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: 1 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 Angeles, 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. (collectively, 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 determined 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, vacate our prior decision, and reverse the district court’s judgment that Novartis’ claims are not invalid for inadequate 

written description. 

BACKGROUND

The ’405 patent discloses methods of treating relapsing-remitting multiple sclerosis (RRMS) using the immunosuppressant fingolimod. E.g., ’405 patent at claim 1, 

8:56–60. Each claim of the ’405 patent requires administering 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 mention 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 under 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 invalid, either as anticipated by Kappos 2006 or for inadequate written description of the no-loading-dose or daily1 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 requirement 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 description 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 patent’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 invention 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 Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 

2002) (“[D]escription is the quid pro quo of the patent system.”). 

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 disadvantages of using” that element. Santarus, 694 F.3d at 

1351. Another reason could be that the specification “distinguishes 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 inadequate written description where specification disclosed 

several species of a genus and claims recited genus but excluded two species of lost interference count). 

The common denominator of these examples is disclosure of the element. That makes sense because “the hallmark of written description is disclosure.” Ariad, 598 F.3d 

at 1351; see also Lockwood, 107 F.3d at 1571 (“It is the disclosures of the applications that count.”). Silence is generally 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 exclusion.”). If it were, then every later-added negative limitation would be supported so long as the patent makes no 

mention of it. While a negative limitation need not be recited 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. Consistent 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 description requirement may be satisfied when a skilled artisan 

would understand the specification as inherently disclosing the negative limitation.2 For example, if the record established 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 silence. 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 missing descriptive matter is necessarily present in the thing 

described in the reference, and that it would be so recognized by persons of ordinary skill.” (internal quotation 

2 Novartis contends the written description requirement 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 disclosure” (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-precedential). 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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marks and citation omitted)). When the specification is itself 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 description 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 particular 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 recitation of a loading dose in the specification, the no-loadingdose 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 noloading-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 discloses “initially” starting with a daily dose was clearly erroneous. The specification nowhere describes “initially” 

administering a daily dosage. The specification says, “Initially 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, admitted this:

Q. And then . . . there’s a sentence that begins: Initially, 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 dosing 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. Altek Sys., 132 F.3d 701, 706 (Fed. Cir. 1997) (citations omitted). As HEC argues in its rehearing petition, the district 

court’s reliance on a misquotation “ferreted into trial testimony 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” administering 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 “information of having a loading dose is not there”). Dr. 

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Lublin also agreed that “[n]othing in the text of the specification of the ’405 patent discloses a rationale for the negative limitation prohibiting an immediately preceding 

loading dose.” J.A. 22872–73. The fact that the specification is silent about loading doses does not support a lateradded claim limitation that precludes loading doses. 

The district court also found, independent of the misquoted “initially” language, that the specification’s disclosure 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 finding 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 complete, 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 “complete” 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 description]? 

A. They would have viewed the patent as a document, 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 district court’s finding is thus forfeit.

Case: 21-1070 Document: 51 Page: 9 Filed: 06/21/2022
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 examples 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 presume only that a patent has adequate written description, 

not that it is complete. Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195 (Fed. Cir. 

1999) (“The presumption of validity includes a presumption that the patent complies with § 112.” (citing N. Telecom, 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 history. 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 noloading-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 discloses the absence of a loading dose. Dr. Steinman testified:

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NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 11

Q. And do you see the sentence there, it says, “Initially 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 preceding loading dose, you would give it before the initial 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 patentee precluded the use of a loading dose. On this record, 

there is no evidence that a skilled artisan would understand silence regarding a loading dose to necessarily exclude 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 particular); J.A. 22794; J.A. 23347–48 (Dr. Steinman acknowledging that loading doses are used in MS treatments); 

J.A. 23475 (Dr. Jusko, Novartis’ pharmacology expert, testifying that fingolimod was given to transplant patients 

with a loading dose, and that he “could envision the possibility 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 mentioning 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 negative 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 disclosure “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 positive limitations, the disclosure must only “reasonably convey[ ] 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 generally 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 rehearing, 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 district 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: 12 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

______________________ 

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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 description support is a fact-based inquiry based on the understandings of a person of ordinary skill in the art, and while 

ultimately recognizing that the standard for negative limitations 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 characterizes 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 applied 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 description requirement is essentially a fact-based inquiry that 

will ‘necessarily vary depending on the nature of the invention 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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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 relevant 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 ‘reasonably convey [] to those skilled in the art that the inventor 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 district court clearly erred. With that, I cannot agree. While 

a showing of “necessary exclusion” would most certainly 

provide written description support for a negative limitation, it is not and should not be a requirement in every case. 

As noted above and as Ariad makes clear, the critical question 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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4 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

at 1351. How that question is resolved depends on the facts 

of each case, assessed through the eyes of the skilled artisan. Our precedent makes that clear.

For example, in Santarus, we found that claims directed to a method of treatment with a pharmaceutical 

composition containing no sucralfate were adequately described by a specification that explained that, although sucralfate is “possibly the ideal agent for stress ulcer 

prophylaxis,” it was known to have occasional adverse effects. 694 F.3d 1344, 1350–51 (Fed. Cir. 2012). In Santarus, as in this case, there was expert testimony providing a 

person of ordinary skill’s understanding of the patent specification. See id. at 1351. The expert testimony in Santarus showed that “a person of ordinary skill in this field . . . 

would have understood from the specification that disadvantages of sucralfate may be avoided by the [claimed] formulation.” Id. 

In In re Bimeda Research & Development Ltd., we held 

that a claim that excluded a specific anti-infective, acriflavine, 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 formulation 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 invention’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 presence 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 specifically; 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 requirement 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 interpretation[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 explained 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 jurisprudence.” Id. at 1356. And we noted that the “‘reason’ required 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 prosecution (“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 decision was supported by evidence of (1) standards set by the 

Joint Electron Device Engineering Council, a global standard-setting body for the microelectronics industry, incorporated by reference in the patent, which specify that DDR 

signals, including CAS, RAS, CAS, and bank address signals, are distinct from each other; (2) a table in the specification 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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6 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

alternative features was sufficient to satisfy the written description 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 description 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 limitation, 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 jurisprudence—that the disclosure must be read from the perspective 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 specification that the new language reflects what the specification 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 negative 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, implicit, 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 preventative 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 perspective of a person of ordinary skill in the art” and found sufficient 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 testimony, that, “[i]f a loading dose were directed, the Patent 

would say that a loading dose should be administered ‘initially.’” 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 persuasive. 

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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. Similarly, the district court found that the “EAE example discloses 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 description in the specification of administration of a daily 

dose “would tell a person of skill that loading doses are excluded 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 dosing regimens, such as “intermittent dosing,” it does not describe 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 treatment 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 discloses 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 comparatively 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 dosage 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 implicit 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 expert testimony describing the understanding of that expression to skilled artisans.

The majority asserts that “the question is not whether 

the patentee intended there to be a loading dose; the question 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 patentee precluded the use of a loading dose but whether the 

claim language that precludes the administration of a loading 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 absence 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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10 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

disclosure excludes a loading dose, but the Kappos 2006 abstract does not. Maj. at 9. I see no tension or legal inconsistency in the district court’s treatment of the Kappos 

2006 abstract. As the court explained, Kappos was an abstract 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 respect 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 evidence of public access. J.A. 28. 

For all these reasons, I respectfully dissent.

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