then
neither does New Pharmatop. This decision is without
prejudice to B. Braun Medical Inc.'s ("Braun")
ability to seek discovery from SCR Pharmatop and/or to amend
its pleadings to add SCR Pharmatop as a party, if necessary.
To the extent New Pharmatop (or any other party) has
suggested that Braun does not need any discovery from SCR
Pharmatop or the inventors on the patents-in-suit, the Court
Braun's Motion to Dismiss for Lack of Jurisdiction Over
the Subject Matter (C.A. No. 17-365 D.I. 49) is DENIED. The
"Mallinckrodt Parties" (i.e., Mallinckrodt IP
Unlimited Co. and Mallinckrodt Hospital Prods. Inc.), and SCR
Pharmatop (with the Mallinckrodt Parties hereinafter
"Plaintiffs") have met their burden to establish,
at this stage of the proceedings, that "SCR Pharmatop,
" "Pharmatop SCR, " "S.C. Pharmatop,
" "Pharmatop SC, " and "Pharmatop"
are one and the same entity. Therefore, based on the evidence
of record at this point, SCR Pharmatop had standing at the
time of the filing of the original and amended complaints. To
the extent they have not done so already, Plaintiffs shall
produce evidence responsive to Braun's requests relating
to standing, including unredacted versions of the Patent
Assignment Agreement and the Asset Purchase Agreement. Any
disputes in this regard should be brought to the Court
through the Discovery Matters Procedures. As the Court has an
ongoing obligation to examine its subject matter
jurisdiction, today's ruling is without prejudice to
Braun renewing a challenge to standing or subject matter
jurisdiction if/when it believes it has a meritorious basis
to do so.
Braun's Motion to Dismiss for Failure to State a Claim
(C.A. No. 17-365 D.l. 62), which seeks dismissal of
Plaintiffs' claims for infringement of U.S. Patent Nos.
6, 992, 218 (the "'218 patent") and 9, 399, 012
(the "'012 patent"), is DENIED. Taking, as the
Court must, the well-pleaded factual allegations of the
complaint as true, Plaintiffs have stated a plausible claim
for patent infringement. Among other things, the Court agrees
with Plaintiffs that it must credit as true the allegations
about the "scientific" fact of what manufacturing
processes must be followed in order to end up with a stable
product of the type claimed in the patent. Braun's motion
essentially asks the Court to take its contrary allegations
as true and to resolve claim construction disputes, as well
as issues of prosecution history estoppel and disclaimers,
and infringement, on a motion filed pursuant to Federal Rule
of Civil Procedure 12. This the Court cannot do.
pursuant to 35 U.S.C. § 271(e): "It shall be an act
of infringement to submit... an application under section ...
505(b)(2) of the Federal Food, Drug, and Cosmetic Act... for
a drug claimed in a patent... if the purpose of such
submission is to obtain approval under such Act to engage in
the commercial manufacture, use, or sale of a drug . ..
claimed in a patent or the use of which is claimed in a
patent before the expiration of such patent." Braun is
alleged to have made such a filing and to have given the
required notice (i.e., "paragraph IV
certification") to Plaintiffs. (See C.A. No.
17-365 D.I. 14 ¶¶ 15, 29-33) Further, the Amended
Complaint identifies additional factual allegations that
Braun likely infringes the '218 and '012 patents
because, inter alia, numerous pharmaceutical
companies have failed to design around the '218
patent's claims (id. ¶ 40) and Braun's
proposed labeling will promote a method of administering
certain dosages of the proposed products infringing at least
claim 1 of the '012 patent (id. ¶¶ 38,
42). This is sufficient to create a justiciable controversy
and, at least in the context of the complaints filed here, to
state a plausible claim for relief. See generally
Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1330
(Fed. Cir. 2003); see also Insys Therapeutics v. Alkem
Labs., Ltd., C.A. No. 17-1419-LPS (D. Del.) D.I. 24 at
concerns raised by Braun as to the purported lack of merit of
Plaintiffs' allegations are more properly raised (if at
all) on a motion for sanctions pursuant to Fed. R. Civ. Proc.
11 or (if Braun prevails on the merits) in connection with a
request that this case be deemed "exceptional" and
attorney fees be awarded pursuant to 35 U.S.C. § 285.
This is particularly so given that Plaintiffs had only 45
days after receiving paragraph IV certifications to decide
whether (and where, and on what patents, and against whom,
etc.) to sue if they wished to obtain the benefit of the
automatic stay of regulatory approval, and because the Court
and the parties are operating under a statutory mandate to
attempt to "expedite" the resolution of this case.
See 21 U.S.C. § 355(c)(3)(C) (providing
"approval [of an application] may be made effective upon
the expiration of the thirty-month period beginning on the
date of the receipt of the notice ... or such shorter or
longer period as the court may order because either party to
the action failed to reasonably cooperate in expediting the
Pharmatop's Motion to Defer B. Braun's Motion to
Dismiss Pending Decision on New Pharmatop's Motion to
Substitute and Extend the Case Schedule (C.A. No. 17-365 D.I.
75) is DENIED AS MOOT. The Court has today granted the motion
to substitute. Should New Pharmatop believe any modifications
of the schedule are required, it may (after meeting and
conferring with the other parties) make a renewed request.
Plaintiffs' Motion for Leave to File Sur-Reply (C.A. No.
17-365 D.I. 93) is DENIED AS MOOT, as the Court has today
denied the motion to dismiss with respect to which the
sur-reply is offered.
Pharmatop's Motion for Leave to File Answering Brief to
Defendant's Motion to Dismiss (C.A. No. 17-365 D.I. 145)
is DENIED AS MOOT, as the Court has today denied the motion
to dismiss with respect to which the brief is offered.
Braun's Motion for Leave to File Motion for Summary
Judgment (C.A. No. 17-365 D.I. 157) is DENIED WITHOUT
PREJUDICE. Braun may renew its motion for leave (which the
Court is likely to grant, for reasons including those
suggested during the April 17, 2018 teleconference
(see C.A. No. 17-365 D.I. 143 at 45, 57-59)) after
the Court issues its claim construction decision, which the
Court anticipates doing within 60 days after the hearing
Braun's Motion to Dismiss for Failure to State a Claim
(C.A. No. 17-660 D.I. 47), which seeks dismissal of
Plaintiffs' claims for infringement of the '012
patent and U.S. Patent No. 9, 610, 265 (the '"265
patent"), is DENIED, for the reasons stated in paragraph
3 above with respect to the similar motion to dismiss filed
in C.A. No. 17-365. (See, e.g., C.A. No. 17-660 D.I.
11 at ¶¶ 52-53)
Mallinckrodt Parties' Motion for Leave to File Sur-Reply
in Further Opposition to B. Braun Medical Inc.'s Motion
to Dismiss (C.A. No. 17-660 D.I. 66) is DENIED AS MOOT, as
the Court has today denied ...