Court Opinion

ID: 4528265
Source: CourtListenerOpinion
Date Created: 2020-04-23 16:00:39.965946+00
Date Added: 2024-06-11T08:44:04.836200
License: Public Domain

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.
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 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

 6              ARGENTUM PHARMACEUTICALS LLC v. NOVARTIS
                                 PHARMACEUTICALS CORP.

 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.