Case: 18-2273 Document: 13 Page: 1 Filed: 04/23/2020

United States Court of Appeals for the Federal Circuit ______________________

ARGENTUM PHARMACEUTICALS LLC, Appellant

v.

NOVARTIS PHARMACEUTICALS CORPORATION, Appellee ______________________

2018-2273 ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2017- 00854, IPR2017-01550, IPR2017-01929, IPR2017-01946. ______________________

Decided: April 23, 2020 ______________________

TERESA STANEK REA, Crowell & Moring, LLP, Wash- ington, DC, argued for appellant. Also represented by DEBORAH YELLIN.

JANE M. LOVE, Gibson, Dunn & Crutcher LLP, New York, NY, argued for appellee. Also represented by ROBERT TRENCHARD. ______________________

Before LOURIE, MOORE, and REYNA, Circuit Judges. Case: 18-2273 Document: 13 Page: 2 Filed: 04/23/2020

2 ARGENTUM PHARMACEUTICALS LLC v. NOVARTIS PHARMACEUTICALS CORP.

MOORE, Circuit Judge. On February 3, 2017, Apotex Inc. and Apotex Corp. (collectively, Apotex) filed a petition for inter partes review of Novartis Pharmaceuticals Corporation’s U.S. Patent No. 9,187,405. The Board instituted proceedings on July 18, 2017, and granted Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., and Sun Pharma Global FZE’s (collectively, Sun); Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth LLC’s; and Argentum Pharmaceuticals LLC’s requests for joinder under 35 U.S.C. § 315(c). After institution, Patent Owner, Novartis, filed a contingent motion to amend. On July 11, 2018, the Board concluded that Apotex, Sun, Teva, Actavis, and Ar- gentum (collectively, Petitioners) had not demonstrated unpatentability of the claims and denied the motion to amend as moot. Petitioners appealed the Board’s findings. During the appeal process, all Petitioners other than Ar- gentum settled their respective appeal with Novartis. 1 On August 29, 2018, before opening briefs had been filed, Novartis filed a motion to dismiss Argentum’s appeal for lack of standing. Argentum opposed the motion on Sep- tember 10, 2018, and included declarations of Jeffrey Gard- ner, Argentum’s CEO, and Anthony Tabasso, President and CEO of KVK-Tech, Inc., Argentum’s manufacturing and marketing partner. We directed Argentum and Novar- tis to address Argentum’s standing in their briefs, which they did. Initially, Argentum argued that we need not reach the issue of its standing because only one party must have standing for an action to proceed in an Article III Court, and “the other seven appellants undisputedly have standing.” Appellant’s Br. viii. Following the settlement

1 Teva, Actavis, and Sun settled before argument and Appeal Nos. 18-2260 (Teva and Actavis) and 18-2230 (Sun) were dismissed, respectively. Apotex settled after ar- gument and Appeal No. 18-2209 was dismissed. Case: 18-2273 Document: 13 Page: 3 Filed: 04/23/2020

ARGENTUM PHARMACEUTICALS LLC v. NOVARTIS 3 PHARMACEUTICALS CORP.

of all parties other than Argentum, Novartis submitted a notice of supplemental authority under Federal Rule of Ap- pellate Procedure 28(j) stating that “now that Argentum is the only appellant, Article III standing has become a threshold issue” and that we must assess our “jurisdiction under Article III of the Constitution before addressing the merits of the case.” D.I. 131 at 2 (citing Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1171 (Fed. Cir. 2017)). 2 Because we hold that Argentum lacks Article III stand- ing, we dismiss the appeal and do not reach the merits of the Board’s ruling on the claims of the ’405 patent. DISCUSSION “Although we have jurisdiction to review final decisions of the Board under 28 U.S.C. § 1295(a)(4)(A), an appellant must meet ‘the irreducible constitutional minimum of standing.’” Amerigen Pharm. Ltd. v. UCB Pharma GmBH, 913 F.3d 1076, 1082 (Fed. Cir. 2019) (quoting Lujan v. De- fenders of Wildlife, 504 U.S. 555, 560 (1992)). This holds true “even if there is no such requirement in order to ap- pear before the administrative agency being reviewed.” Id. (citing Consumer Watchdog v. Wis. Alumni Research Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014)). To prove standing, Argentum bears the burden of showing that it has “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). Ar- gentum must “‘supply the requisite proof of an injury in fact when it seeks review of an agency’s final action in a federal court,’ by creating a necessary record in this court, if the record before the Board does not establish standing.” JTEKT Corp. v. GKN Automotive LTD., 898 F.3d 1217,

2 All citations to the court’s docket are to Apotex Inc. v. Novartis Pharmaceuticals Corp., Appeal No. 2018-2209. Case: 18-2273 Document: 13 Page: 4 Filed: 04/23/2020

4 ARGENTUM PHARMACEUTICALS LLC v. NOVARTIS PHARMACEUTICALS CORP.

1220 (Fed Cir. 2018) (quoting Phigenix, Inc., 845 F.3d at 1171–72). “To establish injury in fact, a[n appellant] must show that he or she suffered ‘an invasion of a legally pro- tected interest’ that is ‘concrete and particularized’ and ‘ac- tual or imminent, not conjectural or hypothetical.’” Spokeo, 136 S. Ct. at 1548 (quoting Lujan, 504 U.S. at 560). An injury is particularized if it “affect[s] the [appellant] in a personal and individual way.” Lujan, 504 U.S. at 560 n.1. Argentum argues that it demonstrated at least three concrete injuries in fact. First, Argentum argues that with- out an opportunity to seek this Court’s redress, it faces a real and imminent threat of litigation as it jointly pursues, along with its partner KVK-Tech, Inc., a generic version of Novartis’ Gilenya® product for which they are in the pro- cess of filing an ANDA. It argues that given that Novartis already sued multiple generic companies to protect Gilenya®, “it is virtually certain that Novartis will sue Ar- gentum and KVK,” which is “far from conjectural” and “constitutes an imminent injury for purposes of standing.” Appellant’s Reply Br. 28. Novartis argues that any ANDA to be filed for a generic version of Gilenya® “will be filed by KVK, Argentum’s manufacturing and marketing partner” (see D.I. 44-3 (Gardner Dec.) ¶ 11), and thus KVK, not Argentum is at risk of being sued. And even if the litigation were personal to Argentum, it would not confer standing because it is merely conjectural. Appellee’s Br. 39 (citing AVX Corp. v. Presidio Components, Inc., 923 F.3d 1357, 1367 (Fed. Cir. 2019) (concluding that appellant did not “sufficiently al- lege[] current or nonspeculative activities of its own that arguably fall within the scope of the upheld claims” to amount to harm to it)). It argues that there is no evidence of “concrete plans for future activity that creates a substan- tial risk of future infringement or [will] likely cause the pa- tentee to assert a claim of infringement.” Appellee’s Br. 39 (quoting JTEKT Corp., 898 F.3d at 1221). Case: 18-2273 Document: 13 Page: 5 Filed: 04/23/2020

ARGENTUM PHARMACEUTICALS LLC v. NOVARTIS 5 PHARMACEUTICALS CORP.

Citing our decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., Argentum responds that “showing a concrete injury-in-fact does not necessitate an already-filed ANDA.” Appellant’s Reply Br. 27 (citing 889 F.3d 1274, 1282–83 (Fed. Cir. 2018), remand order modified by stipu- lation, 738 F. App’x 1017 (Fed. Cir. 2018)). Argentum’s contentions are unavailing. In Altaire, Altaire was the company which intended to file an ANDA and would be at imminent risk of being sued. We held that Altaire had standing because the threat of litigation was “real” and “imminent” and Altaire was affected “in a personal and in- dividual way.” See Altaire, 889 F.3d at 1282–83; see also General Electric Co. v. United Techs. Corp., 928 F.3d 1349, 1353–54 (Fed. Cir. 2019) (determining there was no “con- crete and imminent injury to GE,” and that GE asserted “only speculative harm”). Unlike in Altaire, according to Mr. Gardner, any ANDA to be filed “will be filed by KVK, Argentum’s manufacturing and marketing partner.” D.I. 44-3 (Gardner Dec.) ¶ 11. And Mr. Gardner stated that “Novartis will inevitably sue Argentum’s manufacturing and marketing partner KVK for patent infringement upon KVK’s filing an ANDA for a generic version of GILENYA® . . . .” Id. ¶ 14; see also id. ¶ 15. No ANDA has been filed here, and Argentum has not provided evidence showing that it would bear the risk of any infringement suit or an- ything related to its involvement in the ANDA process be- yond generic statements. See, e.g., id. ¶ 11. Second, Argentum argues that it will incur significant economic injury as its investments in developing a generic version of Gilenya® and preparing an ANDA would be at risk with a “looming infringement action by Novartis.” Ap- pellant’s Br. 49. Specifically, it asserts that it will suffer at least $10–50 million per year in lost profits once the FDA grants provisional approval to the ANDA. Appellant’s Re- ply Br. 28–29 (citing D.I. 44–3 (Gardner Dec.) ¶ 12). No- vartis argues that Argentum’s alleged “economic injury,” which is entirely speculative and not personal to Case: 18-2273 Document: 13 Page: 6 Filed: 04/23/2020

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Argentum, does not suffice to establish injury in fact be- cause it is not concrete or particularized. Argentum has not provided sufficient evidence to es- tablish an injury in fact through economic harm. General Electric, 928 F.3d at 1354–55 (rejecting GE’s economic loss allegation of increased research and development costs where GE failed to provide details such as “an accounting for the additional research and development costs ex- pended” or “evidence that GE actually designed a [product covered by the upheld claims]”). Argentum’s or KVK’s pur- ported investments include KVK’s renovation of manufac- turing facilities that “KVK intends to use . . . to manufacture drugs developed through its joint collabora- tion with Argentum.” D.I. 44–2 (Tabasso Dec) ¶ 4. How- ever, Mr. Tabasso specifically states that “[t]he generic version of PAZEO®,” a drug unrelated to the patent at is- sue, “will be produced in KVK’s new manufacturing space which will come online in the next year.” Id. And Mr. Gardner declared that “Argentum has partnered with KVK . . . to develop generic versions of multiple generic drug products” without providing evidence specific to a ge- neric Gilenya® product. See D.I. 44-3 (Gardner Dec.) ¶ 4; see also id. ¶ 6. Argentum likewise has failed to provide sufficient evi- dence that it invested in KVK’s generic Gilenya® product or ANDA. It stated only in generalities that both “KVK and Argentum have been diligent in working toward FDA submission of the ANDA” and that “Argentum has invested significant man-power and resources to the endeavor.” D.I. 44-3 (Gardner Dec.) ¶ 11; see also id. ¶ 8 (stating that “[e]xternal costs are shared by Argentum and KVK on an opportunity-by-opportunity basis”); id. ¶ 9 (generally stat- ing that “[a] number of products are currently being jointly developed by Argentum and KVK” but listing an unrelated generic product). And its assertion that it will suffer at least $10–50 million per year in lost profits once the FDA grants provisional approval to the ANDA is both conclusory Case: 18-2273 Document: 13 Page: 7 Filed: 04/23/2020

ARGENTUM PHARMACEUTICALS LLC v. NOVARTIS 7 PHARMACEUTICALS CORP.

and speculative. See Appellant’s Reply Br. 28 (citing D.I. 44-3 (Gardner Dec.) ¶ 12). This cannot suffice to establish an injury in fact that is “‘concrete and particularized’ and ‘actual or imminent, not conjectural or hypothetical.’” Spokeo, 136 S. Ct. at 1548 (quoting Lujan, 504 U.S. at 560). Third, Argentum argues that absent relief from this court, Argentum would be estopped under 35 U.S.C. § 315(e) from raising the patentability and validity issues in a future infringement action. Novartis argues that Ar- gentum has not shown that it will be harmed by estoppel where it has not established there is risk of an infringe- ment suit. Appellee’s Br. 42–43 (citing JTEKT Corp., 898 F.3d at 1221). As the court stated in AVX, “we have already rejected invocation of the estoppel provision as a sufficient basis for standing.” 923 F.3d at 1362–63 (citing Phigenix, 845 F.3d at 1175–76 (“§ 315(e) do[es] not constitute an in- jury in fact when, as here, the appellant is not engaged in any activity that would give rise to a possible infringement suit.”) (alteration in original) (internal quotations omit- ted)); see also JTEKT, 898 F.3d at 1221; General Electric, 928 F.3d at 1355. Accordingly, we hold that Argentum has failed to prove that it has suffered an injury in fact neces- sary to establish standing. CONCLUSION We have considered the parties’ remaining arguments and do not find them persuasive. Because Argentum failed to establish an injury sufficient to confer Article III stand- ing, we dismiss the appeal. DISMISSED COSTS Costs to Novartis.