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   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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                                                           USA


     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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                                                          USA


     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
                                                             USA


                                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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                                                             USA


                                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
