Respondents Brief — Argentum Pharmaceuticals LLC, Petitioner v. Novartis Pharmaceuticals Corporation
Supreme Court briefFeb 16, 2021
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No. 20-779
IN THE
Supreme Court of the United States
_______________
ARGENTUM PHARMACEUTICALS LLC,
Petitioner,
v.
NOVARTIS PHARMACEUTICALS CORPORATION,
Respondent.
_______________
On Petition For A Writ Of Certiorari
To The United States Court Of Appeals
For The Federal Circuit
_______________
BRIEF IN OPPOSITION
_______________
JANE M. LOVE, PH.D.
GIBSON, DUNN & CRUTCHER LLP
200 Park Avenue
New York, NY 10166
(212) 351-4000
MARK A. PERRY
Counsel of Record
JACOB T. SPENCER
GIBSON, DUNN & CRUTCHER LLP
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036
(202) 955-8500
MPerry@gibsondunn.com
Counsel for Respondent
QUESTION PRESENTED
Any party seeking judicial review of a final written decision by the Patent Trial and Appeal Board
must establish Article III standing. Accordingly, petitioner submitted declarations regarding the injury it
allegedly would suffer from the Board decision at issue in this case. The Federal Circuit reviewed those
declarations and made the factual finding that petitioner had failed to adduce “sufficient evidence” to establish injury in fact. The question presented is:
Whether the court of appeals correctly found that
petitioner’s evidence of alleged injury was insufficient
to establish Article III standing.
ii
RULE 29.6 STATEMENT
Respondent Novartis Pharmaceuticals Corporation’s parent company is Novartis AG, which is publicly held.
iii
TABLE OF CONTENTS
Page
QUESTION PRESENTED...........................................i
RULE 29.6 STATEMENT .......................................... ii
STATEMENT .............................................................. 1
A. Legal Framework ..................................... 1
B. Factual Background ................................. 5
C. Proceedings Below ................................... 7
REASONS FOR DENYING THE PETITION .......... 10
I.
The Court of Appeals Correctly
Concluded That Argentum’s
Declarations Were Factually
Insufficient To Demonstrate Standing ......... 12
A. Argentum Failed To Show That It
Faced Any Concrete And
Imminent Risk Of Patent
Litigation ................................................ 13
B. Argentum Failed To Show That It
Would Suffer Non-Speculative
Economic Injury ..................................... 17
C. Argentum Failed To Show That It
Would Actually Be Estopped From
Litigating Patent Validity ..................... 19
II. The Question Presented Is FactDependent, And This Case Is A Poor
Vehicle For Considering It ............................ 22
CONCLUSION .......................................................... 26
iv
TABLE OF APPENDICES
Page
APPENDIX A: Declaration of Anthony
Tabasso in Support of Argentum’s
Opposition to Novartis’s Motion to Dismiss,
with Exhibits
(Appeal No. 18-2209, ECF 44-2) (Sept. 10,
2018) ..................................................................... 1a
APPENDIX B: Declaration of Jeffrey Gardner
in Support of Argentum’s Opposition to
Novartis’s Motion to Dismiss, with Exhibits
(Appeal No. 18-2209, ECF 44-3) (Sept. 10,
2018) ................................................................... 10a
v
TABLE OF AUTHORITIES
CASES
Page(s)
AIDS Healthcare Found., Inc. v. Gilead
Scis., Inc.,
890 F.3d 986 (Fed. Cir. 2018) .............................. 16
Altaire Pharm., Inc. v. Paragon Bioteck,
Inc.,
889 F.3d 1274 (Fed. Cir. 2018) .................. 5, 13, 14
Amerigen Pharm. Ltd. v. UCB Pharma
GmBH,
913 F.3d 1076 (Fed. Cir. 2019) .................... 2, 4, 14
Arizonans for Official English v.
Arizona,
520 U.S. 43 (1997) .................................................. 2
AT&T Corp. v. FCC,
317 F.3d 227 (D.C. Cir. 2003) .............................. 20
AVX Corp. v. Presidio Components, Inc.,
923 F.3d 1357 (Fed. Cir. 2019) ............................ 21
Caraco Pharm. Labs., Ltd. v. Novo
Nordisk A/S,
566 U.S. 399 (2012) ............................................ 3, 4
Carney v. Adams,
141 S. Ct. 493 (2020) ................................ 12, 14, 22
Cuozzo Speed Techs., LLC v. Lee,
136 S. Ct. 2131 (2016) ...................................... 2, 12
vi
TABLE OF AUTHORITIES
(CONTINUED)
CASES (continued)
Page(s)
E.I. DuPont de Nemours & Co. v.
Synvina C.V.,
904 F.3d 996 (Fed. Cir. 2018) ................................ 5
Forest Labs., Inc. v. Ivax Pharm., Inc.,
501 F.3d 1263 (Fed. Cir. 2007) ............................ 15
Gen. Elec. Co. v. Raytheon Techs. Corp.,
140 S. Ct. 2820 (2020) .............................. 18, 21, 23
Gen. Elec. Co. v. United Techs. Corp.,
928 F.3d 1349 (Fed. Cir. 2019) ............................ 18
Hollingsworth v. Perry,
570 U.S. 693 (2013) .......................................... 3, 12
Illinois v. Gates,
462 U.S. 213 (1983) .............................................. 16
JTEKT Corp. v. GKN Auto. LTD.,
139 S. Ct. 2713 (2019) .................................... 18, 21
JTEKT Corp. v. GKN Auto. LTD.,
898 F.3d 1217 (Fed. Cir. 2018) ................... 4, 5, 11,
.................................................................. 18, 19, 21
Kowalski v. Tesmer,
543 U.S. 125 (2004) .............................................. 17
Lujan v. Defs. of Wildlife,
504 U.S. 555 (1992) .......................... 2, 3, 12, 13, 24
vii
TABLE OF AUTHORITIES
(CONTINUED)
CASES (continued)
Page(s)
MedImmune, Inc. v. Genentech, Inc.,
549 U.S. 118 (2007) .............................................. 14
Oil States Energy Servs., LLC v.
Greene’s Energy Grp., LLC,
138 S. Ct. 1365 (2018) ............................................ 1
Phigenix, Inc. v. Immunogen, Inc.,
845 F.3d 1168 (Fed. Cir. 2017) .............................. 3
RPX Corp. v. ChanBond LLC,
139 S. Ct. 2713 (2019) .................................... 18, 21
RPX Corp. v. ChanBond LLC,
780 F. App’x 866 (Fed. Cir. 2018) ........................ 18
Sessions v. Morales-Santana,
137 S. Ct. 1678 (2017) .......................................... 17
Spokeo, Inc. v. Robins,
136 S. Ct. 1540 (2016) .......................................... 12
Summers v. Earth Island Inst.,
555 U.S. 488 (2009) .............................................. 12
Thryv, Inc. v. Click-To-Call Techs., LP,
140 S. Ct. 1367 (2020) ............................................ 2
United States v. Munsingwear, Inc.,
340 U.S. 36 (1950) ................................................ 21
viii
TABLE OF AUTHORITIES
(CONTINUED)
STATUTES
Page(s)
21 U.S.C. § 355 ...................................................... 3, 24
35 U.S.C. § 141 ............................................................ 2
35 U.S.C. § 271 ...................................................... 4, 15
35 U.S.C. § 311 ............................................................ 2
35 U.S.C. § 314 ............................................................ 2
35 U.S.C. § 315 ................................ 2, 7, 10, 19, 20, 21
35 U.S.C. § 318 ............................................................ 2
35 U.S.C. § 319 ............................................................ 2
Hatch-Waxman Act, Pub. L. No. 98-417,
98 Stat. 1585 (1984) ............................................... 3
Leahy-Smith America Invents Act, Pub.
L. No. 112-29, 125 Stat. 284 (2011) ....................... 1
REGULATION
21 C.F.R. § 314.105 ................................................... 24
RULE
Sup. Ct. R. 10 ....................................................... 22, 25
BRIEF IN OPPOSITION
Respondent Novartis Pharmaceuticals Corporation (“Novartis”) respectfully submits that the petition
for a writ of certiorari should be denied.
STATEMENT
In an administrative proceeding, the Patent Trial
and Appeal Board (“Board”) issued a final written decision concluding that Novartis’s patent claims are not
unpatentable. Several parties to that administrative
proceeding, including petitioner Argentum Pharmaceuticals LLC (“Argentum”), sought review of the
Board’s decision in the Federal Circuit. After the
other challengers settled with Novartis, the court of
appeals found that Argentum’s evidence was insufficient to establish that it would suffer an injury in fact
from the Board’s decision—an essential predicate to
Article III standing. Accordingly, the Federal Circuit
dismissed Argentum’s appeal for want of jurisdiction.
A. Legal Framework
1. The Leahy-Smith America Invents Act, Pub.
L. No. 112-29, 125 Stat. 284 (2011), established a procedure known as “inter partes review” through which
the United States Patent and Trademark Office is authorized to review the patentability of previously issued patent claims. See Oil States Energy Servs., LLC
v. Greene’s Energy Grp., LLC, 138 S. Ct. 1365, 1370
(2018).
Because Article III does not apply to administrative proceedings, any person “who is not the owner of
a patent” may petition for inter partes review of particular patent claims, regardless of whether it would
satisfy constitutional requirements for standing.
2
35 U.S.C. § 311(a); see Cuozzo Speed Techs., LLC v.
Lee, 136 S. Ct. 2131, 2143-44 (2016) (“Parties that initiate the proceeding need not have a concrete stake
in the outcome; indeed, they may lack constitutional
standing.”). If another person has petitioned for inter
partes review of the same claims, a later petitioner can
“join” in the earlier petition. 35 U.S.C. § 315(c).
Upon receiving a petition for inter partes review,
the Board makes two decisions. The Board, acting on
authority delegated by the Director, first decides
whether to institute review, which is a discretionary
and non-appealable decision. See 35 U.S.C. § 314;
Thryv, Inc. v. Click-To-Call Techs., LP, 140 S. Ct.
1367, 1371 (2020). If the Board institutes review, a
panel of administrative patent judges presides over a
proceeding culminating in a “final written decision”
regarding the patentability of the challenged claims.
35 U.S.C. § 318(a).
“A party to an inter partes review . . . who is dissatisfied with” a final written decision of the Board
may seek review in the Federal Circuit. 35 U.S.C.
§ 141(c); see also id. § 319.
2. To invoke the Federal Circuit’s jurisdiction,
however, “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. Defs. of Wildlife, 504 U.S. 555, 560 (1992)); see also Arizonans for
Official English v. Arizona, 520 U.S. 43, 64 (1997)
(“The standing Article III requires must be met by
persons seeking appellate review, just as it must be
met by persons appearing in courts of first instance.”)
These minimum requirements are an (1) injury in fact
that is both “concrete and particularized” and “actual
3
or imminent,” and that is (2) traceable to the defendant and (3) likely to be redressed by a favorable decision. Lujan, 504 U.S. at 560-61.
The proponent of federal jurisdiction always
“bears the burden of establishing these elements.”
Lujan, 504 U.S. at 561. It must establish standing “as
of the commencement of ” the litigation—in the inter
partes review context, at the time it files its appeal.
Id. at 570 n.5. And it must maintain standing
“throughout all stages of litigation.” Hollingsworth v.
Perry, 570 U.S. 693, 705 (2013).
When standing is challenged or is not self-evident,
a person seeking review of a Board decision in the
Federal Circuit must discharge its burden by identifying record evidence or submitting additional evidence
“at the first appropriate time.” Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1172-73 (Fed. Cir.
2017) (internal quotation marks omitted). This includes evidence that the party has suffered (or imminently will suffer) an injury in fact traceable to the
challenged patent claims and redressable by judicial
review.
3. Before a manufacturer can market a prescription drug, it must obtain approval from the Food and
Drug Administration. Under the Hatch-Waxman Act,
Pub. L. No. 98-417, 98 Stat. 1585 (1984), a would-be
producer of a generic version of a previously approved
drug can file an abbreviated new drug application
(“ANDA”) instead of a full new drug application. A
“typical ANDA shows that the generic drug has the
same active ingredients as, and is biologically equivalent to,” an already-approved reference drug. Caraco
Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S.
399, 405 (2012); see 21 U.S.C. § 355(j). Among other
requirements, an ANDA filer must, as to each patent
4
associated with the reference drug (as listed in the
FDA’s Orange Book), certify whether the patent is
valid and would be infringed by its proposed generic.
See Caraco Pharm. Labs., 566 U.S. at 406-08.
In some circumstances, submitting an ANDA is
deemed by statute to be an act of patent infringement,
“if the purpose of such submission is to obtain approval . . . to engage in the commercial manufacture,
use, or sale” of the generic drug “before the expiration”
of patents associated with the reference drug. 35
U.S.C. § 271(e)(2). That act of patent infringement
gives the patent holder an immediate right to sue. See
id. If the patent holder does so within a specified time,
“the FDA generally may not approve the ANDA until
30 months pass or the court finds the patent invalid
or not infringed.” Caraco Pharm. Labs., 566 U.S. at
407.
4. “[T]ypically in order to demonstrate the requisite injury in an [inter partes review] appeal, the appellant/petitioner must show that it is engaged or will
likely engage in an[ ] activity that would give rise to a
possible infringement suit or has contractual rights
that are affected by a determination of patent validity.” JTEKT Corp. v. GKN Auto. LTD., 898 F.3d 1217,
1220 (Fed. Cir. 2018) (alteration in original; internal
quotation marks and citations omitted).
Because the filing of an ANDA can give rise to an
immediate infringement suit, the Federal Circuit has
held that an ANDA filer generally has standing to
challenge Board decisions related to patents implicated by its ANDA. See Amerigen Pharm., 913 F.3d
at 1083.
The Federal Circuit has not, however, ruled that
an ANDA is a necessary prerequisite to Article III
standing. On the contrary, the court of appeals has
5
also recognized that a party can demonstrate injury in
fact from the risk of an infringement suit even before
it files an ANDA. See Altaire Pharm., Inc. v. Paragon
Bioteck, Inc., 889 F.3d 1274, 1283 (Fed. Cir. 2018).
Similarly, the fact that the would-be competitor “has
no product on the market” at the time of appeal “does
not preclude Article III standing.” JTEKT, 898 F.3d
at 1220.
Whether or not an ANDA has been filed, if standing is challenged or not readily apparent, the party invoking federal jurisdiction must present evidence, not
mere conclusory assertions, that it is likely to be sued
for infringement or faces some other concrete risk of
imminent harm. Compare, e.g., E.I. DuPont de
Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1005
(Fed. Cir. 2018) (declarations sufficient to establish
standing), with JTEKT, 898 F.3d at 1221 (declarations insufficient to show that appellant’s “planned
product would . . . likely lead to charges of infringement”).
B. Factual Background
Novartis holds U.S. Patent No. 9,187,405. Pet.
App. 2a. That patent claims methods for using the
drug fingolimod to treat relapsing-remitting multiple
sclerosis. Id. at 18a. Those methods are embodied in
use of Gilenya®, the world’s first solid oral medicine
for treating relapsing-remitting multiple sclerosis.
See id. at 17a.
According to the declarations it submitted to the
court of appeals in September 2018, Argentum is a
“young company” that “partners with other companies
to develop generic drug products and to bring them to
market.” Supp. Pet. App. 11a, 13a. Argentum assertedly reached a “collaboration agreement” with KVK-
6
Tech, a generic pharmaceutical manufacturer, in January 2016. Id. at 14a. That agreement—which Argentum did not submit to the Federal Circuit—purportedly provides that the two companies will “collaborate” to develop “pharmaceutical products, including
generic drug products”; “prepare, prosecute and defend [inter partes reviews] and litigation under the
Hatch-Waxman Act”; “share in external costs”; and
“share in any financial benefits.” Id. Argentum declared that “[e]xternal costs are shared by Argentum
and KVK on an opportunity-by-opportunity basis” and
“[r]esulting revenues from the collaboration are distributed between the parties.” Id.
Neither Argentum nor KVK has ever sold a generic version of Gilenya®, nor has either filed an
ANDA with the FDA seeking regulatory approval to
produce or market fingolimod. Rather, according to
Argentum’s declarations, the two “agreed” in 2017 to
develop a generic version of Gilenya®. Supp. Pet. App.
15a. The declarations stated that an ANDA for this
generic version would “be filed by KVK,” which had
“represented” to Argentum’s CEO “that the ANDA
[would] likely be filed within the next 8-10 months”—
i.e., sometime between May and July 2019. Id. Argentum declared that both it and KVK had “been diligent in working toward FDA submission of the
ANDA” and that it had “invested significant manpower and resources to the endeavor.” Id. Argentum’s declarations did not, however, specify what
work (if any) had been done toward the filing of an
ANDA, nor did they quantify or provide any details
regarding Argentum’s purportedly “significant” investment. Argentum speculated that “revenues” from
its generic version of Gilenya® would be “$10-50 million per year, with a positive profit margin,” although
7
it did not explain how it arrived at that projection or
what its profits might be. Id. at 16a.
Argentum’s declarations also asserted that “Novartis w[ould] inevitably sue Argentum’s manufacturing and marketing partner KVK for patent infringement upon KVK’s filing an ANDA.” Supp. Pet. App.
17a. The declarations made no prediction regarding
any infringement litigation in the absence of an
ANDA, or whether and how Argentum would be a
proper party to such a lawsuit. And the declarations
were silent as to any separate infringement suit
against Argentum itself.
C. Proceedings Below
1. In February 2017, Apotex Inc. and Apotex
Corp. (together, “Apotex”) filed a petition for inter
partes review of Novartis’s patent claims. Pet. App.
85a. The Board instituted review in July 2017 and
granted requests for joinder under 35 U.S.C. § 315(c)
from Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., Sun Pharma Global FZE,
Teva Pharmaceuticals USA, Inc., Actavis Elizabeth
LLC, and Argentum. Id. at 2a; see also id. at 85a112a. Except for Argentum, all petitioners in the inter
partes review proceeding are generic drug makers
with filed ANDAs for Gilenya®.1
In July 2018, the Board concluded that the inter
partes review petitioners had not shown that Novartis’s patent claims were unpatentable. Pet. App. 13a.
All of those petitioners initially appealed the Board’s
final written decision to the Federal Circuit. But each
1
Although listed as a real party in interest by Argentum, KVK
never sought to join and thus was never a party to the inter
partes review.
8
petitioner other than Argentum eventually settled
with Novartis, and each of their appeals was dismissed. See Appeal No. 18-2260, ECF 74 (Mar. 2019)
(dismissing appeals of Teva Pharmaceuticals USA,
Inc. and Activis Elizabeth LLC); Appeal No. 18-2230,
ECF 125 (Dec. 2019) (dismissing appeals of Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., and Sun Pharma Global FZE); Appeal
No. 18-2209, ECF 134 (Feb. 2020) (dismissing appeals
of Apotex).
2. In August 2018, before merits briefing commenced and before the Federal Circuit had dismissed
the other appellants, Novartis moved to dismiss Argentum’s appeal for lack of standing. Pet. App. 2a.
Argentum opposed that motion and submitted two
declarations that purported to establish its standing
to seek judicial review, one from the President and
CEO of KVK, Anthony Tabasso, the other from its own
CEO, Jeffrey Gardner. See Supp. Pet. App.1a-4a, 10a18a; supra 5-7. Argentum also submitted several exhibits, none of which mentioned any efforts by Argentum or KVK related to generic Gilenya®. See Supp.
Pet. App. 5a-9a, 19a-67a. The court of appeals directed the parties to address Argentum’s standing in
their merits briefs. Pet. App. 2a.
In its opening brief, Argentum argued that the
court of appeals need not decide whether it had standing, because the other appellants satisfied Article III’s
requirements. Pet. App. 2a-3a. Argentum also relied
on its previously submitted declarations, without offering any additional evidence or updating the court
on its purported efforts to develop a generic version of
Gilenya®. See Appeal No. 18-2209, ECF 69, at 47-50.2
2
Along with its reply brief (and after Novartis had settled with
two of the other seven appellants), Argentum filed a motion to
9
By the time the Federal Circuit held oral argument in January 2020, all appellants other than Argentum and Apotex had been dismissed. At argument, Argentum again insisted that the court of appeals did not need to address its standing, “because
the standing issue is only directed to Argentum” and
“Apotex’s standing ha[d] not been challenged.” Jan. 9,
2020 Tr. at 11:13-21.
A month later, however, Novartis settled with
Apotex, leaving Argentum as the sole remaining appellant. Novartis submitted a letter to the court of appeals under Federal Rule of Appellate Procedure 28(j),
informing the court that “Article III standing has become a threshold issue.” Appeal No. 18-2209, ECF
131, at 2. Novartis also filed a suggestion of mootness,
explaining that “[b]ecause Argentum lacks standing,
and is now the sole appellant, this appeal is now
moot.” Appeal No. 18-2209, ECF 132, at 4. In response, Argentum once again relied on its previously
submitted declarations to establish standing. See Appeal No. 18-2209, ECF 135.
3. On April 23, 2020, the Federal Circuit issued
a unanimous opinion dismissing Argentum’s appeal.
Pet. App. 8a. The panel held that Argentum lacked
Article III standing because its declarations were factually insufficient to demonstrate injury in fact. Id. at
3a-8a.
supplement the record with updated declarations. See Appeal
No. 18-2209, ECF 88-1. The panel denied that motion in December 2019. See Appeal No. 18-2209, ECF 121. Argentum does not
challenge that ruling in this Court, and thus the two declarations
and exhibits submitted at the motion-to-dismiss stage comprise
all the record evidence related to Argentum’s standing.
10
The panel first rejected Argentum’s assertion that
it faced “a real and imminent threat of litigation,” Pet.
App. 4a, because “[n]o ANDA has been filed here, and
Argentum has not provided evidence showing that it
would bear the risk of any infringement suit or anything related to its involvement in the ANDA process
beyond generic statements,” id. at 6a.
The panel next rejected Argentum’s assertion that
it would “incur significant economic injury,” because
“Argentum has not provided sufficient evidence to establish an injury in fact through economic harm.” Pet.
App. 6a. Rather, Argentum provided only “generalities,” and “conclusory and speculative” assertions
“without providing evidence specific to a generic
Gilenya® product.” Id. at 6a-7a.
Finally, the panel rejected Argentum’s assertion
that it “would be estopped under 35 U.S.C. § 315(e)
from raising the patentability and validity issues in a
future infringement action” because it had not “established there is a risk of an infringement suit.” Pet.
App. 7a-8a.
Argentum sought rehearing en banc, which the
Federal Circuit denied without calling for a response
and without noted dissent. Pet. App. 9a-10a.
REASONS FOR DENYING THE PETITION
The Federal Circuit found that Argentum had offered insufficient evidence to show injury in fact and
on that basis held that Argentum lacked Article III
standing to appeal. Argentum asks this Court to review the court of appeals’ holding that it lacked constitutional standing. But this case does not present
either of the questions framed by the petition. The
Federal Circuit did not “categorically” preclude joint
venture partners who are not manufacturers or
11
ANDA filers from establishing standing. Pet. i. Nor
did the court of appeals “reject[ ]” statutory estoppel
as a potential cause of injury in fact. Pet. ii. The Federal Circuit has neither adopted nor applied any such
bright-line rules, in this case or any other.
On the contrary, the court of appeals has recognized that a non-manufacturer or ANDA filer may
have standing, but it must prove its own injury in fact
as required by Article III. It could do so by “establish[ing] that it has concrete plans for future activity
that creates a substantial risk of future infringement
or likely [will] cause the patentee to assert a claim of
infringement,” JTEKT Corp. v. GKN Auto. LTD., 898
F.3d 1217, 1221 (Fed. Cir. 2018), or even that it had
made a sufficiently specific “invest[ment]” in the “generic [pharmaceutical] product or ANDA,” Pet. App.
7a.
Here, the Federal Circuit applied well-settled law
and found that Argentum’s declarations were insufficient as a factual matter to meet the injury-in-fact requirement. Pet. App. 6a-8a. The only issue properly
presented by the judgment below is the Federal Circuit’s case-specific finding that Argentum’s evidence
was insufficient to satisfy Article III’s requirements.
There is no reason for this Court to review the court
of appeals’ fact-bound conclusion that Argentum, having been given an opportunity to carry its evidentiary
burden, simply failed to do so. Indeed, even a cursory
review of the evidence—which Argentum did not include with its petition, but which Novartis attaches to
this response for the Court’s convenience—demonstrates that the court of appeals’ factual finding was
entirely correct. And the routine application of longestablished standing principles to this factual record
does not come close to warranting this Court’s review.
12
I.
THE COURT OF APPEALS CORRECTLY CONCLUDED THAT ARGENTUM’S DECLARATIONS
WERE FACTUALLY INSUFFICIENT TO DEMONSTRATE STANDING.
As Argentum concedes, the constitutional requirements for standing are well-settled. See Pet. 22-23.
To invoke the jurisdiction of the Federal Circuit, Argentum was required to show that it had “(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).
It is equally well-settled that while a party need not
satisfy Article III to participate in administrative proceedings, see Cuozzo Speed Techs., LLC v. Lee, 136
S. Ct. 2131, 2143-44 (2016), a “person[ ] seeking appellate review” of such proceedings must establish its
constitutional standing, Hollingsworth v. Perry, 570
U.S. 693, 705 (2013). The proponent of federal jurisdiction “bears the burden of establishing standing as
of the time” it commenced the proceeding “and maintaining it thereafter.” Carney v. Adams, 141 S. Ct.
493, 499 (2020).
“[T]he requirement of injury in fact is a hard floor
of Article III jurisdiction that cannot be removed by
statute.” Summers v. Earth Island Inst., 555 U.S. 488,
497 (2009). To meet this requirement, a party must
show “an invasion of a legally protected interest” that
is “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.” Lujan v. Defs.
of Wildlife, 504 U.S. 555, 560 (1992) (citation and internal quotation marks omitted). And because standing is not a “mere pleading requirement[ ],” injury in
fact “must be supported in the same way as any other
matter on which the [party] bears the burden of proof,
13
i.e., with the manner and degree of evidence required
at the successive stages of the litigation.” Id. at 561
(emphasis added).
Here, the Federal Circuit correctly made the factual finding that Argentum’s two declarations—the
entirety of the evidentiary record on this point—were
insufficient to show injury in fact. The court of appeals did not make any bright-line pronouncement
that joint venture partners (or pre-ANDA filers) cannot suffer injury, that economic harm is insufficient,
or that the statutory estoppel provision may not cause
injury in some circumstances. Rather, the court found
that the evidence as to each of these theories was insufficient to show that Argentum would suffer a concrete and imminent injury. Nothing about that factual finding warrants further review.
A. Argentum Failed To Show That It
Faced Any Concrete And Imminent
Risk Of Patent Litigation.
1. The Federal Circuit correctly found that Argentum’s evidence was insufficient to show that it
“face[d] a real and imminent threat of litigation.” Pet.
App. 4a. The court of appeals has held that a party
can satisfy its burden of establishing injury in fact,
among other ways, by showing that it “intend[s] to file
an ANDA and [is] at imminent risk of being sued.” Id.
at 5a (citing Altaire Pharm., Inc. v. Paragon Bioteck,
Inc., 889 F.3d 1274, 1282-83 (Fed. Cir. 2018)). Here,
however, Argentum’s declarations stated that any
ANDA would “be filed by KVK, Argentum’s manufacturing and marketing partner.” Id. at 5a. And Argentum declared that “Novartis will inevitably sue Argentum’s manufacturing and marketing partner KVK,”
not Argentum, if KVK did so. Id. at 5a-6a (internal
14
quotation marks omitted). In short, the record evidence did not even assert that Argentum faced any
risk of litigation whatsoever.
Moreover, Argentum’s declarations failed to show
that KVK had any concrete plans to file an ANDA or
had taken any substantive step to prepare any portion
of an ANDA. Rather, those declarations filed in 2018
stated only that an ANDA was “likely [to] be filed
within the next 8-10 months.” Supp. Pet. App. 15a
(emphasis added). Nor did Argentum provide any evidence that any scientific work had been done on preparing an ANDA or to develop a generic version of
Gilenya®. Cf. Altaire Pharm., 889 F.3d at 1282-83
(threat of infringement suit was “imminent” when Altaire had previously manufactured and marketed the
product and had concrete plans to file an ANDA);
Amerigen Pharm. Ltd. v. UCB Pharma GmBH, 913
F.3d 1076, 1083-84 (Fed. Cir. 2019) (finding injury in
fact when FDA had already tentatively approved
Amerigen’s ANDA and only the challenged patent
prevented launch of product).
Thus, the Federal Circuit properly rejected as insufficient Argentum’s bare assertions that KVK intended to file an ANDA sometime in the future. As
this Court recently explained, “an injury in fact requires an intent that is concrete,” and the mere expectation of future action is not enough. Carney, 141
S. Ct. at 502. And this Court has long held in an analogous context that “the question in each case is
whether the facts alleged, under all the circumstances, show that there is a substantial controversy,
between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance
of a declaratory judgment.” MedImmune, Inc. v.
Genentech, Inc., 549 U.S. 118, 127 (2007). Argentum
15
failed to satisfy that standard in these circumstances,
because the facts it asserted did not come close to establishing that KVK had any concrete intent to file an
ANDA or had taken any specific steps to do so when
Argentum appealed to the Federal Circuit. Confirming that conclusion, “[n]o ANDA ha[d] been filed”
when the Federal Circuit issued its decision—more
than a year and a half after Argentum submitted its
declarations. Pet. App. 6a.
2. Contrary to Argentum’s assertions, the Federal Circuit did not “categorically . . . preclude redress
for injured members of joint ventures in the pharmaceutical industry by only recognizing” manufacturing
and marketing partners “as having demonstrable injury-in-fact for Article III standing.” Pet. i. Nor did
the Federal Circuit “ignore[ ] the threat of indirect infringement allegations.” Id. at 32.
Although Argentum told the court of appeals that
Novartis would sue KVK, not Argentum, see Supp.
Pet. App. 17a, it now asserts that its joint venture efforts “also give rise to an imminent suit by Novartis
against Argentum for indirect infringement” for inducing KVK’s patent infringement. Pet. 32; see 35
U.S.C. § 271(b) (“Whoever actively induces infringement of a patent shall be liable as an infringer.”).
Even if Argentum had shown that KVK had concrete plans to file an ANDA, its belated assertion that
it would be sued for inducing that infringement is not
supported by any evidence. The Federal Circuit has
recognized that, in some circumstances, a joint venturer’s efforts relating to an ANDA can induce patent
infringement. See Forest Labs., Inc. v. Ivax Pharm.,
Inc., 501 F.3d 1263, 1272 (Fed. Cir. 2007) (finding “induced” infringement by Cipla where “the plan to man-
16
ufacture, import, market, and sell the [patented] products described in the ANDA was undoubtedly a cooperative venture, and Cipla was to manufacture and
sell infringing [patented] products to [its venture partner] for resale in the United States”); cf. AIDS
Healthcare Found., Inc. v. Gilead Scis., Inc., 890 F.3d
986, 993 (Fed. Cir. 2018) (“Jurisdiction for a declaratory action premised on an inducement theory does
not arise in the absence of concrete steps [that] have
been taken with the intent to conduct activity which
could constitute infringement.” (internal quotation
marks omitted; alteration in original)). But here, the
court of appeals concluded that Argentum had not carried its burden because it had “not provided evidence
showing that it would bear the risk of any infringement suit or anything related to its involvement in the
ANDA process beyond generic statements.” Pet. App.
6a (emphasis added). This is an evidentiary failure,
not a legal rule.
3. Equally unavailing is Argentum’s contention
that it should be permitted to advance KVK’s future
interests—for example, if KVK does file an ANDA—
on a third-party standing theory. See Pet. 27-29. As
an initial matter, that argument is not properly before
the Court because it was “not pressed or passed upon
below”; Argentum never argued, and the court of appeals did not address, third-party standing. Illinois v.
Gates, 462 U.S. 213, 222 (1983).
In any event, Argentum’s third-party standing argument is factually and legally meritless. As a matter
of fact, KVK would have lacked standing for the same
reasons Argentum lacked standing: Its supposed intent to file an ANDA sometime in the future was entirely speculative and unsupported by evidence. And
as a matter of law, third-party standing is appropriate
17
only where there is some “hindrance” preventing the
person who possesses the right from protecting its interests. Kowalski v. Tesmer, 543 U.S. 125, 126 (2004).
Argentum’s purported agreement that it is “the sole
party responsible for representing the Joint Venture’s
interests in patent-related litigation,” Pet. 28, reflects
at most KVK’s “disinterest” in advancing its own
rights, not its “disability,” and thus does not qualify
as a hinderance to KVK’s participation in inter partes
review or Argentum’s appeal. Sessions v. MoralesSantana, 137 S. Ct. 1678, 1689 (2017); see also Kowalski, 543 U.S. at 132 (lack of an attorney is no hindrance to indigent prisoners advancing their own
rights).
B. Argentum Failed To Show That It
Would Suffer Non-Speculative Economic Injury.
The Federal Circuit likewise found that Argentum
had “not provided sufficient evidence to establish an
injury in fact through economic harm.” Pet. App. 6a.
Although Argentum and KVK had purportedly invested in manufacturing facilities, they provided no
evidence that those facilities would be used to manufacture “a generic Gilenya® product.” Id. at 6a-7a.
Nor had Argentum “provide[d] sufficient evidence
that it invested in KVK’s generic Gilenya® product or
ANDA,” relying instead on “generalities” that it had
been “diligent in working toward FDA submission of
the ANDA” and “invested significant man-power and
resources to the endeavor.” Id. at 7a. And Argentum’s
“assertion that it w[ould] suffer at least $10-50 million
per year in lost profits once the FDA grants provisional approval to the ANDA [wa]s both conclusory
and speculative.” Id.
18
Argentum acknowledges the fact-bound nature of
the Federal Circuit’s finding with respect to its purported economic injury. See Pet. 29-30. It argues that
the court of appeals should have held that its “sworn
declarations” were enough. Id. at 31. But those declarations did not show that Argentum had invested
any money or resources in actually developing generic
Gilenya®, and their assertion of lost profits was purely
speculative, especially considering that they did not
show any concrete steps even toward preparing or filing an ANDA. Contrary to Argentum’s hyperbolic assertion, the Federal Circuit did not invoke Article III
“to eliminate an entire class of appellants with a direct
financial interest” in inter partes review proceedings.
Id. at 6. Rather, the court of appeals made a routine
factual finding that Argentum had failed to prove any
such direct financial interest.
For the same reasons, Argentum’s argument that
it has suffered an economic injury merely because Novartis has an enforceable patent is unavailing. See
Pet. 25-27. Argentum did not raise this argument in
the court of appeals. Unsurprisingly so, given that the
Federal Circuit has repeatedly rejected efforts to establish a special exception to Article III’s requirements that would permit any inter partes review petitioner standing to appeal—and this Court has repeatedly denied review of those holdings. See, e.g., Gen.
Elec. Co. v. United Techs. Corp., 928 F.3d 1349 (Fed.
Cir. 2019), cert. denied sub nom. Gen. Elec. Co. v. Raytheon Techs. Corp., 140 S. Ct. 2820 (2020); RPX Corp.
v. ChanBond LLC, 780 F. App’x 866 (Fed. Cir. 2018),
cert. denied, 139 S. Ct. 2713 (2019); JTEKT Corp., 898
F.3d 1217, cert. denied, 139 S. Ct. 2713 (2019). Rather, the court of appeals has required evidence that
the would-be appellant “is engaged or will likely engage in an[ ] activity that would give rise to a possible
19
infringement suit or has contractual rights that are
affected by a determination of patent validity.”
JTEKT Corp., 898 F.3d at 1220 (alteration in original;
internal quotation marks and citations omitted).
Here, as the Federal Circuit correctly found, Argentum failed to provide evidence sufficient to make
that showing. And it certainly failed to show that it
has “a generic product that [would be] ready to
launch” but for Novartis’s patent claims. Pet. 27. As
a result, Argentum’s assertion that it would suffer
economic injury was “entirely speculative.” Pet. App.
6a.
C. Argentum Failed To Show That It
Would Actually Be Estopped From Litigating Patent Validity.
Finally, the Federal Circuit correctly found that
the possibility of statutory estoppel under 35 U.S.C.
§ 315(e) did not constitute injury in fact under the circumstances here presented. Pet. App. 7a-8a.
The Federal Circuit’s estoppel ruling—like the
other two bases for its decision—rested on the factual
finding that Argentum had “not established that there
is risk of an infringement suit.” Pet. App. 7a. Argentum has no answer to the court of appeals’ factual
finding beyond asserting without support that “it is all
but a certainty that the parties will have future litigation.” Pet. 33. The evidence—the declarations submitted by Argentum itself—does not support that assertion, as the court of appeals recognized. See Pet.
App. 6a (“Argentum has not provided evidence showing that it would bear the risk of any infringement
suit.”). Indeed, Argentum’s declarations did not even
20
assert that it would be sued by Novartis. See Supp.
Pet. App. 17a.3
Having failed to establish any reasonable likelihood of an infringement suit, Argentum now complains that “the Federal Circuit’s rationale ignores
that [estoppel] also automatically applies to any further proceedings before the Board,” and thus that statutory estoppel has “already attached regardless of
whether Argentum is sued for infringement in district
court.” Pet. 33. But Argentum never argued below
that it had standing because it was already estopped
from bringing further proceedings before the Board.
Rather, it said below 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 highly likely infringement action over the anticipated ANDA.” Appeal No. 18-2209, ECF 69, at 50
(emphasis added). And since Argentum failed to show
that it had any concrete or particularized stake in the
validity of Novartis’s patent claims, its belated estoppel argument makes no difference.
In all events, Argentum could have avoided any
statutory estoppel by not joining the inter partes review. To the extent that Argentum or KVK is estopped from litigating the validity of Novartis’s patent
claims, that is the result of Argentum’s choice to file a
tag-along inter partes review application, to name
3
Argentum’s reliance on AT&T Corp. v. FCC, 317 F.3d 227
(D.C. Cir. 2003), is accordingly misplaced. That decision involved
litigation estoppel, not statutory estoppel. See id. at 237. And
the D.C. Circuit concluded that the collateral estoppel effect of
the agency decision there supported standing because it would
harm the petitioner “in pending litigation.” Id. (emphasis
added). Here, the Federal Circuit found that there was no pending—or imminent—litigation.
21
KVK as a real party in interest without attempting to
join KVK, and to “acquiesce[ ] in the dismissal” of its
appeal without moving to vacate the Board’s decision.
See United States v. Munsingwear, Inc., 340 U.S. 36,
40 (1950). This Court has denied three recent certiorari petitions challenging the Federal Circuit’s standing decisions and invoking estoppel under 35 U.S.C.
§ 315(e). See Gen. Elec. Co., 140 S. Ct. 2820; RPX
Corp., 139 S. Ct. 2713; JTEKT Corp., 139 S. Ct. 2713.
Argentum’s cursory estoppel argument fails even to
mention those denials, much less to explain why the
result should be different here.
*
*
*
Tellingly, Argentum does not attempt to argue
that the question presented is important to anyone
other than itself. Any petitioner dissatisfied with a
final written decision of the Board can obtain Federal
Circuit review, so long as it satisfies Article III’s requirements. For example, a would-be generic manufacturer (or marketing partner) could show injury in
fact by “establish[ing] that it has concrete plans for
future activity that creates a substantial risk of future
infringement or likely [will] cause the patentee to assert a claim of infringement.” JTEKT Corp., 898 F.3d
at 1221; see also AVX Corp. v. Presidio Components,
Inc., 923 F.3d 1357, 1365 (Fed. Cir. 2019) (noting that
a would-be challenger would have standing “if the [patent] claim would block the challenger’s own current
or nonspeculative actions in the rivalry for sales”). Argentum simply failed to carry its burden of proof, as
the court of appeals correctly found.
22
II. THE QUESTION PRESENTED IS FACTDEPENDENT, AND THIS CASE IS A POOR
VEHICLE FOR CONSIDERING IT.
The only issue properly raised by Argentum’s petition is whether the court of appeals misapplied wellsettled law—including Federal Circuit precedent—in
concluding that Argentum’s evidence was insufficient
to establish an injury in fact. But this Court will
“rarely” grant a petition for a writ of certiorari “when
the asserted error consists of . . . the misapplication of
a properly stated rule of law.” Sup. Ct. R. 10. And
whether a litigant’s record evidence is sufficient to
demonstrate injury in fact is a “highly fact-specific”
question that does not ordinarily warrant this Court’s
review. Carney, 141 S. Ct. at 501.
Seeking to evade the fact-bound nature of the
question actually decided by the Federal Circuit, Argentum mischaracterizes the decision below. But this
case does not present the questions Argentum offers
for review. The Federal Circuit did not “categorically”
preclude parties other than the manufacturer or marketer of a generic pharmaceutical from demonstrating
Article III standing, nor did the court categorically
“reject[ ] the Leahy-Smith America Invents Act’s statutory estoppel provisions as a basis to demonstrate injury-in-fact for Article III standing.” Pet. i-ii; see also,
e.g., id. at 5 (“The Federal Circuit focused on the fact
that KVK will be the manufacturing entity and the
entity filing for regulatory approval, which the Federal Circuit deemed to render Argentum’s injury not
personal.”); id. at 6 (“[T]he Federal Circuit’s decision
. . . precludes Argentum from redress on appeal
simply because it is in a joint venture.”). Rather, the
court of appeals held that Argentum offered insuffi-
23
cient evidence to show injury in fact in the circumstances of this case, including specifically the relationship between Argentum and KVK (both of whom submitted declarations).4
Even if this Court were inclined to review whether
and when a party dissatisfied by inter partes review
has Article III standing to appeal, this would be an
especially poor vehicle for doing so. Argentum told the
Federal Circuit in September 2018 that KVK was
likely to submit an ANDA for generic Gilenya® in 8-10
months. Supp. Pet. App. 15a. More than two years
later, no ANDA has been filed. Nor is there any evidence in the record showing any concrete steps KVK
has taken to develop generic Gilenya® or any specific
resources Argentum has devoted to that project. At
this point in the litigation, Argentum’s evidence of ostensible injury appears to be not just stale but inaccurate.5
4
The lone amicus suggests that the Federal Circuit has sometimes applied a too narrow version of the doctrine of competitor
standing. See Stroud Br. 8 (complaining that “[a]ll attempts at
reliance on the competitor standing have been rebuffed”). Competitor standing was neither pressed nor passed upon below, and
is not argued by Argentum in its petition. And just last Term,
this Court declined to review the court of appeals’ application of
that doctrine. See Gen. Elec. Co., 140 S. Ct. 2820. In any event,
the amicus brief confirms that the Federal Circuit’s standing decisions turn on the evidentiary record submitted in each case.
See Stroud Br. 13 (noting that in the second General Electric
case, the court of appeals “took pains to note . . . that it was the
additional attorney argument and record evidence that carried
the day”). The upshot of the decision below is that Argentum’s
evidence was factually insufficient.
5
Even if Argentum or KVK had submitted an ANDA after the
Federal Circuit’s mandate issued—or were to do so in the future—that would make no difference with respect to Argentum’s
standing to appeal to the Federal Circuit. Argentum’s burden
24
Argentum had every opportunity to present evidence supporting injury in fact to the Federal Circuit,
and the court of appeals made the factual finding that
Argentum’s two declarations were insufficient to
carry its burden. Argentum never grapples with the
insufficiency of its own evidence; instead, it makes factual assertions throughout its petition that are not
supported by the declarations. Argentum says, for example, that “[i]ts tireless work with KVK has culminated in an affordable, market-ready generic drug
from which millions of patients will benefit.” Pet. 2.
In fact, there is no evidence in the record that Argentum has taken any concrete steps to develop a generic
version of Gilenya® and, absent the filing of an ANDA
and FDA approval, Argentum cannot market such a
drug. See 21 U.S.C. § 355(a); 21 C.F.R. § 314.105(a).6
Similarly, no evidence supports Argentum’s assertions that it will “be subject to an immediate patent
infringement suit by Novartis upon the filing of an
ANDA,” Pet. 3, that the “risk of an infringement suit
and the resulting automatic stay block Argentum
from market entry,” id. at 4, or that it “stands to lose
significant investment in its joint development of a
market-ready generic fingolimod,” id.7
was to establish the elements of standing as of the time of its
appeal; later events cannot confer standing retrospectively. See
Lujan, 504 U.S. at 570 n.5.
6
Moreover, there is no evidence that there are “millions” of
Gilenya® patients—or even individuals with multiple sclerosis—
in the United States. Pet. 2.
7
Argentum repeats variations of these unsupported assertions throughout its petition. See, e.g., Pet. 8 (“Argentum and its
manufacturing partner KVK have been working to commercialize an affordable, generic version of Gilenya. This joint venture
is ready to bring a generic version to market.” (citation omitted));
id. at 15 (“The generic version of Gilenya will also be produced
25
Argentum argues that it “is ready and eager to
bring a competitive generic to market,” Pet. 5, but
there is no evidence to support that argument. In this
respect and others, Argentum makes no effort to engage the Federal Circuit’s factual finding that its declarations were insufficient to establish injury in fact.
Because that correct finding formed the sole basis for
the court of appeals’ holding that Argentum lacked
standing, this Court should deny review.
Argentum’s failure to adduce sufficient evidence
to establish Article III standing does not suggest that
the Federal Circuit “decided an important question of
federal law.” Sup. Ct. R. 10(c). To the contrary, Argentum’s petition seeks fact-bound error correction in
a case where the court of appeals did not err.
and commercialized from” the manufacturing facilities acquired
by KVK); id. (“All necessary work to commercialize the generic
version of Gilenya has been completed. In other words, Argentum’s generic version of Gilenya is market ready subject to FDA
approval.” (citation omitted)); id. (“With its investments and expected revenues approaching $50 million annually, Argentum
has a concrete and personal stake in bringing its fingolimod to
market free of any encumbrances by the ’405 patent and threats
of litigation by Novartis.”); id. at 17 (“Argentum’s opposition established that it is not a non-practicing entity.”).
26
CONCLUSION
The petition for a writ of certiorari should be denied.
Respectfully submitted.
JANE M. LOVE, PH.D.
GIBSON, DUNN & CRUTCHER LLP
200 Park Avenue
New York, NY 10166
(212) 351-4000
MARK A. PERRY
Counsel of Record
JACOB T. SPENCER
GIBSON, DUNN & CRUTCHER LLP
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036
(202) 955-8500
MPerry@gibsondunn.com
Counsel for Respondent
February 16, 2021
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.