Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 1 of 15 PageID #: 905
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 1 of 15 PagelD #: 905
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`
`JUNO THERAPEUTICS, INC.,
`MEMORIAL SLOAN KETTERING CANCER
`
`CENTER, and
`SLOAN KETTERING INSTITUTE FOR
`
`CANCER RESEARCH,
`
`Plaintiffsa
`
`CA. No. 16-1243-RGA
`
`V.
`
`KITE PHARMA, INC.,
`
`Defendant.
`
`
`KITE PHARMA, INC.’S REPLY BRIEF
`IN SUPPORT OF ITS MOTION TO DISMISS
`
`Kelly E. Farnan (#4395)
`Richards, Layton & Finger, P.A.
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`farnan@rlf.corn
`Attorneys for Defendant
`
`Of Counsel:
`
`Leora Ben-Ami
`Patricia A. Carson
`Mira Mulvaney
`Christopher J. Citro
`KIRKLAND & ELLIS LLP
`
`601 Lexington Avenue
`New York, New York 10022
`212-446-4800
`
`Dated: April 6, 2017
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 2 of 15 PageID #: 906
`Case 1:16-cv-01243—RGA Document 19 Filed 04/06/17 Page 2 of 15 PagelD #: 906
`
`TABLE OF CONTENTS
`
`I.
`
`JUNO HAS NOT MET ITS BURDEN OF PROVING SUBJECT MATTER
`
`JURISDICTION OVER ITS DECLARATORY INFRINGEMENT CLAIMS ............... .. l
`
`A.
`
`Juno’s Suit Is Not Real And Immediate Because FDA Approval Is
`Uncertain............................................................................................................... .. l
`
`B.
`
`Kite’s Separate IPR Appeal Is Irrelevant.............................................................. .. 5
`
`l.
`
`2.
`
`The Inter Partes Review Is a Separate Proceeding Addressing
`Entirely Separate Issues. ........................................................................... .. 5
`
`Kite’s Appeal Is Subject to a Lower Justiciability Standard and
`Does Not Affect this Court’s Jurisdiction over Juno’s Claims ................. .. 6
`
`II.
`
`THE COURT SHOULD DECLINE TO EXERCISE JURISDICTION OVER
`
`JUNO’S CLAIMS BECAUSE KITE IS WITHIN THE SAFE HARBOR ...................... .. 8
`
`III.
`
`CONCLUSION ............................................................................................................... .. 10
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 3 of 15 PageID #: 907
`Case 1:16-cv-01243—RGA Document 19 Filed 04/06/17 Page 3 of 15 PagelD #: 907
`
`TABLE OF AUTHORITIES
`
`Pagegs)
`
`CASES
`
`Amgen, Inc. v. F. Hofi’man-LaRoche Ltd,
`456 F. Supp. 2d 267 (D. Mass. 2006) .................................................................................. ..4, 9
`
`Amgen, Inc. v. Hoechst Marion Roussel, Inc.,
`3 F. Supp. 2d 104 (D. Mass. 1998) .......................................................................................... ..9
`
`Clarus Therapeutics, Inc. v. Lipocine, Inc.,
`CiV. A. No. 15-1004-RGA-MPT, 2016 WL 5868065 (D. Del. Oct. 6, 2016)
`(Andrews, J.) .................................................................................................................. .. passim
`
`Consumer Watchdog v. Wisconsin Alumni Research Foundation,
`753 F.3d 1258 (Fed. Cir. 2014) ............................................................................................ ..7, 8
`
`Envirocare International, Inc. v. Essroc Cement Corp,
`Civil Action No. 09—909, 2010 WL 1979365 (W.D. Pa. May 17, 2010) .............................. ..10
`
`Glaxo, Inc. v. Novopharm, Ltd,
`110 F.3d 1562 (Fed. Cir. 1997) ................................................................................................ ..5
`
`Lujan v. Defenders of Wildlife,
`504 US. 555 (1992) ................................................................................................................. ..6
`
`Massachusetts v. EPA,
`
`549 US. 497 (2007) ............................................................................................................. ..1, 7
`
`MedImmune, Inc. v. Genentech, Inc.,
`
`2549 US. 118 (2007) ............................................................................................................... ..5
`
`PPG Industries, Inc. v. Valspar Sourcing, Inc.,
`No. 16—1406, 2017 WL 526116 (Fed. Cir. Feb. 20, 2017) ...................................................... ..7
`
`Phigenix, Inc. v. Immunogen, Inc.,
`845 F.3d 1168 (Fed. Cir. 2017) ........................................................................................ ..1, 7, 8
`
`Prasco, LLC v. Medicis Pharmaceutical Corp,
`537 F.3d 1329 (Fed. Cir. 2008) ................................................................................................ ..1
`
`SanDisk Corp. v. STMicroelectronics, Inc.,
`480 F.3d 1372 (Fed. Cir. 2007) .............................................................................................. ..10
`
`Sierra Club v. Morton,
`
`405 US. 727 (1972) ................................................................................................................. ..7
`
`ii
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 4 of 15 PageID #: 908
`Case 1:16-cv-01243—RGA Document 19 Filed 04/06/17 Page 4 of 15 PagelD #: 908
`
`Summers v. Earth Island Institute,
`
`555 US 488 (2009) ................................................................................................................. ..7
`
`US. Water Services, Inc. v. Chemtreat, Inc.,
`
`No. 11-CV-0895, 2012 WL 5904341 (D. Minn. 2012) ........................................................... ..10
`
`STATUTES
`
`21 U.S.C. § 355(1) .......................................................................................................................... ..5
`
`35 U.S.C. § 271(c)(1) ........................................................................................................... ..passim
`
`35 U.S.C. § 311 .............................................................................................................................. ..6
`
`
`
`35 U.S.C. § 312 .............................................................................................................................. ..6
`
`35 U.S.C. § 316(a)(5) ..................................................................................................................... ..6
`
`35 U.S.C. § 319 .............................................................................................................................. ..7
`
`RULES
`
`Fed. R. CiV. P. 26 ........................................................................................................................... ..6
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.51(b) ...................................................................................................................... ..6
`
`153 Cong. Rec. H10,274 (Sept. 7, 2007) ....................................................................................... ..5
`
`iii
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 5 of 15 PageID #: 909
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 5 of 15 PagelD #: 909
`
`This case should be dismissed for one simple reason: it does not yet belong in court. No
`
`one disputes that Juno must prove “a controversy of sufficient ‘immediacy and reality’ to create
`
`a justiciable controversy.” E.g., Prasco, LLC v. Medicis Pharm. Corp, 537 F.3d 1329, 1338
`
`(Fed. Cir. 2008). But Juno has not done so (and, indeed, cannot). There is no immediate dispute
`
`to address: the FDA has not yet accepted and begun review of Kite’s submission, and approval
`
`of KTE-C19 remains entirely speculative as, after all, KTE-C19 is in an entirely new class of
`
`drugs the FDA has never previously considered, let alone approved. Juno tries to obfuscate the
`
`issue by noting that Kite separately appealed from a Patent Trial and Appeal Board (“PTAB”)
`
`decision addressing distinct issues. That effort to piggyback off of Kite’s separate appeal falls
`
`short because it conflates two entirely different proceedings: Kite’s appeal from an agency
`
`decision and Juno’s action in this Court. The former, which is authorized by statute, implicates a
`
`lower justiciability standard—as the Supreme Court and the Federal Circuit have held. See, e. g.,
`
`Massachusetts v. EPA, 549 U.S. 497, 517-18 (2007); Phigenix, Inc. v. Immunogen, Inc, 845 F.3d
`
`1168, 1172 n.2 (Fed. Cir. 2017). That appeal certainly does not indicate that Juno satisfied its
`
`burden to demonstrate “immediacy and reality” in this litigation. And in any event, even if this
`
`Court could exercise subject matter jurisdiction, it should not do so, because Kite’s activities all
`
`remain within a statutory safe harbor. This Court should dismiss Juno’s Complaint.
`
`I.
`
`JUNO HAS NOT MET ITS BURDEN OF PROVING SUBJECT MATTER
`
`JURISDICTION OVER ITS DECLARATORY INFRINGEMENT CLAIMS.
`
`A.
`
`Juno’s Suit Is Not Real And Immediate Because FDA Approval Is Uncertain.
`
`As the declaratory judgment plaintiff, Juno bears the burden of establishing that its claims
`
`involve an actual dispute that is both real and immediate. E. g, Clams Therapeutics, Inc. v.
`
`Lipocine, Inc, Civ. A. No. 15-1004-RGA-MPT, 2016 WL 5868065, at >"2 (D. Del. Oct. 6, 2016)
`
`(Andrews, J.). Juno’s theory of liability presupposes that Kite will obtain FDA approval for
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 6 of 15 PageID #: 910
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 6 of 15 PagelD #: 910
`
`KTE-Cl9. But because whether and when the FDA will approve KTE-Cl9 remains entirely
`
`speculative, Juno’s claims lack the requisite immediacy.
`
`As a threshold matter, the only basis for Juno’s suit is any allegedly infringing activity it
`
`anticipates Kite will take after Kite obtains FDA approval. Juno has admitted as much: Juno
`
`nowhere disputes that all of Kite’s past and present activities with KTE-Cl9 fall under the safe
`
`harbor of 35 U.S.C. § 27l(e)(l). See D.I. 16 at 10—17. Those activities cannot, therefore, provide
`
`the basis for jurisdiction over Juno’s declaratory judgment claims. See D.l. 9 at 8—10. It follows
`
`inexorably (as Juno does not dispute) that Kite could be potentially liable for infringement only
`
`based on commercial making, using, selling, or offering to sell KTE-Cl9 at some point in the
`
`future. See D.I. 16 at 10—17. Because FDA approval is a necessary predicate to such activities,
`
`see, e.g., D.I. 16 at 17, jurisdiction over this case turns on the timing and uncertainty surrounding
`
`whether and when such approval may occur, see D.I. 9 at 8—10.
`
`And that approval remains highly speculative. As of the date of Juno’s Complaint, Kite
`
`had just begun submitting the first sections of its BLA regarding KTE-Cl9 to the FDA. D.l. ll
`
`1} 8. Kite continued to make submissions to the FDA, and recently completed its filing. Reply Ex.
`
`1.1 The FDA has not yet completed its preliminary review and accepted Kite’s BLA for filing,
`
`and it remains uncertain if and when any approval will occur. See D.I. 9 at 5—6, 12—16.
`
`That is particularly true where, as here, approval involves a novel biologic, which faces
`
`uncertain regulatory scrutiny and requirements, making any approval necessarily speculative.
`
`See, e. g., Reply Ex. 2 at 2, 8. Juno does not dispute that KTE-Cl9 is a novel biologic that is
`
`among the first CAR therapies to be considered by the FDA. D.I. 16 at 4. As an unprecedented
`
`therapy, KTE-Cl9 will be subject to a searching review by the FDA. For example, the FDA will
`
`Reply Exhibit numbers refer to the Declaration of Kelly B. Farnan in Support of Kite
`1
`Pharma, lnc.’s Reply in Support of its Motion to Dismiss, filed herewith.
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 7 of 15 PageID #: 911
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 7 of 15 PagelD #: 911
`
`determine not only whether KTE-Cl9 itself is safe and effective, an involved process for a
`
`complicated, highly advanced product, but will also evaluate closely the manufacturing process,
`
`facilities, storage, and testing of both Kite’s engineered cell cultures and the KTE-Cl9 product
`
`itself. See, e. g., Reply EX. 3 at 2—3. Although the FDA does set goals for review, including for
`
`breakthrough therapies like KTE-Cl9, this high level of scrutiny often results in the process
`
`taking longer than projected. See D.I. 9 at 5—6, 14. It is thus uncertain how long FDA review will
`
`take and what additional information the FDA will require from Kite.
`
`Aside from the complexity of the review process inherent in the review of a novel
`
`product such as KTE-Cl9, KTE-Cl9 may face additional scrutiny because of the safety concerns
`
`raised by the failure of Juno’s JCAR15 product. Juno’s ROCKET trial, evaluating JCAR015 , an
`
`embodiment of the ’ 190 patent, was twice placed on clinical hold due to multiple patient deaths.
`
`See D.I. 9 at 6—7. In fact, Juno recently announced that it terminated development of JCAR015
`
`following these safety issues. E. g, Reply EX. 4 at 1—3. FDA approval of any drug is far from a
`
`given; it is especially uncertain where, as here, another drug in this unprecedented class produced
`
`the kinds of safety concerns that led to Juno’s high-profile shutdown of its JCAR015 program.
`
`Given these uncertainties surrounding if and when KTE-Cl9 will be approved, and
`
`therefore if and when Kite could engage in allegedly infringing activity, the concerns raised by
`
`this Court in Clams are salient. See D.I. 9 at 13—14. It is purely speculative when KTE-Cl9
`
`could enter the market and potentially give rise to an infringement claim, and none of the alleged
`
`preparation by Kite does anything to make that day more certain or imminent.
`
`None of Juno’s arguments undermine the simple reality that FDA approval is speculative.
`
`Juno spends considerable time discussing optimistic statements Kite employees have made
`
`regarding approval of KTE-Cl9, arguing that they support immediacy and reality. See D.I. 16 at
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 8 of 15 PageID #: 912
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 8 of 15 PagelD #: 912
`
`6—7, 15, 19. But as much as Kite hopes its employees’ statements are proven right, they are just
`
`that: forward-looking statements that are necessarily “subject to change and involve a number of
`
`risks and uncertainties that may cause actual results to differ materially.” D.I. 18 EX. 4 at 2—3,
`
`EX. 5 at 2. And, of course, Kite’s statements have no real-world bearing on the timing or result of
`
`the FDA’s eventual review.
`
`Indeed, Juno should know that hopeful statements regarding
`
`approval do not amount
`
`to actual approval. Like Kite, Juno has made similar optimistic
`
`statements regarding potential approval of its JCAR015 CD19 CAR T product. See, e.g., Reply
`
`EX. 5 at 3 (“For JCAR015 in adult ALL, this Phase 2 trial has the potential to serve as our
`
`registration study and we will continue to plan for an approval in the U.S. in 2017.”); Reply EX.
`
`6 at 3 (“[I]f the ROCKET trial achieves results in the range of the Phase 1 MSK trial, we believe
`
`JCAR015 will be an important advance for adult ALL patients .
`
`.
`
`.
`
`. We remain on track for an
`
`approval as early as the first half of 2018.”). Still, clinical trials with JCAR015 were ultimately
`
`halted due to multiple patient deaths and Juno has ceased developing that therapy. See Reply EX.
`
`4 at 1—3; D1. 9 at 6—7. KTE-C19 will undoubtedly be subject to intense regulatory scrutiny, and
`
`optimistic statements do not guarantee success.
`
`Juno fares no better on the law, because the authorities it cites in support of its contention
`
`that its Complaint presents an immediate dispute are readily distinguishable. In Amgen, Inc. v. F.
`
`Hoflman-LaRoche Ltd, 456 F. Supp. 2d 267, 277 (D. Mass. 2006), the court exercised subject
`
`matter jurisdiction over a suit against a BLA filer prior to FDA approval. However, unlike here,
`
`the defendant was seeking approval for a drug that was “materially indistinguishable” from that
`
`marketed by the patentee. See id at 271, 274. In addition, the defendant had allegedly imported
`
`product outside of the § 271(c)(1) safe harbor, a current act of infringement. See id at 278—79.
`
`Glaxo, Inc. v. Novopharm, Ltd, 110 F.3d 1562, 1564 (Fed. Cir. 1997) considered an ANDA
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 9 of 15 PageID #: 913
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 9 of 15 PagelD #: 913
`
`application, meaning that the defendant had submitted an application for a generic version of an
`
`approved drug. See 21 U.S.C. § 3550). In both these cases,
`
`the existence of a previously
`
`approved drug made approval more likely, reducing the uncertainty involved.2
`
`At bottom, “[d]etermining whether immediacy and reality are present is fact specific and
`
`must be determined on a case-by-case basis by considering the totality of the circumstances.”
`
`Clarus, 2016 WL 5868065, at *2 (citing Medlmmune, Inc. v. Genentech, Inc, 549 US. 118, 127
`
`(2007)). And in this case, all the facts point the same way: given the significant uncertainties
`
`surrounding approval of Kite’s not yet complete BLA, FDA approval of KTE-C19 is entirely
`
`speculative and Juno’s claims thus lack the requisite immediacy. See D.I. 9 at 10—17.
`
`B.
`
`Kite’s Separate IPR Appeal Is Irrelevant.
`
`Kite’s appeal from the PTAB’s inter partes review (IPR) decision regarding the validity
`
`of the ’ 190 patent has no bearing on whether this Court has jurisdiction over Juno’s declaratory
`
`judgment claims. The IPR proceeding is entirely separate, and in any event, Kite’s appeal of the
`
`PTAB implicates a different justiciability analysis. Juno’s arguments to the contrary fall short.
`
`1.
`
`The Inter Partes Review Is a Separate Proceeding Addressing Entirely
`Separate Issues.
`
`As a threshold matter, Juno is wrong to suggest that the Kite and Juno’s separate IPR
`
`proceeding is relevant in any way to this infringement action. Congress created IPR proceedings
`
`to provide third parties with “an expeditious, less costly alternative to litigating the validity of the
`
`patent in the courts,” e. g, 153 Cong. Rec. H10,274 (Sept. 7, 2007) (Statement of Rep. Boucher),
`
`and empowered the PTAB to hear only petitions “to cancel as patentable 1 or more claims of a
`
`patent... under section 102 [for anticipation] or 103 [for obviousness],” 35 U.S.C. §312(b).
`
`Contrary to Juno’s assertion, Kite does not assert that patentees can never bring a
`2
`declaratory judgment action against a drug prior to FDA approval. See D.I. 16 at 10—12. Indeed,
`Amgen and Glaxo are good examples of the kinds of cases where jurisdiction has been held to be
`proper—but the facts that made jurisdiction proper there simply do not exist here.
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 10 of 15 PageID #: 914
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 10 of 15 PagelD #: 914
`
`Issues of infringement cannot be raised. Moreover, IPR proceedings are subject to a different
`
`standard of claim construction and burden of proof, with limited opportunities for discovery, and,
`
`unlike declaratory judgment suits, no justiciability requirements.3 See, e. g. , §§ 311—12, 316.
`
`Contrary to Juno’s claims that “Kite initiated this patent dispute,” D.l. 16 at 8, Kite was
`
`never involved in any proceeding concerning any alleged infringement by KTE-Cl9 prior to
`
`Juno’s Complaint. Rather, further to its steadfast belief that the ‘190 patent is invalid, Kite
`
`properly took advantage of the IPR option provided by Congress, seeking review of the validity
`
`of the ’190 Patent. Given the constraints of IPR proceedings, Kite’s petition related to the
`
`invalidity of the ’190 patent only, not any questions of alleged infringement of the ’190 patent.
`
`Thus, the instant litigation is the first and only proceeding concerning the alleged infringement of
`
`the ’190 patent by KTE-C19.
`
`2.
`
`Kite ’s Appeal Is Subject to a Lower Justiciability Standard and Does Not
`Aflect this Court ’s Jurisdiction over Juno ’s Claims.
`
`The irrelevance of the IPR proceeding to the instant litigation aside, Kite’s ability to
`
`appeal that decision has no bearing on Juno’s ability to bring an infringement suit. While an
`
`appeal from an agency proceeding must present a case or controversy, the Supreme Court has
`
`consistently held that “[t]he person who has been accorded a procedural right to protect his
`
`concrete interests can assert that right without meeting all the normal standards for redressability
`
`and immediacy.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 572 n.7 (1992); see also, e. g.,
`
`Summers v. Earth Island Inst, 555 U.S. 488, 497 (2009); Massachusetts, 549 U.S. at 517—18. By
`
`creating a procedural right, e.g.,
`
`to appeal, Congress can expand the scope of injuries and
`
`Juno suggests that a “trial” before the PTAB in an IPR is as burdensome as litigation. D.I.
`3
`16 at 20. Although IPR proceedings include expert discovery and several hours of oral
`arguments, they do not involve the same level of discovery as in district court litigations,
`especially where, as here, there is an allegation of willful infringement. Compare Fed. R. Civ. P.
`26, with 35 U.S.C. § 316(a)(5), and 37 CPR § 42.51(b).
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 11 of 15 PageID #: 915
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 11 of 15 PagelD #: 915
`
`disputes that a court may hear to the fullest extent permitted by Article 111, such that the appellant
`
`must only establish some injury-in-fact, and not immediacy or redressability. See, e. g., Sierra
`
`Club v. Morton, 405 US. 727, 738 (1972); Summers, 555 US. at 497 (“Unlike redressability,
`
`however, the requirement of injury in fact is a hard floor of Article III jurisdiction that cannot be
`
`removed by statute.”).
`
`This is the case for appeals from IPR proceedings. The very authorities cited by Juno
`
`make clear that an IPR appeal to the Federal Circuit need not satisfy the same justiciability
`
`requirements as district court litigation. See D1. 16 at 7—10. Congress has given a right to appeal
`
`to any “party dissatisfied with the final written [IPR] decision of the Patent Trial and Appeal
`
`Board.” 35 U.S.C. § 319. In light of this, in Phigenix, cited extensively by Juno, the Federal
`
`Circuit noted that although an appellant must establish an injury-in-fact, “it need not ‘meet[] all
`
`the normal standards for redressability and immediacy’ when, as here, a statute provides the
`
`appellant with a right
`
`to appeal.” 845 F.3d at 1172 n.2 (alteration in original)
`
`(quoting
`
`Massachusetts, 549 US. at 517—18). That is, all an appellant from an IPR proceeding must
`
`demonstrate that it has “more than a general grievance” concerning the patents at issue such that
`
`it has “a particularized, concrete interest in the patentability of the subject matter.” PPG Indus,
`
`Inc. v. Valspar Sourcing, Inc, No. 16—1406, 2017 WL 526116, at >"1 (Fed. Cir. Feb. 20, 2017)
`
`(citation omitted). “[A] legitimate concern that [the] manufacture and sale of [a product] would
`
`draw an infringement action” is sufficient. Id; see also Consumer Watchdog v. Wis. Alumni
`
`Research Found, 753 F.3d 1258, 1261 (Fed. Cir. 2014) (suggesting that standing to appeal an
`
`IPR decision would be proper if appellant “allege[s] that it is engaged in any activity .
`
`.
`
`. that
`
`could form the basis for an infringement claim” or “that it intends to engage in such activity”).
`
`Critically, the Federal Circuit has recognized that appellants from IPR determinations need not
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 12 of 15 PageID #: 916
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 12 of 15 PagelD #: 916
`
`show that their injury is immediate or redressable. See, e.g., Phigem'x, 845 F.3d at 1172 n.2.
`
`These are prudential rather than constitutional aspects of the standing requirement that are
`
`relaxed when Congress has accorded a procedural
`
`right
`
`to appeal. See, e.g., Consumer
`
`Watchdog, 753 F.3d at 1261. Kite has standing to appeal the IPR decision because it has “a
`
`particularized, concrete interest in the patentability of the [’ 190] patent.” See, e.g., id That Kite’s
`
`marketing of this product is not imminent is irrelevant in that context. See, e. g., Phigenix, 845 at
`
`1172 n.2. To proceed with the instant suit, by contrast, Juno has to prove that infringement by
`
`Kite is imminent.4 And for the reasons already given, Juno has failed to do so.
`
`II.
`
`THE COURT SHOULD DECLINE TO EXERCISE JURISDICTION OVER
`
`JUNO’S CLAIMS BECAUSE KITE IS WITHIN THE SAFE HARBOR
`
`Even if there is subject matter jurisdiction here, this Court should decline to exercise it
`
`because Kite’s present activates are undisputedly within the statutory safe harbor. In Clams, this
`
`Court considered a similar factual scenario, wherein a declaratory judgment infringement action
`
`was filed before either party had marketed a product and while the defendant was within the safe
`
`harbor. See D1. 9 at 17—18. Because the defendant had not engaged in any unprotected activity,
`
`as well as the fact that neither party had an approved product, this Court declined to hear the suit
`
`because “[t]o allow a declaratory judgment action to proceed in a case such as this one where
`
`Defendant is not currently infringing, has not engaged in any product marketing, and has not
`
`solicited orders, would be to allow Plaintiff to circumvent the Safe Harbor Provision.” 2016 WL
`
`5868065, at *4; see also D1. 9 at 17—18. While Juno focuses on the regulatory circumstances in
`
`Clams, see D1. 16 at 14—15, the result in that case did not turn on those circumstances and
`
`See, e. g, Consumer Watchdog, 753 F.3d at 1262 (contrasting declaratory judgment
`4
`actions with IPR appeals and emphasizing that “a statutory grant of a procedural right may relax
`the requirements of immediacy and redressability, and eliminate any prudential limitations,
`which distinguishes the present inquiry from that governing a declaratory judgment action.”
`(citation omitted))
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 13 of 15 PageID #: 917
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 13 of 15 PagelD #: 917
`
`instead turned on the fact that the defendant should not be forced in to court during a time at
`
`which Congress sought to preclude infringement suits, see 2016 WL 5868065, at >"4.
`
`Other courts have reached the same conclusion. For example, Amgen, Inc. v. Hoechst
`
`Marion Roussel, Inc, 3 F. Supp. 2d 104, 112—13 (D. Mass. 1998), stayed a declaratory judgment
`
`action brought against a BLA filer prior to approval in view of the safe harbor provision. The
`
`court found that “subjecting the Defendants to an infringement litigation at present may run afoul
`
`of the Congressional policy underlying the section 271(c)(1) exemption.” Id at 112. The court
`
`noted the “the importance of [the plaintiffl’s desire to have the infringement question settled
`
`authoritatively at the earliest stage” and that the plaintiff “st[ood] to lose considerable revenues
`
`to a competing product,” but still declined to hear the case until good cause could be shown, e. g.,
`
`by FDA approval, Id at 113. Here, Juno does not have a competing product and admits that it
`
`will not have one at the time it alleges KTE-C19 would be approved, see D1. 16 at 4, making it
`
`unnecessary for this case to be heard now.
`
`In addition,
`
`the LaRoche case cited by Juno
`
`considered Hoechst, and distinguished it solely on the grounds that the plaintiff there alleged that
`
`the defendant was importing product outside of the safe harbor. See 456 F. Supp. 2d at 278—79.
`
`This distinction does not apply here. See D.l. 9 at 8—10; supra Part LA.
`
`The Novartis decision cited by Juno also recognized that defendants should not be forced
`
`to litigate infringement claims during the safe harbor period. See D1. 18 Ex. 8 at 22—23. There,
`
`the court ultimately decided to hear the accused infringers’ declaratory judgment action because
`
`delaying would mean that they would be forced to either abandon their work or continue their
`
`efforts and increase their eventual liability. Id The court held that “exercising jurisdiction here—
`
`where the potential infringer rather than the patent holder brought suit—is consistent with the
`
`purpose of the safe harbor.” Id at 23. This procedural posture was distinguished from the reverse
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 14 of 15 PageID #: 918
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 14 of 15 PagelD #: 918
`
`alignment because “the patent holder loses nothing by waiting, as the alleged infringer cannot
`
`market the product until gaining government approval” and “the purposes of the [safe harbor] are
`
`not undermined by holding that jurisdiction does not attach until after the product moves beyond
`
`testing.” Id (citation omitted). In the case at bar, Kite has not waived the protection of the
`
`statutory safe harbor, and forcing it to litigate this case would frustrate a scheme specifically
`
`created by Congress. Juno, though, “loses nothing by waiting.”
`
`Each of the authorities cited by Juno in urging the Court
`
`to hear
`
`its case is
`
`distinguishable. SanDisk Corp. v. STMicroelectronics, Inc., 480 F.3d 1372, 1375 (Fed. Cir.
`
`2007), involved semiconductors and thus regulatory approval was not at issue. Moreover, the
`
`accused infringer and not the patentee brought that suit, following extensive failed licensing talks
`
`surrounding its then-marketed products. Id at 1374—77. Likewise, Envirocare International, Inc.
`
`v. Essroc Cement Corp, Civil Action No. 09—909, 2010 WL 1979365, at *1—5 (W.D. Pa. May
`
`17, 2010), considered a cement plant component, and there patentee alleged that both an
`
`infringing sale and use had occurred. Finally, U.S. Water Services, Inc. v. Chemtreat, Inc, No.
`
`11-cv-0895 (PJS/TNL), 2012 WL 5904341, at *1 (D. Minn. 2012), involved water treatment
`
`systems. The court declined to dismiss the accused infringer’s declaratory counterclaims because
`
`it was the plaintiff who filed the litigation and who threatened to add infringement claims. Id. at
`
`*5. Here, Juno brought this suit, involving future infringement by a biologic product protected by
`
`the safe harbor. This Court has held that such suits should not be heard, and Juno’s authorities do
`
`not change this sound judgment.
`
`III.
`
`CONCLUSION
`
`For the foregoing reasons and those set forth in Kite’s Opening Brief in Support of Its
`
`Motion to Dismiss, Kite respectfully requests that this Court dismiss Juno’s Complaint.
`
`10
`
`

`

`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 15 of 15 PageID #: 919
`Case 1:16-cv-01243-RGA Document 19 Filed 04/06/17 Page 15 of 15 PagelD #: 919
`
`/s/ Kelly E. Farnan
`Kelly E. Farnan (#4395)
`Richards, Layton & Finger, P.A.
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(3 02) 651-7700
`farnan@rlf.com
`Attorneys for Defendant
`
`Of Counsel:
`
`Leora Ben-Ami
`Patricia A. Carson
`Mira Mulvaney
`Christopher J. Citro
`KIRKLAND & ELLIS LLP
`
`601 Lexington Avenue
`New York, New York 10022
`212-446-4800
`
`Dated: April 6, 2017
`
`11
`
`