Case: 17-1694
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`Document: 106
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`Page: 1
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`Filed: 02/07/2019
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`@Hniteh games (fllnurt of gppeals
`
`fur the jeheral QEirtuit
`
`MOMENTA PHARMACEUTICALS, INC.,
`Appellant
`
`V.
`
`BRISTOL-MYERS SQUIBB COMPANY,
`Appellec
`
`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
`
`

`

`Case: 17-1694
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`Document: 106
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`2
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`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”).l 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.
`
`

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`MOMENTA PHARM., INC. V. BRISTOL-MYERS SQUIBB CO.
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`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. § 31.9:
`
`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 courtjurisdiction,
`citing the constitutionalrequirements 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. 280'), enclosing a press release captioned “Mo-
`menta Pharmaceuticals Completes Strategic Review to
`
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`MOMENTA PHARM., INC. V, BRISTOL'MYERS SQUIBB CO.
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`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 1V1834,
`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. EMS 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
`
`

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`MOMENTA PHARM., INC. V. BIRTS’J‘OL-MYERS SQUIBB CO.
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`5
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`when any termination notice will be delivered,” Declara-
`tion, 1[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 1I6.
`
`BMS responded that a third party’s possible future de-
`velopment of this abandoned product does not provide con-
`’
`M
`stitutional standing to Momenta.
`BMS stated that
`.
`Momentas 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 u. 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 U. Arkansas, 495 U.S. 149, 158 (1990)).
`
`On December 10, 2018 EMS filed another Letter under
`Rule 286), 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.
`
`

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`MOMENTA PHARIVI., 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. U. Cuno, 547 US.
`332, 341—42 (2006) (quoting Raines U. Byrd, 521 US. 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 u. Defenders of Wildlife, 504 US 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 Massaclmsetts u. E.P.A., 549 US.
`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 US. 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 U. Earth Island Institute, 555
`US. 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.
`U. Robins, 136 S. Ct. 1540, 1549 (2016).
`
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`7
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`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 U. Simpson, 170 F.3d 1092, 1094 (Fed. Cir. 1999).
`The Court recognized that “[plarties 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 0. 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 u. Wis. Alumni Research Found, 753
`F.3d 1258, 1262 (Fed. Cir. 2014); see also Raines, 521 US.
`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 0. Village ofBellwoocl, 441 US. 91, 100
`(1979)»; Preiser‘ u. New/atria, 422 US. 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, Moment-a has not shown “an in-
`vasion of a legally protected interest” that is “actual or
`imminent, not conjectural or hypothetical.” See Lujan, 504
`US. 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
`
`

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`MOMENTA PHARM., INC. V. BRIS'J‘OL-IVIYERS SQUIBB CO.
`
`power ofjudicial review.” Warm u. Seldin, 422 US. 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 Hallingswor‘t/i U. Perry, 570 US.
`693, 704 (2013) (the party must be in the position of
`“seek[ing] a remedy for a personal and tangible harm”);
`Gill 0. 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 U. Coffman, 549 US. 437, 441 (2007»).
`
`Momenta’s argument that it might at some future time
`receive a royalty from Mylan, if Mylan should produ‘ce an
`Orencia® biosimilar, has no support in precedent.
`See
`Clapper, 568 U.S. at 414 11.5 (To establish Article III stand-
`ing, “[p]laintiffs cannot
`rely on speculation about
`the
`
`The legislative record on enactment of the America
`3
`Invents Act, e.g., HR. 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 par-fies 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.
`
`

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`MOMENTA PHARM., INC. V. BRISTOL-MYERS SQUIBB CO.
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`9
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`unfettered choices made by independent actors not before
`the court.” (internal quotation marks and citation omit-
`ted)); United Transp. Union u. ICC, 891 F.2d 908, 912 (DC.
`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.
`I)”.7)1.I(-7’I,Og(37’l,, Inca, 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. U. 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. U. 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 Altai/'8 Pharm.., Inc. 0. 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]. DuPont dc Nenmws & C0. U. Synuina 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
`
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`MOMENTA PI-IARM., INC. V. BRISTOL-MYERS SQUIBB CO.
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`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 Arizona/is for Official English U. Ari-
`zona, 520 US. 43, 67 (1997) (“[Ahi 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. U. Laidlaw Erie/i. Serus. (TOG), Inc, 528 US.
`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 oft/ie Earth, 528 US. at 189430. How-
`ever, when the potential for injury has been mooted by
`events, the federal courts are deprived of jurisdiction. See
`California 0. San, Pablo & Tulare R. (10., 149 US. 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,
`
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`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 \vin. See, e. g, Milwaukee
`Police Ass’n v.'Bcl. o/‘Fire & Police Con'1,m,’r's 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.” Wart/l, 422 US. 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
`
`

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`@niteh States (Enurt of gnpealg
`
`for the 31727321731 @irtutt
`
`MOMEN'I‘A FHA R MAC EU’I‘I CALS, IN C.,
`
`Appe/ [(1 77,!
`
`BRISTOL—MYERS SQUIBB COMPANY,
`
`A ulna/[cw
`
`2017-1694-
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2015-
`01537.
`
`JUDGMENT
`
`THIS CAUSE having been considered, it is
`
`' ORDERED AND ADJUDGE'D:
`
`DISMISSED
`
`ENTERED BY ORDER 0}“ THE COURT
`
`Februag 7 2019
`
`/_s/ Peter R. Marks’ceiner
`Peter R. Marksteiner
`
`Clerk of Court
`
`

`

`Case: 17-1694
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`Document: 108
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`Page: 1
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`Filed: 03/18/2019
`
`@Hniteh étatez Qtnurt of appeals
`
`for the jfeheral (Eirwit
`
`MOMENTA PHARMACEUTICALS, INC,
`
`‘ lppeilartt
`
`BRISTOL-MYERS SQUIBB COMPANY,
`
`‘ l[we] 1’00
`
`2017-1694
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2015-
`01537.
`
`MANDATE
`
`In‘ accordance with the judgment of this Court, entered
`February 07, 2019, and pursuant to Rule 41 of the Federal
`Rules of Appellate Procedure,
`the formal mandate is
`hereby issued.
`
`March 18, 2019
`
`FOR THE COURT
`
`/s/ Peter R. Marksteiner
`Peter R. Marksteiner
`Clerk of Court
`
`