Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc.

United States Court of Appeals
for the Federal Circuit
______________________
ALTAIRE PHARMACEUTICALS, INC.,
Appellant
v.
PARAGON BIOTECK, INC.,
Appellee
______________________
2017-1487
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. PGR2015-
00011.
______________________
Decided: May 2, 2018
______________________
CRAIG E. COUNTRYMAN, Fish & Richardson, PC, San
Diego, CA, argued for appellant. Also represented by
OLIVER RICHARDS; CHARLES W. SABER, DIPU A. DOSHI,
JONATHAN W.S. ENGLAND, MARK J. THRONSON, Blank
Rome LLP, Washington, DC.
RICHARD TORCZON, Wilson, Sonsini, Goodrich &
Rosati, PC, Washington, DC, argued for appellee. Also
represented by MICHAEL T. ROSATO, ANDREW SWANSON
BROWN, SONJA ROCHELLE GERRARD, STEVEN WILLIAM
PARMELEE, Seattle, WA; DOUGLAS H. CARSTEN, San Diego,
CA.
2 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
______________________
Before O’MALLEY, SCHALL, and WALLACH, Circuit Judges.
Opinion for the court filed by Circuit Judge WALLACH.
Dissenting opinion filed by Circuit Judge SCHALL.
WALLACH, Circuit Judge.
Appellant Altaire Pharmaceuticals, Inc. (“Altaire”)
sought post-grant review of claims 1–13 (“the Asserted
Claims”) of Appellee Paragon Bioteck, Inc.’s (“Paragon”)
U.S. Patent No. 8,859,623 (“the ’623 patent”). The U.S.
Patent and Trademark Office’s Patent Trial and Appeal
Board (“PTAB”) issued a final written decision determin-
ing that Altaire failed to prove that the Asserted Claims
were unpatentable for obviousness over two production
lots of Altaire’s phenylephrine hydrochloride ophthalmic
solution products, Lots #11578 and #11581, 1 which are
used to dilate patients’ pupils. See Altaire Pharm., Inc. v.
Paragon Bioteck, Inc., No. PGR2015-00011 (P.T.A.B. Nov.
14, 2016) (J.A. 1–21).
Altaire appeals. We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(4)(A) (2012). We reverse-in-part, vacate-
in-part, and remand.
BACKGROUND
I. The Relevant Facts
Phenylephrine contains a chiral center with two enan-
tiomers known as R- and S-phenylephrine hydrochloride.
J.A. 2; see J.A. 1150. The R-phenylephrine hydrochloride,
1 Lots #11581 and #11582 are the same formula-
tion. J.A. 738. Altaire relied on testing performed on Lot
#11582 to support its assertion that the Asserted Claims
would have been obvious over Lots #11578 and #11581.
See, e.g., J.A. 737–38.
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 3
but not the S-phenylephrine hydrochloride, is useful to
dilate pupils. See ’623 patent col. 6 ll. 21–30; see also
J.A. 737. To determine the phenylephrine hydrochloride
products’ effectiveness, industry members measure the
products’ “chiral purity,” which is the relative amount of
each enantiomer expressed as a percentage. See ’623
patent col. 1 ll. 15–20, col. 3 ll. 43–48; see also J.A. 750.
By 2000, Altaire was manufacturing R-phenylephrine
hydrochloride products, including products containing
2.5% and 10% phenylephrine hydrochloride ophthalmic
solution. J.A. 733. In 2011, Altaire and Paragon entered
into an agreement to pursue U.S. Food and Drug Admin-
istration (“FDA”) approval for Altaire’s products. See
J.A. 1909–13 (“the Agreement”). Pursuant to the Agree-
ment, “Paragon shall be responsible for preparing and
submitting the [new drug] applications [(‘NDAs’)] in
support of the products,” and “Altaire will provide and
bear the costs for the chemistry, manufacturing, and
controls . . . in support of an NDA filing for the products.”
J.A. 1910 (capitalization modified).
Paragon submitted an NDA, and the FDA responded
by recommending that Paragon, inter alia, “[c]onsider
adding a chiral purity test to the d[r]ug product specifica-
tion or provide a justification for not doing so.” J.A. 773.
In response, Altaire measured the optical rotation of Lot
#11578, a 2.5% phenylephrine hydrochloride ophthalmic
solution product, and Lot #11582, a 10% phenylephrine
hydrochloride ophthalmic solution product, see J.A. 783–
91; see also ’623 patent col. 4 ll. 33–34 (“[I]t is known in
the art chiral purity can be determined by optical rota-
tion.”). Altaire provided a summary of these optical
rotation test results to Paragon, and Paragon submitted a
supplementary NDA filing to the FDA, which approved
Paragon’s NDA in March 2013. J.A. 739; see J.A. 783–91.
In addition to the optical rotation tests, Altaire conducted
high performance liquid chromatography (“HPLC”) test-
4 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
ing on Lots #11578 and #11582, which it internally refers
to as “TMQC-247.” J.A. 11, 802.
In June 2013, Paragon’s counsel proposed an amend-
ment to the Agreement “to address [a] new patent appli-
cation filing . . . discussed with Altaire.” J.A. 1840.
Altaire responded that: “the formulation, processes[,] and
controls applicable to the . . . product[s] were developed
solely by [Altaire’s Chief Executive Mr.] Al Sawaya and
Altaire[] and are . . . the proprietary and confidential
information of Altaire”; the Agreement “does not contem-
plate Paragon using such information to support a patent
application”; and “any such patent application should
identify either [Mr.] Al Sawaya or Altaire as the sole
inventor.” J.A. 1839. Although Paragon’s counsel re-
sponded that they “look[ed] forward to further discus-
sions,” J.A. 1839, there is no indication in the record that
Paragon’s counsel responded to the substantive comments
raised by Altaire.
In November 2013, Paragon filed a drug patent appli-
cation that issued as the ’623 patent. J.A. 22. Entitled
“Methods and Compositions of Stable Phenylephrine
Formulations,” the ’623 patent includes thirteen claims.
’623 patent col. 12 l. 39–col. 13 l. 14. Independent claim 1
is illustrative and recites:
A method of using an ophthalmic composition for
pupil dilation, the composition comprising R-
phenylephrine hydrochloride having an initial
chiral purity of at least 95% and an aqueous buff-
er, wherein the chiral purity of R-phenylephrine
hydrochloride is at least 95% of the initial chiral
purity after 6 months, the method comprising:
administering the composition into an eye
of an individual in need thereof, wherein
the composition is stored between -10 to
10 degree Celsius prior to administration,
and wherein the composition comprises R-
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 5
phenylephrine hydrochloride having a chi-
ral purity of at least 95% when adminis-
tered after storage.
Id. col. 12 ll. 39–50. Dependent claims 2–13 depend from
independent claim 1, either directly or indirectly. See id.
col. 12 l. 51–col. 13 l. 14.
In March 2014, while the application that led to the
’623 patent was being prosecuted, Paragon requested “all
the work [Altaire] ha[s] on chiral purity” for its annual
report to the FDA. J.A. 1606. In response, Altaire sent
Paragon a report purporting to confirm that Altaire’s
TMQC-247 methodology accurately measures relative
quantities of R- or S-phenylephrine hydrochloride.
J.A. 1602; see J.A. 1536–601, 1603–05.
In April 2015, Altaire filed a complaint against Para-
gon in the U.S. District Court for the Eastern District of
New York (“Eastern District”), alleging that Paragon
breached a nondisclosure clause of the Agreement be-
tween the parties, see Appellant’s Br. viii; Appellee’s
Br. vii, and Paragon responded by alleging that Altaire
materially breached the nondisclosure clause and seeking
the right to terminate the Agreement, J.A. 1012, 1020; see
J.A. 1911–12 (Non-Disclosure Clause). In April 2017,
Altaire filed another complaint against Paragon in the
Eastern District, seeking a declaratory judgment of
invalidity of the ’623 patent. See Appellant’s Br. viii;
Appellee’s Br. vii, 22–23. At the time of argument, both of
these actions were pending.
II. Procedural History
In May 2015, Altaire filed a petition for post-grant re-
view of the ’623 patent, arguing that the Asserted Claims
would have been obvious over Lots #11578 and #11581,
see J.A. 37–114, and attaching the supporting declaration
6 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
of Mr. Al Sawaya 2 (“First Al Sawaya Declaration”), see
J.A. 732–61. As relevant here, Altaire contended that:
the product labeling of Lots #11578 and #11581 instructed
that the products should be stored between 2 and 8 de-
grees Celsius, see J.A. 50–52, 733–35, which is within the
-10 to 10 degrees Celsius range required by the Asserted
Claims, see ’623 patent col. 12 l. 47; and the TMQC-247
test results demonstrated that Lots #11578 and #11581
remained at 99.99% chiral purity, see J.A. 65–69, 745–51,
796–99, 802–03, which exceeds the 95% chiral purity
minimum of the Asserted Claims, see ’623 patent col. 12
l. 50.
Paragon filed a preliminary response. See J.A. 804–
47. As relevant here, Paragon argued that: Mr. Al
Sawaya “is not an expert or even [a person having] ordi-
nary skill in the art [(‘PHOSITA’)], but rather, a fact
witness,” J.A. 824; see J.A. 824–26; and “the techniques
upon which the petition relies—i.e., (1) a [United States
Pharmacopeia (‘USP’)] standard HPLC protocol” that does
not measure relative quantities of R- or S-phenylephrine
hydrochloride; and “(2) an optical rotation comparison—
cannot reliably determine chiral purity,” J.A. 818; see
J.A. 818–24.
The PTAB determined that “it is more likely than not
that [the Asserted Claims] of the ’623 patent are un-
patentable as obvious over Altaire’s [p]roduct[s]” and
instituted post-grant review. J.A. 1079; see J.A. 1061–81.
In its patent owner response, Paragon, inter alia, reiter-
ated its challenge to the First Al Sawaya Declaration, see
J.A. 1112–15, and contended that the tests Altaire per-
formed on Lots #11578 and #11581 do not satisfy the
requirements of 37 C.F.R. § 42.65(b) (2016), see J.A. 1115–
2 While the record refers to the President of Altaire
as both “Al Sawaya” and “Assad Sawaya,” we refer to him
as “Mr. Al Sawaya” for consistency.
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 7
22, which requires parties “rel[ying] on a technical test or
data from such a test” to
provide an affidavit explaining: (1) [w]hy the test
or data is being used; (2) [h]ow the test was per-
formed and the data was generated; (3) [h]ow the
data is used to determine a value; (4) [h]ow the
test is regarded in the relevant art; and (5) [a]ny
other information necessary for the [PTAB] to
evaluate the test and data.
37 C.F.R. § 42.65(b).
In its reply, Altaire included a second declaration of
Mr. Al Sawaya (“Second Al Sawaya Declaration”), discuss-
ing his experience in the pharmaceutical industry. See
J.A. 1418–25. Altaire contended that its TMQC-247 test
differs from the standard HPLC test in the USP, see
J.A. 1393–99, and provided additional information regard-
ing how the TMQC-247 test is performed, see J.A. 1505–
601, as well as evidence that this test data previously had
been shared with Paragon during the FDA approval
process, see J.A. 1602–06. 3 Finally, Altaire argued that
Paragon previously acknowledged the validity of optical
rotation test data by submitting them to the FDA and
discussing optical rotation testing in the ’623 patent. See
J.A. 1390, 1401–02.
3 Altaire argued that, regardless of whether the
USP standard HPLC separates R- and S-phenylephrine
hydrochloride, Altaire developed the TMQC-247 testing
method as a “proprietary HPLC procedure” to measure
relative quantities of R- and S-phenylephrine hydrochlo-
ride. J.A. 11; see J.A. 1506. Altaire further contended
that it validated that its TMQC-247 testing method
satisfies the USP testing guidelines. J.A. 12–13; see
J.A. 1539; see also J.A. 971–76.
8 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
In its Final Written Decision, the PTAB determined
that Altaire had failed to prove by a preponderance of the
evidence that the Asserted Claims would have been
obvious. J.A. 20. In reaching this conclusion, the PTAB
determined that Altaire failed to timely qualify Mr. Al
Sawaya as an expert, see J.A. 7–9, the TMQC-247 test
data were entitled to no weight, see J.A. 10–17, and the
optical rotation test data were unpersuasive, see J.A. 17–
20.
DISCUSSION
I. Altaire Has Article III Standing
In its opening brief, 4 Altaire argued that it has Article
III standing “because it faces an imminent risk of suit on
the ’623 patent and it is suffering a concrete reputational
injury based on Paragon’s misappropriation of Altaire’s
invention.” Appellant’s Br. 47; see id. at 47–52; Reply
Br. 28. Paragon opposed, arguing that Altaire lacks
standing “because [Altaire] is not now engaging in infring-
ing activities and any future plans it may have to engage
in infringing activities are, at most, contingent” and that
“Altaire has suffered no reputational injury for failing to
be named as an inventor, and . . . , even if had suffered
such injury, it could not be remedied by post-grant review
4 Before the parties fully briefed this appeal, Para-
gon filed a motion to dismiss, asserting that Altaire
lacked Article III standing to appeal the PTAB’s Final
Written Decision. See Paragon’s Mot. to Dismiss 1, ECF
No. 16. Altaire opposed, see Altaire’s Opp’n to Paragon’s
Mot. to Dismiss 1, ECF No. 25, and Paragon replied, see
Paragon’s Reply in Supp. of Its Mot. to Dismiss 1, ECF
No. 29. A single judge of this court “deem[ed] it the better
course to deny the motion and for the parties to address
standing in their briefs.” Order 2, ECF No. 30.
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 9
of the ’623 patent.” Appellee’s Br. 28, 28–29; see id. at 27–
38.
A. Article III Standing Requirements in an Appeal from a
Final Agency Action
“Standing to sue is a doctrine rooted in the traditional
understanding of a case or controversy” required by
Article III. Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547
(2016); Hollingsworth v. Perry, 570 U.S. 693, 704 (2013)
(explaining that Article III discusses the powers granted
to the judiciary and, inter alia, “confines the judicial
power of federal courts to deciding actual ‘Cases’ or ‘Con-
troversies’” (quoting U.S. Const. art. III, § 2)). “[T]he
irreducible constitutional minimum of standing” consists
of “three elements.” Lujan v. Defs. of Wildlife, 504 U.S.
555, 560 (1992). An appellant “must have (1) suffered an
injury in fact, (2) that is fairly traceable to the challenged
[action], and (3) that is likely to be redressed by a favora-
ble judicial decision.” Spokeo, 136 S. Ct. at 1547 (citations
omitted); see Monsanto Co. v. Geertson Seed Farms, 561
U.S. 139, 150 (2010) (setting forth these three criteria for
standing to challenge the decision of a lower tribunal). 5
The party seeking judicial review, here Altaire, bears the
burden of establishing that it has standing on appeal. See
DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 342 (2006).
5 We recite the standing framework using the des-
ignations “appellant” and “appellee,” rather than “plain-
tiff” and “defendant,” because we are the court of first
instance in an appeal challenging the PTAB’s final writ-
ten decision in a post-grant review. 35 U.S.C. § 141(c)
(2012) (“A party to . . . a post-grant review who is dissatis-
fied with the final written decision of the [PTAB] . . . may
appeal the [PTAB]’s decision only to the . . . Federal
Circuit.”).
10 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
As to the first element, “[t]o establish injury in fact,
a[n appellant] must show that he or she suffered ‘an
invasion of a legally protected interest’ that is ‘concrete
and particularized’ and ‘actual or imminent, not conjec-
tural or hypothetical.’” Spokeo, 136 S. Ct. at 1548 (quot-
ing Lujan, 504 U.S. at 560). A “concrete” injury must
“actually exist” but may be either “tangible” or “intangi-
ble.” Id. at 1548, 1549; see id. at 1549 (explaining that
“the risk of real harm” may “satisfy the requirement of
concreteness”). An injury is “particularized” if it affects
an appellant “in a personal and individual way.” Id. at
1548 (internal quotation marks and citation omitted);
accord Hollingsworth, 570 U.S. at 705.
We recently “established the legal standard for
demonstrating standing in an appeal from a final agency
action,” including “the burden of production[,] the evi-
dence an appellant must produce to meet that burden[,]
and when an appellant must produce that evidence.”
Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1172
(Fed. Cir. 2017) (footnote omitted). We explained that
“[a]n appellant’s obligation to establish injury in fact
remains firm even though it need not meet all the normal
standards for redressability and immediacy when, as
here, a statute provides that appellant with a right to
appeal.” Id. at 1172 n.2 (internal quotation marks and
citation omitted); see 35 U.S.C. § 141(c).
B. Altaire Has Demonstrated Injury in Fact
In support of its Opposition, Altaire appended a decla-
ration of Altaire’s general counsel, Michael Sawaya. See
Altaire’s Opp’n to Paragon’s Mot. to Dismiss Ex. 1, ECF
No. 25 (“Sawaya Opp’n Decl.”). 6 Michael Sawaya testified
6 Paragon does not contest that Altaire’s affidavit
satisfies the summary judgment burden of production, see
generally Appellee’s Br., which may be satisfied by an
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 11
that “Altaire intends to resume marketing its proprietary
formulation of the . . . product[s] in the event
the . . . Agreement is terminated early as is sought by
Paragon in the concurrent district court litigation in the
Eastern District,” placing Altaire “under near immediate
threat of termination of the Agreement.” Sawaya Opp’n
Decl. ¶ 16; see id. ¶¶ 18–19. Michael Sawaya further
testified that Paragon previously sought to terminate the
Agreement in the U.S. District Court for the District of
Oregon but that the action was dismissed. Id. ¶ 17.
According to Michael Sawaya, “Altaire believes that
Paragon will inevitably sue Altaire for patent infringe-
ment upon Altaire filing an [Abbreviated New Drug
Application (‘ANDA’)] with the FDA,” such that “invali-
dating the ’623 patent in the post-grant review proceeding
that is the subject of this appeal is imperative to removing
that patent as an obstacle to the filing and approval of
Altaire’s ANDA.” Id. ¶ 22.
Altaire has sufficiently demonstrated imminent harm.
Although “a fear of future harm that is only subjective is
not an injury or threat of injury . . . that can be the basis
of an Article III case or controversy,” Prasco, LLC v.
Medicis Pharm. Corp., 537 F.3d 1329, 1338 (Fed. Cir.
2008) (citation omitted), “the threat of future injury” may
be sufficient to establish injury in fact if the “threat was
real[ and] imminent,” id. at 1339; see Caraco Pharm.
Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1291 (Fed.
Cir. 2008) (stating that “proving a reasonable apprehen-
sion of suit is . . . one of many ways a [party]
can . . . establish that an action presents a justiciable
Article III controversy”). Here, Paragon is actively seek-
affidavit and which requires the party seeking “review of
a final agency action [whose] standing [has] come[] into
doubt” to produce evidence of standing “at the earliest
possible opportunity,” Phigenix, 845 F.3d at 1172–73.
12 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
ing a declaratory judgment that it has the right to termi-
nate the Agreement in the Eastern District. See
J.A. 1881–82 (asserting a count for “Declaratory Judg-
ment: Right to Terminate” that lists Altaire’s alleged
prior material breaches and states that “Altaire’s prior
material breaches under the Agreement entitle Paragon
to terminate the Agreement and to seek all appropriate
damages”). Even if Paragon does not terminate the
Agreement, it will expire in 2021. See J.A. 1909. Once
the Agreement is terminated, “Altaire intends to
file . . . an ANDA,” Sawaya Opp’n Decl. ¶ 19, and “to
resume marketing its proprietary formulation of
the . . . product[s],” id. ¶ 16, and it previously has demon-
strated its production and marketing capabilities, such
that it will be able to resume operations without difficul-
ty, see id. ¶ 5. Moreover, Michael Sawaya testified to the
imminence of Paragon’s infringement suit, see id. ¶ 22,
and Paragon refused to stipulate that it will not sue
Altaire for infringement of the ’623 patent, see Oral Arg.
at 17:07–18:03, http://oralarguments.cafc.uscourts.gov/
default.aspx?fl=2017-1487.mp3.
While we recognize that “[a] claim is not ripe for adju-
dication if it rests upon contingent future events that may
not occur as anticipated, or indeed may not occur at all,”
Texas v. United States, 523 U.S. 296, 300 (1998) (internal
quotation marks and citation omitted), we conclude that,
under these circumstances, Altaire’s injury is inevitable.
Therefore, Altaire has satisfied its burden of production
by producing sufficient evidence that the threat of in-
fringement litigation is an injury that is “real” and “im-
minent.” Prasco, 537 F.3d at 1339.
Having determined that Altaire faces imminent inju-
ry, we next must determine whether that injury is con-
crete and particularized. See Spokeo, 136 S. Ct. at 1548
(“Particularization is necessary to establish injury in
fact . . . .”); id. (“Concreteness . . . is quite different from
particularization.”). Here, Michael Sawaya explained
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 13
that “invalidating the ’623 patent in the post-grant review
proceeding . . . is imperative to removing that patent as
an obstacle to the filing and approval of Altaire’s ANDA
for its proprietary product[,] which was misappropriated
in the ’623 patent by Paragon.” Sawaya Opp’n Decl. ¶ 22.
Because the Agreement specifically prevents Altaire from
manufacturing its products, we conclude that Altaire has
suffered a “concrete” harm and is affected “in a personal
and individual way.” Spokeo, 136 S. Ct. at 1548.
Altaire’s injury is compounded by the likelihood that
it would be estopped from arguing that the ’623 patent
would have been obvious over Lots #11578 and #11581.
Pursuant to the estoppel provision in 35 U.S.C.
§ 325(e)(2), “[t]he petitioner in a post-grant re-
view . . . may not assert . . . in a civil action . . . that [a]
claim is invalid on any ground that the petitioner raised
or reasonably could have raised during that post-grant
review.” While we have explained that “a similar estoppel
provision ‘does not constitute an injury in fact’
when . . . the appellant ‘is not engaged in any activity that
would give rise to a possible infringement suit,’” Phigenix,
845 F.3d at 1175–76 (brackets omitted) (quoting Consum-
er Watchdog v. Wis. Alumni Research Found., 753 F.3d
1258, 1262 (Fed. Cir. 2014)), this case materially differs
from both past cases. As explained above, Altaire’s injury
is imminent, whereas the appellant in Consumer Watch-
dog “only alleged a general grievance concerning” the
challenged patent, see 753 F.3d at 1263, and the appellant
in Phigenix only alleged its aspirations of licensing its
patent portfolio, see 845 F.3d at 1174. Although we do not
decide whether this potential estoppel effect is sufficient
independently to establish standing, the estoppel effect in
this case further supports Altaire’s claimed injury in fact.
Therefore, considering these factors collectively, we hold
that Altaire has demonstrated injury in fact, see Teva
Pharm. USA, Inc. v. Novartis Pharm. Corp., 482 F.3d
1330, 1341 (Fed. Cir. 2007) (stating that the appellant
14 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
“remains under the threat of an infringement suit” be-
cause the statute of limitations had not yet run and that
“this threat of litigation is a present injury creating a
justiciable controversy”), such that it has standing to
challenge the PTAB’s Final Written Decision, see Phige-
nix, 845 F.3d at 1172 n.2.
II. The PTAB Violated the Administrative Procedure Act
by Refusing to Consider Mr. Al Sawaya’s Testimony, the
TMQC-247 Data, and the Optical Rotation Test Data
A. Standard of Review
“We review the [PTAB]’s procedures for compliance
with the Administrative Procedure Act [(‘APA’)], 5 U.S.C.
§ 551 et seq. [(2012)].” Dell Inc. v. Acceleron, LLC, 818
F.3d 1293, 1298 (Fed. Cir. 2016); see 5 U.S.C. § 706
(providing that “[t]he reviewing court shall . . . (2) hold
unlawful and set aside agency action, findings, and con-
clusions found to be . . . (A) arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law”
(emphasis added)). “We review the PTAB’s decision of
how it manages its permissive rules of trial proceedings
for an abuse of discretion.” Redline Detection, LLC v. Star
Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015) (cita-
tion omitted). “An abuse of discretion occurs if the deci-
sion (1) is clearly unreasonable, arbitrary, or fanciful;
(2) is based on an erroneous conclusion of law; (3) rests on
clearly erroneous fact findings; or (4) involves a record
that contains no evidence on which the [PTAB] could
rationally base its decision.” Id. (internal quotation
marks and citation omitted).
B. Mr. Al Sawaya’s Declarations
The PTAB assigned “no weight” to Mr. Al Sawaya’s
opinion on the TMQC-247 and optical rotation test data in
the First Al Sawaya Declaration because Altaire had
“failed to timely qualify Mr. [Al] Sawaya as an expert
witness in this proceeding.” J.A. 9. In reaching this
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 15
conclusion, the PTAB “decline[d] to consider the [Second
Al] Sawaya [D]eclaration,” which purported to qualify Mr.
Al Sawaya as an expert, “because it [wa]s improper reply
evidence.” J.A. 9. We hold that the PTAB abused its
discretion by failing to consider Mr. Al Sawaya’s testimo-
ny.
Here, the First Al Sawaya Declaration extensively
discussed the results of the TMQC-247 and optical rota-
tion tests. See J.A. 732–61. When Paragon challenged
Mr. Al Sawaya’s qualifications to testify and personal
knowledge of the tests, see J.A. 1112–15, Altaire submit-
ted the Second Al Sawaya Declaration, see J.A. 1418–21,
and appended a copy of Mr. Al Sawaya’s résumé, see
J.A. 1423–25. The Second Al Sawaya Declaration demon-
strates Mr. Al Sawaya’s “over [fifty] years of experience in
the pharmaceutical industry” and “extensive experience
testing and analyzing results for a variety of testing
methodologies relevant to the pharmaceutical field,
including . . . [HPLC] reports[] and optical rotation re-
ports.” J.A. 1418, 1421. Nevertheless, the PTAB ignored
Mr. Al Sawaya’s qualifications, determining that “the
issue here is not whether Mr. [Al] Sawaya qualifies as an
expert witness in the abstract; rather, it is whether
[Altaire] has properly qualified Mr. [Al] Sawaya as an
expert witness with respect to the testimony he has
provided in this proceeding.” J.A. 7. The PTAB erred for
two reasons.
First, § 42.65(b) does not require that the affidavit
corroborating the technical test or data be submitted by
an expert. Cf. Graver Tank & Mfg. Co. v. Linde Air
Prods. Co., 339 U.S. 605, 609 (1950) (stating that, in the
context of the doctrine of equivalents, “[p]roof can be
made in any form,” including “through testimony of
experts or others versed in the technology” (emphasis
added)). Compare 37 C.F.R. § 42.65(a) (discussing
“[e]xpert testimony”), with id. § 42.65(b) (requiring “an
16 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
affidavit” without limiting it to an expert (emphasis
added)).
Second, Paragon challenged Mr. Al Sawaya’s qualifi-
cations to testify and personal knowledge of the tests in
its Patent Owner Response, see J.A. 1112–15, so that it
was proper for Altaire to submit the Second Al Sawaya
Declaration, which “respond[ed] to arguments raised in
the corresponding . . . [P]atent [O]wner [R]esponse,” 37
C.F.R. § 42.23(b); see 5 U.S.C. § 556(d) (entitling a party
“to submit rebuttal evidence”); see also Belden Inc. v.
Berk-Tek LLC, 805 F.3d 1064, 1078, 1082 (Fed. Cir. 2015)
(holding that a declaration appended to a reply brief
“fairly respond[ed] only to arguments made in . . . [the
patent owner]’s response,” as required by § 42.23(b), and
that the patent owner had “a meaningful opportunity to
respond,” as required by the APA). To the extent the
PTAB was concerned about Paragon’s ability to respond
to the extensive qualifications set forth in the Second Al
Sawaya Declaration, the PTAB could have permitted
Paragon to file a surreply, see Belden, 805 F.3d at 1081
(stating that the PTAB “has long granted permission to
file surreplies despite the absence of any regulation
providing for such filings” (footnote omitted)), as Paragon
requested, see J.A. 1724.
Although the PTAB “has broad discretion to regulate
the presentation of evidence,” Belden, 805 F.3d at 1081,
that discretion is not without limits, see Ultratec, Inc. v.
CaptionCall, LLC, 872 F.3d 1267, 1274 (Fed. Cir. 2017)
(stating that “[t]he agency does not have unfettered
discretion in [evidentiary] matters”). The PTAB’s decision
to assign no weight to Mr. Al Sawaya’s testimony was an
abuse of discretion. See id. at 1275 (holding that the
PTAB “abused its discretion when it refused to admit and
consider . . . trial testimony”); cf. Aqua Prods., Inc. v.
Matal, 872 F.3d 1290, 1325 (Fed. Cir. 2017) (en banc)
(plurality opinion) (“[A]n agency’s refusal to consider
evidence bearing on the issue before it is, by definition,
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 17
arbitrary and capricious within the meaning of 5 U.S.C.
§ 706, which governs review of agency adjudications.
That means that the agency must take account of all the
evidence of record, including that which detracts from the
conclusion the agency ultimately reaches.” (citations
omitted)). This decision influenced, at least in part, the
PTAB’s rejection of the TMQC-247 and optical rotation
test data. See J.A. 14 (rejecting the testimony in the First
Al Sawaya Declaration as insufficient), 17 (rejecting the
TMQC-247 test data because Altaire had not “point[ed] to
any credible evidence accompanying the Petition”), 19
(rejecting the optical rotation test data because Altaire
had not identified “any credible evidence” and “ha[d] not
provided any affidavit” in support). On remand, the
PTAB must consider Mr. Al Sawaya’s testimony when
evaluating the reliability of the TMQC-247 and optical
rotation test data.
C. TMQC-247 Test Data
Regarding the TMQC-247 test results, the PTAB de-
termined that Altaire had not “point[ed] to any credible
evidence accompanying the Petition that meets the re-
quirements of § 42.65(b)” and, thus, “even if [it] accept[ed
Altaire]’s assertion that the HPLC data of Altaire’s
[p]roduct[s] were generated using its allegedly proprietary
HPLC method TMQC-247, [it] g[a]ve no weight to those
data.” J.A. 17. In reaching that decision, the PTAB
refused to consider two exhibits appended to Altaire’s
Reply that “provide[d] information about the standards
and samples[’] preparation as well as the procedures for
running the [TMQC-247] test.” J.A. 15; see J.A. 15 (“[Al-
taire] . . . did not submit the [exhibits] until filing its
Reply, when [Paragon] no longer ha[d] the opportunity to
respond. As a result, we do not consider Exhibits 1027
and 1028.” (citations omitted)); see also J.A. 1505–22
(Exhibit 1027), 1523–32 (Exhibit 1028). We conclude that
the PTAB abused its discretion by refusing to consider
Altaire’s Reply evidence.
18 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
Given Paragon’s past reliance on the TMQC-247 test
data before the FDA, Altaire submitted the additional
information regarding the TMQC-247 test at the first
opportunity at which it reasonably could have been ex-
pected. When seeking FDA approval of the NDA, Para-
gon requested “all the work [Altaire] ha[s] on chiral
purity,” J.A. 1606, and Altaire responded by sending the
additional TMQC-247 test data, J.A. 1602–05. Paragon
concedes that it relied upon the TMQC-247 test data to
obtain FDA approval of the NDA. See J.A. 1602–06; see
also Oral Arg. at 18:41–19:00 (Q: “Did your client use
their testing methods before the FDA?” A: “The client did
pass through methods that they gave to the FDA. Yes.”
Q: “So they relied on those methods? Is that true?”
A: “It is true that they relied on their data to provide to
the FDA.”). As a result, we conclude that Altaire had no
reason to suspect that Paragon would later challenge the
data, upon which it previously relied, as unreliable before
the PTAB.
After Paragon unexpectedly challenged Altaire’s
TMQC-247 test data for failure to comply with § 42.65(b)
in its Patent Owner Response, see J.A. 1112–15, Altaire
submitted its Reply, appending additional information on
the TMQC-247 test, see J.A. 1418–25, 1505–606. This
included Exhibits 1027 and 1028. See J.A. 1505–32.
Similar to the Second Al Sawaya Declaration, Altaire
properly “respond[ed] to [those] arguments raised in
[Paragon’s Patent Owner R]esponse” by submitting addi-
tional evidence demonstrating the reliability of the
TMQC-247 testing method. 37 C.F.R. § 42.23(b); see 5
U.S.C. § 556(d); see also Belden, 805 F.3d at 1078. To the
extent Paragon wished to contest this additional evidence,
the PTAB could have permitted Paragon to file a surreply.
See Belden, 805 at 1081.
In light of Paragon’s past reliance on the TMQC-247
test data, we conclude that the PTAB abused its discre-
tion by “refus[ing] to consider evidence” regarding the
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 19
reliability of the TMQC-247 testing method. Aqua, 872
F.3d at 1325 (citation omitted); see Ultratec, 872 F.3d at
1275. On remand, the PTAB shall consider all relevant
TMQC-247 information in determining whether Altaire
satisfied the requirements of § 42.65(b) and, if it did,
whether the TMQC-247 test data render obvious the
Asserted Claims.
D. Optical Rotation Test Data
Finally, regarding the optical rotation test, the PTAB
determined that Paragon “presented sufficient evidence to
challenge the accuracy of estimating enantiomer purity
based on the specific rotation,” such that it “[was] not
persuaded that [Altaire]’s optical-rotation data amount to
a preponderance of the evidence to show that Altaire’s
[p]roduct[s] meet[] the chiral-purity limitations of the
[Asserted C]laims.” J.A. 19, 20. As with the TMQC-247
test data, Paragon relied upon this optical rotation test
data before the FDA. See J.A. 783–91. Indeed, the ’623
patent itself recognizes that the optical rotation test can
be used to determine chiral purity. See ’623 patent col. 4
ll. 33–34.
Nevertheless, the PTAB rejected the data, stating
that, “for the optical rotation data, as for the [TMQC-247]
data, [Altaire] has not provided any affidavit in compli-
ance with . . . § 42.65(b).” J.A. 19. However, as explained
above, see supra Section II.B–C, the PTAB abused its
discretion by refusing to consider Mr. Al Sawaya’s testi-
mony and the additional information on the TMQC-247
test data. To the extent the PTAB’s decision to reject as
unpersuasive the optical rotation test data rested upon
these erroneous determinations, the PTAB must recon-
sider the reliability of the optical rotation test data pur-
suant to § 42.65(b) on remand.
20 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
CONCLUSION
We have considered Paragon’s remaining arguments
and find them unpersuasive. We reverse the U.S. Patent
and Trademark Office’s Patent Trial and Appeal Board’s
decision regarding the Al Sawaya Declarations. We
vacate the U.S. Patent and Trademark Office’s Patent
Trial and Appeal Board’s determination that the TMQC-
247 and optical rotation test data did not satisfy the
requirements of 37 C.F.R. § 42.65(b) and that the Assert-
ed Claims would not have been obvious over Lots #11578
and #11581. We remand for further consideration con-
sistent with this opinion. Accordingly, the Final Written
Decision of the U.S. Patent and Trademark Office’s Pa-
tent Trial and Appeal Board is
REVERSED-IN-PART, VACATED-IN-PART, AND
REMANDED
COSTS
Costs to Altaire.
United States Court of Appeals
for the Federal Circuit
______________________
ALTAIRE PHARMACEUTICALS, INC.,
Appellant
v.
PARAGON BIOTECK, INC.,
Appellee
______________________
2017-1487
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. PGR2015-
00011.
______________________
SCHALL, Circuit Judge, dissenting.
My concern in this case is with the issue of standing.
In my view, Altaire has failed to establish that it has
standing to bring this appeal. I therefore would dismiss
for lack of jurisdiction.
I.
Under Article III of the Constitution, in order for a
court to have jurisdiction to decide a case, the case must
present an actual “case or controversy.” Hollingsworth v.
Perry, 570 U.S. 693, 704 (2013). Standing to sue is a
necessary component of an Article III case or controversy.
Id. In order to have standing, a plaintiff or, as in this
case, an appellant “must have (1) suffered an injury in
2 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
fact, (2) that is fairly traceable to the challenged conduct
of the [appellee], and (3) that is likely to be redressed by a
favorable judicial decision.” Spokeo, Inc. v. Robins, 136 S.
Ct. 1540, 1547 (2016). Altaire bears the burden of estab-
lishing that it has standing. See DaimlerChrysler Corp. v.
Cuno, 547 U.S. 332, 342 (2006).
As the majority opinion makes clear, the standing is-
sue in this case turns on the injury-in-fact requirement.
Under that requirement, an appellant must allege an
injury “that is concrete and particularized and actual or
imminent, not conjectural or hypothetical.” Spokeo, 136 S.
Ct. at 1548 (internal quotation marks and citation omit-
ted). For the reasons set forth below, I believe that Al-
taire has failed to demonstrate that it is threatened with
imminent harm, the only type of harm asserted in this
case. It thus has failed to show that it has suffered an
injury in fact. It therefore lacks standing.
II.
The undisputed facts are these: In 2011, Altaire and
Paragon entered into an agreement to pursue U.S. Food
and Drug Administration (“FDA”) approval for Altaire’s
phenylephrine hydrochloride products (the “Agreement”).
By its terms, the Agreement terminates on May 30, 2021.
See Joint Appendix (“J.A.”) 1909. Subsequently, a dispute
arose between the parties, which apparently led Altaire to
file two lawsuits in federal court in the Eastern District of
New York. In the first suit, Altaire Pharmaceuticals, Inc.
v. Paragon BioTeck, Inc., Case No. 2:15-cv-02416
(E.D.N.Y.) (“the breach of contract suit”), Altaire alleges
that Paragon breached the Agreement by, among other
things, disclosing Altaire’s confidential and proprietary
product information in its patent application and in its
resulting U.S. Patent No. 8,859,623 (“the ’623 patent”).
See Complaint and Jury Demand at 7 (No. 2:15-cv-02416)
(E.D.N.Y. April 28, 2015). Paragon has denied Altaire’s
allegations, has alleged that Altaire has materially
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 3
breached the Agreement, and has counterclaimed for,
among other things, a declaratory judgment giving it the
right to terminate the Agreement prior to its 2021 termi-
nation date. Paragon BioTeck, Inc.’s Answer, Affirmative
Defenses, Counterclaims, and Third-Party Complaint at
9, 22 (No. 2:15-cv-02416) (E.D.N.Y. Aug. 14, 2015).
In the second suit, Altaire Pharmaceuticals, Inc. v.
Paragon BioTeck, Inc., Case No. 1:17-cv-01837 (E.D.N.Y.)
(“the inventorship suit”), Altaire alleges, among other
things, that the ’623 patent is invalid for failure to name
the inventor, and it seeks correction of inventorship.
Complaint and Jury Demand at 27, 29, 32, and 37 (No.
1:17-cv-01837) (E.D.N.Y. April 3, 2017). The inventorship
suit is currently stayed pursuant to 35 U.S.C. § 325(a)(2).
III.
I start from the premise that the standing issue in
this case turns entirely on the pending litigation in the
Eastern District of New York. I say that because, alt-
hough both Altaire and the majority point to the Agree-
ment’s 2021 termination date, Appellant’s Br. 47–48,
Majority Op. at 12, I am unable to see how the fact that
the Agreement is scheduled to terminate in 2021 supports
standing at this point. Put most simply, what we have is
a situation in which the parties to a contract that is due to
terminate in approximately three years are in a dispute.
At the same time, in view of the terms of the Agreement,
Altaire cannot infringe the ’623 patent while the Agree-
ment is in effect. These circumstances, it seems to me,
come nowhere near providing Altaire with grounds for
claiming that it is subject to imminent harm. Timing is
important for a showing of imminence, or immediacy.
The longer the time between when suit is initiated and
when potential infringement may occur, “the more likely
the case lacks the requisite immediacy.” Sierra Applied
Scis., Inc. v. Advanced Energy Indus., Inc., 363 F.3d 1361,
1379 (Fed. Cir. 2004). See Lang v. Pacific Marine and
4 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
Supply Co., Ltd., 895 F.2d 761, 764–65 (Fed. Cir. 1990)
(insufficient evidence of standing to seek a declaratory
judgment of patent infringement where “[t]he accused
infringing ship’s hull would not be finished until at least
nine months after the complaint was filed”). Thus, in my
view, the fact that the Agreement terminates in 2021
cannot support standing.
IV.
I turn now to the breach of contract suit. * In that re-
gard, the majority rests its conclusion that Altaire has
demonstrated imminent harm upon three considerations.
The first consideration is the fact that, in the breach of
contract suit, Paragon is seeking a declaratory judgment
that it has the right to terminate the Agreement prior to
its 2021 termination date. Majority Op. at 11–12. The
second consideration consists of statements made by
Michael Sawaya, Altaire’s general counsel, in paragraph
22 of his February 24, 2017 declaration submitted in
support of Altaire’s opposition to Paragon’s motion to
dismiss. Id. at 10–11. There, Mr. Sawaya states that
“Altaire believes that Paragon will inevitably sue Altaire
for patent infringement upon Altaire filing an [Abbreviat-
ed New Drug Application (“ANDA”)] with the FDA.”
Altaire’s Opp’n to Paragon’s Mot. to Dismiss at Ex. 1, ECF
No. 25 at ¶ 22. Continuing, Mr. Sawaya states that
“Altaire therefore believes that invalidating the ’623
patent in the post-grant review proceeding that is the
subject of this appeal is imperative to removing that
patent as an object to the filing and approval of Altaire’s
ANDA for its proprietary product which was misappropri-
ated in the ’623 patent by Paragon.” Id. And third, the
* Neither Altaire nor the majority points to the in-
ventorship suit as a factor to be considered in the stand-
ing analysis.
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 5
majority notes that, when questioned at oral argument,
counsel for Paragon declined to stipulate that Paragon
will not sue Altaire for infringement of the ’623 patent.
Majority Op. at 12. The majority recognizes that “[a]
claim is not ripe for adjudication if it rests upon contin-
gent future events that may not occur as anticipated, or
indeed may not occur at all.” Id. (quoting Texas v. United
States, 523 U.S. 296, 300 (1998)) (internal quotation
marks and citation omitted). However, it concludes that,
under the circumstances of this case, as outlined above,
“Altaire’s injury is inevitable.” Id. at 12.
V.
I am unable to agree with the majority that Altaire
has demonstrated imminent harm. First, leaving aside
the possibility of a settlement, one of two things will
happen in the breach of contract suit. Either Altaire will
prevail; or Paragon will prevail, in which case Paragon
perhaps will be given the right to terminate the Agree-
ment. At this point, though, we do not know what will
happen. Moreover, should Altaire prevail in the suit, the
possibility that Paragon will be given the right to termi-
nate the Agreement before 2021—which is a critical
linchpin of Altaire’s claim of imminent harm—will have
been eliminated. It seems to me that, by any standard,
we presently are in a situation where a determination of
imminent harm is speculative. See First Data Corp. v.
Inselberg, 870 F.3d 1367, 1375 (Fed. Cir. 2017). In that
case, First Data sought, among other things, a declaratory
judgment of noninfringement. Citing Texas v. United
States, we stated that a claim is not ripe for adjudication
if it rests upon contingent future events that may not
occur as anticipated or may not occur at all, 870 F.3d at
1375 (citations omitted). We then concluded that because
the parties against whom First Data and its co-plaintiff
had brought the declaratory judgment action did not
currently have an ownership interest in the patents at
issue, any potential infringement claim relied on the
6 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
“contingent future event” of recovering title to the patents
at issue. That, in turn required a court to invalidate an
assignment agreement, and only if that case were success-
ful could the patent claims no longer be contingent on a
future event that “may not occur at all.” Id. See also
Sandoz Inc. v. Amgen Inc., 773 F.3d 1274, 1280–81 (Fed.
Cir. 2014) (no standing where Sandoz did not demon-
strate that certain future possibilities for changing or
eliminating the patent dispute were so unlikely to arise
that they should not play a significant role in the Article
III determination; the events exposing Sandoz to in-
fringement liability “may not occur as anticipated, or
indeed may not occur at all”) (quoting Texas v. United
States, 523 U.S. at 300)).
I also do not believe that Altaire is helped by Mr.
Sawaya’s declaration. As noted, the primary concern
expressed by Mr. Sawaya is the threat of a patent in-
fringement suit by Paragon in the event Altaire files an
ANDA with the FDA, should the Agreement be terminat-
ed. Mr. Sawaya’s belief is based upon the contingency of
the Agreement being terminated—either in three years,
or upon Paragon’s prevailing on its declaratory judgment
claim in the breach of contract suit. Either way, for the
reasons discussed above relating to the scheduled, or
possible, termination of the Agreement, I do not believe
Mr. Sawaya’s belief can support a claim of imminent
harm.
It is true that where Congress has accorded a litigant
the right to appeal an administrative decision, the re-
quirement of immediacy, or imminence, for standing may
be relaxed. Consumer Watchdog v. Wis. Alumni Research
Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014) (citing
Massachusetts v. E.P.A., 549 U.S. 497, 517–18 (2007)).
However, “[a]lthough imminence is concededly a some-
what elastic concept, it cannot be stretched beyond its
purpose, which is to ensure that the alleged injury is not
too speculative for Article III purposes.” Defs. of Wildlife,
ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC. 7
504 U.S. at 565, n. 2. I believe that finding imminent
harm in the circumstances of this case would stretch
immediacy—even a relaxed concept of immediacy—
beyond its breaking point.
Finally, I discount, as a factor in the equation, the re-
fusal of counsel for Paragon to stipulate at oral argument
that Paragon will not sue Altaire for patent infringement.
Quite simply, in view of the contentions of the parties and
the posture of the litigation in the Eastern District of New
York, I do not see how counsel could have agreed to such a
stipulation.
For the foregoing reasons, I conclude that Altaire has
failed to demonstrate a threat of imminent harm and,
thus, injury in fact.
I note one additional point. The majority posits that
Altaire’s injury is compounded by the likelihood that, if it
does not challenge the Board’s decision before us, it could
be estopped from arguing that the ’623 patent would have
been obvious over Altaire’s Lots #11578 and #11581.
Majority Op. at 13–14. The majority states, “Although we
do not decide whether this potential estoppel effect is
sufficient independently to establish standing, the estop-
pel effect in this case further supports Altaire’s claimed
injury in fact.” Id. at 13. I do not agree that concerns of
estoppel can help carry the day for Altaire. Estoppel
‘“does not constitute an injury in fact’ when . . . the appel-
lant ‘is not engaged in any activity that would give rise to
a possible infringement suit,’” Phigenix, Inc. v. Immuno-
gen, Inc., 845 F.3d 1168, 1175–76 (Fed. Cir. 2017) (quot-
ing Consumer Watchdog, 753 F.3d at 1262). Here, Altaire
currently is under contract through May of 2021 to manu-
facture, and supply Paragon with, phenylephrine hydro-
chloride products. See J.A. 1909–10. Thus, the
Agreement prevents Altaire’s activities from constituting
infringement until it ends by its own terms in 2021,
unless Paragon prevails in the breach of contract dispute,
8 ALTAIRE PHARM., INC. v. PARAGON BIOTECK, INC.
is given the right to terminate the Agreement, and actual-
ly terminates it. In short, currently Altaire is not engaged
in any activity that would give rise to a possible infringe-
ment suit.
CONCLUSION
Based upon the foregoing, I believe that Altaire has
failed to demonstrate that it has suffered an injury in
fact. In my view, it thus has failed to carry its burden of
establishing that it has standing. Accordingly, I would
dismiss its appeal. I therefore respectfully dissent.