Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company

United States Court of Appeals
for the Federal Circuit
______________________
MOMENTA PHARMACEUTICALS, INC.,
Appellant
v.
BRISTOL-MYERS SQUIBB COMPANY,
Appellee
______________________
2017-1694
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2015-
01537.
______________________
Decided: February 7, 2019
______________________
DEANNE MAYNARD, Morrison & Foerster LLP, Wash-
ington, DC, argued for appellant. Also represented by
SETH W. LLOYD, BRIAN ROBERT MATSUI, JOSEPH R.
PALMORE; BRIAN M. KRAMER, San Diego, CA.
CHRISTOPHER NEIL SIPES, Covington & Burling LLP,
Washington, DC, argued for appellee. Also represented by
BRADLEY KEITH ERVIN, MEGAN PATRICIA KEANE, GEORGE
FRANK PAPPAS.
WILLIAM BARNETT SCHULTZ, Zuckerman Spaeder LLP,
Washington, DC, for amicus curiae Association for
2 MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO.
Accessible Medicines. Also represented by CARLOS T.
ANGULO, JEREMY KREISBERG.
BRIAN MATTHEW BOYNTON, Wilmer Cutler Pickering
Hale and Dorr LLP, Washington, DC, for amici curiae
Pharmaceutical Research and Manufacturers of America,
Biotechnology Innovation Organization. Also represented
by CHRISTOPHER ASTA, THOMAS SAUNDERS.
______________________
Before NEWMAN, DYK, and CHEN, Circuit Judges.
NEWMAN, Circuit Judge.
Momenta Pharmaceuticals, Inc. (“Momenta”) appeals
the decision of the Patent Trial and Appeal Board (“PTAB”
or “Board”) sustaining patentability of claims 1 through 15
(all the claims) of United States Patent No. 8,476,239 (“the
’239 Patent”) owned by Bristol-Myers Squibb Company
(“BMS”). 1 The appeal is dismissed for absence of stand-
ing/jurisdiction and for mootness. 2
BACKGROUND
The ’239 Patent, entitled “Stable Protein Formula-
tions,” describes and claims specific fluid formulations of
the protein molecule CTLA4Ig (cytotoxic T-lymphocyte as-
sociated protein 4 immunoglobulin), an immunosuppres-
sive agent used in treatment of immune system disorders
such as rheumatoid arthritis. The product has the common
name “abatacept” and the BMS brand name Orencia®.
1 Momenta Pharm., Inc. v. Bristol-Myers Squibb Co.,
2016 WL 7987985 (P.T.A.B. Dec. 22, 2016).
2 Momenta’s unopposed Motion to amend Protective
Order (Dkt. 101), filed Nov. 2, 2018, is granted. BMS’s un-
opposed Motion to Supplement the Record on Standing
(Dkt. 90-1), filed Nov. 11, 2017, is granted.
MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO. 3
Momenta in July 2015 petitioned the United States Pa-
tent & Trademark Office (“PTO”) for Inter Partes Review
of the ’239 Patent, in accordance with the post-grant review
provisions of the America Invents Act, codified at 35 U.S.C.
§ 311 et seq. At that time Momenta was reportedly at-
tempting to develop a biosimilar counterpart of Orencia®.
The PTAB instituted review, conducted trial, and sus-
tained patentability of the ’239 Patent claims.
Momenta filed an appeal to the Federal Circuit, as pro-
vided by 35 U.S.C. § 319:
35 U.S.C. § 319. Appeal
A party dissatisfied with the final written decision
of the Patent Trial and Appeal Board under section
318(a) may appeal the decision pursuant to sec-
tions 141 [appeal to the Federal Circuit] through
144. Any party to the inter partes review shall
have the right to be a party to the appeal.
BMS moved to dismiss the appeal, stating that Momenta
does not have standing to invoke federal court jurisdiction,
citing the constitutional requirements of Article III. BMS
stated that Momenta’s proposed product had failed its
Phase 1 clinical trials and had been withdrawn.
Momenta responded that it had not abandoned its in-
tent to produce a counterpart of the Orencia® product, that
the ’239 Patent is an obstacle to these activities, and that
it is injured by the estoppel provision, 35 U.S.C. § 315(e).
Momenta stated that this appeal meets the criteria of Ar-
ticle III, citing the “relaxed” standard for Article III com-
pliance when the right of appeal is established by statute.
We duly heard argument on the motion to dismiss and on
the merits of the appeal, and took the case under submis-
sion.
On October 1, 2018, Momenta filed a Letter under Fed.
R. App. P. 28(j), enclosing a press release captioned “Mo-
menta Pharmaceuticals Completes Strategic Review to
4 MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO.
Refocus its Operations and Drive Shareholder Value.”
(Dkt. 98). The press release announced “the completion of
its strategic review aimed at reducing costs of biosimilar
development,” and that “[t]he Company has initiated dis-
cussions with its collaboration partner, Mylan, to exit its
participation in the development of its other five biosimilar
programs including M834, a proposed biosimilar to
ORENCIA®, and intends to focus solely on the continued
development of M710 [proposed biosimilar to EYLEA®].”
Press release, at 1. Momenta’s Letter stated that it “will
promptly inform the Court of any outcome of its discussions
with Mylan that might affect this Court’s ongoing jurisdic-
tion.” Letter, at 1. BMS responded that this information
confirms Momenta’s lack of standing to appeal. (Dkt. 99).
Momenta did not further communicate to the court,
and on October 23, 2018 we issued an Order to Show Cause
why the appeal should not be dismissed as moot. (Dkt. 100).
Momenta responded on November 2, 2018, stating that the
appeal was not moot because:
As of today, the companies continue to be jointly
responsible under that agreement for product de-
velopment and for sharing the costs of that devel-
opment, which are substantial. And because of
BMS’s patent and the Board’s decision upholding
it, Momenta and its partner Mylan still face the
same fork in the road about the commercial formu-
lation for their biosimilar product—they must de-
cide whether to proceed with the current
formulation or switch to a more expensive and po-
tentially less commercially viable option. That de-
cision and the costs associated with it still turn on
the outcome of this appeal.
Momenta Response to Order to Show Cause, at 2–3 (Dkt.
102). Momenta included a Declaration of its Chief Busi-
ness Officer, Young Kwon, who declared that “[t]he parties
have not yet reached an understanding about whether or
MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO. 5
when any termination notice will be delivered,” Declara-
tion, ¶5, and recited Momenta’s economic interest in any
Orencia® biosimilar that might be developed by Mylan,
and Momenta’s potential right to royalties from Mylan
should this product be developed by Mylan. Id. at ¶6.
BMS responded that a third party’s possible future de-
velopment of this abandoned product does not provide con-
stitutional standing to Momenta. BMS stated that
Momenta’s “possible future royalty . . . is too speculative to
support standing,” BMS Response to Order to Show Cause,
at 7, November 13, 2018 (Dkt. 104), and that “hypothetical
future harm falls short of the ‘certainly impending’ injury-
in-fact required by Article III.” BMS Letter, at 1, October
3, 2018 (Dkt. 99) (quoting Clapper v. Amnesty Int’l USA,
568 U.S. 398, 402 (2013)). In Clapper the Court stated that
“we have repeatedly reiterated that ‘threatened injury
must be certainly impending to constitute injury in fact,’
and that ‘[a]llegations of possible future injury’ are not suf-
ficient.” 568 U.S. at 409 (emphases original) (quoting
Whitmore v. Arkansas, 495 U.S. 149, 158 (1990)).
On December 10, 2018 BMS filed another Letter under
Rule 28(j), enclosing a Preliminary Prospectus Supplement
and a Form 8-K that Momenta had filed with the Securities
and Exchange Commission on December 6, 2018. These
documents state:
We have elected to terminate our collaboration
agreement with Mylan with respect to the develop-
ment of . . . M834, a proposed biosimilar to
ORENCIA® . . . . On November 19, 2018, we deliv-
ered a formal notice of this partial termination to
Mylan, as provided in the collaboration agreement.
Preliminary Prospectus Supplement at S-2; Form 8-K at 3.
(Dkt. 105). BMS states that these documents confirm Mo-
menta’s lack of or loss of standing, and establish that the
appeal is moot. Momenta has not responded, and has not
withdrawn its appeal.
6 MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO.
DISCUSSION
“No principle is more fundamental to the judiciary’s
proper role in our system of government than the constitu-
tional limitation of federal-court jurisdiction to actual cases
or controversies.” DaimlerChrysler Corp. v. Cuno, 547 U.S.
332, 341–42 (2006) (quoting Raines v. Byrd, 521 U.S. 811,
818 (1997)).
Precedent has distinguished the standards for statuto-
rily authorized appeals of decisions of administrative agen-
cies, compared with the jurisdictional standards for
bringing a declaratory action directly in federal court. The
Court stated in Lujan v. Defenders of Wildlife, 504 U.S. 555
(1992):
The person who has been accorded a procedural
right to protect his concrete interests can assert
that right without meeting all the normal stand-
ards for redressability and immediacy.
Id. at 572 n.7; see also Massachusetts v. E.P.A., 549 U.S.
497, 517–18 (2007). The Court stated that Congress may
“elevat[e] to the status of legally cognizable injuries con-
crete, de facto injuries that were previously inadequate in
law.” Lujan, 504 U.S. at 578. However, the appellant must
always have a “concrete and particularized” interest in the
outcome – an interest, to the extent one existed, that has
now been eliminated by Momenta. Id. at 560.
The Court in Summers v. Earth Island Institute, 555
U.S. 488 (2009) elaborated that although the criteria of im-
mediacy and redressability may be relaxed on appropriate
facts, “[u]nlike redressability, however, the requirement of
injury in fact is a hard floor of Article III jurisdiction that
cannot be removed by statute.” Id. at 497. The Court reit-
erated that “Article III standing requires a concrete injury
even in the context of a statutory violation.” Spokeo, Inc.
v. Robins, 136 S. Ct. 1540, 1549 (2016).
MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO. 7
It is established that the “‘case’ and ‘controversy’ re-
strictions for standing do not apply to matters before ad-
ministrative agencies and boards, such as the PTO,”
Ritchie v. Simpson, 170 F.3d 1092, 1094 (Fed. Cir. 1999).
The Court recognized that “[p]arties that initiate the [Inter
Partes Review] proceeding need not have a concrete stake
in the outcome; indeed, they may lack constitutional stand-
ing.” Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct.
2131, 2143–44 (2016).
Although the statutory grant of judicial review may
“relax” the Article III criteria, judicial review of agency ac-
tion remains subject to the constitutional foundation of in-
jury-in-fact, lest the court occupy only an advisory role.
Consumer Watchdog v. Wis. Alumni Research Found., 753
F.3d 1258, 1262 (Fed. Cir. 2014); see also Raines, 521 U.S.
at 820 n.3 (“Congress cannot erase Article III’s standing
requirements by statutorily granting the right to sue to a
plaintiff who would not otherwise have standing.” (citing
Gladstone, Realtors v. Village of Bellwood, 441 U.S. 91, 100
(1979))); Preiser v. Newkirk, 422 U.S. 395, 401 (1975) (“[A]
federal court has neither the power to render advisory
opinions nor to decide questions that cannot affect the
rights of litigants in the case before them.” (internal cita-
tion and quotation marks omitted)).
Although Momenta had initially stressed that it had
spent millions of dollars in its development of an Orencia®
biosimilar, now upon Momenta’s termination of all poten-
tially infringing activity, Momenta has not shown “an in-
vasion of a legally protected interest” that is “actual or
imminent, not conjectural or hypothetical.” See Lujan, 504
U.S. at 560. On abandoning development of this product,
Momenta has no legally protected interest in the validity
of the ’239 Patent, and there is no “real need to exercise the
8 MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO.
power of judicial review.” Warth v. Seldin, 422 U.S. 490,
508 (1975). 3
Momenta argues that since the purpose of the America
Invents Act is to provide an alternative to district court lit-
igation, appeal should be available from the PTAB as it
would be available from a district court decision. Momenta
states that the estoppel provision provides injury-in-fact,
and that this suffices to support constitutional standing.
However, estoppel of Momenta is irrelevant now that Mo-
menta has “exited” its development of the Orencia® prod-
uct. Estoppel cannot constitute an injury-in-fact when
Momenta “is not engaged in any activity that would give
rise to a possible infringement suit.” Consumer Watchdog,
753 F.3d at 1262; see also Hollingsworth v. Perry, 570 U.S.
693, 704 (2013) (the party must be in the position of
“seek[ing] a remedy for a personal and tangible harm”);
Gill v. Whitford, 138 S. Ct. 1916, 1929 (2018) (“the require-
ment of such a personal stake [in the outcome] ‘ensures
that courts exercise power that is judicial in nature’” (quot-
ing Lance v. Coffman, 549 U.S. 437, 441 (2007))).
Momenta’s argument that it might at some future time
receive a royalty from Mylan, if Mylan should produce an
Orencia® biosimilar, has no support in precedent. See
Clapper, 568 U.S. at 414 n.5 (To establish Article III stand-
ing, “[p]laintiffs cannot rely on speculation about the
3 The legislative record on enactment of the America
Invents Act, e.g., H.R. Rep. No. 112-98, pt. 1 (2011) at 45-
47, suggests that judicial review was explicitly provided in
inter partes reexamination and then in inter partes review
because the limitation on the right to appeal from ex parte
reexamination had “proved to make it a less viable alter-
native . . . than Congress intended.” Id. at 45. However,
the legislative record does not suggest a congressional in-
tent to adjust the application of Article III to PTAB ap-
peals.
MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO. 9
unfettered choices made by independent actors not before
the court.” (internal quotation marks and citation omit-
ted)); United Transp. Union v. ICC, 891 F.2d 908, 912 (D.C.
Cir. 1989) (“[F]or standing purposes, we may reject as
overly speculative those links which are predictions of fu-
ture events (especially future actions to be taken by third
parties).”).
The Federal Circuit has applied these principles to var-
ied facts in several America Invents Act appeals from
PTAB decisions. In Consumer Watchdog the court held
that a general public interest without a particularized or
personal interest and injury does not provide standing to
appeal a decision of the PTAB. 753 F.3d at 1262–63. In
Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1173–76
(Fed. Cir. 2017), the court held that Phigenix did not
achieve standing based on Phigenix’s assertion of a possi-
ble future economic interest.
In RPX Corp. v. ChanBond LLC, No. 17–2346, ECF 39
(Fed. Cir. Jan. 17, 2018), the court held there was not
standing to appeal because it was “undisputed that RPX is
not engaged in any potentially infringing activity regard-
ing the ’822 patent.” Id. at *5. In JTEKT Corp. v. GKN
Automotive Ltd., the court opined that there may be cir-
cumstances in which a PTAB petitioner “has no product on
the market at the present time” yet “does not preclude Ar-
ticle III standing,” provided that the petitioner has “con-
crete plans for future activity that creates a substantial
risk of future infringement.” 898 F.3d 1217, 1220–21
(Fed. Cir. 2018) (citing Altaire Pharm., Inc. v. Paragon Bi-
oteck, Inc., 889 F.3d 1274, 1280–83 (Fed. Cir. 2018), re-
mand order modified by stipulation, 738 F. App’x 1017
(Fed. Cir. 2018)).
In E.I. DuPont de Nemours & Co. v. Synvina C.V., 904
F.3d 996, 1005 (Fed. Cir. 2018), the court held that appeal
was available because the parties were direct competitors
and were in commercial dispute, and the petitioners faced
10 MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO.
a significant risk of patent infringement in their demon-
stration plant that was entering into operation. The court
determined that the actions implicating the ’921 patent in-
cluded “significant ‘involvement in research [and] commer-
cial activities involving’ the claimed subject matter” and
explained that standing was present “because DuPont ‘has
concrete plans’ for present and ‘future activity that create[]
a substantial risk of future infringement or likely cause the
patentee to assert a claim of infringement.’” Id. (citations
omitted).
However, Momenta has now made clear that no con-
crete plans are afoot.
Momenta also argues that since it was engaged in in-
fringing activity when these proceedings began, it has not
lost its standing to complete the review. However, even
though Momenta may have been working in pursuit of po-
tentially infringing activity, it is established that jurisdic-
tion must exist throughout the judicial review, and an
intervening abandonment of the controversy produces loss
of jurisdiction. See Arizonans for Official English v. Ari-
zona, 520 U.S. 43, 67 (1997) (“[A]n actual controversy must
be extant at all stages of review, not merely at the time the
complaint is filed.” (citations omitted)); Friends of the
Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S.
167, 189 (2000) (“The requisite personal interest that must
exist at the commencement of the litigation (standing)
must continue throughout its existence (mootness).” (inter-
nal citation and quotation marks omitted)).
Standing and mootness may not be coextensive in all
cases. See Friends of the Earth, 528 U.S. at 189–90. How-
ever, when the potential for injury has been mooted by
events, the federal courts are deprived of jurisdiction. See
California v. San Pablo & Tulare R. Co., 149 U.S. 308, 313–
14 (1893). If a case does not “present a ‘case or controversy’
due to developments during litigation, those claims become
moot.” Canadian Lumber Trade Alliance v. United States,
MOMENTA PHARM., INC. v. BRISTOL-MYERS SQUIBB CO. 11
517 F.3d 1319, 1338 (Fed. Cir. 2008). Precedent illustrates
exceptions to mootness, for example when the issue has
avoided review and is likely to be repeated, or when the
defendant voluntarily ceased the challenged activity and
the plaintiff seeks to preserve its win. See, e.g., Milwaukee
Police Ass’n v. Bd. of Fire & Police Comm’rs of the City of
Milwaukee, 708 F.3d 921, 929–30 (7th Cir. 2013). In es-
sence, “mootness is the doctrine of standing set in a time
frame; that is, the requisite personal interest that must ex-
ist at the time of commencement of the litigation (standing)
must continue throughout its existence (mootness).” Id. at
929 (quotations and alteration omitted).
Here the cessation of potential infringement means
that Momenta no longer has the potential for injury,
thereby mooting the inquiry.
“The rules of standing, whether as aspects of the Art.
III case-or-controversy requirement or as reflections of pru-
dential considerations defining and limiting the role of the
courts, are threshold determinants of the propriety of judi-
cial intervention.” Warth, 422 U.S. at 517–18. It is appar-
ent that Momenta does not have standing to maintain this
appeal in the federal courts.
CONCLUSION
Momenta does not have standing to invoke federal ap-
pellant jurisdiction, and the appeal is mooted by Mo-
menta’s discontinuance of any potentially infringing
activity.
APPEAL DISMISSED