Court Opinion

ID: 9911604
Source: CourtListenerOpinion
Date Created: 2023-12-20 16:01:36.041594+00
Date Added: 2024-06-11T12:51:36.154874
License: Public Domain

Case: 23-1805    Document: 52    Page: 1   Filed: 12/20/2023

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

     UNITED THERAPEUTICS CORPORATION,
                  Appellant

                            v.

          LIQUIDIA TECHNOLOGIES, INC.,
                      Appellee
               ______________________

                        2023-1805
                  ______________________

     Appeal from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in No. IPR2021-
 00406.
                  ______________________

                Decided: December 20, 2023
                  ______________________

     DOUGLAS H. CARSTEN, McDermott Will & Emery, LLP,
 Irvine, CA, argued for appellant. Also represented by
 ARTHUR PAUL DYKHUIS; ADAM WILLIAM BURROWBRIDGE,
 Washington, DC; WILLIAM COVINGTON JACKSON, Goodwin
 Procter LLP, Washington, DC; SHAUN R. SNADER, United
 Therapeutics Corporation, Washington, DC.

    SANYA SUKDUANG, Cooley LLP, Washington, DC, ar-
 gued for appellee.   Also represented by BRITTANY
 CAZAKOFF, JONATHAN DAVIES.
Case: 23-1805    Document: 52      Page: 2    Filed: 12/20/2023

 2                      UNITED THERAPEUTICS CORPORATION v.
                                LIQUIDIA TECHNOLOGIES, INC.

                  ______________________

     Before LOURIE, PROST, and REYNA, Circuit Judges.
 LOURIE, Circuit Judge.
      United Therapeutics Corporation (“UTC”) appeals
 from the final written decision of the U.S. Patent and
 Trademark Office Patent Trial and Appeal Board (“the
 Board”) in an inter partes review (“IPR”) concluding that
 claims 1–8 of U.S. Patent 10,716,793 (“the ’793 patent”) are
 unpatentable. Liquidia Techs., Inc. v. United Therapeutics
 Corp., No. IPR2021-00406, 2022 WL 2820717 (P.T.A.B.
 July 19, 2022) (“Decision”). For the following reasons, we
 affirm.
                        BACKGROUND
      UTC owns the ’793 patent, which is directed to meth-
 ods of treating pulmonary hypertension comprising inhala-
 tion of treprostinil. Claim 1 is the only independent claim.
 It reads as follows:
     1. A method of treating pulmonary hypertension
     comprising administering by inhalation to a hu-
     man suffering from pulmonary hypertension a
     therapeutically effective single event dose of a for-
     mulation comprising treprostinil or a pharmaceu-
     tically acceptable salt thereof with an inhalation
     device, wherein the therapeutically effective single
     event dose comprises from 15 micrograms to 90 mi-
     crograms of treprostinil or a pharmaceutically ac-
     ceptable salt thereof delivered in 1 to 3 breaths.
 ’793 patent at col. 18, ll. 23–31. As relevant here, depend-
 ent claims 4, 6, and 7 include additional limitations di-
 rected to dry powders. Those claims read as follows:
     4. The method of claim 1, wherein the inhalation
     device is a dry powder inhaler.
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     6. The method of claim 4, wherein the formula-
     tion is a powder.
     7. The method of claim 6, wherein the powder
     comprises particles less than 5 micrometers in di-
     ameter.
 Id. at col. 18, ll. 36–37, 40–43.
      Liquidia Technologies, Inc. (“Liquidia”) petitioned for
 IPR of all claims of the ’793 patent, asserting that they
 would have been obvious over, inter alia, U.S. Patent
 6,521,212 (“the ’212 patent”), in view of Voswinckel JESC
 (“JESC”) 1 and Voswinckel JAHA (“JAHA”) 2 (collectively,
 “the Voswinckel abstracts”). The ’212 patent, an unrelated
 patent owned by UTC, is directed to methods of delivering
 benzindene prostaglandins, such as treprostinil sodium, to
 patients via inhalation to treat pulmonary hypertension.
 See ’212 patent at Abstract, J.A. 1207. JESC is an abstract
 that describes a study in which patients inhaled solutions
 of treprostinil in concentrations of 16, 32, 48, and 64 μg/mL
 via a nebulizer. See J.A. 1240. JAHA is an abstract that
 describes a study in which patients inhaled solutions of
 treprostinil sodium via a nebulizer in 3 single breaths. See
 id. at 1243.
      Before the Board, UTC challenged the prior art status
 of the Voswinckel abstracts, arguing that Liquidia had
 failed to adequately show that those references qualified as
 “printed publications” under pre-AIA 35 U.S.C. § 102(b).

     1   R. Voswinckel et al., Inhaled treprostinil is a potent
 pulmonary vasodilator in severe pulmonary hypertension,
 25 EUROPEAN HEART J. 22 (2004), J.A. 1234–1240.
     2   Robert Voswinckel et al., Inhaled Treprostinil So-
 dium (TRE) For the Treatment of Pulmonary Hypertension,
 in Abstracts from the 2004 Scientific Sessions of the Amer-
 ican Heart Association, 110 CIRCULATION III-295 (Oct. 26,
 2004), J.A. 1241–43.
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                                 LIQUIDIA TECHNOLOGIES, INC.

 Decision at *3. Specifically, UTC argued that, because in
 its petition Liquidia relied on those abstracts having been
 stored in libraries, it was required to establish that the ab-
 stracts would have both been available at the library and
 sufficiently indexed or categorized by priority date. Id. at
 *4. The Board observed, however, that Liquidia had not
 relied solely on the availability of those references in librar-
 ies to establish their prior art status. Id. Rather, Liquidia
 had also asserted that each abstract had been presented at
 a public conference and that they were both cited in other
 documents dating from before the priority date of the ’793
 patent. Id. On the second of these two theories, the Board
 concluded that Liquidia had shown by a preponderance of
 the evidence that each of the Voswinckel abstracts was
 prior art because it had been cited in a “research aid,” i.e.,
 a publicly accessible article that provided a “sufficiently
 definite roadmap leading to” the abstract. Id. at *5 (quot-
 ing Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331,
 1350 (Fed. Cir. 2016)).
      Having found the Voswinckel abstracts to be prior art,
 the Board concluded that a person of ordinary skill in the
 art would have been motivated to combine those abstracts
 with the ’212 patent to arrive at the claimed invention. See
 id. at *5–9. This, the Board found, was true despite UTC’s
 evidence of objective indicia of nonobviousness, such as un-
 expected results, copying, and long-felt and unmet need.
 Id. at *9–13. Accordingly, the Board found all claims of the
 ’793 patent unpatentable as obvious. See id. at *15.
     UTC requested rehearing of the Board’s decision, and
 included a request for rehearing by the U.S. Patent and
 Trademark Office’s Precedential Opinion Panel (“the
 Panel”) on the issue of whether or not the Voswinckel ab-
 stracts were prior art. See Liquidia Tech., Inc. v. United
 Therapeutics Corp., IPR2021-00406, Paper 81 (Oct. 26,
 2022) at 2, J.A. 885. The Panel denied UTC’s request but
 determined that the Board had failed to consider whether
 the “research aids” in which the abstracts were cited were
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 themselves available prior to the critical date of the ’793
 patent, i.e., May 15, 2005. Id. It also determined that the
 Board had not adequately addressed whether the
 Voswinckel abstracts “were publicly accessible by way of
 their presentation and/or inclusion in distributed materi-
 als, such as at a conference or library.” Id. Accordingly,
 the Panel directed the Board to, in its consideration on re-
 hearing, “clearly identify whether the [Voswinckel ab-
 stracts] qualify as prior art.” Id. at 3, J.A. 886.
     In its decision on rehearing, the Board maintained that
 the Voswinckel abstracts were prior art. See Liquidia
 Tech., Inc. v. United Therapeutics Corp., IPR2021-00406,
 Paper 82 (Feb. 2, 2023) (“Rehearing Decision”), J.A. 50–67.
 Conceding that it had overlooked the fact that the research
 aids did not pre-date May 15, 2005, see id. at 5–7, J.A.
 54–56, the Board nevertheless found that Liquidia had ad-
 equately shown that the abstracts had been publicly dis-
 tributed at conferences prior to that date, id. at 7–12, J.A.
 56–61. Specifically, the Board concluded that JESC was
 distributed at the European Society of Cardiology Congress
 that was held from August 28, 2004, to September 1, 2004,
 in Munich, Germany, and that JAHA was distributed at
 the American Heart Association’s Scientific Sessions that
 occurred from November 7, 2004, to November 10, 2004, in
 New Orleans, Louisiana. Id.; see J.A. 1241. Both parties’
 experts agreed that a person of ordinary skill in the art
 would have been one of over 20,000 attendees at each of
 those conferences and that an “abstract book” from which
 each of the abstracts was excerpted would have been pro-
 vided to all attendees. Rehearing Decision at 10, 12, J.A.
 59, 61. Accordingly, the Board maintained that the ab-
 stracts were prior art and denied UTC’s rehearing request.
    UTC timely appealed. We have jurisdiction under
 28 U.S.C. § 1295(a)(4)(A) and 35 U.S.C. § 141(c).
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 6                      UNITED THERAPEUTICS CORPORATION v.
                                LIQUIDIA TECHNOLOGIES, INC.

                         DISCUSSION
     We review the Board’s legal determinations de novo, In
 re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), and its fac-
 tual findings for substantial evidence, In re Gartside,
 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is sup-
 ported by substantial evidence if a reasonable mind might
 accept the evidence as adequate to support the finding.
 Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).
 Moreover, we review the Board’s determination whether,
 under the Board’s own regulations, a party exceeded the
 scope of a proper reply for abuse of discretion. Axonics, Inc.
 v. Medtronic, Inc., 75 F.4th 1374, 1380 (Fed. Cir. 2023).
     UTC raises three challenges on appeal. First, it argues
 that the Board erred in determining that the Voswinckel
 abstracts are prior art. Second, it argues that, even if those
 abstracts are prior art, the Board erred in finding that the
 claimed dose would have been obvious over the ’212 patent
 in combination with the Voswinckel abstracts. And finally,
 it argues that the Board legally erred in its treatment of
 dependent claims 4, 6, and 7, and that its obviousness de-
 termination as to those claims was not supported by sub-
 stantial evidence. We address each argument in turn.
                               I
      UTC contends that the Board’s prior art analysis as to
 the Voswinckel abstracts suffered from two errors. First,
 it argues that the Board’s analysis improperly exceeded the
 prior art theories set forth in Liquidia’s petition. Second,
 it argues that the Board’s determination that the abstracts
 were publicly accessible as of the critical date was not sup-
 ported by substantial evidence.
                               A
     By statute, the scope of an IPR is limited to the grounds
 set forth in the initial petition. 35 U.S.C. § 312(a)(3); see
 SAS Inst. Inc., v. Iancu, 138 S. Ct. 1348, 1357 (“[T]he stat-
 ute tells us that the petitioner’s contentions, not the
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 Director’s discretion, define the scope of the litigation all
 the way from institution through to conclusion.”). It is
 therefore improper for the Board to deviate from the
 grounds in the petition and raise its own theories of un-
 patentability. Sirona Dental Sys. GmbH v. Institut Strau-
 mann AG, 892 F.3d 1349, 1356 (Fed. Cir. 2018). UTC
 argues that the Board violated this principle when it con-
 cluded that the Voswinckel abstracts were prior art based
 on an “abstract book” theory. In UTC’s view, this theory
 was not advanced by Liquidia until its Reply before the
 Board, and that it was therefore untimely. See Appellant’s
 Br. at 33. We disagree.
      As the Board recognized, Liquidia’s IPR petition as-
 serted that each of the Voswinckel abstracts was publicly
 presented or published at least one year before the priority
 date of the ’793 patent, making each of them printed pub-
 lications within the meaning of § 102(b). See Decision at
 *4; see also Petition at 22, 24, J.A. 133, 135. UTC first chal-
 lenged the sufficiency of those grounds in its post-institu-
 tion Patent Owner Response. See Patent Owner Response
 at 11–18, J.A. 372–79. Thereafter, in its Reply, Liquidia
 asserted, with additional evidence, that both Voswinckel
 abstracts were publicly presented and sufficiently dissem-
 inated at conferences prior to the critical date such that
 they qualified as printed publications. See J.A. 471,
 474–75.
     The Board found that Liquidia’s arguments and evi-
 dence raised in its Reply were not untimely as they were
 made in direct response to UTC’s attack on the prior art
 status of the abstracts first raised in its post-institution Pa-
 tent Owner Response. Decision at *4, J.A. 10. This conclu-
 sion was not an abuse of the Board’s discretion. See Anacor
 Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–82 (Fed. Cir.
 2018) (explaining that the petitioner “may introduce new
 evidence after the petition stage if the evidence is a legiti-
 mate reply to evidence introduced by the patent owner”);
 see also Axonics, 75 F.4th at 1380 (explaining that a
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 8                      UNITED THERAPEUTICS CORPORATION v.
                                LIQUIDIA TECHNOLOGIES, INC.

 petitioner’s entitlement to respond to new arguments made
 in a patent owner response is consistent with SAS). As the
 Board observed, Liquidia’s arguments were not incon-
 sistent with, and therefore not new over, the grounds
 raised in its IPR petition—that the Voswinckel abstracts
 were publicly accessible prior to the critical date. Ericsson
 Inc. v. Intell. Ventures I LLC, 901 F.3d 1374, 1380 (Fed.
 Cir. 2018) (“[T]he Board has discretion to determine
 whether a petition for inter partes review identified the
 specific evidence relied on in a reply and when a reply con-
 tention crosses the line from the responsive to the new.”).
 Accordingly, we conclude that the Board did not abuse its
 discretion in considering the arguments and evidence
 raised in Liquidia’s Reply.
                              B
      UTC next argues that, even if timely, the Board erred
 in finding that the Voswinckel abstracts were publicly ac-
 cessible because its “abstract book” theory was entirely
 “hypothetical” and supported only by “conclusory expert
 testimony.” Appellant’s Br. at 37. In its view, the Board’s
 theory would have been adequately supported only if
 Liquidia had provided “evidence of actual existence or dis-
 semination” of the books. Id. (emphasis added). But that
 is not the proper standard.
     Public accessibility is the “touchstone in determining
 whether a reference constitutes a ‘printed publication.’”
 Blue Calypso, 815 F.3d at 1348 (quoting In re Hall,
 781 F.3d 897, 898–99 (Fed. Cir. 1986)). “Our cases have
 consistently held that the standard for public accessibility
 is whether a person of ordinary skill in the art could, after
 exercising reasonable diligence, access a reference.” Sam-
 sung Elecs. Co. v. Infobridge Pte. Ltd., 929 F.3d 1363, 1374
 (Fed. Cir. 2019). Once accessibility is proved, “there is no
 requirement to show that particular members of the public
 actually received the information.” Jazz Pharms., Inc. v.
 Amneal Pharms., LLC, 895 F.3d 1347, 1356 (Fed. Cir.
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 2018) (quoting Constant v. Adv. Micro-Devices, Inc.,
 848 F.2d 1560, 1569 (Fed. Cir. 1988)) (emphasis added).
 Contrary to UTC’s position then, Liquidia had no obliga-
 tion to produce, for example, a declarant testifying to hav-
 ing received the abstract books in which the Voswinckel
 abstracts appeared, let alone the abstract books them-
 selves.
     We find that the Board’s conclusion that the
 Voswinckel abstracts were sufficiently disseminated such
 that each constituted a printed publication was supported
 by substantial evidence. Specifically, the Board deter-
 mined that the two 2004 conferences at which the abstracts
 were presented were attended by over 20,000 attendees.
 Rehearing Decision at 7–12, J.A. 58–61.          And both
 Liquidia’s and UTC’s experts testified that every attendee
 of either conference would have received a copy of the ab-
 stract book in which each of the Voswinckel abstracts ap-
 peared. See id. Further still, the Board found that neither
 abstract book would have been disseminated with any ex-
 pectation of privacy, given that the conference attendees
 included scientists, physicians, and nurses, as well as jour-
 nalists. See id. at 59. Substantial evidence therefore sup-
 ports the Board’s conclusion that the Voswinckel abstracts
 qualify as prior art.
                              II
    UTC’s next challenges pertain to the Board’s obvious-
 ness analysis as to independent claim 1.
                              A
     Claim 1 requires the inhalation of a therapeutically ef-
 fective single event dose of 15 micrograms to 90 mi-
 crograms of treprostinil or a therapeutically acceptable salt
 thereof. ’793 patent at col. 18, ll. 28–30. The Board con-
 cluded that, although no reference explicitly taught this
 dose, the person of ordinary skill in the art would have un-
 derstood the solutions in JESC to have delivered an
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 10                     UNITED THERAPEUTICS CORPORATION v.
                                LIQUIDIA TECHNOLOGIES, INC.

 amount of treprostinil within the claimed range. Decision
 at *6–7. That finding was supported by substantial evi-
 dence.
      JESC discloses the administration of treprostinil solu-
 tion via a nebulizer to patients in concentrations of 16, 32,
 48, and 64 μg/mL. J.A. 1240. As the Board recognized,
 JESC does not disclose the volume of solution adminis-
 tered, which is necessary to calculate the amount (in μg) of
 treprostinil administered. Decision at *6. Accordingly, the
 Board looked to the declarations of Liquidia’s two experts,
 each of which testified that, at the time of the invention,
 nebulizers delivered at least 1 mL and up to 5 mL of solu-
 tion. Id. (citing J.A. 1054, 1166). Based on those delivery
 volumes, the Board concluded that the amounts of trepros-
 tinil delivered in JESC would have been from 16–80, 32–
 160, 48–240, or 64–320 μg, each of which has at least one
 endpoint that falls within the claimed range of 15–90 μg.
 Id.
       UTC argues that the Board’s conclusion was error be-
 cause the experts’ testimony related only to fill volume, not
 volume actually delivered. Appellant’s Br. at 43. Because
 no nebulizer can be 100% efficient, UTC argues it was error
 to rely on the experts’ testimony without accounting for
 other factors, such as patients’ breathing volume and pat-
 terns, and individual nebulizer characteristics (e.g., resid-
 ual volume, nebulization rate, etc.). Id. But the Board
 considered, and rejected, those same arguments. Specifi-
 cally, it concluded that, “[t]o the extent that something less
 than the entire fill volume was delivered to the patient,
 . . . the preponderance of the evidence still supports actual
 delivered solution volume being at least one milliliter.” De-
 cision at *7. And, to be sure, UTC’s own expert testified
 that, in 2006, he had not administered treprostinil via a
 nebulizer that utilized less than one milliliter of drug solu-
 tion. Id. (citing J.A. 3185).
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     Accordingly, the Board’s finding that the combination
 of the ’212 patent, JESC, and JAHA would have rendered
 obvious claim 1 was supported by substantial evidence.
                              B
      UTC further challenges the Board’s consideration of its
 evidence of objective indicia of nonobviousness, arguing
 that the Board “clearly erred” by concluding that UTC had
 failed to even allege that the invention demonstrated un-
 expected results over the ’212 patent, JESC, and JAHA.
 Appellant’s Br. at 49–50 (citing Decision at *10). This ar-
 gument, only a single paragraph in UTC’s opening brief,
 borders on waiver. See SmithKline Beecham Corp. v. Apo-
 tex Corp., 439 F.3d 1312, 1320 (Fed. Cir. 2006). But even
 if given due consideration, we conclude that the Board’s de-
 termination was supported by substantial evidence.
     Before the Board, UTC only provided evidence that the
 claimed compositions exhibited unexpected results over in-
 haled iloprost, intravenous epoprostenol, and intravenous
 treprostinil. See Decision at *10. But, as the Board recog-
 nized, the claims require inhaled treprostinil, which is
 taught by each of the ’212 patent, JESC, and JAHA, mak-
 ing those references the closest prior art. And the only ar-
 gument made by UTC that the claimed invention was
 unexpected over those references was a conclusory state-
 ment that “the ability to administer treprostinil at high
 doses in only 1–3 breaths and with fewer side effects was
 unexpected.” J.A. 585. With no other evidence to consider,
 we see no error in the Board’s conclusion that UTC failed
 to satisfy its burden in establishing unexpected results.
                             III
     Finally, we turn to UTC’s challenge to the Board’s
 treatment of dependent claims 4, 6, and 7, which are di-
 rected to the inhalation of dry powder formulations of
 treprostinil. UTC argues that the Board failed to consider
 each claim as a separate invention and that none of the ’212
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                                 LIQUIDIA TECHNOLOGIES, INC.

 patent, JESC, or JAHA discloses any dry powder dosages.
 Specifically, it argues that the Board failed to explain why
 a person of ordinary skill in the art would “reasonably ex-
 pect to succeed in preparing a therapeutically effective dry
 powder formulation” using concentrations prepared only
 for solutions. Appellant’s Br. at 55.
      But, as Liquidia explains, UTC never raised this par-
 ticular argument before the Board. Instead, it argued that
 claims 4, 6, and 7 were not obvious “because the prior art
 lacks disclosure of a single event dose of 15–90 μg delivered
 in 1–3 breaths, regardless of the form of administration
 (liquid or powder).” Patent Owner Response at 41, J.A. 401
 (emphases added). We therefore find UTC’s argument for-
 feited. Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d
 1288, 1296 (Fed. Cir. 2009) (explaining that this court may
 decline to consider an argument “[i]f a party fail[ed] to raise
 [that] argument before the trial court, or present[ed] only
 a skeletal or undeveloped argument to the trial court.”).
      In any event, the Board’s conclusion that dependent
 claims 4, 6, and 7 were obvious was supported by substan-
 tial evidence. Namely, as the Board observed, the ’212 pa-
 tent, which is also owned by UTC, discloses the use of an
 “inhaler,” and that “solid formulations, usually in the form
 of a powder, may be inhaled in accordance with the present
 invention.” ’212 patent at col. 5, ll. 30, 37–39, J.A. 1228. It
 also teaches that such formulations have particle sizes of
 preferably “less than 5 micrometers in diameter.” Id. at
 col. 5, ll. 39–41, J.A. 1228. The Board relied not only on
 these disclosures, but also on the unrebutted testimony of
 Liquidia’s expert that a person of ordinary skill in the art
 would have had a reasonable expectation of success in ar-
 riving at the claimed dry powder formulation based on the
 combined teachings of the ’212 patent, JESC, and JAHA.
 Decision at *14.
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                      CONCLUSION
     We have considered UTC’s remaining arguments and
 find them unpersuasive. For the reasons provided above,
 we affirm the Board’s unpatentability determination.
                       AFFIRMED