Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 1 of 25 PageID #: 1090
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`SHILPA PHARMA, INC.,
`
`Plaintiff,
`
`v.
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
`Defendant.
`
`C.A. No. 21-558-MN
`
`JURY TRIAL DEMANDED
`
`NOVARTIS’S OPENING BRIEF IN SUPPORT OF ITS RULE 12(C) MOTION TO
`DISMISS SHILPA’S CLAIMS OF WILLFUL INFRINGEMENT
`
`Dated: May 25, 2022
`
`OF COUNSEL:
`
`Jane M. Love, Ph.D
`Robert W. Trenchard
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue
`New York, NY 10166
`Tel: (212) 351-4000
`jlove@gibsondunn.com
`rtrenchard@gibsondunn.com
`
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Counsel for Defendant
`Novartis Pharmaceuticals Corporation
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 2 of 25 PageID #: 1091
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`The Court Should Dismiss Shilpa’s Claims of Willful Infringement .............................. 7
`
`A. Without Mr. Iyer’s Evidence, the Claim of Pre-Suit Willfulness Should
`Be Dismissed ....................................................................................................................8
`
`B.
`
`The Court Should Also Dismiss Any Claim of Post-Suit Willfulness ...........................11
`
`1.
`
`2.
`
`The Complaint in This Case Fails to Provide Enough to Allege
`Post-Suit Willful Infringement ............................................................................. 11
`
`A Complaint Alone Cannot Provide Notice for a Claim of Post-
`Complaint Willfulness .......................................................................................... 13
`
`II.
`
`III.
`
`The Court Should Dismiss Shilpa’s Claims of Indirect Infringement ........................... 15
`
`The Court Should Dismiss Shilpa’s Claims with Prejudice .......................................... 17
`
`i
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 3 of 25 PageID #: 1092
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Anspach, et al. v. City of Philadelphia, Dept. of Public Health, et al.,
`503 F.3d 256 (3d Cir. 2007).......................................................................................................6
`
`APS Technology, Inc. v. Vertex Downhole, Inc.,
`2020 WL 4346700 (D. Del. 2020) ...........................................................................................10
`
`In re Baker Hughes Inc.,
`215 F.3d (Fed. Cir. 2000)...........................................................................................................9
`
`Bayer Healthcare LLC v. Baxalta Inc.,
`989 F.3d 964 (Fed. Cir. 2021)....................................................................................................8
`
`Bench Walk Lighting LLC v. LG Innotek Co., Ltd.,
`530 F. Supp. 3d 468 (D. Del. Mar. 31, 2021) ..................................................................7, 8, 16
`
`Berkheimer v. HP Inc.,
`890 F.3d 1469 (Fed. Cir. 2018)................................................................................................12
`
`Bioverativ Inc. v. CSL Behring LLC,
`2020 WL 1332921 (D. Del. Mar. 23, 2020) ............................................................................14
`
`Boston Scientific Corp. v. Nevro Corp.,
`560 F. Supp. 3d 837 (D. Del. 2021) .......................................................................................7, 9
`
`Callwave Communications LLC v. AT & T Mobility LLC,
`2014 WL 5363741 (D. Del. Jan. 28, 2014) ..............................................................................15
`
`Cellcontrol, Inc. v. Mill Mountain Capital, LLC,
`2022 WL 598752 (W.D. Va. 2022) .......................................................................................7, 8
`
`Chester County Intermediate Unit v. Pennsylvania Blue Shield,
`896 F. 2d 808 (3d Cir. 1990)......................................................................................................6
`
`Citrix Sys., Inc. v. Avi Networks, Inc.,
`363 F. Supp. 3d 511 (D. Del. 2019) .........................................................................................12
`
`Cohesive Techs., Inc. v. Waters Corp.,
`543 F.3d 1351 (Fed. Cir. 2008)................................................................................................11
`
`Commil USA LLC v. Cisco Sys., Inc.,
`572 U.S. 632 (2015) ...........................................................................................................15, 16
`
`ii
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 4 of 25 PageID #: 1093
`
`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`Compagnie de Grands Hotels d’Afrique SA v. Starwood Cap. Grp. Global I LLC,
`2021 WL 6883231 (D. Del. Feb. 10, 2021) .............................................................................17
`
`Deere & Company v. AGCO Corporation,
`2019 WL 668492 (D. Del. 2019) .............................................................................................10
`
`DoDots Licensing Solutions LLC v. Lenovo Holding Company, Inc.,
`2019 WL 3069773 (D. Del. 2019) .............................................................................................6
`
`Dynamic Data Technologies, LLC v. Amlogic Holdings Ltd.,
`2020 WL 4365809 (D. Del. 2020) .......................................................................................9, 16
`
`EF Operating Corp. v. Am. Bldgs.,
`993 F.2d 1046 (3d Cir. 1993)...................................................................................................10
`
`Election Systems & Software, LLC v. Smartmatic USA Corporation,
`2019 WL 1040541 (D. Del. 2019) ...........................................................................................10
`
`Express Mobile, Inc. v. Squarespace, Inc.,
`2021 WL 3772040 (D. Del. 2021) ...........................................................................................16
`
`Fowler v. UPMC Shadyside,
`578 F.3d 203 (3d Cir. 2009).......................................................................................................6
`
`Halo Electronics, Inc. v. Pulse Electronics, Inc.,
`579 U.S. 93 (2016) .................................................................................................................1, 7
`
`Helios Streaming, LLC v. Vudu, Inc.,
`2020 WL 3167641 (D. Del. June 15, 2020) .............................................................................14
`
`iFIT Inc. v. Peloton Interactive, Inc.,
`2022 WL 609605 (D. Del. 2022) .....................................................................................7, 8, 14
`
`IpVenture Inc. v. Lenovo Grp. Ltd.,
`2013 WL 126276 (D. Del. Jan. 8, 2013) ..................................................................................13
`
`Koken v. GPC Int'l, Inc.,
`443 F. Supp. 2d 631 (D. Del. 2006) .........................................................................................17
`
`Malvern Panalytical Ltd v. Ta Instruments-Waters LLC,
`2021 WL 3856145 (D. Del. 2021) .........................................................................................7, 8
`iii
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 5 of 25 PageID #: 1094
`
`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`Nncrystal US Corp. v. Nanosys, Inc.,
`2022 WL 1091283 (D. Del. Apr. 12, 2022) .............................................................................17
`
`Oneida Motor Freight, Inc. v. United Jersey Bank,
`848 F. 2d 414 (3d Cir. 1988)......................................................................................................9
`
`Oshiver v. Levin, Fishbein, Sedran & Berman,
`38 F.3d 1380 (3d Cir. 1994).......................................................................................................6
`
`Peters v. Active Mfg. Co.,
`129 U.S. 530 (1889) .................................................................................................................12
`
`Revell v. Port Auth. of N.Y.,
`598 F.3d 128 (3d Cir. 2010).......................................................................................................5
`
`Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC,
`No. 2021-1609, 2021-1633, -- F.4th --, 2022 WL 1052320 (Fed. Cir. Apr. 8,
`2022) ........................................................................................................................................15
`
`Secured Mail Sols. LLC v. Universal Wilde, Inc.,
`873 F.3d 905 (Fed. Cir. 2017)....................................................................................................6
`
`SRI Int’l, Inc. v. Cisco Sys., Inc.,
`930 F.3d 1295 (Fed. Cir. 2019), cert. den., 140 S.Ct. 1108 (2020) .........................................14
`
`Tonal Systems, Inc. v. ICON Health & Fitness, Inc.,
`2021 WL 1785072 (D. Del. 2021) ...........................................................................................10
`
`Upsher-SmithLabs., Inc. v. Pamlab, L.L.C.,
`412 F.3d 1319 (Fed. Cir. 2005)................................................................................................12
`
`Valinge Innovation AB v. Halstead New England Corp.,
`2018 WL 2411218 (D. Del. May 29, 2018) .......................................................................6, 7, 8
`
`Wrinkl, Inc. v. Facebook, Inc., et al.,
`2021 WL 4477022 (D. Del. 2021) .......................................................................................7, 13
`
`ZapFraud, Inc. v. Barracuda Networks, Inc.,
`528 F. Supp. 3d 247 (D. Del. 2021) .........................................................................8, 11, 14, 16
`
`iv
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 6 of 25 PageID #: 1095
`
`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`Other Authorities
`
`Gilenya September 21, 2010 NDA Approval letter, available at
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022527s000lt
`r.pdf (last accessed May 23, 2022) .........................................................................................12
`
`Treatises
`
`5A Wright & Miller, Federal Practice and Procedure: Civil 2nd, § 1357 .....................................6
`
`v
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 7 of 25 PageID #: 1096
`
`PRELIMINARY STATEMENT
`
`Novartis moves under Federal Rule of Civil Procedure 12(c) to dismiss Shilpa’s claims of
`
`willful and indirect infringement. These claims depend on factual allegations that Shilpa has now
`
`withdrawn. Without that backing, the Complaint lacks any putative basis for the claims, and they
`
`should be dismissed.
`
`Shilpa’s Complaint originally asserted willful infringement based on conversations in
`
`2016, when Shilpa’s outside counsel Mr. Chid Iyer allegedly told Novartis’s in-house counsel that
`
`multiple sclerosis drug Gilenya® infringes Shilpa’s U.S. Patent No. 9,266,816. But in late April
`
`2022, Shilpa disclaimed any reliance on Mr. Iyer’s allegations to avoid his disqualification under
`
`the lawyer-witness rule. That reversal dooms these claims. Shilpa cites nothing besides Mr. Iyer’s
`
`allegations as support. Shorn of those allegations, the claims lack any basis.
`
`Courts routinely dismiss willful and indirect infringement claims that lack foundation.
`
`Willful infringement under Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016),
`
`and induced and contributory infringement under 35 U.S.C. §§ 271(b) and (c), all require the
`
`patentee to show the accused infringer knew the challenged conduct infringed. Shilpa relied on
`
`Mr. Iyer’s allegations to plead that knowledge. Having abandoned those allegations, Shilpa must
`
`also give up the claims that depend on them.
`
`Novartis accordingly asked Shilpa to withdraw its willful and indirect infringement claims
`
`before bringing this motion. Shilpa ignored that request. But Shilpa cannot have it both ways—
`
`either Mr. Iyer must be disqualified, or Shilpa must give up the claims based on his allegations.
`
`The Court should dismiss.
`
`1
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 8 of 25 PageID #: 1097
`
` The facts here are from the Complaint (D.I. 1) and docket entries and other materials from
`
`FACTS
`
`the disqualification motion that are subject to judicial notice.
`
`The Complaint
`
`Plaintiff Shilpa Pharma, Inc. is the U.S. operating company of Shilpa Medicare Limited,
`
`an Indian company. (Id. ¶ 2.) Defendant Novartis Pharmaceuticals Corporation sells multiple
`
`sclerosis medicine Gilenya, the subject of this case. (Id. ¶¶ 14, 15.)
`
`Shilpa contends that Gilenya infringes the 816 Patent, which claims a specific crystal
`
`form—or polymorph––of Gilenya’s active ingredient fingolimod hydrochloride. (Id. ¶¶ 11, 13,
`
`14.) Specifically, Shilpa alleges the active ingredient in Gilenya is in the form of the polymorph
`
`“Form-β” claimed in the 816 Patent. (Id. ¶¶ 13, 25, 34, 44.)
`
`The U.S. Patent and Trademark Office granted the 816 Patent in February 2016. (Id. ¶ 9.)
`
`According to the Complaint, Shilpa “[i]n March, 2016 . . . advised Novartis of the issuance of the
`
`’816 patent.” (Id. ¶ 28.) Thereafter, “[r]epresentatives of each company met . . . [and]
`
`GILENYA® was discussed. After consideration, Novartis did not further respond to Shilpa’s offer
`
`of a license.” (Id.) The Complaint alleges from this that Novartis was on “notice of the ’816
`
`patent, and Shilpa’s view that the GILENYA® Products were covered by one or more of its claims,
`
`since early 2016.” (Id.; see also id. ¶ 49 (“Defendant was aware of the ’816 patent since at least
`
`March, 2016, when Shilpa Medicare Limited first notified Defendant of the ‘816 patent and
`
`informed them of Plaintiff’s belief that GILENYA® was covered by one or more of its claims.”).)
`
`Based on these allegations, Shilpa claims Novartis “knows or should know that the . . . sale
`
`in the United States . . . of its GILENYA® Products . . . constitute[s] infringement of the ’816
`
`patent without a good faith belief that the ’816 patent is invalid or not infringed.” (Id. ¶ 50.) Shilpa
`
`2
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 9 of 25 PageID #: 1098
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`thus contends that “[Novartis] deliberately and intentionally continues to . . . sell . . . infringing
`
`GILENYA® Products without authorization from [Shilpa].” (Id.) In addition, based in part on
`
`this alleged “knowledge that its acts are encouraging infringement[,]” Shilpa contends that
`
`Novartis “is liable . . . under 35 U.S.C. § 271(b)” for induced infringement and “35 U.S.C.
`
`§ 271(c)” for contributory infringement. (Id. ¶¶ 36–37; see also id. ¶¶ 47–48.)
`
`The Disqualification Motion
`
`Novartis served interrogatories seeking more detail about the “basis” for Shilpa’s
`
`willfulness and indirect infringement allegations. (D.I. 43-1 at 2–23, especially at 11–12, 16–18.)
`
`Shilpa replied that in “February, 2016, Mr. Chid Iyer, outside counsel to Shilpa
`
`Pharmaceuticals, contacted Mr. Peter Waibel, Head of Patent Litigation at Novartis
`
`Pharmaceuticals Corporation, about the issuance of the ‘816 patent and its applicability to
`
`Novartis’ commercial Gilenya® product.” (Id. at 11–12.) At a later meeting with Mr. Iyer and
`
`others, “Mr. Waibel stated that they would consider the applicability of the ‘816 patent to the
`
`Gilenya® product and respond in due course.” (Id at 12.) “Mr. Iyer followed up in an email to
`
`Mr. Waibel of April 18, 2016.” (Id.) Thereafter, “Mr. Iyer and Mr. Waibel discussed the ‘816
`
`patent in one or more subsequent phone conferences, but no agreement was reached.” (Id.) Shilpa
`
`identified these facts as the basis for willful direct and indirect infringement. (Id. at 17.)
`
`Shilpa’s interrogatory responses put Mr. Iyer’s evidence squarely at issue. Novartis thus
`
`moved to disqualify under the lawyer-witness rule, ABA Model Rule 3.7. (D.I. 42.) Shilpa’s
`
`interrogatory responses made clear that Mr. Iyer was a “necessary” witness under the rule. His
`
`testimony would be relevant, material, not merely cumulative, and unobtainable elsewhere. (See
`
`id. at 11–14.) He could not then also be Shilpa’s advocate. Shilpa opposed (D.I. 53), and submitted
`
`3
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 10 of 25 PageID #: 1099
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`a declaration from Mr. Iyer stating that he had communicated personally with Novartis in every
`
`instance when Shilpa contends Novartis was made aware that Gilenya infringed. (D.I. 54.)
`
`The Special Master and Her Report
`
`The Court appointed former U.S. District Judge Sue Robinson as Special Master to provide
`
`a Report and Recommendation on Novartis’s motion. (D.I. 98.) In analyzing the issues, Judge
`
`Robinson pressed Shilpa to answer whether, aside from Mr. Iyer’s evidence, there were “other
`
`factual bases that support Shilpa’s allegations of willful and induced infringement?” As Judge
`
`Robinson went on, “[i]n other words … isn’t Mr. Iyer the only witness/evidence to the 2016
`
`meetings that form the basis for the allegations?” (May 25, 2022 Declaration of Robert W.
`
`Trenchard, Ex. A (Apr. 14, 2022 email from S. Robinson).)
`
`Shilpa responded by letter on April 20, 2022. (D.I. 93.) Notwithstanding the interrogatory
`
`responses, Shilpa emphatically disclaimed any reliance on Mr. Iyer’s allegations. Shilpa’s letter
`
`states—in bold underlined terms—that “the 2016 correspondence and in-person meeting do not
`
`form the basis for the willfulness allegations.” (Id. at 1 (emphasis in original).) Shilpa went
`
`further: “[o]ther than establishing knowledge of the patent (uncontested), the early 2016
`
`communications are irrelevant to Shilpa’s demonstrating willfulness.” (Id. at 2.) Instead,
`
`according to Shilpa, “[o]nce Novartis had knowledge of the patent, its intent for willfulness
`
`purposes is established by reference to its own conduct.” (Id.)
`
`Judge Robinson relied on these representations in deciding Novartis’s motion. To start,
`
`Judge Robinson found that “Shilpa itself made Mr. Iyer’s knowledge relevant, material, not merely
`
`cumulative, and unobtainable elsewhere when it asserted in its responses to interrogatories that the
`
`allegations of willful/induced infringement were based on such interactions.” (D.I. 98 at 5.) Judge
`
`Robinson then found that—“despite its interrogatory responses”—Shilpa now “argues that ‘the
`
`4
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 11 of 25 PageID #: 1100
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`2016 correspondence and in-person meeting do not form the basis’ of its inducement or willfulness
`
`allegations”; according to Shilpa, “knowledge of the ‘816 patent is not contested and, once
`
`knowledge is proven, Novartis’ intent for willfulness (and inducement) purposes ‘is established
`
`by reference to its own conduct. Nothing Mr. Iyer said or is alleged to have said is relevant to
`
`Novartis’ intent.’” (Id. at 6.)
`
`In other words, “Shilpa has now represented that it will rely solely on the fact that Novartis
`
`knew about the ‘816 patent and continued to infringe and to induce others to infringe. According
`
`to Shilpa, any other evidence of intent will be gleaned from Novartis itself.” (Id. (emphasis in
`
`original).) Judge Robinson denied Novartis’s motion on that basis without prejudice to renewal at
`
`a later date. (Id. at 7.) The Court has since adopted the Report and Recommendation without
`
`objection from Shilpa. (D.I. 101.)
`
`After receiving Judge Robinson’s Report, Novartis asked Shilpa to drop the willfulness
`
`and indirect infringement claims from the case. Shilpa’s counsel promised to consult with their
`
`client, but then never responded further. Novartis now moves to dismiss.
`
`ARGUMENT
`
`Federal Rule of Civil Procedure 12(c) provides that after “the pleadings are closed—but
`
`early enough not to delay trial—a party may move for judgment on the pleadings.” The pleadings
`
`on Shilpa’s deliberate infringement claims closed on March 30, 2022, when Novartis filed an
`
`amended answer. (D.I. 85.) With trial not set until October 10, 2023 (D.I. 21 at 14), this motion
`
`will not delay trial.
`
`“A motion for judgment on the pleadings based on the defense that the plaintiff has failed
`
`to state a claim is analyzed under the same standards that apply to a Rule 12(b)(6) motion.” Revell
`
`v. Port Auth. of N.Y., 598 F.3d 128, 134 (3d Cir. 2010). Under those standards, first “the court
`
`5
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 12 of 25 PageID #: 1101
`
`separates the factual and legal elements of a claim, accepting ‘all of the complaint’s well-pleaded
`
`facts as true, but [disregarding] any legal conclusions.’” Valinge Innovation AB v. Halstead New
`
`England Corp., 2018 WL 2411218, at *10–12 (D. Del. May 29, 2018) (quoting Fowler v. UPMC
`
`Shadyside, 578 F.3d 203, 210–11 (3d Cir. 2009)). “Second, the court determines ‘whether the
`
`facts alleged in the complaint are sufficient to show that the plaintiff has a “plausible claim for
`
`relief.”’” Id. (quoting Fowler, 578 F.3d at 211). “A plausible claim does more than merely allege
`
`entitlement to relief; it must also demonstrate the basis for that ‘entitlement with its facts.’” Id.
`
`Shilpa has now withdrawn the only facts alleged to support claims of willful and indirect
`
`infringement—a deliberate, strategic decision Judge Robinson then relied upon in ruling on
`
`Novartis’s motion to disqualify. Shilpa’s decision and Judge Robinson’s reliance on it are now
`
`matters of public record subject to judicial notice. See Anspach, et al. v. City of Philadelphia,
`
`Dept. of Public Health, et al., 503 F.3d 256, 273 n.11 (3d Cir. 2007) (“Courts ruling on Rule
`
`12(b)(6) motions may take judicial notice of public records.”); Oshiver v. Levin, Fishbein, Sedran
`
`& Berman, 38 F.3d 1380, 1384 n.2 (3d Cir. 1994) (court may take judicial notice of “matters of
`
`public record” including “items appearing in the record of the case”) (citing 5A Wright & Miller,
`
`Federal Practice and Procedure: Civil 2nd, § 1357, and Chester County Intermediate Unit v.
`
`Pennsylvania Blue Shield, 896 F. 2d 808, 812 (3d Cir. 1990)). So while the Complaint cites Mr.
`
`Iyer’s facts in support of the claims, “‘[a] court need not “accept as true allegations that contradict
`
`matters properly subject to judicial notice.’” DoDots Licensing Solutions LLC v. Lenovo Holding
`
`Company, Inc., 2019 WL 3069773, at *1 (D. Del. 2019) (quoting Secured Mail Sols. LLC v.
`
`Universal Wilde, Inc., 873 F.3d 905, 913 (Fed. Cir. 2017)).
`
`Here, the facts subject to judicial notice show that Shilpa has withdrawn reliance on Mr.
`
`Iyer’s allegations to prevent his disqualification. Without those facts, Shilpa cannot state any claim
`
`6
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 13 of 25 PageID #: 1102
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`either for willful infringement under Halo, or intentional indirect infringement under 35 U.S.C. §§
`
`271(b) and (c).
`
`I.
`
`The Court Should Dismiss Shilpa’s
`Claims of Willful Infringement
`
`Courts in this District and elsewhere treat willful infringement allegations as separate
`
`claims subject to a motion to dismiss, and routinely dismiss such claims when they lack sufficient
`
`support. See, e.g., iFIT Inc. v. Peloton Interactive, Inc., 2022 WL 609605, at *2 (D. Del. 2022)
`
`(dismissing willful infringement claim for lack of adequate factual support in complaint); Wrinkl,
`
`Inc. v. Facebook, Inc., et al., 2021 WL 4477022, at *6 (D. Del. 2021) (same); Boston Scientific
`
`Corp. v. Nevro Corp., 560 F. Supp. 3d 837, 845 (D. Del. 2021) (same); Malvern Panalytical Ltd
`
`v. Ta Instruments-Waters LLC, 2021 WL 3856145, at *3–4 (D. Del. 2021) (same); Bench Walk
`
`Lighting LLC v. LG Innotek Co., Ltd., 530 F. Supp. 3d 468, 491–493 (D. Del. Mar. 31, 2021)
`
`(same); see also, e.g., Cellcontrol, Inc. v. Mill Mountain Capital, LLC, 2022 WL 598752, at *4–5
`
`(W.D. Va. 2022) (same).
`
`Here, the withdrawal of Mr. Iyer’s allegations relinquished any willful infringement claim.
`
`In assessing willfulness, “the focus must be on ‘subjective willfulness of a patent infringer,
`
`intentional or knowing[.]’” Valinge, 2018 WL 2411218, at *10–12 (quoting Halo, 579 U.S. 93 at
`
`105). Thus, “to sufficiently plead willful infringement, a plaintiff must allege facts plausibly
`
`showing that as of the time of the claim’s filing, the accused infringer: (1) knew of the patent-in-
`
`suit; (2) after acquiring that knowledge, it infringed the patent; and (3) in doing so, it knew, or
`
`should have known, that its conduct amounted to infringement of the patent.” Id. at *13.
`
`As Valinge makes clear, knowledge of the patent plus infringing conduct, by themselves,
`
`are not enough. There must also be “some other factual allegations that go to the accused
`
`infringer’s subjective intent to infringe—i.e., that plausibly demonstrate that the accused infringer
`7
`
`

`

`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 14 of 25 PageID #: 1103
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`not only knew of the patent-in-suit, but also knew or should have known that what it was doing
`
`(and what it continued to do) amounted to infringement of that patent.” (Id.) In other words,
`
`“proof that the defendant knew about the asserted patent” is a separate element from whether
`
`defendant knew “its conduct amounted to infringement.” ZapFraud, Inc. v. Barracuda Networks,
`
`Inc., 528 F. Supp. 3d 247, 249 (D. Del. 2021). “The Federal Circuit has instructed that
`
`‘[k]nowledge of the asserted patent and evidence of infringement is necessary, but not sufficient,
`
`for a finding of willfulness. Rather, willfulness requires deliberate or intentional infringement.’”
`
`iFIT Inc., 2022 WL 609605, at *2 (citing Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964,
`
`988 (Fed. Cir. 2021)). “[S]imply knowing about the asserted patents but acting anyway is not
`
`enough to state a claim for willful infringement and … survive a motion to dismiss.” Cellcontrol,
`
`Inc. v. Mill Mountain Capital, LLC, 2022 WL 598752, at *4–5 (W.D. Va. 2022).
`
`That makes sense. Someone can know about a patent but mistakenly or reasonably believe
`
`in good faith they do not infringe. In that case, there would be infringement, but it would not be
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`willful or intentional. The Complaint accordingly must plead more than notice of the patent plus
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`actual infringement.
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`A.
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`Without Mr. Iyer’s Evidence, the Claim of
`Pre-Suit Willfulness Should Be Dismissed
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`Shilpa has nothing more. Judge Robinson found Shilpa now relies “solely on the fact that
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`Novartis knew about the ‘816 patent and continued to infringe and to induce others to infringe.
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`According to Shilpa, any other evidence of intent will be gleaned from Novartis itself.” (D.I. 98
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`at 6 (emphasis in original).) That is not enough under Rule 12(c) for this claim to survive.
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`For instance, in Malvern Panalytical Ltd v. Ta Instruments-Waters LLC, 2021 WL
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`3856145, at *3–4 (D. Del. 2021), the court found pre-suit knowledge of the patent but still
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`dismissed for lack of allegations to support a claim of knowing infringement. In Bench Walk
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`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 15 of 25 PageID #: 1104
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`Lighting, 2021 WL 65071, at *11–12, the court similarly dismissed a complaint where the pre-suit
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`letter identified some patents but failed to explain how defendant infringed. Likewise, in Boston
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`Scientific Corp., 560 F. Supp. 3d at 843, the court dismissed a complaint alleging knowledge of
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`the patent but not knowledge of infringement. And in Dynamic Data Technologies, LLC v.
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`Amlogic Holdings Ltd., 2020 WL 4365809, *5 (D. Del. 2020), the court found that, while the
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`complaint alleged knowledge of the patent, it failed to allege that defendant “had knowledge of its
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`infringement of the asserted patents.”
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`Notwithstanding this settled authority, Shilpa told Judge Robinson that “[o]nce Novartis
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`had knowledge of the patent, its intent for willfulness purposes is established by reference to its
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`own conduct.” (D.I. 93 at 2.) That is exactly the opposite of the law. Shilpa must plead more
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`than knowledge of the patent plus allegedly infringing conduct. Having withdrawn Mr. Iyer’s
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`allegations, it no longer has any basis for doing so.
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`The doctrines of judicial and quasi-estoppel would bar Shilpa from taking inconsistent
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`positions before Judge Robinson earlier and this Court now. “The doctrine of judicial estoppel
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`bars a party that has previously asserted a legal position from asserting an inconsistent or contrary
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`legal position in a late proceeding.” Oneida Motor Freight, Inc. v. United Jersey Bank, 848 F. 2d
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`414, 419 (3d Cir. 1988). Quasi-estoppel is a similar rule recognizing a “duty of consistency.” In
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`re Baker Hughes Inc., 215 F.3d, 1297, 1301-02 (Fed. Cir. 2000). It prevents litigants “from
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`shifting to a contrary position touching on the same facts or transaction” and “the earlier position
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`was then to the advantage of the [litigant] but that it is now to the [litigant’s] advantage to shift …
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`position.” Id. at 1301. As the Third Circuit has held, the “smooth, efficient working of the judicial
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`process depends heavily upon the assumption that [representations made in briefs] will be made
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`after careful, deliberate evaluation by skilled attorneys who must ultimately accept responsibility
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`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 16 of 25 PageID #: 1105
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`for the consequences of their decisions. It goes without saying that one cannot casually cast aside
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`representations, oral or written, in the course of litigation simply because it is convenient to do
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`so[.]” EF Operating Corp. v. Am. Bldgs., 993 F.2d 1046, 1050 (3d Cir. 1993). Shilpa thus cannot
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`escape the position it took on disqualification.
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`Cases sustaining willfulness allegations illustrate what is now missing from Shilpa’s
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`Complaint. Most typically, willfulness can be established if the patentee tells the defendant before
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`the lawsuit about the alleged infringement. As the court held in Tonal Systems, Inc. v. ICON
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`Health & Fitness, Inc., 2021 WL 1785072, at *6 (D. Del. 2021), a patentee can state a willfulness
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`claim if it “pleads facts indicating that: (1) prior to suit, it sent the alleged infringer one or more
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`notice letters, in which it identified the relevant patents, identified the accused product and
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`explained in sufficient detail why it was that the product infringes the patents; and (2) thereafter,
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`the alleged infringer continued to engage in infringing activities[.]” Similar allegations sufficed
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`in APS Technology, Inc. v. Vertex Downhole, Inc., 2020 WL 4346700, at *7–8 (D. Del. 2020), and
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`Election Systems & Software, LLC v. Smartmatic USA Corporation, 2019 WL 1040541, at *2 (D.
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`Del. 2019). And in Deere & Company v. AGCO Corporation, 2019 WL 668492, at *4–6 (D. Del.
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`2019), it sufficed that the patentee had verbally told the defendant of the patent and infringement.
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`The Complaint has none of this. Shilpa never wrote to Novartis to explain how Gilenya
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`allegedly infringes. To the contrary, to the extent any emails passed between the parties in 2016,
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`they are bereft of any discussion of how Gilenya might infringe. (See D.I. 54-1 to 54-4.) And Mr.
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`Iyer’s alleged oral warning of infringement has now been withdrawn in an effort to rescue him
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`from disqualification—if that vague allegation by itself could have been enough.1 Shilpa
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`1 Mr. Iyer emphasizes in his disqualification declaration that he never explained how the
`fingolimod hydrochloride in Gilenya might satisfy the crystal form claims of the 816 Patent. (D.I.
`10
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`Case 1:21-cv-00558-MN Document 107 Filed 05/25/22 Page 17 of 25 PageID #: 1106
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`accordingly has withdrawn the only allegation that possibly could have stated a willfulness claim,
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`and that claim accordingly should be dismissed.
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`B.
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`The Court Should Also Dismiss Any
`Claim of Post-Suit Willfulness
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`Nor does the Complaint anywhere allege facts to support a claim of willfulness for post-
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`suit sales. For that reason alone, the entirety of Shilpa’s willfulness claim should be dismissed.
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`But should Shilpa seek to rely on the Complaint’s allegations for this purpose, that would not
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`suffice anyway.
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`“District courts across the country are divided over whether a defendant must have the
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`knowledge necessary to sustain claims of indirect and willful infringement before the filing of the
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`lawsuit. Current and recent judges of this District have also taken different views on this issue.”
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`Zapfraud, 528 F. Supp. 3d at 250 and n.2 (collecting cases). Even if a complaint in theory could
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`supply the state of min