Boston Scientific Corporation et al v. Edwards Lifesciences Corporation
MEMORANDUM OPINION re: DI 65. Signed by Judge Sherry R. Fallon on 2/28/17. (cak)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BOSTON SCIENTIFIC CORPORATION
and BOSTON SCIENTIFIC SCIMED, INC.,
LIFESCIENCES PVT, INC., and EDWARDS
LIFE SCIENCES LLC,
Counterclaim and Third-Party
BOSTON SCIENTIFIC CORPORATION,
BOSTON SCIENTIFIC SCIMED, INC., and
SADRA MEDICAL, INC.,
Counterclaim and Third-Party
C.A. No. 16-275-SLR-SRF
Presently before the court in this patent infringement action is the motion for leave to
amend an answer pursuant to Federal Rule of Civil Procedure 15(a)(2), filed by defendant and
counterclaim plaintiff, Edwards Lifesciences Corporation, as well as counterclaim and thirdparty plaintiffs, Edwards Lifesciences PVT, Inc. and Edwards Lifesciences LLC (collectively,
"Edwards"). (D.I. 65) Plaintiffs and counterclaim defendants, Boston Scientific Corporation
and Boston Scientific Scimed, Inc. (collectively, "Boston Scientific"), oppose the motion. (D.I.
75) For the following reasons, the court will grant Edwards' motion for leave to amend its
On April 19, 2016, Boston Scientific filed this suit against Edwards, alleging
infringement of U.S. Patent No. 8,992,608 ("the '608 patent"). (D.I. 1) On June 9, 2016,
Edwards filed its answer and counterclaims. (D.I. 10) On November 30, 2016, Edwards filed a
motion to amend its answer to add a prior use affirmative defense under 35 U.S.C. § 273. (D.1.
65 at ii 1) Pursuant to the scheduling order, 1 the deadline to amend pleadings was November 30,
2016. (D.I. 34 at ii 2) The motion presently pending before the court was filed on the final day
for amending pleadings set forth in the scheduling order. Fact discovery is scheduled to be
completed by May 26, 2017. (Id. at ii l(a))
Rule 15(a)(2) of the Federal Rules of Civil Procedure provides that after a responsive
pleading has been filed, a party may amend its pleading "only with the opposing party's written
consent or the court' s leave," and "[t]he court should freely give leave when justice so requires."
Fed. R. Civ. P. 15(a)(2). The decision to grant or deny leave to amend lies within the discretion
of the court. See Foman v. Davis, 371 U.S. 178, 182 (1962); In re Burlington Coat Factory Secs.
Litig., 114 F.3d 1410, 1434 (3d Cir. 1997). The Third Circuit has adopted a liberal approach to
the amendment of pleadings. See Dole v. Arco, 921F.2d484, 487 (3d Cir. 1990). In the absence
of undue delay, bad faith, or dilatory motives on the part of the moving party, the amendment
The parties have entered into three joint stipulations to amend the scheduling order. (D .I. 51 ;
D.I. 59; D.I. 69) However, none of the modifications to the original scheduling order have
altered the deadline for amended pleadings or the fact discovery deadline.
should be freely granted, unless it is futile or unfairly prejudicial to the non-moving party. See
Foman, 371 U.S. at 182; In re Burlington, 114 F.3d at 1434.
Sufficiency of the Pleading
Boston Scientific argues that Edwards' proposed amendment lacks sufficient information
to allege an affirmative prior use defense, although it does not formally raise a futility challenge.
(D.I. 73 at ii 7) Edwards counters that the proposed amendment provides sufficient information
to put Boston Scientific on notice that Edwards is asserting a prior use defense pursuant to § 273,
and more detailed facts supporting that defense will be revealed during the course of fact
discovery. (D.I. 75 at ii 9)
The court concludes that Edwards' prior use affirmative defense is factually sufficient at
this stage of the proceedings because affirmative defenses pleaded pursuant to Rule 8(c) are not
held to the same pleading requirements as claims for relief brought in accordance with Rule 8(a).
"Due to the differences between Rules 8(a) and 8(c) in text and purpose, Twombly and Iqbal
do not apply to affirmative defenses, which need not be plausible to survive. [An affirmative
defense] must merely provide fair notice of the issue involved." Senju Pharm. Co. v. Apotex,
Inc., 921 F. Supp. 2d 297, 303 (D. Del. 2013) (internal quotation marks and citations omitted).
"Rule 8(a) requires a 'statement of the claim showing that the pleader is entitled to relief while
Rule 8(c) only requires a pleader to 'state' an affirmative defense." Tyco Fire Prod. LP v.
Victaulic Co., 777 F. Supp. 2d 893, 899 (E.D. Pa. 2011) (emphasis in original) (citing
Charleswell v. Chase Manhattan Bank, N A., C.A. No. 01-119, 2009 WL 4981730 (D.V.I. Dec.
8, 2009)). Boston Scientific has failed to point to any authority requiring a heightened pleading
standard for asserting an affirmative defense. Consequently, the court concludes that Edwards'
prior use affirmative defense is factually sufficient.
The court does not find that Edwards' proposed amended answer would cause undue
delay. First, Edwards' motion for leave to amend was filed within the deadline set forth in the
scheduling order for amending pleadings, which generally precludes a finding of undue delay.
(D.I. 34 at iJ 2); see Invensas Corp. v. Renesas Elecs. Corp., C.A. No. 11-448-GMS-CJB, 2013
WL 1776112, at *3 (D. Del. Apr. 24, 2013) (granting plaintiffs motion to amend and finding no
undue delay when plaintiff filed on the last day set by the scheduling order to amend pleadings);
Butamax Advanced Biofuels LLC v. Gevo, Inc. , C.A. No. 11-54-SLR, 2012 WL 2365905, at *2
(D. Del. June 21, 2012) (holding that a motion to amend filed on the deadline for amended
pleadings was "filed timely and, therefore, there can be no unfair prejudice to defendant");
LifePort Scis. LLC v. Endologix Inc., C.A. No. 12-1791-GMS, D.I. 105 at 2 (D. Del. July 29,
2015) ("Even assuming the plaintiff is correct that the defendant could have filed its motion
sooner, the court cannot say the delay was undue ... when this was explicitly contemplated as a
possibility."). Second, the case is still in its early stages, and fact discovery is not scheduled to
close until May 26, 2017. Edwards' purported failure to explain the delay between the filing of
its initial answer and the filing of the proposed amended answer is insufficient to deny leave to
amend under the facts of the present case. "The mere passage of time does not require that a
motion to amend a complaint be denied on grounds of delay." Cureton v. Nat'! Collegiate
Athletic Ass 'n, 252 F.3d 267, 273 (3d Cir. 2001).
Boston Scientific has also failed to show it will be unduly prejudiced by Edwards'
amended answer. A non-moving party's opposition to an amended pleading must "show that it
was unfairly disadvantaged or deprived of the opportunity to present facts or evidence which it
would have offered had the ... amendments been timely." Bechtel v. Robinson, 886 F.2d 644,
652 (3d Cir. 1989) (internal quotation marks omitted). The court must consider "whether
allowing an amendment would result in additional discovery, cost, and preparation to defend
against new facts or new theories." Cureton, 252 F.3d at 273. Although Boston Scientific
claims that it did not anticipate the addition of Edwards' prior use defense when it negotiated the
discovery limits in the scheduling order, Boston Scientific acknowledged the possibility of an
amended answer by stipulating to the deadline for amended pleadings in the scheduling order at
the time of discovery negotiations. (D.I. 73 at if 10) To the extent Boston Scientific would be
prejudiced by the need to obtain additional discovery directed to the prior use defense, a limited
grant of additional discovery is warranted, as discussed at§ IV.D, irifra.
Boston Scientific requests additional discovery in the form of three (3) additional
interrogatories, five (5) additional requests for production of documents, and fifteen (15)
additional requests for admission, limited to the new prior use defense, as well as a forty-five
(45) day extension to serve the document requests. (D.I. 73 at if 11) In response, Edwards
expresses willingness to expand the agreed-upon discovery limits, but notes that Boston
Scientific still has seven (7) unused interrogatories, forty-three (43) unused requests for
production, and one hundred (100) unused requests for admission. (D.I. 75 at iii! 14, 17)
Edwards also indicates that a substantial number of documents already produced in discovery
serve as a basis for its prior use defense. (Id. at ~ 15)
The court concludes that additional limited discovery is appropriate in light of the newly
asserted prior use defense. In view of the unused requests available to Boston Scientific under
the scheduling order, however, the number of additional requests sought by Boston Scientific is
unnecessary. Therefore, Boston Scientific's request for additional discovery is granted as
follows: two (2) additional interrogatories, five (5) additional requests for production of
documents, and ten (10) additional requests for admission. In the event a further extension is
necessary to serve the additional discovery requests, the court will consider a reasonable
extension absent a stipulation from the parties.
For the foregoing reasons, Edwards' motion for leave to amend is granted. (D.I. 65) An
Order consistent with this Memorandum Opinion shall issue.
This Memorandum Opinion is filed pursuant to 28 U.S.C. § 636(b)(l)(A), Fed. R. Civ. P.
72(a), and D. Del. LR 72.l(a)(2). The parties may serve and file specific written objections
within fourteen (14) days after being served with a copy ofthis Memorandum Opinion. Fed. R.
Civ. P. 72(a). The objections and responses to the objections are limited to ten (10) pages each.
The parties are directed to the court's Standing Order For Objections Filed Under Fed. R.
Civ. P. 72, dated October 9, 2013, a copy of which is available on the court's website,
Dated: February 28, 2017
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