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Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 1 of 9 PageID #: 11508
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BOSTON SCIENTIFIC CORP. and
`BOSTON SCIENTIFIC
`NEUROMODULATIONN CORP.
`
`NEVROCORP.
`
`Plaintiff,
`
`V.
`
`Defendant.
`
`Civil Action No. 16-1163-CFC
`CONSOLIDATED
`
`MEMORANDUM ORDER
`
`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
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`to amend its Answer to Boston Scientific's Complaint to add an affirmative
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`defense and declaratory judgment counterclaim of patent unenforceability based on
`
`inequitable conduct by Boston Scientific. D.I. 193. Nevro seeks to asse1i
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`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
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`[and misrepresenting material information to] the Patent Office." D.I. 194 at 1.
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 2 of 9 PageID #: 11509
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`I.
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`LEGAL STANDARD
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`Federal Rule of Civil Procedure 15 governs amendments to pleadings
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`generally, providing that "[t]he court should freely give leave [to amend] when
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`justice so requires." See Fed. R. Civ. P. 15(a)(2). When a party moves to amend
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`past the date set by the scheduling order, Federal Rule of Civil Procedure 16(b)
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`also applies. See Fed. R. Civ. P. 16(b)(4); see also E. Minerals & Chems. Co. v.
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`Mohan, 225 F.3d 330, 340 (3d Cir. 2000). In pertinent part, Rule 16(b) provides:
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`"A schedule may be modified only for good cause and with the judge's consent."
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`Fed. R. Civ. P. 16(b)(4). "Good cause is present when the schedule cannot be met
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`despite the moving party's diligence." Meda Phann. Inc. v. Teva Pharm. USA,
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`Inc., 2016 WL 6693113, at *1 (D. Del. Nov. 14, 2016).
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`If a movant meets its burden under Rule 16(b )( 4) to show that good cause
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`exists, the comi may then consider whether it should grant leave to amend under
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`Rule 15(a)(2). See Intellectual Ventures I LLC v. Toshiba Corp., 2016 WL
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`4690384, at* 1 (D. Del. Sept. 7, 2016) ("Only after having found the requisite
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`showing of good cause will the comi consider whether the proposed amended
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`pleading meets the standard under Fed. R. Civ. P. 15."). "The Third Circuit has
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`adopted a liberal policy favoring the amendment of pleadings to ensure that claims
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`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.
`
`2
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 3 of 9 PageID #: 11510
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`Co., 921 F.2d 484,487 (3d Cir. 1990)). Absent a showing of undue delay, bad
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`faith or dilatory motive, undue prejudice, repeated failure to cure deficiencies by
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`amendment previously allowed, or futility of the amendment, leave to amend under
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`Rule 15 should generally be permitted. Id. at 520-21 (citing Foman v. Davis, 371
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`U.S. 178, 182 (1962)).
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`II. DISCUSSION
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`Nevro filed the present motion to amend after the deadline for filing
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`amendments to pleadings set by the scheduling order that was in place at the time
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`Nevro filed this motion. D.I. 27; D.I. 193. Nevro, therefore, must show good
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`cause under Rule 16(b) for seeking to amend after the deadline. I find that Nevro
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`has met that burden to show good cause because the inequitable conduct claim
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`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
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`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
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`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
`
`3
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 4 of 9 PageID #: 11511
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`entitled to confirm factual allegations before amending to include the inequitable
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`conduct defense." See Enzo Life Scis., Inc. v. Digene Corp., 270 F. Supp. 2d 484,
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`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.
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`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.,
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`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
`
`4
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 5 of 9 PageID #: 11512
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`pleading standard for inequitable conduct-to the extent that Nevro alleges that
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`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
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`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
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`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.
`
`5
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 6 of 9 PageID #: 11513
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`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
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`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
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`U.S. Patent No. 6,553,263 (#263 patent) that expressly stated that the use of
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`rechargeable IPGs was already known in the prior art and that listed four
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`references that disclose IPGs with rechargeable batteries. D.I. 194 at 7-8, 10-11.
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`Nevro alleges further that Mr. Gold described one of the four references in detail in
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`communications with the #263 patent examiner, D.I. 194 at 8, and that Mr. Gold
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`and the inventors confirmed during their depositions the above allegations and
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`expressly admitted during their depositions that they knew of at least one prior art
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`reference that disclosed rechargeable IPGs, D.I. 194 at 9, 10-11. Nevro also
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`alleges that Mr. Gold and the inventors' omissions and misrepresentation were
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`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.
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`Finally, Nevro asse1is that "[w]hen confronted at his deposition with his
`
`6
`
`

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`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 7 of 9 PageID #: 11514
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`misleading statements and failure to disclos[ e] ... Mr. Gold became nervous,
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`evasive, and threatened to walk out of the deposition." D.I. 194 at 9. "[A] district
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`court may infer intent from indirect and circumstantial evidence," Therasense, Inc.
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`v. Becton, Dickinson & Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011), and thus these
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`allegations are sufficient to allege inequitable conduct at the pleading stage.
`
`Second, Boston Scientific argues that Nevro unduly delayed in filing the
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`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
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`of Mr. Gold, Mr. Chen, and Mr. Meadows taken by Nevro about a month before it
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`filed the present motion and through the IPR proceeding that was resolved 15 days
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`before Nevro filed the present motion. D.I. 194 at 16. Also, Nevro sought to take
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`those depositions in October and December of 2017-well before fact discovery
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`was scheduled to close on March 2, 2018 (in the scheduling order in place when
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`Nevro filed the present motion). D.I. 186. Nevro thus did not unduly delay in
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`filing the present motion.
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`Finally, Boston Scientific argues that allowing Nevro to amend will unfairly
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`prejudice Boston Scientific because "Nevro' s belated amendment would ...
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`fore[ e] a reopening of the discove1y pe1·iod and require[ e] [Boston Scientific] to
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`defend against inequitable conduct allegations made against several witnesses,
`
`7
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`

`

`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 8 of 9 PageID #: 11515
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`including Mr. Gold and the patent agent who assisted him, who are no longer
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`employed by [Boston Scientific], on a compressed timeframe after Nevro had more
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`than a year to develop its theory." D .I. 215 at 20. Boston Scientific will not,
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`however, have to reopen discovery or respond to Nevro's claim on a "compressed
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`timeframe." This case was consolidated with another case between Boston
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`Scientific and Nevro on June 22, 2020. See Docket, June 2, 2020 Oral Order. And
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`the schedule for the consolidated case sets the end of fact discovery for February
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`18, 2021, the end of expert discovery for May 28, 2021, and a trial for October 18,
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`2021. Boston Scientific Corp. v. Nevro Corp., C.A. No. 18-644, ECF No. 51, Ex.
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`A. Boston Scientific will therefore have sufficient time to respond to Nevro's new
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`claim.
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`Because Boston Scientific has not made a showing of undue delay, bad faith,
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`dilatory motive, futility, or undue prejudice, I will grant Nevro's motion to amend.
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`NOW THEREFORE, at Wilmington this Fifteenth day of September in
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`2020, IT IS HEREBY ORDERED that Defendant Nevro Corp.'s Motion for
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`Leave to Amend Its Answer to Assert an Affirmative Defense and Counterclaim of
`
`8
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 342 Filed 09/15/20 Page 9 of 9 PageID #: 11516
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`Unenforceability Due to Inequitable Conduct (D.I. 193) is GRANTED.
`
`UNITED STATE~C
`
`9
`
`

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