Case: 19-2400 Document: 41 Page: 1 Filed: 07/31/2020
United States Court of Appeals
for the Federal Circuit
______________________
IBSA INSTITUT BIOCHIMIQUE, S.A., ALTERGON,
S.A., IBSA PHARMA INC.,
Plaintiffs-Appellants
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant-Appellee
______________________
2019-2400
______________________
Appeal from the United States District Court for the
District of Delaware in No. 1:18-cv-00555-RGA, Judge
Richard G. Andrews.
______________________
Decided: July 31, 2020
______________________
RYAN JOHNSON, Fenwick & West LLP, New York, NY,
argued for plaintiffs-appellants. Also represented by
JEFFREY J. OELKE, LAURA MORAN; ERICA RUTH SUTTER,
Mountain View, CA.
JOHN CHRISTOPHER ROZENDAAL, Sterne Kessler Gold-
stein & Fox, PLLC, Washington, DC, argued for defendant-
appellee. Also represented by KRISTINA CAGGIANO KELLY,
MICHAEL E. JOFFRE, DEIRDRE M. WELLS.
______________________
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2 IBSA INSTITUT BIOCHIMIQUE v. TEVA PHARMACEUTICALS
USA
Before PROST, Chief Judge, REYNA and HUGHES, Circuit
Judges.
PROST, Chief Judge.
IBSA Institut Biochimique, S.A., Altergon, S.A., and
IBSA Pharma Inc. (collectively, “IBSA”) appeal a decision
by the United States District Court for the District of Del-
aware holding claims 1, 2, 4, and 7–9 of
U.S. Patent
No. 7,723,390 (“the ’390 patent”) invalid as indefinite un-
der
35 U.S.C. § 112. See IBSA Institut Biochimique, S.A.
v. Teva Pharm. USA, Inc., No. 1:18-cv-00555-RGA,
2019
WL 3936656 (D. Del. Aug. 20, 2019) (“Decision”); Claim
Construction Order and Final Judgment,
id., ECF No. 111.
For the reasons below, we affirm.
I
IBSA is the assignee of the ’390 patent. The ’390 patent
issued from U.S. Application No. 10/188,467 (“the ’467 ap-
plication”). In addition, the ’390 patent claims priority
from Italian Patent Application No. MI2001A1401 (“the
Italian Application”), which is written in Italian and ap-
pears in the ’390 patent’s file history.
The ’390 patent, entitled “Pharmaceutical Formula-
tions for Thyroid Hormones,” provides “pharmaceutical for-
mulations based on thyroid hormones enabling a safe and
stable oral administration in the framework of the strict
therapeutic index prescribed in case of thyroid disorders.”
’390 patent Abstract. The ’390 patent is listed in the U.S.
Food and Drug Administration’s Approved Drug Products
with Therapeutic Equivalence Evaluations (the “Orange
Book”) for IBSA’s Tirosint® product. Tirosint® is a soft gel
capsule formulation containing the active ingredient levo-
thyroxine sodium.
Teva Pharmaceuticals USA, Inc. (“Teva”) sought to
market a generic version of Tirosint® and filed Abbreviated
New Drug Application (“ANDA”) No. 211369. The ANDA
included a certification pursuant to 21 U.S.C.
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§ 355(j)(2)(A)(vii)(IV) (“Paragraph IV certification”) that
the ’390 patent is invalid, unenforceable, or will not be in-
fringed by Teva’s generic product. IBSA, after receiving
notice of Teva’s Paragraph IV certification, filed suit ulti-
mately alleging infringement of claims 1, 2, 4, and 7–9.
II
Central to this appeal is the parties’ dispute over the
construction of “half-liquid,” which appears in independent
claim 1. Claims 2, 4, and 7–9 each ultimately depend from
claim 1. Claim 1 is shown below:
1. A pharmaceutical composition comprising
thyroid hormones or their sodium salts in the
form of either:
a) a soft elastic capsule consisting of a shell of
gelatin material containing a liquid or half-
liquid inner phase comprising said thyroid
hormones or their salts in a range between
0.001 and 1% by weight of said inner phase,
dissolved in gelatin and/or glycerol, and op-
tionally ethanol, said liquid or half-liquid
inner phase being in direct contact with said
shell without any interposed layers, or
b) a swallowable uniform soft-gel matrix com-
prising glycerol and said thyroid hormones
or their salts in a range between 0.001 and
1% by weight of said matrix.
’390 patent claim 1.
IBSA proposed that the term “half-liquid” should be
construed to mean “semi-liquid, i.e., having a thick con-
sistency between solid and liquid.” J.A. 75. Teva argued
that the term “half-liquid” is indefinite or should be con-
strued as “a non-solid, non-paste, non-gel, non-slurry, non-
gas substance.” J.A. 79.
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The district court held claims 1, 2, 4, and 7–9 invalid
as indefinite. In support, the court found, first, that IBSA’s
proposed construction was unsupported by the record, and,
second, that the meaning of “half-liquid” was not otherwise
reasonably ascertainable from the record.
A
The district court began by acknowledging that the
parties “agree that the intrinsic record does not define
‘half-liquid.’” Decision,
2019 WL 3936656, at *4 (citing
J.A. 78). It then turned to the intrinsic evidence IBSA pre-
sented.
IBSA pointed out that the Italian Application used the
term “semiliquido” in the same places where the ’390 pa-
tent used “half-liquid,” and where a certified translation of
the Italian Application prepared for IBSA in 2019 used
“semi-liquid.” IBSA contended that there is a link between
these terms such that a person of ordinary skill in the art
(“POSA”) would understand “half-liquid” and “semi-liquid”
to be synonyms. The district court disagreed.
The district court observed that there were a number
of differences between the certified translation and the
’390 patent’s specification, besides the use of “half-liquid.”
These differences included the “Field of Invention” and
“Prior Art” sections. Because of these differences, the court
reasoned that the document that best reflected the appli-
cant’s intent was the document submitted for examina-
tion—the ’467 application. Accordingly, the district court
gave the Italian Application and the certified translation
no weight in its analysis and determined that differences
between the certified translation and the ’390 patent’s
specification were intentional.
The district court also noted that, during prosecution,
the applicant proposed a dependent claim using the term
“semi-liquid.” This claim depended on an independent
claim that used the term “half-liquid.” Although the
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dependent claim using the term “semi-liquid” was removed
by the applicant, the district court reasoned this portion of
the prosecution history was “evidence that the applicant
did not mean ‘semi-liquid’ when he used the term ‘half-liq-
uid.’” Decision,
2019 WL 3936656, at *5.
Similarly, in reviewing the ’390 patent’s specification,
the district court determined that citation to pharmaceuti-
cal references, including Remington’s Pharmaceutical Sci-
ences, which used the term “semi-liquid,” did not show that
“half-liquid” meant “semi-liquid.” Instead, the court rea-
soned that such citation showed that the applicant knew of
the term “semi-liquid” yet intentionally chose not to use it.
Id. at *4.
The district court then turned to the extrinsic evidence.
The court found IBSA’s extrinsic evidence “minimally pro-
bative” and “unpersuasive.”
Id. at *5. It first determined
that IBSA’s reliance on dictionary definitions did not sup-
port IBSA’s position because they were not in the context
of the claimed invention. Likewise, the court found that
IBSA’s reliance on a handful of patents from other compa-
nies did not support IBSA’s position. The court concluded
that, because IBSA failed to present evidence regarding the
use of the term “half-liquid” in the art besides these pa-
tents, which used the term “half-liquid” only in the context
of “half-liquid bases,” it is “exceedingly unlikely that [‘half-
liquid’] was a term of art at the relevant date.”
Id. at *6.
Finally, because the court determined that the opinion of
IBSA’s expert, Dr. Chyall, was exclusively based on evi-
dence that the court already found unpersuasive, the court
afforded Dr. Chyall’s opinion no weight on this matter.
Id.
B
After determining that IBSA’s proposed construction
was not supported by the record, the district court turned
to the second part of its analysis and sought to determine
whether a skilled artisan could nevertheless ascertain a
reasonably certain meaning for “half-liquid.”
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The court first noted that the language of claim 1 does
not provide “what manner of substance qualifies as a half-
liquid.”
Id. Instead, the court determined that claim 1’s
language only supports that a “half-liquid” is neither a liq-
uid nor a solid.
The district court next determined that a POSA read-
ing the specification would understand that a “half-liquid”
is not, or at least is not necessarily, a gel or a paste. The
court reached this conclusion based on a passage of the ’390
patent stating: “In particular, said soft capsule contains an
inner phase consisting of a liquid, a half-liquid, a paste, a
gel, an emulsion or a suspension comprising the liquid (or
half-liquid) vehicle and the thyroid hormones together with
possible excipients in suspension or solution.” See
id.
(quoting ’390 patent col. 7 l. 65–col. 8 l. 2).
The district court then analyzed the prosecution his-
tory. The court noted that the prosecution history con-
tained two instances in which the applicant distinguished
the claimed invention from alleged prior art. In one in-
stance, in overcoming an obviousness rejection, the appli-
cant stated that the claimed invention “is not a
macromolecular gel-lattice matrix.”
Id. (quoting
J.A. 232 (emphases in original)). In the second instance,
the applicant stated that the claimed invention is not a
“high concentration slurry.”
Id. (citing J.A. 258). While the
court noted that the full scope of these disclaimers was not
clear, the court determined that the “applicant disclaimed
some portion of the claim’s scope that might otherwise
qualify as a half-liquid.”
Id.
Finally, the district court reviewed the extrinsic evi-
dence. Noting Dr. Chyall’s “difficulty articulating the
boundaries of ‘half-liquid’” during his deposition, the dis-
trict court determined that the opinion of Teva’s expert,
Dr. Khan, that “half-liquid is not a well-known term in the
art” must be correct.
Id. at *7.
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Accordingly, the district court concluded that the “am-
biguity renders it impossible for a POSA to know, with rea-
sonable certainty, whether they are dealing with a half-
liquid within the meaning of the claim.”
Id. The court held
claims 1, 2, 4, and 7–9 invalid under
35 U.S.C. § 112.
IBSA timely appealed. We have jurisdiction under
28 U.S.C. § 1295(a)(1).
III
A
The definiteness requirement of
35 U.S.C. § 112 “must
take into account the inherent limitations of language.”
Nautilus, Inc. v. Biosig Instruments, Inc.,
572 U.S. 898, 909
(2014). At the same time, “a patent must be precise enough
to afford clear notice of what is claimed, thereby ‘ap-
pris[ing] the public of what is still open to them.’”
Id. (quot-
ing Markman v. Westview Instruments, Inc.,
517 U.S. 370,
373 (1996) (alteration in original)). Accordingly, a “claim
is invalid for indefiniteness if its language, read in light of
the specification and prosecution history, ‘fail[s] to inform,
with reasonable certainty, those skilled in the art about the
scope of the invention.’” HZNP Meds. LLC v. Actavis Labs.
UT, Inc.,
940 F.3d 680, 688 (Fed. Cir. 2019) (quoting Nau-
tilus, 572 U.S. at 901 (alteration in original)).
We review the ultimate question of indefiniteness de
novo. Id at 698. “Determinations about governing legal
standards and about intrinsic evidence are reviewed de
novo, and any factual findings about extrinsic evidence rel-
evant to the question, such as evidence about knowledge of
those skilled in the art, are reviewed for clear error.” BASF
Corp. v. Johnson Matthey Inc.,
875 F.3d 1360, 1365 (Fed.
Cir. 2017).
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8 IBSA INSTITUT BIOCHIMIQUE v. TEVA PHARMACEUTICALS
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B
1
“We look first to the language of the claim to determine
whether the meaning of [‘half-liquid’] is reasonably clear.”
Berkheimer v. HP Inc.,
881 F.3d 1360, 1363 (Fed. Cir.
2018). As neither party meaningfully disputes, the claim
language of the ’390 patent does not make the meaning of
“half-liquid” reasonably clear. The term “half-liquid” is
merely used alongside “liquid” to describe the inner phase
of a soft elastic capsule. See ’390 patent claim 1 (“a soft
elastic capsule consisting of a shell of gelatin material con-
taining a liquid or half-liquid inner phase”). Therefore, the
claim language clarifies only that a “half-liquid” differs
from a liquid.
2
We next look to the specification. The district court re-
lied on a passage of the specification stating that “[i]n par-
ticular, said soft capsule contains an inner phase consisting
of a liquid, a half-liquid, a paste, a gel, an emulsion or a
suspension comprising the liquid (or half-liquid) vehicle
and the thyroid hormones together with possible excipients
in suspension or solution,” to determine that a “half-liquid
is not, or at least is not necessarily, a gel or a paste.” Deci-
sion,
2019 WL 3936656, at *6 (quoting ’390 patent col. 7
l. 65–col. 8 l. 2). Not only do we agree with the district
court’s interpretation of this passage, but a second passage
reinforces this interpretation. See ’390 patent col. 10
ll. 38–39 (“Soft capsules (SEC) with liquid, half-liquid,
paste-like or gel-like inner phase”). These disjunctive lists
designate that a “half-liquid” is an alternative to the other
members of the list, including pastes and gels. See, e.g.,
SkinMedica, Inc. v. Histogen Inc.,
727 F.3d 1187, 1199–
1200 (Fed. Cir. 2013) (“The disjunctive ‘or’ plainly desig-
nates that a series describes alternatives.”). Pastes and
gels, however, have a thick consistency between a liquid
and a solid and would be included in IBSA’s proposed
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construction. Such inclusion is at odds with the above pas-
sages and creates uncertainty as to the boundaries of a
“half-liquid.”
IBSA argues that other portions of the specification are
“at odds” with the above passages. Appellant Br. 63. As
support, IBSA points to a passage of the specification de-
scribing a preferred formulation of the so-called Third Em-
bodiment. This preferred formulation refers to “an SEC
capsule containing an inner phase consisting of a paste or
gel comprising gelatin and thyroid hormones or pharma-
ceutically acceptable salts thereof . . . in a liquid or half liq-
uid vehicle.” ’390 patent col. 9 ll. 14–19. As Teva points
out, however, IBSA conflates the vehicle within the inner
phase with the inner phase itself, without “explain[ing]
whether and why it contends the two are the same.” Ap-
pellee Br. 46; see also J.A. 90. Accordingly, we disagree
with IBSA that this passage, which discusses both the in-
ner phase and the vehicle, is at odds with the specification’s
listing of “half-liquids” as alternatives to pastes and gels.
In light of the specification’s guidance discussed above,
we are not persuaded by IBSA’s reliance on other portions
of the specification that it contends support its proposed
construction. For example, IBSA contends that the speci-
fication’s citation to the Remington’s primer on making
“semi-liquids” using a rotary-die machine highlights that
the applicant intended for “half-liquid” and “semi-liquid” to
be synonyms. Even if this were the case, the discussion in
Remington’s of using a rotary-die machine does not help es-
tablish boundaries of a “half-liquid,” given the lack of clar-
ity in the specification described above. In addition, IBSA’s
reliance on the ’390 patent’s listing of a handful of “liquid
or half-liquid vehicles,” ’390 patent col. 8 ll. 43–54, pro-
vides little guidance regarding the boundaries of a “half-
liquid,” as described by the specification. Similarly, the
specification’s suggestion to modify the viscosity of the cap-
sule content does not help clarify the boundaries of a “half-
liquid.”
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3
Next we turn to the prosecution history. IBSA con-
tends that the Italian Application is the best source to un-
derstand the inventors’ understanding of their invention
and that the district court erred in how it considered the
Italian Application. IBSA argues that because the term
“semiliquido” appears in the Italian Application “the same
number of times, in the same places, to describe the same
things” as “half-liquid” does in the ’390 patent, a POSA
would equate “semiliquido” with “half-liquid.” Appellant
Br. 44. IBSA then contends, based on its certified transla-
tion, that “semiliquido” means “semi-liquid.” Together
IBSA contends that a POSA would find that “half-liquid”
and “semi-liquid” are synonyms. We disagree.
Besides the differences the district court discussed be-
tween the Italian Application and the ’390 patent, Teva
also points out that the language of claim 1 of the ’390 pa-
tent differs from that of claim 1 of the Italian application.
As Teva notes, claim 1 of the ’390 patent incorporates the
Fourth Embodiment of the ’390 patent, which was not
found in the Italian Application. Further, unlike the ’390
patent, the Italian Application does not use the term “gel.”
For example, the ’390 patent includes the passage “an in-
ner phase consisting of a liquid, a half-liquid, a paste, a gel,
an emulsion or a suspension,” while the certified transla-
tion of the Italian Application translates the Italian Appli-
cation as “an internal phase consisting of a liquid, a semi-
liquid, a paste, an emulsion or a suspension.” Appellant
Br. 67 (Table 1). Accordingly, we agree with Teva that a
POSA would likely consider the discrepant usage of “half-
liquid” and “semiliquido” between the ’390 patent and the
Italian Application to be intentional, implying that the dif-
ferent word choice has a different scope.
Furthermore, and contrary to IBSA’s suggestion, such
weighing of the evidence does not unfairly subordinate a
foreign priority application and does not amount to a
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refusal to consider a foreign priority document. Rather,
when discrepancies between a foreign priority document
and the U.S. filing exist, it may be proper to view the dis-
crepancies as intentional. See Abbott Labs. v. Sandoz, Inc.,
566 F.3d 1282, 1290 (Fed. Cir. 2009) (determining that alt-
hough a Japanese priority application mentioned Crystal
A and B, the fact that the patent-at-issue excluded Crystal
B “strongly suggest[ed] that the [patent-at-issue] inten-
tionally excluded Crystal B compounds”). 1
In addition to the Italian Application, another portion
of the prosecution history reinforces our conclusion that the
applicant intentionally used “half-liquid” instead of “semi-
liquid.” During the prosecution of the ’390 patent the ap-
plicant had a pending claim using “half-liquid” and another
claim, depending from that claim, using the term “semi-liq-
uid.” See Decision,
2019 WL 3936656, at *5. Although the
claim using “semi-liquid” was ultimately removed, this is
additional evidence that the applicant knew the term
“semi-liquid” yet elected to use “half-liquid” to mean some-
thing different.
1 We also disagree with IBSA’s suggestion that the
district court refused to consider the Italian Application
solely because it was in a foreign language. While the court
noted in a footnote that it was “dubious that Italian-lan-
guage materials, even if part of the intrinsic record, inform
a POSA’s understanding of what the patent claims,” it nev-
ertheless considered the Italian Application and reasona-
bly decided that the language of the U.S. filing was
“significantly more probative of what the applicant meant
than a litigation-inspired translation [of the Italian Appli-
cation] done in 2019.” Decision,
2019 WL 3936656, at *4 &
n.3.
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Accordingly, the intrinsic evidence fails to establish the
boundaries of a “half-liquid.” We next turn to the extrinsic
evidence.
4
IBSA contends that extrinsic evidence, including dic-
tionary definitions, other patents, and expert testimony,
supports its proposed construction. The district court dis-
agreed. It concluded that the dictionary definitions and
four patents that predated the ’390 patent are not related
to the ’390 patent and therefore do not provide context for
what “half-liquid” means. In addition, the court found that
Dr. Chyall was unable to articulate a boundary for what
constitutes a “half-liquid” and could not tell how a skilled
artisan would know when matter is not a “half-liquid” in-
ner phase. Based on our review of the extrinsic evidence,
we determine that the district court did not clearly err in
its analysis.
Despite arguing that “half-liquid” would be a recog-
nizable term of art, IBSA identified no scientific dictionar-
ies containing the term. Instead, of the dictionaries that
IBSA relies on, only one—a non-scientific dictionary—in-
cluded the term “half-liquid” and only did so in defining the
term “semi-liquid” as a “Half liquid; semifluid.” Appellant
Br. 61 (citing J.A. 605). But even Dr. Chyall, during his
deposition injected uncertainty into this definition when he
stated that “semifluid” and “half-liquid” are not necessarily
synonymous. J.A. 724 at 91:10–92:8.
Second, the four cited patents that use “half-liquid”
only use the term in the context of “half-liquid bases” and
“half-liquid polyols.” Because these patents use the term
“half-liquid” in different contexts than the ’390 patent,
these patents do not help define “half-liquid” in the context
of the ’390 patent. IBSA did not provide any other scientific
literature to support its position. Rather, its expert testi-
fied that he was unaware of any textbook or peer-reviewed
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scientific journal that uses the term “half-liquid.” J.A. 742
at 164:11–165:12.
Third, Dr. Chyall’s testimony demonstrates the diffi-
culty a POSA would face in ascertaining the boundaries of
a “half-liquid.” For example, when asked how someone
could determine whether he or she made a soft-capsule in-
ner phase that was not a “half-liquid,” Dr. Chyall stated he
was not sure. J.A. 714 at 50:7–14. Dr. Chyall was also
unsure whether his construction of “half-liquid” would ex-
clude the types of gel and slurry distinguished during pros-
ecution. J.A. 738 at 147:4–148:18. As the district court
found, Dr. Chyall’s testimony corroborates Dr. Khan’s opin-
ion that “half-liquid” is not a well-known term in the art.
After reviewing the extrinsic evidence, we see no clear
error in the court’s determination that the extrinsic evi-
dence does not supply “half-liquid” with a definite meaning
under § 112, where the intrinsic evidence has failed to do
so.
IV
We have considered IBSA’s remaining arguments and
find them unpersuasive. Taken together, the intrinsic and
extrinsic evidence fail to inform, with reasonable certainty,
those skilled in the art about the scope of the invention. We
therefore affirm the judgment of the district court.
AFFIRMED
