Case 1:16-cv-01243-RGA Document 22 Filed 06/13/17 Page 1 of 6 PageID #: 1017
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`JUNO THERAPEUTICS, INC., MEMORIAL
`SLOAN KETTERING CANCER CENTER,
`and SLOAN KETTERING INSTITUTE FOR
`CANCER RESEARCH,
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`Plaintiffs;
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`Civil Action No. 16-1243-RGA
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`V.
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`KITE PHARMA, INC.,
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`Defendant.
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`MEMORANDUM OPINION
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`Jack B. Blumenfeld, Esq., MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE;
`Morgan Chu, Esq., IRELL & MANELLA LLP, Los Angeles, CA; Andrei Iancu, Esq., IRELL &
`MANELLA LLP, Los Angeles, CA; Alan J. Heinrich, Esq., IRELL & MANELLA LLP, Los
`Angeles, CA; Elizabeth C. Tuan, Esq., IRELL & MANELLA LLP, Los Angeles, CA.
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`Attorneys for Plaintiff
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`Kelly E. Farnan, Esq., RICHARDS LAYTON & FINGER, P.A., Wilmington, DE; Leora Ben(cid:173)
`Ami, Esq., KIRKLAND & ELLIS LLP, New York, NY; Patricia A. Carson, Esq., KIRKLAND
`& ELLIS LLP, New York, NY; Mira Mulvaney, Esq., KIRKLAND & ELLIS LLP, New York,
`NY; Christopher J. Citro, Esq., KIRKLAND & ELLIS LLP, New York, NY.
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`Attorneys for Defendant
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`June ii, 2017
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`Case 1:16-cv-01243-RGA Document 22 Filed 06/13/17 Page 2 of 6 PageID #: 1018
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`ANDREW~T~
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`Presently before the Court is Defendant's Motion to Dismiss (D.I. 8) and related briefing
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`(D.I. 9, 16, 19). For the reasons that follow, Defendant's motion is granted.
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`I.
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`Background
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`Plaintiffs in this action are the assignee and exclusive licensee of U.S. Patent No.
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`7,446,190 ("the '190 patent"). (D.I. 16 at 7). Plaintiffs have not yet successfully developed an
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`FDA approved therapy based on the invention disclosed in the '190 patent. (D.I. 9 at 10).
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`Defendant, on the other hand, has initiated submission of a Biologics License Application
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`("BLA") to the FDA for a therapy Plaintiffs contend infringes or will infringe the '190 patent. 1
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`(D.I. 16 at 6). Defendant filed a petition for Inter Partes Review ("IPR") with the Patent &
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`Trademark Office in 2015 seeking cancellation of all claims of the '190 patent. (D.I. 1, if19).
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`The petition was granted, but on December 16, 2016, the Patent Trial and Appeal Board
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`("PT AB") issued a final decision finding Petitioner (Defendant in the instant action) had not
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`proven that any of the claims were invalid. (D.I. 16 at 9). Plaintiffs brought this action on
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`December 19, 2016, seeking a declaratory judgment that Defendant infringes or will infringe the
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`' 190 patent.
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`II.
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`Legal Standard
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`The purpose of the Declaratory Judgment Act is "to prevent avoidable damages from
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`being incurred by a person uncertain of his rights and threatened with damage by delayed
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`adjudication." Minnesota Min. & Mfg. Co. v. Norton Co., 929 F.2d 670, 673 (Fed. Cir. 1991).
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`1 Although the statute governing the BLA process includes provisions relating to infringement suits where the
`biological product at issue enjoys patent protection as well as an abbreviated FDA approval process for biosimilars
`of licensed biologics, this provision is not at issue in the instant case because there is no FDA approved biological
`product that is an embodiment of the' 190 patent. See 42 U.S.C. § 262(k), (1). This is not a case, therefore, where
`Defendant's submission of its BLA is considered an act of infringement under 35 U.S.C. § 217(e)(2), which would
`otherwise provide the jurisdictional basis for Plaintiffs' suit. See Sandoz Inc. v. Amgen Inc., 2017 WL 250733 7, at
`*6 (U.S. June 12, 2017).
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`Case 1:16-cv-01243-RGA Document 22 Filed 06/13/17 Page 3 of 6 PageID #: 1019
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`For a court properly to exercise declaratory judgment jurisdiction, there must exist "a substantial
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`controversy, between parties having adverse legal interests, of sufficient immediacy and reality
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`to warrant the issuance of a declaratory judgment." Maryland Cas. Co. v. Pac. Coal & Oil Co.,
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`312 U.S. 270, 273 (1941). Determining whether immediacy and reality are present is fact
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`specific and must be determined on a case-by-case basis by considering the totality of the
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`circumstances. Medimmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007). "The burden is
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`on the party claiming declaratory judgment jurisdiction to establish that such jurisdiction existed
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`at the time the claim for declaratory relief was filed and that it has continued since." Benitec
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`Australia, Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1344 (Fed. Cir. 2007).
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`In order to meet the immediacy prong, "there must be a showing of 'meaningful
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`preparation' for making or using that product." Cat Tech LLC v. TubeMaster, Inc., 528 F.3d
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`871, 881 (Fed. Cir. 2008) (quoting Arrowhead Indus. Water, Inc. v. Ecolochem, Inc., 846 F.2d
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`731, 736 (Fed. Cir. 1988)). Timing is important for a showing of immediacy. The longer the
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`time between when suit is initiated and when potential infringement may occur, "the more likely
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`the case lacks the requisite immediacy." Sierra Applied Scis., Inc. v. Advanced Energy Indus.,
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`Inc., 363 F.3d 1361, 1379 (Fed. Cir. 2004). For example, immediacy was not found where an
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`accused infringer's product "would not be finished until at least 9 months after the complaint
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`was filed" and the accused infringer had not engaged in any marketing activities. Lang v. Pac.
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`Marine & Supply Co., 895 F.2d 761, 764 (Fed. Cir. 1990). The Federal Circuit also found
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`immediacy lacking where a potentially infringing product was not "built and operational until
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`about a year after the complaint was filed-a period longer than the nine months determined to
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`be too long in Lang." Sierra Applied Scis., Inc., 363 F.3d at 1379.
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`Case 1:16-cv-01243-RGA Document 22 Filed 06/13/17 Page 4 of 6 PageID #: 1020
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`III. Discussion
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`Defendant seeks dismissal of this declaratory judgment action, arguing the Court lacks
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`subject matter jurisdiction. (D.I. 9 at 11 ). Defendant contends its activities to date fall within the
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`Safe Harbor Provision of the Patent Act and are, therefore, non-infringing activities. (Id.).
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`Defendant further argues the alleged future infringement is speculative, as it is unclear when, or
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`even whether, Defendant's BLA will be approved. (Id. at 18).
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`As an initial matter, I reject Plaintiffs' argument that Defendant's filing of a petition for
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`IPR and its subsequent appeal of the PT AB' s final decision means that Defendant
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`"acknowledges its belief that Article III jurisdiction exists over the parties' dispute regarding the
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`'190 Patent." (D.I. 16 at 12). Because the right to appeal an IPR decision is provided by statute,
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`"certain requirements of standing-namely immediacy and redressability, as well as prudential
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`aspects that are not part of Article III-may be relaxed." Consumer Watchdog v. Wisconsin
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`Alumni Research Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014). In other words, Defendant's
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`IPR appeal is not subject to the same requirement of immediacy as Plaintiffs' declaratory
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`judgment action.
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`Plaintiffs argue that there is no "bright-line rule" that the§ 27l(e)(l) safe harbor protects
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`an alleged infringer from a declaratory judgment action. (D.I. 15). The Safe Harbor Provision of
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`the Patent Act provides protection for potentially infringing activities if those activities are
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`"solely for uses reasonably related to the development and submission of information under a
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`Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological
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`products." 35 U.S.C. § 27l(e)(l). Defendant argues that all of its activities to date related to the
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`accused product fall within this provision. (D.I. 9 at 12). Specifically, Defendant contends that
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`it has only manufactured the accused product in connection with "clinical development studies,"
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`designed to generate the data necessary for its BLA submission, and it has only used the accused
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`product in clinical trials, also designed to generate supporting data for the BLA submission.
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`(Id.).
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`Plaintiffs have not alleged Defendant currently infringes, nor do they dispute that all of
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`Defendant's activities to date are related to seeking FDA approval. Rather, Plaintiffs argue that
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`"[t]he Federal Circuit has already rejected the bright-line rule" that the safe harbor provision
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`protects an accused infringer from suit prior to FDA approval. (D.I. 16 at 15). Plaintiffs cite to
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`Glaxo, a case in which the Defendant had submitted an Abbreviated New Drug Application
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`("ANDA") seeking to make and sell a generic version of an FDA approved drug. Glaxo, Inc. v.
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`Novopharm, Ltd., 110 F.3d 1562, 1564 (Fed. Cir. 1997). I fail to see the relevance of Glaxo to
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`the instant case. In Glaxo, the Federal Circuit upheld the District Court's discretionary decision
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`to hear the declaratory judgment action because the plaintiff had alleged sufficient facts "to
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`create an actual case or controversy." Id. at 1571. According to the court, those facts included
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`"imminent FDA approval and actual threats of future infringement." Id. In the instant case,
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`Defendant has not filed an ANDA because there is no FDA approved embodiment of the '190
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`patent. There is a significant difference, both in terms of timing and certainty, between the
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`ANDA approval process and the process of obtaining approval of a BLA.
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`Plaintiffs have not alleged sufficient facts from which I could conclude that FDA
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`approval of Defendant's BLA is imminent or even certain. Plaintiffs filed this suit on December
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`19, 2016, approximately six months ago. (DJ. 1). Plaintiffs have not alleged that Defendant's
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`BLA will receive FDA approval at any time in the near future. Plaintiffs suggest that
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`Defendant's recent BLA filings, coupled with Defendant's own statements of its intent to market
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`the product once FDA approval is obtained, constitutes sufficient evidence to meet the
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`immediacy requirement. (D.I. 16 at 18). I disagree. Based on the evidence in the record at this
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`time, FDA approval of this novel treatment is speculative at best and there is no evidence that a
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`decision is expected on Defendant's BLA in the immediate future.
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`Defendant argues in the alternative that even if Plaintiffs could establish the immediacy
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`prong for declaratory judgment jurisdiction, I should decline to exercise jurisdiction over this
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`case. (D.I. 9 at 21). Although I have found immediacy lacking here, I will address why I would
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`decline to exercise jurisdiction in the alternative even if I thought Plaintiffs could meet the
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`immediacy requirement.
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`Exercising jurisdiction in this case would conflict with the purpose of the Safe Harbor
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`Provision of the Patent Act. The intent of the Safe Harbor is to provide drug manufacturers with
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`protection for activities related to seeking FDA approval. See Intermedics, Inc. v. Ventritex Co.,
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`1993 WL 87405, at *5 (Fed. Cir. 1993). To allow a declaratory judgment action to proceed in a
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`case such as this one, where Plaintiffs acknowledge Defendant is not currently infringing and has
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`only engaged in activities falling within the provisions of the Safe Harbor, would be to allow
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`Plaintiffs to circumvent the Safe Harbor Provision. As the Federal Circuit has stated, "[t]o
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`permit [Defendant] to be protected from direct suit for infringement and yet allow the same
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`activities to be subject to suit in a declaratory judgment action would be nonsensical." Id. at *4.
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`III. Conclusion
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`For the reasons set forth herein, Defendant's Motion to Dismiss (D.I. 8) is GRANTED.
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`An appropriate order will be entered.
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