Court Opinion

ID: 6495296
Source: CourtListenerOpinion
Date Created: 2022-06-27 14:01:34.313221+00
Date Added: 2024-06-11T08:46:17.568623
License: Public Domain

Case: 21-1070   Document: 51   Page: 1   Filed: 06/21/2022

   United States Court of Appeals
       for the Federal Circuit
                ______________________

 NOVARTIS PHARMACEUTICALS CORPORATION,
              Plaintiff-Appellee

                          v.

    ACCORD HEALTHCARE, INC., AUROBINDO
 PHARMA LTD., AUROBINDO PHARMA USA, INC.,
 DR. REDDY’S LABORATORIES, INC., DR. REDDY’S
          LABORATORIES, LTD., EMCURE
       PHARMACEUTICALS LTD., HERITAGE
      PHARMACEUTICALS INC., GLENMARK
    PHARMACEUTICALS INC., USA, GLENMARK
   PHARMACEUTICALS LIMITED, HETERO USA,
  INC., HETERO LABS LIMITED UNIT-V, HETERO
   LABS LIMITED, MYLAN PHARMACEUTICALS,
     INC., PRINSTON PHARMACEUTICAL INC.,
  STRIDES GLOBAL PHARMA PRIVATE LIMITED,
   STRIDES PHARMA, INC., TORRENT PHARMA
    INC., TORRENT PHARMACEUTICALS LTD.,
 ZYDUS PHARMACEUTICALS (USA) INC., CADILA
    HEALTHCARE LTD., APOTEX INC., APOTEX
   CORP., SUN PHARMACEUTICAL INDUSTRIES,
 LTD., SUN PHARMACEUTICAL INDUSTRIES INC.,
            SUN PHARMA GLOBAL FZE,
                   Defendants

   HEC PHARM CO., LTD., HEC PHARM USA INC.,
             Defendants-Appellants
            ______________________

                      2021-1070
                ______________________
Case: 21-1070     Document: 51     Page: 2   Filed: 06/21/2022

 2      NOVARTIS PHARMACEUTICALS   v. ACCORD HEALTHCARE INC.

     Appeal from the United States District Court for the
 District of Delaware in No. 1:18-cv-01043-KAJ, Circuit
 Judge Kent A. Jordan.
                 ______________________

                   Decided: June 21, 2022
                   ______________________

     JANE M. LOVE, Gibson, Dunn & Crutcher LLP, New
 York, NY, argued for plaintiff-appellee. Also represented
 by PAUL E. TORCHIA, ROBERT TRENCHARD.

      PAUL SKIERMONT, Skiermont Derby LLP, Dallas, TX,
 argued for defendants-appellants. Also represented by
 SARAH ELIZABETH SPIRES; MIEKE K. MALMBERG, Los Ange-
 les, CA.
                 ______________________

     Before MOORE, Chief Judge, LINN and HUGHES, Circuit
                           Judges.
       Opinion for the court filed by Chief Judge MOORE.
        Dissenting opinion filed by Circuit Judge LINN.

 MOORE, Chief Judge.
      HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (col-
 lectively, HEC) petition for rehearing of our prior decision
 in this case, 21 F.4th 1362 (Fed. Cir. 2022), in which we
 affirmed a final judgment of the United States District
 Court for the District of Delaware. The district court de-
 termined that claims 1–6 of U.S. Patent No. 9,187,405 are
 not invalid and that HEC infringes them. Because the ’405
 patent fails to disclose the absence of a loading dose, the
 district court clearly erred in finding that the negative
 claim limitation “absent an immediately preceding loading
 dose” added during prosecution to overcome prior art
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 NOVARTIS PHARMACEUTICALS     v. ACCORD HEALTHCARE INC.       3

 satisfies the written description requirement of 35 U.S.C.
 § 112(a). We grant HEC’s petition for panel rehearing, va-
 cate our prior decision, and reverse the district court’s judg-
 ment that Novartis’ claims are not invalid for inadequate
 written description.
                         BACKGROUND
     The ’405 patent discloses methods of treating relaps-
 ing-remitting multiple sclerosis (RRMS) using the immu-
 nosuppressant fingolimod. E.g., ’405 patent at claim 1,
 8:56–60. Each claim of the ’405 patent requires adminis-
 tering fingolimod “at a daily dosage of 0.5 mg, absent an
 immediately preceding loading dose regimen.” Id. at claim
 1. A loading dose is a “higher-than-daily dose . . . usually
 given as the first dose.” J.A. 27 ¶ 63 (internal quotation
 marks omitted). The patent’s specification does not men-
 tion loading doses, much less the absence of a loading dose.
 Instead, it describes administering fingolimod at regular
 intervals (e.g., once daily, multiple times per day, or every
 other day). ’405 patent at 11:20–38.
     Novartis owns the ’405 patent and markets a drug un-
 der the brand name Gilenya that purportedly practices the
 patent. HEC filed an abbreviated new drug application
 (ANDA) with the Food and Drug Administration seeking
 approval to market a generic version of Gilenya. Novartis
 sued HEC in the District of Delaware, alleging that HEC’s
 ANDA infringes all claims of the ’405 patent. 1
     After a four-day bench trial, the district court found
 that HEC’s ANDA infringes and that the claims are not in-
 valid, either as anticipated by Kappos 2006 or for inade-
 quate written description of the no-loading-dose or daily-

     1   Novartis sued several other defendants who also
 filed ANDAs, but those cases were settled or stayed before
 trial.
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 4    NOVARTIS PHARMACEUTICALS    v. ACCORD HEALTHCARE INC.

 dosage limitations. HEC appeals as to written description.
 We have jurisdiction under 28 U.S.C. § 1295(a)(1).
                         DISCUSSION
     “Whether a claim satisfies the written description re-
 quirement is a question of fact that, on appeal from a bench
 trial, we review for clear error.” Allergan, Inc. v. Sandoz
 Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015) (quoting Alcon
 Rsch. Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1190 (Fed.
 Cir. 2014)). Under the clear error standard, we defer to the
 district court’s findings “in the absence of a definite and
 firm conviction that a mistake has been made.” Scanner
 Techs. Corp. v. ICOS Vision Sys. Corp. N.V., 528 F.3d 1365,
 1374 (Fed. Cir. 2008) (cleaned up). Inadequate written de-
 scription must be shown by clear and convincing evidence.
 Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336,
 1351 (Fed. Cir. 2011) (citing ICU Med., Inc. v. Alaris Med.
 Sys., Inc., 558 F.3d 1368, 1376 (Fed. Cir. 2009)).
                              A
     To satisfy the written description requirement, a pa-
 tent’s specification must “reasonably convey[ ] to those
 skilled in the art that the inventor had possession of the
 claimed subject matter as of the filing date.” Ariad
 Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
 Cir. 2010) (en banc). Such possession must be “shown in
 the disclosure.” Id. It is not enough that a claimed inven-
 tion is “an obvious variant of that which is disclosed in the
 specification.” Lockwood v. Am. Airlines, Inc., 107 F.3d
 1565, 1572 (Fed. Cir. 1997). Disclosure is essential; it is
 “the quid pro quo of the right to exclude.” Kewanee Oil Co.
 v. Bicron Corp., 416 U.S. 470, 484 (1974); see also Enzo Bi-
 ochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir.
 2002) (“[D]escription is the quid pro quo of the patent sys-
 tem.”).
     For negative claim limitations, like the no-loading-dose
 limitation at issue here, there is adequate written
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 NOVARTIS PHARMACEUTICALS    v. ACCORD HEALTHCARE INC.       5

 description when, for example, “the specification describes
 a reason to exclude the relevant [element].” Santarus, Inc.
 v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012);
 Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1355 (Fed. Cir.
 2015) (same); Nike, Inc. v. Adidas AG, 812 F.3d 1326, 1348
 (Fed. Cir. 2016) (same), overruled on other grounds by Aqua
 Prods., Inc. v. Matal, 872 F.3d 1290, 1301 (Fed. Cir. 2017)
 (en banc). A reason to exclude an element could be found
 in “statements in the specification expressly listing the dis-
 advantages of using” that element. Santarus, 694 F.3d at
 1351. Another reason could be that the specification “dis-
 tinguishes among” the element and alternatives to it.
 Inphi, 805 F.3d at 1357; see also In re Johnson, 558 F.2d
 1008, 1017–19 (C.C.P.A. 1977) (reversing rejection for in-
 adequate written description where specification disclosed
 several species of a genus and claims recited genus but ex-
 cluded two species of lost interference count).
     The common denominator of these examples is disclo-
 sure of the element. That makes sense because “the hall-
 mark of written description is disclosure.” Ariad, 598 F.3d
 at 1351; see also Lockwood, 107 F.3d at 1571 (“It is the dis-
 closures of the applications that count.”). Silence is gener-
 ally not disclosure. See Seabed Geosolutions (US) Inc. v.
 Magseis FF LLC, 8 F.4th 1285, 1288 (Fed. Cir. 2021)
 (“[S]ilence does not support reading the claims to exclude
 gimbaled geophones.” (citations omitted)); MPEP
 § 2173.05(i) (9th ed. Rev. 10.2019, June 2020) (“The mere
 absence of a positive recitation is not a basis for an exclu-
 sion.”). If it were, then every later-added negative limita-
 tion would be supported so long as the patent makes no
 mention of it. While a negative limitation need not be re-
 cited in the specification in haec verba, there generally
 must be something in the specification that conveys to a
 skilled artisan that the inventor intended the exclusion,
 such as a discussion of disadvantages or alternatives. Con-
 sistent with our precedent in Santarus, Inphi and Nike, the
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 6       NOVARTIS PHARMACEUTICALS   v. ACCORD HEALTHCARE INC.

 written description requirement cannot be met through
 simple disregard of the presence or absence of a limitation.
      While a written description’s silence about a negative
 claim limitation is a useful and important clue and may
 often be dispositive, it is possible that the written descrip-
 tion requirement may be satisfied when a skilled artisan
 would understand the specification as inherently disclos-
 ing the negative limitation. 2 For example, if the record es-
 tablished that in a particular field, the absence of mention
 of a limitation necessarily excluded that limitation, written
 description could be satisfied despite the specification’s si-
 lence. See Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed.
 Cir. 1998) (“[M]issing descriptive matter must necessarily
 be present in the . . . specification such that one skilled in
 the art would recognize such a disclosure.” (citing Cont’l
 Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268 (Fed.
 Cir. 1991))); see also In re Robertson, 169 F.3d 743, 745
 (Fed. Cir. 1999) (“To establish inherency [for purposes of
 anticipation], . . . evidence must make clear that the miss-
 ing descriptive matter is necessarily present in the thing
 described in the reference, and that it would be so recog-
 nized by persons of ordinary skill.” (internal quotation

     2    Novartis contends the written description require-
 ment may be satisfied by “implicit disclosure” as distinct
 from express or inherent disclosure. Novartis Br. 50–51.
 Yet it fails to identify any case holding that “implicit dis-
 closure” (whatever that means) is sufficient. Novartis cites
 In re Kolstad, a non-precedential decision involving express
 disclosure. 907 F.2d 157 (Fed. Cir. 1990) (non-preceden-
 tial). If an implicit disclosure is one that would render the
 limitation obvious to a skilled artisan, such a disclosure
 cannot under our precedent satisfy the written description
 requirement. Lockwood, 107 F.3d at 1572 (“A description
 which renders obvious the invention for which an earlier
 filing date is sought is not sufficient.”).
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 NOVARTIS PHARMACEUTICALS     v. ACCORD HEALTHCARE INC.       7

 marks and citation omitted)). When the specification is it-
 self silent regarding a negative limitation, testimony from
 a skilled artisan as to possibilities or probabilities that the
 recited element would be excluded would not suffice, lest
 such testimony could effectively eliminate the written de-
 scription requirement. If silence were generally sufficient,
 all negative limitations would be supported by a silent
 specification. If, however, a patent owner could establish
 that a particular limitation would always be understood by
 skilled artisans as being necessarily excluded from a par-
 ticular claimed method or apparatus if that limitation is
 not mentioned, the written description requirement would
 be satisfied despite the specification’s silence.
                               B
     The district court found that because there is no reci-
 tation of a loading dose in the specification, the no-loading-
 dose limitation is supported. J.A. 26 ¶ 61. The district
 court further found that the no-loading-dose limitation is
 disclosed in the specification because “[t]he Prophetic Trial
 describes giving a ‘daily dosage of 0.5 . . . mg’ fingolimod to
 treat RRMS, started ‘initially.’ The Prophetic Trial tells a
 person of skill that on day 1, treatment begins with a daily
 dose of 0.5 mg, not a loading dose.” J.A. 26 ¶ 62 (citations
 omitted). Novartis, likewise, argues that the specification
 satisfies the written description requirement for the no-
 loading-dose limitation because it indicates that the dosing
 regimen starts by “initially” administering a daily dosage.
 Novartis Br. 44.
      The district court’s finding that the specification dis-
 closes “initially” starting with a daily dose was clearly er-
 roneous. The specification nowhere describes “initially”
 administering a daily dosage. The specification says, “Ini-
 tially patients receive treatment for 2 to 6 months.” ’405
 patent at 11:13–14. This sentence speaks to the initial
 length of treatment, not the dosage with which treatment
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 8    NOVARTIS PHARMACEUTICALS     v. ACCORD HEALTHCARE INC.

 begins. Dr. Lublin, one of Novartis’ physician experts, ad-
 mitted this:
     Q. And then . . . there’s a sentence that begins: In-
     itially, patients receive treatment for two to six
     months. Do you see that?
     A. I do.
     Q. And what does that tell you about how the dos-
     ing would work?
     A. It suggests to me they’re taking the dosing
     that’s outlined in that first sentence continually for
     two to six months.
 J.A. 22792 (emphasis added).
     The contrary testimony of Novartis’ second physician
 expert, Dr. Steinman, is inconsistent with the plain text of
 the specification and therefore carries no weight.
 J.A. 23343 (testifying that “initially” is “really zooming in
 on Day 1” and conveying that treatment starts with “a daily
 dose of 0.5”). “[E]xpert testimony that is inconsistent with
 unambiguous intrinsic evidence should be accorded no
 weight.” Bell & Howell Document Mgmt. Prods. Co. v. Al-
 tek Sys., 132 F.3d 701, 706 (Fed. Cir. 1997) (citations omit-
 ted). As HEC argues in its rehearing petition, the district
 court’s reliance on a misquotation “ferreted into trial testi-
 mony by Novartis’ experts” was clearly erroneous. Pet. for
 Reh’g 6; see J.A. 26–27 ¶¶ 62–63 (district court relying on
 testimony that specification describes “initially” adminis-
 tering daily dosage).
      The ’405 specification discloses neither the presence
 nor absence of a loading dose. Loading doses—whether to
 be used or not—are simply not discussed. Novartis’ experts
 readily admitted this. J.A. 23344 (“Q. Is there anywhere
 in [the specification] that you saw reference to the loading
 dose? A. No.”); J.A. 22791 (Dr. Lublin testifying that “in-
 formation of having a loading dose is not there”). Dr.
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 NOVARTIS PHARMACEUTICALS    v. ACCORD HEALTHCARE INC.       9

 Lublin also agreed that “[n]othing in the text of the speci-
 fication of the ’405 patent discloses a rationale for the neg-
 ative limitation prohibiting an immediately preceding
 loading dose.” J.A. 22872–73. The fact that the specifica-
 tion is silent about loading doses does not support a later-
 added claim limitation that precludes loading doses.
     The district court also found, independent of the mis-
 quoted “initially” language, that the specification’s disclo-
 sure of a daily dosage combined with its silence regarding
 a loading dose would “tell a person of skill that loading
 doses are excluded from the invention.” J.A. 26 ¶ 61. That,
 too, was clearly erroneous. Novartis does not defend this
 finding. 3 And for good reason.
     There is significant tension in the district court’s find-
 ing that the specification’s disclosure excludes a loading
 dose, but that the Kappos 2006 abstract does not. Both are
 silent regarding loadings doses, and both disclose a daily
 dosage. The district court defended this inconsistency by
 claiming that “[u]nlike a patent, which is presumed com-
 plete, an abstract [like Kappos 2006] is not presumed to
 contain all of the necessary information about the study.”
 J.A. 30 ¶ 74. This concept that a patent is presumed “com-
 plete” infected the district court’s analysis and the experts’
 testimony regarding the no-loading-dose limitation. For
 example, Dr Lublin testified:
     Q. What would a person of skill reading the patent
     have thought about [the] question [of written de-
     scription]?
     A. They would have viewed the patent as a docu-
     ment, as a complete document, that should give you

     3    Nor could it. Novartis admittedly did not “argue
 below that inherency . . . applies to the ’405 Patent’s
 method claims.” Novartis Br. 50. Any defense of the dis-
 trict court’s finding is thus forfeit.
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 10    NOVARTIS PHARMACEUTICALS    v. ACCORD HEALTHCARE INC.

      all the information you need to carry out the
      claims, and that information of having a loading
      dose is not there, and what’s instead there is exam-
      ples of daily dose, daily dose, daily dose.
 J.A. 22791. A patent is not presumed complete such that
 things not mentioned are necessarily excluded. We pre-
 sume only that a patent has adequate written description,
 not that it is complete. Nat’l Recovery Techs., Inc. v. Mag-
 netic Separation Sys., Inc., 166 F.3d 1190, 1195 (Fed. Cir.
 1999) (“The presumption of validity includes a presump-
 tion that the patent complies with § 112.” (citing N. Tele-
 com, Inc. v. Datapoint Corp., 908 F.2d 931, 941 (Fed. Cir.
 1990))).
      Importantly, the disclosure of a daily dosage cannot
 amount to a disclosure that there can be no loading dose,
 because such a finding is at odds with the prosecution his-
 tory. The Patent Office allowed the claims only after the
 applicants added the no-loading-dose limitation.
 J.A. 23903 (examiner’s rejection in parent application);
 J.A. 23892–93 (applicants’ response); see also Novartis Br.
 11–12. The applicants explained that they added the no-
 loading-dose limitation “to specify that the [daily dosage]
 cannot immediately follow a loading dose regimen” and “to
 further distinguish their claims from the disclosure of
 [prior art].” J.A. 23892. If reciting “daily dosage” without
 mentioning a loading dose necessarily excluded a loading
 dose, there would have been no reason for the applicants to
 add the no-loading-dose limitation. Neither the applicants
 nor the examiner understood the words “daily dosage”
 without the words “no loading dose” to convey the absence
 of a loading dose. Accordingly, the district court’s contrary
 finding was clearly erroneous.
     There is expert testimony that the specification dis-
 closes the absence of a loading dose. Dr. Steinman testi-
 fied:
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 NOVARTIS PHARMACEUTICALS    v. ACCORD HEALTHCARE INC.       11

     Q. And do you see the sentence there, it says, “Ini-
     tially patients receive treatment for 2 to 6 months.”
     What would that tell a person of skill?
     A. Well, there were two places [in the specification]
     that if there were going to be an immediately pre-
     ceding loading dose, you would give it before the in-
     itial treatment, so you would really necessarily
     want to put it right there. And the second place
     was earlier when you talked about a daily dosage
     of 0.5. But there were two gates that if you wanted
     to interject something about a loading dose, those
     were the opportunities in this. And it was zero out
     of two places where they, I think, necessarily would
     have put it in.
 J.A. 23334–35. This expert testimony is focused on where
 in the specification the patentee would have mentioned a
 loading dose if they intended a loading dose to be included.
 But the question is not whether the patentee intended
 there to be a loading dose; the question is whether the pa-
 tentee precluded the use of a loading dose. On this record,
 there is no evidence that a skilled artisan would under-
 stand silence regarding a loading dose to necessarily ex-
 clude a loading dose. In fact, all the experts agreed that
 loading doses are sometimes given to MS patients. See
 J.A. 22780 (Dr. Lublin explaining that loading doses have
 been used in trials of MS drugs and with fingolimod in par-
 ticular); J.A. 22794; J.A. 23347–48 (Dr. Steinman acknowl-
 edging that loading doses are used in MS treatments);
 J.A. 23475 (Dr. Jusko, Novartis’ pharmacology expert, tes-
 tifying that fingolimod was given to transplant patients
 with a loading dose, and that he “could envision the possi-
 bility of starting with a loading dose”). And, importantly,
 there is intrinsic evidence that a skilled artisan would not
 understand reciting a daily dosage regimen without men-
 tioning a loading dose to exclude a loading dose.
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 12   NOVARTIS PHARMACEUTICALS      v. ACCORD HEALTHCARE INC.

     We do not today create a heightened standard for neg-
 ative claim limitations. Just as disclosure is the “hallmark
 of written description” for positive limitations, Ariad, 598
 F.3d at 1351, so too for negative limitations. That disclo-
 sure “need not rise to the level of disclaimer.” Santarus,
 694 F.3d at 1351. Nor must it use the same words as the
 claims. Lockwood, 107 F.3d at 1572 (“[T]he exact terms
 need not be used in haec verba.” (citing Eiselstein v. Frank,
 52 F.3d 1035, 1038 (Fed. Cir. 1995))). Rather, as with pos-
 itive limitations, the disclosure must only “reasonably con-
 vey[ ] to those skilled in the art that the inventor had
 possession of the claimed subject matter as of the filing
 date.” Ariad, 598 F.3d at 1351. While silence will not gen-
 erally suffice to support a negative claim limitation, there
 may be circumstances in which it can be established that a
 skilled artisan would understand a negative limitation to
 necessarily be present in a disclosure. This is not such a
 case.
                        CONCLUSION
      The district court’s finding that the no-loading-dose
 limitation meets the written description requirement was
 clearly erroneous. We grant HEC’s petition for panel re-
 hearing, vacate our prior decision, and reverse the district
 court’s judgment that the claims of the ’405 patent are not
 invalid. We need not reach HEC’s argument that the dis-
 trict court also clearly erred in finding adequate written
 description for the “daily dosage of 0.5 mg” limitation.
                        REVERSED
                            COSTS
 No costs.
Case: 21-1070   Document: 51    Page: 13   Filed: 06/21/2022

    United States Court of Appeals
        for the Federal Circuit
                 ______________________

  NOVARTIS PHARMACEUTICALS CORPORATION,
               Plaintiff-Appellee

                           v.

     ACCORD HEALTHCARE, INC., AUROBINDO
  PHARMA LTD., AUROBINDO PHARMA USA, INC.,
  DR. REDDY'S LABORATORIES, INC., DR. REDDY'S
           LABORATORIES, LTD., EMCURE
        PHARMACEUTICALS LTD., HERITAGE
       PHARMACEUTICALS INC., GLENMARK
     PHARMACEUTICALS INC., USA, GLENMARK
    PHARMACEUTICALS LIMITED, HETERO USA,
   INC., HETERO LABS LIMITED UNIT-V, HETERO
    LABS LIMITED, MYLAN PHARMACEUTICALS,
      INC., PRINSTON PHARMACEUTICAL INC.,
   STRIDES GLOBAL PHARMA PRIVATE LIMITED,
    STRIDES PHARMA, INC., TORRENT PHARMA
     INC., TORRENT PHARMACEUTICALS LTD.,
  ZYDUS PHARMACEUTICALS (USA) INC., CADILA
     HEALTHCARE LTD., APOTEX INC., APOTEX
    CORP., SUN PHARMACEUTICAL INDUSTRIES,
  LTD., SUN PHARMACEUTICAL INDUSTRIES INC.,
             SUN PHARMA GLOBAL FZE,
                    Defendants

   HEC PHARM CO., LTD., HEC PHARM USA INC.,
             Defendants-Appellants
            ______________________

                       2021-1070
                 ______________________
Case: 21-1070    Document: 51       Page: 14    Filed: 06/21/2022

 2    NOVARTIS PHARMACEUTICALS      v. ACCORD HEALTHCARE INC.

     Appeal from the United States District Court for the
 District of Delaware in No. 1:18-cv-01043-KAJ, Circuit
 Judge Kent A. Jordan.
                 ______________________

 LINN, Circuit Judge, dissenting.
     The majority, while recognizing that written descrip-
 tion support is a fact-based inquiry based on the under-
 standings of a person of ordinary skill in the art, and while
 ultimately recognizing that the standard for negative limi-
 tations is the same as for any other limitation, nonetheless
 applies a heightened written description standard to the
 facts of this case in requiring not only a “reason to exclude”
 but a showing that the negative limitation in question was
 “necessarily excluded.” In doing so, the majority character-
 izes the district court’s fact finding as clearly erroneous and
 concludes that written description support for the no-load
 limitation is lacking. In my opinion, the district court ap-
 plied the correct standard and found ample support in the
 written description for the no-load limitation. For these
 reasons, I respectfully dissent.
                               I
     A specification that “reasonably conveys to those
 skilled in the art that the inventor had possession of the
 claimed subject matter as of the filing date” has adequate
 written description of the claimed invention. Ariad
 Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
 Cir. 2010). “[T]he test requires an objective inquiry into
 the four corners of the specification from the perspective of
 a person of ordinary skill in the art.” Id. Our case law
 makes clear that “[c]ompliance with the written descrip-
 tion requirement is essentially a fact-based inquiry that
 will ‘necessarily vary depending on the nature of the inven-
 tion claimed.’” Enzo Biochem, Inc. v. Gen-Probe Inc., 323
 F.3d 956, 963 (Fed. Cir. 2002) (quoting Vas-Cath Inc. v.
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 NOVARTIS PHARMACEUTICALS    v. ACCORD HEALTHCARE INC.       3

 Mahurkar, 935 F.2d 1555, 1562 (Fed. Cir. 1991)). It is well
 established that there is no “new and heightened standard
 for negative claim limitations.” Inphi Corp. v. Netlist, Inc.,
 805 F.3d 1350, 1356 (Fed. Cir. 2015). While the court in
 Santarus, Inc. v. Par Pharmaceutical, Inc. observed that
 “[n]egative claim limitations are adequately supported
 when the specification describes a reason to exclude the rel-
 evant limitation,” we did not hold that a specification must
 describe a reason to exclude a negative limitation. 694 F.3d
 1344, 1351 (Fed. Cir. 2012). A specification that describes
 a reason to exclude the relevant negative limitation is but
 one way in which the written description requirement may
 be met.
      The majority begins its opinion with the recognition
 that a written description’s silence about a negative claim
 limitation, while serving as a “useful and important clue,”
 is not necessarily dispositive of whether that limitation is
 adequately supported. Maj. at 6. I agree. The majority
 concludes with a citation to Ariad for the proposition that
 “as with positive limitations, the disclosure must only ‘rea-
 sonably convey [] to those skilled in the art that the inven-
 tor had possession of the claimed subject matter as of the
 filing date.’” Maj. at 12 (citing Ariad, 598 F.3d at 1351).
 With that, I also agree. But the majority in its analysis
 employs the heightened standard of “necessary exclusion”
 against which to assess the district court’s fact findings in
 this case and uses that standard to conclude that the dis-
 trict court clearly erred. With that, I cannot agree. While
 a showing of “necessary exclusion” would most certainly
 provide written description support for a negative limita-
 tion, it is not and should not be a requirement in every case.
 As noted above and as Ariad makes clear, the critical ques-
 tion in assessing written description support for a negative
 limitation is the same as for any other limitation: “Does
 the written description reasonably convey to those skilled
 in the art that the inventor had possession of the claimed
 subject matter as of the filing date?” See Ariad, 598 F.3d
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 at 1351. How that question is resolved depends on the facts
 of each case, assessed through the eyes of the skilled arti-
 san. Our precedent makes that clear.
      For example, in Santarus, we found that claims di-
 rected to a method of treatment with a pharmaceutical
 composition containing no sucralfate were adequately de-
 scribed by a specification that explained that, although su-
 cralfate is “possibly the ideal agent for stress ulcer
 prophylaxis,” it was known to have occasional adverse ef-
 fects. 694 F.3d 1344, 1350–51 (Fed. Cir. 2012). In Santa-
 rus, as in this case, there was expert testimony providing a
 person of ordinary skill’s understanding of the patent spec-
 ification. See id. at 1351. The expert testimony in Santa-
 rus showed that “a person of ordinary skill in this field . . .
 would have understood from the specification that disad-
 vantages of sucralfate may be avoided by the [claimed] for-
 mulation.” Id.
      In In re Bimeda Research & Development Ltd., we held
 that a claim that excluded a specific anti-infective, acrifla-
 vine, was not adequately described by a disclosure that was
 inconsistent with the exclusion of acriflavine but not other
 anti-infectives or antibiotics. 724 F.3d 1320, 1324 (Fed.
 Cir. 2013). The claim at issue in Bimeda was directed to a
 method of preventing mastitis in dairy cows by sealing the
 teat canal of a cow’s mammary gland with a seal formula-
 tion that excludes acriflavine. Other claims in the same
 patent excluded all anti-infective agents. We noted that
 the patent repeatedly distinguished the invention as able
 to prevent mastitis without the use of antibiotics. Based
 on the written description’s consistent description of the in-
 vention’s non-antibiotic approach to preventing mastitis,
 we concluded that the patent’s disclosure was “inconsistent
 with a claim which excludes acriflavine, but not the pres-
 ence of other anti-infectives or antibiotics.” Id. (citation
 and quotation marks omitted). We did not require that the
 specification describe a reason to exclude acriflavine spe-
 cifically; rather, we found only that a negative limitation
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 NOVARTIS PHARMACEUTICALS     v. ACCORD HEALTHCARE INC.       5

 which is inconsistent with the disclosure is not adequately
 described.
     In Inphi, we confirmed that the written description re-
 quirement is satisfied where “‘the essence of the original
 disclosure’ conveys the necessary information—‘regardless
 of how it’ conveys such information, and regardless of
 whether the disclosure’s ‘words [a]re open to different in-
 terpretation[s].’” 805 F.3d at 1354 (quoting In re Wright,
 866 F.2d 422, 424–25 (Fed. Cir. 1989) (citation and internal
 quotation marks omitted, emphasis in Inphi)). We ex-
 plained that “Santarus simply reflects the fact that the
 specification need only satisfy the requirements of § 112,
 paragraph 1 as described in this court’s existing jurispru-
 dence.” Id. at 1356. And we noted that the “‘reason’ re-
 quired by Santarus is provided, for instance, by properly
 describing alternative features of the patented invention.”
 Id. (citing In re Johnson, 558 F.2d 1008, 1019 (C.C.P.A.
 1977)).
     In Inphi, we found that substantial evidence supported
 the Patent Trial and Appeal Board’s (“Board”) finding that
 a negative limitation which had been added during prose-
 cution (“DDR chip selects that are not CAS, RAS, or bank
 address signals”) was adequately described by an original
 specification which did not expressly articulate a reason to
 exclude RAS and CAS signals. We found the Board’s deci-
 sion was supported by evidence of (1) standards set by the
 Joint Electron Device Engineering Council, a global stand-
 ard-setting body for the microelectronics industry, incorpo-
 rated by reference in the patent, which specify that DDR
 signals, including CAS, RAS, CAS, and bank address sig-
 nals, are distinct from each other; (2) a table in the specifi-
 cation which excludes RAS and CAS signals; and (3)
 various passages from the specification, including a figure
 which distinguishes chip select signals, command signals
 (including RAS and CAS signals) and bank address signals.
 We concluded that the specification’s disclosure of
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 alternative features was sufficient to satisfy the written de-
 scription standard for the negative limitation. Id. at 1357.
     In Nike, Inc. v. Adidas AG, we reiterated that Santarus
 did not create a heightened standard for written descrip-
 tion of negative limitations. 812 F.3d 1326, 1348 (Fed. Cir.
 2016), overruled on other grounds by Aqua Prods., Inc. v.
 Matal, 872 F.3d 1290 (Fed. Cir. 2017) (en banc). We stated
 that negative limitations, like all other limitations, are
 held to “the customary standard for the written description
 requirement.” Id. In Nike, we found a limitation of “flat
 knit edges,” which Adidas characterized as a negative lim-
 itation, was adequately described by three figures in the
 specification depicting the claimed textile element which
 Nike’s expert opined could be made using flat knitting in
 contrast to another figure’s textile element which is formed
 using a circular knitting machine. Id. at 1348–49.
      The central tenet of our written description jurispru-
 dence—that the disclosure must be read from the perspec-
 tive of a person of skill in the art—further recognizes that
 the disclosure need not describe a limitation in haec verba.
 See, e.g., All Dental Prods., LLC v. Advantage Dental Prod.,
 Inc., 309 F.3d 774, 779 (Fed. Cir. 2002) (citing Eiselstein v.
 Frank, 52 F.3d 1035, 1039 (Fed. Cir. 1995) (“[T]he failure
 of the specification to specifically mention a limitation that
 later appears in the claims is not a fatal one when one
 skilled in the art would recognize upon reading the specifi-
 cation that the new language reflects what the specifica-
 tion shows has been invented.”); see also Ariad, 598 F.3d at
 1351.
     The Manual of Patent Examining Procedure (“MPEP”)
 similarly provides for written description in various forms.
 In addition to stating that the “mere absence of a positive
 recitation” is not enough, the MPEP also correctly states
 that no specific form of disclosure is required and provides
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 for implicit written description. 1 MPEP § 2173.05(i) states
 that “a lack of literal basis in the specification for a nega-
 tive limitation may not be sufficient to establish a prima
 facie case for lack of descriptive support.” And MPEP
 § 2163 states that “newly added claims or claim limitations
 must be supported in the specification through express, im-
 plicit, or inherent disclosure.” MPEP § 2163 (emphasis
 added). What is critical is how a person of skill in the art
 would read the disclosure—not the exact words used.
     In other words, context and the knowledge of those
 skilled in the art matter. And, as the Supreme Court has
 made clear, when assessing what the written description
 reveals to a skilled artisan, common sense also matters.
 KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)
 (holding that, in an obviousness analysis, “[r]igid preven-
 tative rules that deny factfinders recourse to common
 sense, however, are neither necessary under our case law
 nor consistent with it”).
                               II
      Here, the district court conducted “an objective inquiry
 into the four corners of the specification from the perspec-
 tive of a person of ordinary skill in the art” and found suf-
 ficient written description in the EAE model and the
 Prophetic Trial. J.A. 37 (citing Ariad, 598 F.3d at 1351).
 The district court found that the “Prophetic Trial describes
 giving a ‘daily dosage of 0.5 . . . mg’ fingolimod to treat
 RRMS, started ‘initially.’” J.A. 26 ¶ 62 (quoting ’405 patent
 col. 11 ll. 8–13). The court found, crediting expert testi-
 mony, that, “[i]f a loading dose were directed, the Patent
 would say that a loading dose should be administered ‘ini-
 tially.’”    J.A. 26 ¶ 62 (citing J.A. 23334–35 (Tr.

     1   I cite the MPEP, not because the court is bound by
 it but because I find its reasoning informative and persua-
 sive.
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 756:16–757:8); J.A. 23441–42 (Tr. 863:22–864:18)). The
 district court thus made the unremarkable, and factually
 supported, determination that “starting with a daily dose
 plainly implies that there is no loading dose.” J.A. 27. Sim-
 ilarly, the district court found that the “EAE example dis-
 closes a dosing regimen which does not involve a loading
 dose.” J.A. 27 ¶ 64 (citing J.A. 23345 (Tr. 767:3–5); J.A.
 22793 (Tr. 215:16–21)). The district court held that the de-
 scription in the specification of administration of a daily
 dose “would tell a person of skill that loading doses are ex-
 cluded from the invention.” J.A. 26 ¶ 61. The court also
 found that “[a] loading dose is necessarily a higher-than
 daily dose.” J.A. 27 ¶ 63 (Tr. 766:4-766:6). Finally, the
 court found that, while the patent describes alternate dos-
 ing regimens, such as “intermittent dosing,” it does not de-
 scribe administering those regimens with loading doses.
 J.A. 27 ¶ 65. Thus, the district court concluded, “[t]he EAE
 model and the Prophetic Trial . . . indicate to a person of
 ordinary skill that the claimed invention did not include
 the administration of a loading dose.” J.A. 37–38. The
 cited passages of the specification provide clear disclosure
 of a dosing regimen that is not dependent upon or subject
 to the administration of a loading dose.
      The majority finds that the word “initially” “speaks to the
 initial length of treatment not the dosage with which treat-
 ment begins.” Maj. at 7–8. Here, the district court found that
 the “Prophetic Trial describes giving a ‘daily dosage of 0.5
 . . . mg’ fingolimod to treat RRMS, started ‘initially.’” J.A.
 26. While other interpretations of the word “initially” might
 be reasonable, the language, used in context, also supports
 the district court’s finding that the written description dis-
 closes excluding a loading dose. We are not free to substitute
 our own factual findings for those of the district court absent
 clear error because “a district court judge who has presided
 over, and listened to, the entire proceeding has a compara-
 tively greater opportunity to gain the necessary ‘familiarity
 with specific scientific problems and principles,’ . . . than an
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 appeals court judge who must read a written transcript or
 perhaps just those portions referenced by the parties.” Teva
 Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 319 (2015)
 (quoting Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339
 U.S. 605, 610 (1950)).
     The majority asserts that the disclosure of a daily dos-
 age cannot amount to a disclosure that there can be no
 loading dose, because such a finding is at odds with the
 prosecution history and the fact that the examiner allowed
 the claims only after the no-load limitation was added.
 Maj. at 10. According to the majority, if reciting a “daily
 dosage” necessarily excluded a loading dose, there would
 have been no reason to add the no-dose limitation. Id. at
 10:19-22. But Novartis, in adding the no-load limitation
 was doing no more than what applicants regularly do to
 secure allowance in making explicit that which was im-
 plicit prior to the amendment. There is no basis to read
 more into the prosecution history and certainly no basis to
 negate the clear disclosure of a “daily dosage” and the ex-
 pert testimony describing the understanding of that ex-
 pression to skilled artisans.
     The majority asserts that “the question is not whether
 the patentee intended there to be a loading dose; the ques-
 tion is whether the patentee precluded the use of a loading
 dose.” Maj. at 11. I submit that the question posed by the
 majority is misstated. The question is not whether the pa-
 tentee precluded the use of a loading dose but whether the
 claim language that precludes the administration of a load-
 ing dose is supported by the written description passages
 that disclose the effective administration of nothing more
 than a “daily dose.” In context, that disclosure, according
 to the testimony of the Novartis’s experts, implies the ab-
 sence of a loading dose to the ordinarily skilled artisan.
 That is all that is required.
    Finally, the majority finds significant tension between
 the district court’s finding that the specification’s
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 disclosure excludes a loading dose, but the Kappos 2006 ab-
 stract does not. Maj. at 9. I see no tension or legal incon-
 sistency in the district court’s treatment of the Kappos
 2006 abstract. As the court explained, Kappos was an ab-
 stract with no presumption of enablement or completeness,
 and it in any event did not include the animal trials that
 form an important part of Novartis’s arguments with re-
 spect to the ’405 patent. As importantly, the district court
 also found no evidence that Kappos 2006 was publicly
 available before the priority date because there was no ev-
 idence of public access. J.A. 28.
      For all these reasons, I respectfully dissent.