Boston Scientific Corp. et al v. Nevro Corp.
MEMORANDUM ORDER granting 193 MOTION to Amend Answer To Assert An Affirmative Defense And Counterclaim Of Unenforceability Due To Inequitable Conduct filed by Nevro Corp. Signed by Judge Colm F. Connolly on 9/15/2020. (nmf)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BOSTON SCIENTIFIC CORP. and
Civil Action No. 16-1163-CFC
Plaintiffs Boston Scientific Corporation and Boston Scientific
Neuromodulation Corporation (collectively, Boston Scientific) sued Defendant
Nevro Corporation for patent infringement. D.I. 1. Before me is Nevro's motion
to amend its Answer to Boston Scientific's Complaint to add an affirmative
defense and declaratory judgment counterclaim of patent unenforceability based on
inequitable conduct by Boston Scientific. D.I. 193. Nevro seeks to asse1i
inequitable conduct on the grounds that Boston Scientific "both secured issuance
of and defended the patentability of one of its asse1ied patents in this case, U.S.
Patent No. 6,895,280 [the #280 patent], by concealing material information from
[and misrepresenting material information to] the Patent Office." D.I. 194 at 1.
Federal Rule of Civil Procedure 15 governs amendments to 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 Phann. Inc. v. Teva Pharm. USA,
Inc., 2016 WL 6693113, at *1 (D. Del. Nov. 14, 2016).
If a movant meets its burden under Rule 16(b)( 4) to show that good cause
exists, the comi 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) ("Only after having found the requisite
showing of good cause will the comi consider whether the proposed amended
pleading meets the standard under Fed. R. Civ. P. 15."). "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, Inc. v.
Terex Corp., 722 F. Supp. 2d 509, 520 (D. Del. 2010) (citing Dole v. Arco Chem.
Co., 921 F.2d 484,487 (3d Cir. 1990)). Absent a showing of undue delay, bad
faith or dilatory motive, undue prejudice, repeated failure to cure deficiencies by
amendment previously allowed, or futility of the amendment, leave to amend under
Rule 15 should generally be permitted. Id. at 520-21 (citing Foman v. Davis, 371
U.S. 178, 182 (1962)).
Nevro filed the present motion to amend after the deadline for filing
amendments to pleadings set by the scheduling order that was in place at the time
Nevro filed this motion. D.I. 27; D.I. 193. Nevro, therefore, must show good
cause under Rule 16(b) for seeking to amend after the deadline. I find that Nevro
has met that burden to show good cause because the inequitable conduct claim
Nevro seeks to add is based in part on evidence that Nevro discovered after the
deadline. Specifically, Nevro bases its claim on evidence revealed in depositions
taken after the deadline and on conduct that occurred at an inter partes review
(IPR) proceeding that was resolved after the deadline. D.I. 194 at 1-2.
Boston Scientific argues that Nevro has not shown good cause because
Nevro could have discovered from pubic information before the deadline the facts
underlying its inequitable conduct claim. D.I. 215 at 13. Because inequitable
conduct must be pled with particularity, however, even ifNevro could have
obtained evidence to support its claims from public information, Nevro "was
entitled to confirm factual allegations before amending to include the inequitable
conduct defense." See Enzo Life Scis., Inc. v. Digene Corp., 270 F. Supp. 2d 484,
488 (D. Del. 2003). Nevro thus had good cause to wait until after it had taken the
depositions of the relevant actors and after a decision had been issued in the
relevant IPR proceeding before it sought to add the inequitable conduct claim so
that it could confirm its allegations. See id. at 489 (allowing Digene to add a claim
for inequitable conduct after the deadline for amendments because "Digene is
pleading a new legal theory based on a new set of facts, which were recently
confirmed by the depositions of Drs. Englehardt and Rab bani").
Because Nevro has met its burden to show good cause under Rule 16, I next
consider whether I should grant Nevro leave to amend under Rule 15(a)(2).
Boston Scientific argues that I should use my discretion under Rule 15 to deny
leave to amend because (1) Nevro's proposed claim for inequitable conduct will be
futile, (2) Nevro unduly delayed in seeking to amend, and (3) the proposed
amendment will prejudice Boston Scientific. D.I. 215 at 15, 18, 19, 20. I disagree.
First, it does not appear at this time that Nevro's claim for inequitable
conduct will be futile. A "proposed amendment is not futile [where it] would
withstand a motion to dismiss." Free Speech Coal., Inc. v. Attorney Gen. of US.,
677 F.3d 519, 545 (3d Cir. 2012). And Nevro's claim would likely withstand a
motion to dismiss-even with Federal Rule of Civil Procedure 9(b)'s heightened
pleading standard for inequitable conduct-to the extent that Nevro alleges that
Boston Scientific's in-house prosecuting attorney Bryant R. Gold and inventors
Joey Chen and Paul Meadows made material misrepresentations and omissions
during prosecution of the #280 patent and the #280 patent's parent, U.S. Patent No.
6,516,227 (the #227 patent).
Inequitable conduct occurs when "( 1) an individual associated with the
filing and prosecution of a patent application made an affirmative
misrepresentation of a material fact, failed to disclose material information, or
submitted false material information; and (2) the individual did so with a specific
intent to deceive the [Patent Office]." Exergen Corp. v. Wal-Mart Stores, Inc., 575
F.3d 1312, 1327 (Fed. Cir. 2009). "[T]o plead the 'circumstances' of inequitable
conduct with the requisite 'particularity' under Rule 9(b ), the pleading must
identify the specific who, what, when, where, and how of the material
misrepresentation or omission committed before the [Patent Office]." Id. at 1328.
The pleading must also "include sufficient allegations of underlying facts from
which a comi may reasonably infer that a specific individual (1) knew of the
withheld material information or of the falsity of the material misrepresentation,
and (2) withheld or misrepresented this information with a specific intent to
deceive the [Patent Office]." Id. at 1328-29.
Here, Nevro has alleged the "who, what, when, where, and how" of Mr.
Gold and the inventors' alleged material misrepresentation and omissions before
the Patent Office. Nevro alleges facts to establish that ( 1) Mr. Gold knowingly
made a false statement to the Patent Office during prosecution of the #227 patent
that the patent's use of implantable pulse generators (IPGs) with rechargeable
batteries was novel and (2) Mr. Gold and the inventors knowingly failed to list
references that disclosed IPGs with rechargeable batteries in the #227 and #280
patent applications. D.I. 194 at 17-18. Nevro alleges that just two days after filing
the #227 patent's application, Mr. Gold and the inventors filed an application for
U.S. Patent No. 6,553,263 (#263 patent) that expressly stated that the use of
rechargeable IPGs was already known in the prior art and that listed four
references that disclose IPGs with rechargeable batteries. D.I. 194 at 7-8, 10-11.
Nevro alleges further that Mr. Gold described one of the four references in detail in
communications with the #263 patent examiner, D.I. 194 at 8, and that Mr. Gold
and the inventors confirmed during their depositions the above allegations and
expressly admitted during their depositions that they knew of at least one prior art
reference that disclosed rechargeable IPGs, D.I. 194 at 9, 10-11. Nevro also
alleges that Mr. Gold and the inventors' omissions and misrepresentation were
material because the Patent Office allowed the #227 patent based on Mr. Gold's
arguments that use ofIPGs with rechargeable batteries was novel. D.I. 194 at 18.
Finally, Nevro asse1is that "[w]hen confronted at his deposition with his
misleading statements and failure to disclos[ e] ... Mr. Gold became nervous,
evasive, and threatened to walk out of the deposition." D.I. 194 at 9. "[A] district
court may infer intent from indirect and circumstantial evidence," Therasense, Inc.
v. Becton, Dickinson & Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011), and thus these
allegations are sufficient to allege inequitable conduct at the pleading stage.
Second, Boston Scientific argues that Nevro unduly delayed in filing the
present motion to amend. D.I. 215 at 19. Nevro, however, promptly filed the
present motion after obtaining evidence that confirmed the factual basis for its
inequitable conduct claim. Nevro confirmed its allegations through the depositions
of Mr. Gold, Mr. Chen, and Mr. Meadows taken by Nevro about a month before it
filed the present motion and through the IPR proceeding that was resolved 15 days
before Nevro filed the present motion. D.I. 194 at 16. Also, Nevro sought to take
those depositions in October and December of 2017-well before fact discovery
was scheduled to close on March 2, 2018 (in the scheduling order in place when
Nevro filed the present motion). D.I. 186. Nevro thus did not unduly delay in
filing the present motion.
Finally, Boston Scientific argues that allowing Nevro to amend will unfairly
prejudice Boston Scientific because "Nevro' s belated amendment would ...
fore[ e] a reopening of the discove1y pe1·iod and require[ e] [Boston Scientific] to
defend against inequitable conduct allegations made against several witnesses,
including Mr. Gold and the patent agent who assisted him, who are no longer
employed by [Boston Scientific], on a compressed timeframe after Nevro had more
than a year to develop its theory." D .I. 215 at 20. Boston Scientific will not,
however, have to reopen discovery or respond to Nevro's claim on a "compressed
timeframe." This case was consolidated with another case between Boston
Scientific and Nevro on June 22, 2020. See Docket, June 2, 2020 Oral Order. And
the schedule for the consolidated case sets the end of fact discovery for February
18, 2021, the end of expert discovery for May 28, 2021, and a trial for October 18,
2021. Boston Scientific Corp. v. Nevro Corp., C.A. No. 18-644, ECF No. 51, Ex.
A. Boston Scientific will therefore have sufficient time to respond to Nevro's new
Because Boston Scientific has not made a showing of undue delay, bad faith,
dilatory motive, futility, or undue prejudice, I will grant Nevro's motion to amend.
NOW THEREFORE, at Wilmington this Fifteenth day of September in
2020, IT IS HEREBY ORDERED that Defendant Nevro Corp.'s Motion for
Leave to Amend Its Answer to Assert an Affirmative Defense and Counterclaim of
Unenforceability Due to Inequitable Conduct (D.I. 193) is GRANTED.
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