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: 41 Page: 1 Filed: 01/03/2022
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: January 3, 2021

______________________ 

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 O’MALLEY, Circuit 

Judges. 

Opinion for the court filed by Circuit Judge O’MALLEY. 

Dissenting opinion filed by Chief Judge MOORE

O’MALLEY, Circuit Judge.

HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (collectively, “HEC”) appeal from a district court bench trial in 

which the court found that a patent assigned to Novartis 

Pharmaceuticals Corp. (“Novartis”), U.S. Patent 

No. 9,187,405 (“the ’405 patent”), is not invalid and that 

HEC’s Abbreviated New Drug Application (“ANDA”) infringes. HEC argues that the district court erred in finding 

that the ’405 claims do not fail the written description requirement of 35 U.S.C. § 112(a). Because we do not discern 

any clear error in the district court’s decision, we affirm.

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I. BACKGROUND

Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya. The medication is used to treat relapsing remitting multiple sclerosis 

(“RRMS”), a form of multiple sclerosis (“MS”). MS is a debilitating immune-mediated demyelinating disease in 

which the immune system attacks the myelin coating the 

nerves in the central nervous system. Most MS patients 

initially present as RRMS patients, but many eventually 

develop a secondary progressive form of MS, causing them 

to experience growing disability. There is currently no cure 

for MS. The disease is managed by reducing or preventing 

relapses and thereby slowing disability.

HEC filed an ANDA seeking approval to market a generic version of Gilenya. Novartis sued, alleging that 

HEC’s ANDA infringes all claims of the ’405 patent.1

A. The ’405 Patent

The ’405 patent claims methods to treat RRMS with 

fingolimod (also known as FTY720 and 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol in the ’405 patent) or a 

fingolimod salt, such as fingolimod hydrochloride (also 

known as Compound A in the ’405 patent), at a daily dosage 

of 0.5 mg without an immediately preceding loading dose. 

’405 patent col. 12 ll. 49–55. 

A loading dose is a higher than daily dose “usually 

given ‘as the first dose.’” J.A. 27 (¶ 63) (quoting J.A. 23125 

(Tr. 547:12–18) and citing J.A. 23344 (Tr. 766:4–6)). Both 

parties’ experts agreed with this definition. J.A. 23125 

(547:12–18) (HEC’s expert, Dr. Hoffman, testifying that “a 

1 Novartis sued several other defendants who had 

also filed ANDA applications. The cases as to those other 

defendants all settled or were stayed prior to trial, which 

proceeded only as to HEC.

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loading dose is a higher-than-therapeutic level dose, usually given . . . as the first dose in order to get therapeutic 

levels up quickly . . . and it’s usually for more acute situations”); J.A. 23344 (Tr. 766:4–6) (Novartis’s expert, Dr. 

Steinman, agreeing that “a loading dose is a higher-thandaily dose”). It is undisputed that loading doses were wellknown in the medical field generally and in the prior art. 

And the experts in this case agree that loading doses are 

used for some medicaments used in connection with MS.

The ’405 patent has six claims. Claim 1 of the ’405 patent recites: 

A method for reducing or preventing or alleviating 

relapses in Relapsing-Remitting multiple sclerosis 

in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in 

a pharmaceutically acceptable salt form, at a daily 

dosage of 0.5 mg, absent an immediately preceding 

loading dose regimen.

Claims 3 and 5 are similar but are directed to a 

“method of treating” RRMS and a “method of slowing progression of” RRMS, respectively, rather than a “method for 

reducing or preventing or alleviating relapses in” RRMS. 

Id. col. 12 ll. 59–64, col. 13 ll. 1–6. Claims 2, 4, and 6 are 

dependent claims that limit the methods of claims 1, 3, and 

5, respectively, to administration of 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride, i.e., fingolimod hydrochloride. Id. col. 12 ll. 56–58, col. 12 ll. 

65–67, col. 13 ll. 7–9.

The ’405 patent was filed on April 21, 2014. It claims 

priority to a British patent application that was filed on 

June 27, 2006. The parties, for the most part, focus their 

discussion on the specification of the ’405 patent, despite 

HEC’s argument that the inventors did not possess the invention as of the 2006 priority date. HEC’s argument that 

the 2006 application does not contain adequate written 

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description of the ’405 claims requires reference to the 2006 

application itself. Thus, we find it necessary to look to the 

specification of the 2006 priority application, despite the 

parties’ failure to fully explain the contents of that application. Although the specifications are different from each 

other, they are, in all aspects relevant to this appeal, substantively similar. 

The specifications of the ’405 patent and the 2006 priority application both describe the use of a class of S1P receptor modulators, including fingolimod, to treat or prevent 

“neo-angiogenesis associated with a demyelinating disease, 

e.g. multiple sclerosis.” ’405 patent col. 1 ll. 5–8; J.A. 

23751. The specifications each identify fingolimod hydrochloride (Compound A) as a particularly preferred compound within the class of S1P receptor modulators. ’405 

patent col. 8 ll. 17–30; J.A. 23759–60. 

Both specifications describe the results of an Experimental Autoimmune Encephalomyelitis (“EAE”) experiment. ’405 patent col. 10 ll. 32–col. 11 ll. 2; J.A. 23762–63. 

In the EAE experiment, a disease that mimics RRMS was 

induced in Lewis rats.2 The rats suffered acute disease 

within 11 days after immunization, with almost complete 

remission around day 16 and relapse around day 26. The 

specifications report that an S1P receptor modulator, e.g., 

Compound A (fingolimod hydrochloride) “significantly 

blocks disease-associated neo-angiogenesis when administered to the animals at a dose of from 0.1 to 20 mg/kg p.o.”3 

’405 patent col. 10 ll. 61–64; J.A. 23763. They further report that disease relapse was completely inhibited in rats 

to which Compound A was “administered daily at a dose of 

2 Lewis rats are inbred laboratory rats used to study 

disease. Inbred Rats, CHARLES RIVER, 

https://www.criver.com/sites/default/files/resources/InbredRatsDatasheet.pdf (last visited November 5, 2021).

3 P.o. indicates oral administration.

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0.3 mg/kg” or “administered p.o. at 0.3 mg/kg every 2nd or 

3rd day or once a week.” ’405 patent col. 10 ll. 64–col. 11 ll. 

3; J.A. 23763. 

Both specifications then describe a prophetic human 

clinical trial (“Prophetic Trial”).4 ’405 patent col. 11 ll.

3–38; J.A. 23763–64. The Prophetic Trial describes a trial 

in which RRMS patients would receive 0.5, 1.25, or 2.5 mg 

of an S1P receptor modulator, e.g., Compound A (fingolimod hydrochloride), per day for two to six months. ’405 

patent col. 11 ll. 8–14; J.A. 23763. The specifications do not 

mention a loading dose associated with the Prophetic Trial. 

’405 patent col. 11 ll. 8–14; J.A. 23763. 

Both specifications then describe a wide range of potential dosages, which “will vary depending upon, for example, 

the compound used, the host, the mode of administration 

and the severity of the condition to be treated.” ’405 patent

col. 11 ll. 20–24; J.A. 23764. Those potential dosages include a “preferred daily dosage range [of] about from 0.1 to 

100 mg” and “a dose of 0.5 to 30 mg [of Compound A] every 

other day or once a week.” ’405 patent col. 11 ll. 24–38; J.A. 

23764. 

B. The District Court Proceedings

After a four-day bench trial, the district court found 

that HEC’s ANDA product would infringe claims 1–6 of the 

’405 patent. The court also found that HEC had not shown 

that the ’405 patent is invalid for (1) insufficient written 

description for the no-loading-dose limitation and for the 

4 Prophetic trials explain how a drug would be administered and how a patient given that drug should be 

monitored in a clinical trial. Prophetic trials are not clinical trials that are performed; they are merely described on 

paper. Prophetic trials are sometimes used in patent applications because clinical trials are expensive and time 

consuming.

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claimed 0.5 mg daily dose or (2) anticipation. HEC appeals 

the district court’s findings as to written description for the 

0.5 mg daily dose and no-loading-dose limitations.

With respect to the written description for the claimed 

0.5 mg daily dose, the district court found that a skilled artisan would understand that the inventors possessed a 0.5 

mg daily dose based on one of the successful doses in the 

EAE experiment results, 0.3 mg/kg weekly. The court credited the testimony of two of Novartis’s expert witnesses, Dr. 

Lawrence Steinman, M.D., and Dr. William Jusko, Ph.D.,

to make the leap from a 0.3 mg/kg weekly rat dosage to a 

0.5 mg daily human dosage. The court noted that the 0.5 

mg daily dose is also illustrated in the Prophetic Trial. The 

district court concluded that there was sufficient written 

description for the 0.5 mg daily dosage limitation.

With respect to the written description for the “absent 

an immediately preceding loading dose” limitation, the district court again found sufficient written description in the 

EAE model and the Prophetic Trial. Neither the Prophetic 

Trial nor the EAE model recite a loading dose. 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 (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

(citing J.A. 23334–35 (Tr. 756:16–757:8); J.A. 23441–42 

(Tr. 863:22–864:18)). Similarly, the district court found 

that the “EAE example discloses a dosing regimen which 

does not involve a loading dose.” J.A. 27 (citing J.A. 23345

(Tr. 767:3–5); J.A. 22793 (Tr. 215:16–21)). 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. 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 

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the administration of a loading dose,” and, thus, the patent 

provides sufficient written description of the negative limitation. J.A. 37–38. 

HEC appeals. We have jurisdiction under 28 U.S.C. 

§ 1295(a)(1). 

II. DISCUSSION

On appeal, HEC challenges the district court’s decisions concerning the ’405 patent’s written description of the 

0.5 mg daily dose limitation and the no-loading-dose negative limitation. “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 Lab’ys, Inc., 745 F.3d 1180, 

1190 (Fed. Cir. 2014)). Under the clear error standard, we 

will not overturn the district court’s factual finding unless 

we have a “‘definite and firm conviction’ that a mistake has 

been made.” Nuvo Pharms. (Ireland) Designated Activity 

Co. v. Dr. Reddy’s Lab’ys Inc., 923 F.3d 1368, 1376 (Fed. 

Cir. 2019) (quoting Scanner Techs. Corp. v. ICOS Vision 

Sys. Corp. N.V., 528 F.3d 1365, 1374 (Fed. Cir. 2008)).

The written description requirement is found in section 

112 of the patent statute, which provides that the patent’s 

specification must contain “a written description of the invention, and of the manner and process of making and using it.”5 35 U.S.C. § 112(a). 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 

5 35 U.S.C. § 112(a) also contains the separate “enablement” requirement, which is not at issue in this appeal. 

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specification from the perspective of a person of ordinary 

skill in the art.” Id. 

HEC challenges the district court’s decisions concerning the ’405 patent’s written description of two limitations: 

the 0.5 mg daily dose limitation and the no-loading-dose 

negative limitation. 

Despite arguing that the inventors did not possess the 

claimed subject matter in 2006, HEC bases its arguments, 

not on the 2006 priority application’s written description, 

but on the ’405 patent’s specification—leaving it to this 

court to independently search the 2006 priority application 

for written description of the claims. HEC’s confusion is 

ultimately of no moment, as we find that the claims have

adequate written description support in portions of the ’405 

specification which also appear in the 2006 priority application.6

A. Written Description for the Dosage Limitation

HEC argues that, as of the 2006 priority date, the inventors did not possess a 0.5 mg daily dose of fingolimod. 

It argues that, as of that date, 0.5 mg/day was considered 

too low to be effective to treat RRMS. It describes Novartis’s calculation of the 0.5 mg/day human dose as derived 

6 Both parties wrongly assume that, if the 2006 priority application lacks sufficient written description of the 

’405 patent’s claims, those claims are invalid. If the 2006 

priority application lacks sufficient written description for 

the ’405 patent’s claims, the ’405 patent’s claims are not 

automatically rendered invalid; they are merely deprived 

of the 2006 priority date. See 35 U.S.C. § 119; see also Paice 

LLC v. Ford Motor Co., 881 F.3d 894, 906 (Fed. Cir. 2018)

(“For claims to be entitled to a priority date of an earlierfiled application, the application must provide adequate 

written description support for the later-claimed limitations.”). 

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from the lowest disclosed dose in the rat EAE model described in the specification as “undisclosed mathematical 

sleights of hand.” Appellant’s Br. 7. And it argues that the 

Prophetic Trial, which lists a 0.5 mg daily dose along with 

two other dosages, does not provide sufficient written description of the 0.5 mg dose. Finally, it asserts that “blaze 

marks” directing a skilled artisan to the 0.5 mg daily dose 

are absent from the ’405 patent. 

We do not find HEC’s arguments convincing. The Prophetic Trial and the EAE model provide sufficient written 

description to show that, as of the priority date, the inventors possessed a 0.5 daily fingolimod dosage as claimed in 

the ’405 patent. The Prophetic Trial describes dosing 

RRMS patients with fingolimod hydrochloride at daily dosages of 0.5, 1.25, or 2.5 mg. ’405 patent col. 11 ll. 8–16. The 

Prophetic Trial’s disclosure of two other dosages does not 

detract from the written description of the claimed dose. 

Nor do disclosures of dosage ranges in other areas of the 

specification lead away from the claimed dose. 

The rat EAE model describes additional information 

which provides further written description for the 0.5 

mg/day limitation. The EAE model describes a dosage of 

0.3 mg/kg per week as effective to “fully block[] disease-associated angiogenesis and completely inhibit[] the relapse 

phases.” ’405 patent col. 10 ll. 64–col. 11 ll. 2. The district 

court credited the testimonies of Dr. Steinman and Dr. 

Jusko to arrive at the claimed 0.5 mg/day human dosage 

from the EAE experiment’s 0.3 mg/kg per week rat dosage. 

Those experts both testified that a skilled artisan would 

have converted the lowest daily rat dose described in the 

EAE experiment (0.3 mg/kg weekly) to a daily dose (0.042 

mg/kg daily). J.A. 24 (citing J.A. 23325–26 (Tr. 

747:6–748:19); J.A. 23443 (Tr. 865:12–24); J.A. 23482 (Tr. 

904:2–18)). The district court found, again based on expert 

testimony, that a skilled artisan “would immediately recognize that 0.3 mg/kg weekly (0.042 mg/kg daily) in rats” is 

approximately 60% lower “than the lowest known effective 

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dose in the prior art (0.1 mg/kg daily).” J.A. 24–25 (citing 

J.A. 23440–41 (Tr. 862:25–863:21)). It found that a skilled 

artisan “would understand that the EAE results in the ’405 

Patent therefore demonstrate that a proportionally lower 

dose (again, roughly 60% lower) could be effective in humans.” J.A. 25 (citing J.A. 23443–45 (Tr. 865:4–867:4); J.A. 

23480–85 (Tr. 902:17–907:8)). It further found that a 

skilled artisan “would understand that the inventors translated the lowest dose that had ever been seen as effective 

from their EAE experiment (0.3 mg/kg once per week) to 

the 0.5 dose.” J.A. 25 (citing J.A. 23356–57 (Tr. 

778:25–779:14)). 

HEC attacks the expert testimony underlying the district court’s determination that the EAE experiment describes a 0.5 mg daily human dose as “undisclosed 

mathematical sleights of hand.” Appellant’s Br. 7. We disagree. A “disclosure need not recite the claimed invention

in haec verba.” Ariad, 598 F.3d at 1352. The disclosure 

need only “clearly allow persons of ordinary skill in the art 

to recognize that the inventor invented what is claimed.” 

Id. at 1351. To accept HEC’s argument would require us 

to ignore the perspective of the person of ordinary skill in 

the art and require literal description of every limitation, 

in violation of our precedent. We find no clear error in the 

district court’s reliance on expert testimony in finding description of the 0.5 mg daily human dose in the EAE experiment results. 

We also reject HEC’s argument that the ’405 patent 

does not have necessary “blaze marks” pointing to the 0.5 

mg daily dose. “Blaze marks” directing an investigator of 

ordinary skill in the art to the claimed species from among 

a forest of disclosed options are not necessary in this case. 

In cases where the specification describes a broad genus 

and the claims are directed to a single species or a narrow 

subgenus, we have held that the specification must contain 

“‘blaze marks’ that would lead an ordinarily skilled investigator toward such a species among a slew of competing 

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possibilities.” Novozymes v. DuPont Nutrition Biosciences 

APS, 723 F.3d 1336, 1349 (Fed. Cir. 2013). 

“Blaze marks” are not necessary where the claimed 

species is expressly described in the specification, as the 

0.5 mg daily dosage is here. See, e.g., Snitzer v. Etzel, 465 

F.2d 899, 902 (C.C.P.A. 1972) (finding that interference 

counts directed to the activation of a glass laser with trivalent ytterbium ions were adequately described by a specification listing fourteen materials which may be used as 

active laser ingredients, including trivalent ytterbium, and 

noting that “there would seem to be little doubt that the 

literal description of a species provides the requisite legal 

foundation for claiming that species”). The ’405 patent 

does not contain the laundry-list-type disclosures that we 

have found require guidance to direct a skilled artisan to 

the claimed species—it contains the Prophetic Trial listing 

three doses, 0.5, 1.25, and 2.5 mg/day. While other sections 

of the specification disclose larger ranges of potential doses

for S1P receptor modulators, e.g., 0.1 to 100 mg/day doses, 

those disclosures do not diminish the literal description of 

the 0.5 mg/day dose in the Prophetic Trial. All described 

dose ranges include the 0.5 mg/day dose. And smaller dosage ranges, such as 0.5–30 mg/day, are disclosed for fingolimod hydrochloride. Even if blaze marks were required 

in this case, the Prophetic Trial and 0.5–30 mg/day dosage 

range would provide a skilled artisan more than sufficient 

guidance to direct them to the claimed 0.5 mg/day dose. 

Much of HEC’s argument is directed to its assertion

that no one, including the inventors, knew that a 0.5 

mg/day dose would be effective as of the 2006 priority date. 

That argument fails for two reasons. First, efficacy is not 

a requirement of the claims. The claims require only administration of a 0.5 mg/day dose for, inter alia, treatment 

purposes. The district court found that the purpose limitations are adequately described, and HEC has not appealed 

that finding. Thus, cases such as Nuvo Pharms., 923 F.3d 

1368, in which this court found that claims directed to an 

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amount of uncoated PPI that is effective to raise the gastric 

pH to at least 3.5 were not adequately described by a specification that “provides nothing more than the mere claim 

that uncoated PPI might work” where skilled artisans 

“would not have thought it would work,” are distinguishable. See id. at 1381. Second, as explained above, the EAE 

model provides evidence that the inventors knew that a 

60% lower dose would be effective. 

For these reasons, we find no clear error in the district 

court’s holding that the 0.5 mg/day dosage limitation is adequately described. The district court’s holding is supported by the specification and ample expert testimony 

interpreting that specification. 

B. Written Description for the Negative Limitation 

HEC argues that there is no written description of the 

negative limitation because the ’405 specification contains 

no recitation of a loading dose “or its potential benefits or 

disadvantages at all.” Appellant’s Br. 40. It further argues 

that the district court’s finding of written description of the 

negative limitation within the ’405 specification contradicts the district court’s finding that Kappos 2006, which is 

similarly silent as to loading doses, does not anticipate the

claims. We find both arguments unavailing. 

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). We 

are aware of no case that suggests otherwise. And, while 

HEC asserts that “[i]t is well-settled law that silence alone 

cannot serve as a basis for” a negative limitation, Appellant’s Br. 41, HEC identifies no case that actually supports 

that proposition. To the contrary, we repeatedly have resisted imposition of heightened written description standards for negative limitations, such as that urged by HEC. 

For example, in Santarus, Inc. v. Par Pharmaceutical, 

Inc., we found that claims directed to a method of 

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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. We explained 

that “[n]egative claim limitations are adequately supported 

when the specification describes a reason to exclude the relevant limitation.” Id. We did not hold that a specification 

must describe a reason to exclude a negative limitation. 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. 

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 antiinfectives or antibiotics.” Id. (citation and 

quotation marks omitted). We did not require that the 

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specification describe a reason to exclude acriflavine specifically, but, rather, found only that a negative limitation 

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)). 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 CS, 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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16 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). 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. at1348–49. 

Similarly, in Erfindergemeinschaft Uropep GBR v. Eli 

Lilly & Co., Judge Bryson, sitting by designation in the 

Eastern District of Texas, explained that the law does not 

require that the disclosure explain a negative limitation. 

276 F. Supp. 3d 629, 657–58 (E.D. Tex. 2017), aff’d, 739 F. 

App’x 643 (Fed. Cir. 2018). Judge Bryson explained, citing 

Bimeda, that “[w]hat is prohibited is a negative limitation 

that is contrary to the thrust of the invention.” Id. at 658. 

He noted that “a patentee can choose to claim any particular embodiments identified in the specification and exclude 

others, without explanation, as long as the claim does not 

indicate to persons of skill that it covers embodiments inconsistent with, and therefore unsupported by, the disclosure.” Id. 

In asserting that “silence alone cannot serve as a basis 

for” a negative limitation, Appellant’s Br. 41, HEC attempts to create a new heightened written description 

standard for negative limitations. In doing so, it ignores a 

central tenet of our written description jurisprudence—

that the disclosure must be read from the perspective of a 

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person of skill in the art—as well as precedent stating that 

the disclosure need not describe a limitation in haec verba. 

See, e.g., All Dental Prodx, LLC v. Advantage Dental Prod., 

Inc., 309 F.3d 774, 779 (Fed. Cir. 2002) (“[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.” (citing Eiselstein v. Frank, 

52 F.3d 1035, 1039 (Fed. Cir. 1995)); see also Ariad, 598 

F.3d at 1351. 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”).

The dissent notes that the Manual of Patent Examining Procedure (“MPEP”)7 states: “The mere absence of a positive recitation is not a basis for an exclusion.” MPEP 

§ 2173.05(i). As the dissent puts it—“silence alone is insufficient.” Dissent at 4. Both the MPEP and the dissent are 

correct in their statement of the law: the “mere absence of 

a positive recitation” is not enough and “silence alone is insufficient.” But the dissent, like HEC, ignores that it is 

how a skilled artisan reads a disclosure that matters. Written description may take any form, so long as a skilled artisan would read the disclosure as describing the claimed 

invention.

Our case law makes clear that “[c]ompliance with the 

written description requirement is essentially a fact-based 

7 The MPEP is not binding on this court but may be 

persuasive. 

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18 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

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. Mahurkar, 935 F.2d 1555, 1562 (Fed. Cir. 1991)). 

The 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 for implicit written description. 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. 

HEC and the dissent urge us to elevate form over substance by creating a new rule that a limitation which is not 

expressly recited in the disclosure is never adequately described, regardless of how a skilled artisan would read that 

disclosure. As we have several times before, we reject the 

invitation to create a heightened written description standard for negative limitations. As with all other limitations, 

the negative limitation here must be accompanied by an 

original disclosure which conveys to a person of ordinary 

skill that the inventor was in possession of the claimed invention. See Ariad, 598 F.3d at 1351. And, as in all other 

written description challenges, HEC was required to show 

by clear and convincing evidence that the negative limitation was not adequately described. The district court did 

not clearly err in finding that HEC failed to do so. 

In determining that there is adequate written description of the negative limitation, the district court correctly, 

and quite carefully, conducted “an objective inquiry into 

the four corners of the specification from the perspective of 

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a person of ordinary skill in the art” as required by our 

precedent. See Ariad, 598 F.3d at 1351. We review the 

evidence cited by the district court below and discern no 

clear error in the court’s analysis or conclusions.

The Prophetic Trial describes giving RRMS patients 

fingolimod hydrochloride “at a daily dosage of 0.5, 1.25 or 

2.5 mg p.o.” ’405 patent col. 11 ll. 8–9. It further states 

that: “Initially patients receive treatment for 2 to 6 

months.” Id. col. 11 ll. 13–14. Dr. Steinman, one of Novartis’s expert witnesses, testified from the perspective of a 

skilled artisan that, if the Prophetic Trial included a loading dose, the patent would explicitly state as much: 

“[T]here were two places where if there were going 

to be a loading dose, you would explicitly state it. 

. . . . 

So the first place one might explicitly say there 

was—there was a preceding loading dose is when 

you described the daily dosage, the reason being a 

loading dose would occur before the first daily dose.

The second place is even more dramatic, because 

they say, “Initially patients received treatment for 

2 to 6 months.” So now they’re really zooming in 

on Day 1, what is that treatment, it’s a daily dose 

of 0.5.

So there were two perfectly logical places that if 

there was going to be a loading dose, it would have 

been stated.

. . . . 

That’s where you would put it if you were going to 

give a loading dose.

J.A. 23343 (Tr. 765:2–25). 

Similarly, Dr. Fred Lublin, Ph.D., another expert testifying for Novartis, testified that a person of skill in the art 

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20 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

“would have viewed the patent as a document, as a complete document, that should give you 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 (Tr. 213:6–15). Dr. Lublin testified that a “loading 

dose is a greater than normal dose that you give until you 

return to a maintenance dose” and a loading dose is “not a 

daily dose.” J.A. 22792 (Tr. 214:1–9). He further testified

that “[o]ne would expect in a patent that if there was going 

to be a loading dose, it would be specified.” J.A. 22793 (Tr. 

215:5–8). And a third expert testifying for Novartis, Dr. 

Jusko, similarly testified that, from the perspective of a 

person of skill in pharmacology, the Prophetic Trial has a 

“specified initial regimen that does not include a loading 

dose.” J.A. 23442 (Tr. 864:14–16).

The district court credited this expert testimony, as 

well as the testimony from HEC’s own expert, Dr. Paul 

Hoffman, M.D., who agreed that “a loading dose is a higherthan-therapeutic level dose, usually given . . . as the first 

dose.” J.A. 23125 (Tr. 547:14–18); J.A. 27. Based on that 

evidence, the court concluded that the “absence of an immediately preceding loading dose from the specification, 

and from the Prophetic Trial, would tell a person of skill 

that loading doses are excluded from the invention.” J.A. 

26. We discern no clear error in that finding. The district 

court further noted that the rat EAE experiment does not 

describe a loading dose. J.A. 26. It again credited the testimony of multiple expert witnesses who testified that the 

EAE model did not include a loading dose. J.A. 26. Dr. 

Jusko, in response to a question about whether there are 

any loading doses in the EAE model, stated: “Not that I’m 

aware of.” J.A. 22793 (Tr. 215:16–21). Dr. Steinman similarly testified that no loading dose was used in the EAE 

experiment. J.A. 23345 (Tr. 767:3–5). HEC’s own expert 

witness, Dr. Hoffman, testified that the EAE model does

not talk about a loading dose. J.A. 23209 (Tr. 631:18–22). 

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NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 21

Based on both the specification’s disclosure of the rat EAE 

model and the ample expert testimony providing evidence 

of how a person of ordinary skill would read that disclosure, 

the district court concluded that the “EAE example discloses a dosing regimen which does not involve a loading 

dose.” J.A. 27. Finally, the district court noted that, while 

the patent “describes alternative dosing regimens, like ‘intermittent dosing,’ [it] does not describe loading doses.” 

J.A. 27. 

The district court concluded that the “EAE model and 

the Prophetic Trial . . . both indicate to a person of ordinary 

skill that the claimed invention did not include the administration of a loading dose.” J.A. 37–38. We are not left 

with the “definite and firm conviction” that the district 

court made a mistake in coming to this conclusion. See

Nuvo Pharms., 923 F.3d at 1376 (quoting Scanner Techs., 

528 F.3d at 1374). To the contrary, the district court’s conclusion appears wholly correct. To arrive at the opposite 

conclusion would require us to disregard the perspective of 

a person of skill in the art—something our precedent 

simply does not allow. See Ariad, 598 F.3d at 1351. 

We also find unpersuasive HEC’s argument that the 

district court’s written description decision contradicts its 

determination that the ’405 patent is not anticipated by 

Kappos 2006. HEC notes that neither Kappos 2006 nor the 

’405 patent’s specification explicitly state that a loading 

dose should not be administered. But HEC’s argument ignores the differences between the two district court findings and ignores the differences between the disclosures of 

Kappos 2006 and the ’405 specification. 

As a granted patent, the ’405 patent is presumed valid. 

Thus, it is also presumed to have a complete written description. See 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.”). No such presumption 

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22 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

applies to disclosures of a prior art reference that is not itself a granted patent, such as Kappos 2006. Further, the 

perspective of a person of skill in the art is important in 

both the written description and the anticipation inquiries. 

And, in this case, the district court credited the testimony 

of two expert witnesses, Dr. Lublin and Dr. Steinman, who 

testified that a person of skill in the art would not presume 

that the Kappos 2006 abstract was complete. J.A. 30 (citing J.A. 22782 (Tr. 204:12–19) (Dr. Lublin testifying that 

abstracts “have to by design” leave out information describing clinical trials); J.A. 23475 (Tr. 897:1–5) (Dr. Steinman

testifying that “an abstract, like a press release, like any 

kind of announcement, is inherently incomplete,” while “a 

publication and a patent are presumed complete”)). Thus, 

although neither the ’405 specification nor Kappos 2006 include the phrase “loading dose,” it was not clear error for 

the district court to find that a skilled artisan would read

the specification as not including a loading dose and would

read Kappos 2006 as silent on the presence or absence of a 

loading dose. 

Differences between the ’405 patent’s specification and 

Kappos 2006 justify the district court’s findings that the 

specification describes the absence of a loading dose while 

Kappos 2006 does not anticipate that negative limitation. 

The specification includes the Prophetic Trial, which the 

district court found “describes giving a ‘daily dosage of 0.5 

. . . mg’ fingolimod to treat RRMS, started ‘initially.’” J.A. 

26. The district court found that, “[o]n this record, starting 

with a daily dose plainly implies that there is no loading 

dose.” J.A. 27. Kappos 2006 consists of two paragraphs 

describing a planned clinical trial and, with respect to dosing, states only that “[a]pproximately 1.100 patients . . . 

are being randomised in a 1:1:1 ratio to once-daily fingolimod 1.25 mg, fingolimod 0.5 mg, or placebo, for up to 24 

months.” J.A. 24723–24. Kappos 2006 nowhere says that 

the daily fingolimod dosage should be “initially” administered. Thus, differences between Kappos 2006 and the ’405 

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NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 23

patent justify the district court’s conclusions that Kappos 

2006 does not anticipate the claims and the ’405 specification adequately describes the claims. 

The dissent takes umbrage with the district court’s 

finding that the “Prophetic Trial describes giving a ‘daily 

dosage of 0.5 . . . mg’ fingolimod to treat RRMS, started ‘initially’” because the ’405 patent says “[i]nitially, patients receive treatment for 2 to 6 months.” Dissent at 6–7; J.A. 26; 

’405 patent col. 11 ll. 13–14. The dissent would find that the 

“word ‘initially’ is not modifying the daily dosage; it is modifying the initial length of treatment in this example.” Dissent 

at 6–7. The dissent, thus, would substitute its own factual 

findings for those of the district court. But, if the 2–6 month 

“initial” dose does not differ in any way from the previously 

described daily doses, the language, used in context, must exclude a loading dose. As we have already explained, the district court did not clearly err in finding that the “Prophetic 

Trial describes giving a ‘daily dosage of 0.5 . . . mg’ fingolimod to treat RRMS, started ‘initially.’” J.A. 26. And 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 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 dissent also asserts that, on this record, the term 

“daily dose” would not convey to a skilled artisan that no 

loading dose should be used. Dissent at 7–8. But the district court’s decision did not rely only on the term “daily 

dose.” Rather, as noted above, the district court found that 

“starting with a daily dose plainly implies that there is no 

loading dose,” as a loading dose is a larger-than-daily dose. 

J.A. 27 (emphasis added). We need not, and do not, go 

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24 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

further than the district court to make findings about the 

term “daily dose.” The dissent’s assertion to the contrary 

and allegation that we “tease[] an entirely new claim limitation out of an entirely common term, relegating the legal 

determination of a term’s meaning to the backseat of an 

expert’s post-hoc rationalization” is, frankly, baffling. See

Dissent at 8. 

Written description in this case, as in all cases, is a factual issue. In deciding that the district court did not clearly 

err in finding written description for the negative limitation in the ’405 patent, we do not establish a new legal 

standard that silence is disclosure, as the dissent asserts. 

Instead, we merely hold that, on this record, the district 

court did not clearly err in finding that a skilled artisan 

would read the ’405 patent’s disclosure to describe the “absent an immediately preceding loading dose” negative limitation.

III. CONCLUSION

For the foregoing reasons, we affirm the district court’s 

decision. 

AFFIRMED

Case: 21-1070 Document: 41 Page: 24 Filed: 01/03/2022
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: 41 Page: 25 Filed: 01/03/2022
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.

______________________ 

MOORE, Chief Judge, dissenting.

The majority dramatically expands a patentee’s ability 

to add, years after filing a patent application, negative 

claim limitations that have zero support in the written description. By doing so, it contradicts our well-established 

precedent and nullifies the Patent Office’s guidance in the 

Manual of Patent Examining Procedure (MPEP). I would 

reverse the district court’s finding that there exists written 

description support as it is inconsistent with our established precedent. Silence is not disclosure. 

I 

“The hallmark of written description is disclosure.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 

(en banc). The description in the specification must clearly 

allow a skilled artisan to recognize that the inventor invented what is claimed. Id. The ’405 patent contains no 

written description support for the limitation “absent an 

immediately preceding loading dose regimen.” This negative limitation was added in response to an obviousness rejection during prosecution of the ’405 patent’s co-pending 

parent application. J.A. 23892–94. Claim 1: 

1. A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally 

administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in 

a pharmaceutically acceptable salt form, at a daily 

dosage of 0.5 mg, absent an immediately preceding 

loading dose regimen. 

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NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 3

There is no disclosure in the specification of preventing 

a loading dose. Loading doses—whether to be used or not—

are never discussed. As the majority concedes, we have 

long held that silence cannot support a negative limitation; 

for if the specification is silent there is no evidence that the 

inventor actually possessed the invention. Maj. at 17

(“Both the MPEP and the dissent are correct in their statement of the law: the ‘mere absence of a positive recitation’ 

is not enough, and ‘silence alone is insufficient.’”). “Negative claim limitations are adequately supported when the 

specification describes a reason to exclude the relevant limitation,” such as by listing the disadvantages of some embodiment. Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 

1344, 1351 (Fed. Cir. 2012). In Inphi Corp. v. Netlist, Inc., 

805 F.3d 1350, 1356 (Fed. Cir. 2015), we explained that reciting alternative features of the patented invention may 

also suffice.1 In Nike, Inc. v. Adidas AG, we again reiterated that the specification should indicate a reason to exclude. 812 F.3d 1326, 1348 (Fed. Cir. 2016). This law, our 

law, does not create a heightened standard for negative 

claim limitations; it simply requires some disclosure to 

demonstrate that the inventor was not, as in this case, ambivalent about loading doses.2 

1 Erfindergemeinschaft Uropep GBR v. Eli Lilly & 

Co., 276 F. Supp. 3d 629, 657–59 (E.D. Tex. 2017), consistent with Inphi, holds that when a patent discloses 

many alternatives, the claims are permitted to claim only 

some and exclude others. The specification here does not 

disclose alternatives (some with and some without loading 

doses). 

2 In re Bimeda Research & Development Ltd., 724 

F.3d 1320, 1323–24 (Fed. Cir. 2013), does not help the majority at all. The court simply held that, when the patent 

repeatedly emphasizes that the invention was “without 

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4 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

Following our clear precedent, the Patent Office’s

MPEP provides the following guidance: “The mere absence 

of a positive recitation is not a basis for an exclusion,” i.e., 

silence alone is insufficient. MPEP § 2173.05(i). That remains true even if it would have been obvious to a skilled 

artisan to exclude the undisclosed feature. Rivera v. Int’l 

Trade Comm’n, 857 F.3d 1315, 1322 (Fed. Cir. 2017) (“The 

knowledge of ordinary artisans may be used to inform what 

is actually in the specification, but not to teach limitations 

that are not in the specification, even if those limitations 

would be rendered obvious by the disclosure.”). 

Nowhere in the patent does it say a loading dose should 

not be administered. Nowhere does it discuss alternatives 

(including or not including a loading dose). Nowhere does 

it give advantages or disadvantages of including a loading 

dose. Indeed, it provides no reason to exclude a loading 

dose. Even Novartis’ expert, Dr. Lublin, agreed: 

Q: Nothing in the text of the specification of the 

’405 patent discloses a rationale for the negative 

limitation prohibiting an immediately preceding 

loading dose, correct? 

A: I don’t believe so.

J.A. 22872–73. And 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, Novartis’ second 

physician expert, 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 

using antibiotics,” a claim which allows some antibiotics 

lacks written description support. Id. 

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NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 5

dose”). The ’405 patent provides nothing to signal to the 

public that the inventors possessed a treatment excluding 

a loading dose when a loading dose was a known possibility.

The patent is silent, eerily silent. Consistent with Santarus, Inphi, and Nike, there needed to be some discussion 

of loading doses in order to show that the inventors in fact 

invented this treatment method that is not just ambivalent 

to, but expressly excludes, a loading dose. This is not a 

heightened written description requirement; it is simply a 

written description requirement. 

The district court relied on the disclosure’s silence to 

support the negative loading dose limitation, reasoning 

that silence “would tell a person of skill that loading doses 

are excluded from the invention.” J.A. 26 ¶ 61. We have 

rejected the notion that a skilled artisan’s knowledge can 

speak for a mute specification. See Rivera, 857 F.3d at 

1322. Here, the expert that the majority relies upon to supplement a silent disclosure concludes that a loading dose is 

excluded because the patent is silent on loading doses: “the 

patent [i]s a document, as a complete document, that 

should give you all the information you need to carry out 

the claims, and that information of having a loading dose 

is not there.” Maj. at 19–20 (quoting J.A. 22791). If silence 

were sufficient then every later-added negative limitation 

would be supported as long as the patent makes no mention of it. This is a fundamental error of law. 

Novartis explained its support for the no-loading-dose 

limitation as follows:

Judge Linn: There is nothing in the patent that 

says treatment begins with the daily dose? 

Novartis: Ummm the prophetic example says 

treatment begins initially and treatment is the 0.5

mg daily dose so if that begins initially it excludes 

the possibility of a loading dose. 

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6 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

*** 

Chief Judge Moore: The patent says “Initially, patients receive treatment for 2 to 6 months,” and you 

believe I should construe that as initially there is 

no loading dose? 

Novartis: Yes, your honor a loading dose is excluded from that treatment. 

Oral Argument at 35:30–37:13. The majority claims that 

the Prophetic Example in the specification describes 

“start[ing] ‘initially’” by “giving a ‘daily dose of 0.5 . . . mg.’” 

Maj. at 7; Maj. at 22 (same). This is a false and inaccurate 

quotation. The word “initially” does not precede or modify 

the daily dosage sentence; it follows it three full sentences 

later. To be clear, the patent does NOT say treatment begins initially with a daily dose. Here is the actual quote:

20 patients with relapsing-remitting MS receive 

said compound at a daily dosage of 0.5, 1.25 or 2.5 

mg p.o. The general clinical state of the patient is 

investigated weekly by physical and laboratory examination. Disease state and changes in disease 

progression are assessed every 2 months by radiological examination (MRI) and physical examination. Initially, patients receive treatment for 2 to 6 

months. Thereafter, they remain on treatment for 

as long as their disease does not progress and the 

drug is satisfactorily tolerated. 

’405 patent at 11:8–16. The word “initially” is not some 

complex, scientific term in need of expert explanation. It is 

basic English. The word “initially” is not modifying the 

daily dosage; it is modifying the initial length of treatment

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NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 7

in this example.3 To the extent that the district court 

reached a fact finding to the contrary, it is inconsistent 

with the straight-forward, quite clear language of the patent and therefore clearly erroneous.4 

Novartis also claims that the use of the term “daily dosage” itself would convey to a skilled artisan that no loading 

dose should be used. This is not only unsupported by the 

record; it is contradicted at every turn. First, the claim already said “daily dosage” before the negative limitation 

was added. It was allowed only after the applicants added 

the no loading dose limitation. J.A. 23903 (Examiner’s rejection in parent application); J.A. 23892–93 (Applicant 

Response in same); see also Novartis Br. 11–12. The applicants explained they added the no-loading-dose limitation 

“to specify that the [daily dosage] cannot immediately follow a loading dose regiment. Applicants have made these 

amendments to further distinguish their claims from the 

disclosure of [the prior art].” J.A. 23892.5 If daily already 

meant no loading dose, then there would have been no reason for the claims to recite both a “daily dosage” and the 

negative loading dose limitation. The same logic applies to 

3 I note that even if the Prophetic Example were to 

be understood as not having included a loading dose that

does not mean that loading doses must be prohibited (as 

the claims now require). 

4 Nothing about this analysis “substitute[s] . . . factual findings for those of the district court.” Maj. at 23. 

Instead, it merely points out how it is clear error for the 

majority, district court, and Novartis to misquote the specification. 

5 Novartis stated during argument that this limitation was “added to clarify that the claim does not overlap 

with [the prior art].” Oral Argument at 21:34–41. This litigation claim cannot be reconciled with their own prosecution statements. 

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8 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

the specification, which only mentioned “daily dosage.” 

This prosecution makes clear that neither the applicant 

nor the examiner believed that the use of the term “daily 

dosage” alone conveyed the absence of a loading dose. 

There is no evidence that daily had a special meaning 

in the field of pharmacology. Daily is not a complex or complicated term of art that requires expert testimony to explain. The district court construed the claim term “daily 

dosage of 0.5 mg” to mean “the amount of drug that someone takes in a given day.” J.A. 18670. Neither party argued the term excludes a loading dose. Id. And for good 

reason—it has a plain meaning, and the prosecution history shows it does not implicitly exclude a loading dose. 

Novartis backdoors a claim construction argument, arguing that “experts understood the patent’s description of a 

‘daily dose’ as exclusive of a loading dose,” Novartis Br. 46, 

but it and the district court already defined daily dosage 

otherwise. 

Rather than defend Novartis’ reliance on the “daily 

dosage” language, the majority pivots to focus on the district court’s statement that “starting with a daily dose 

plainly implies that there is no loading dose.” Maj. at 23–

24 (quoting J.A. 27). But that statement is just another 

example of the district court (and now the majority) rewriting the specification with expert testimony. The patent 

never says “starting with a daily dose,” and the district 

court relied exclusively on expert testimony to support that 

finding. See J.A. 27 (citing J.A. 23344). But “[t]he 

knowledge of ordinary artisans may . . . not [be used] to 

teach limitations that are not in the specification[.]” Rivera, 857 F.3d at 1322. Novartis, and now the majority, 

teases an entirely new claim limitation out of an entirely 

common term, relegating the legal determination of a 

term’s meaning to the backseat of an expert’s post-hoc rationalization. 

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In fact, the district court found that a nearly identical 

disclosure in the prior art (Kappos 2006, a Novartis-supported study) did not anticipate because it failed to disclose 

the negative loading dose limitation. Kappos disclosed a 

study administering 0.5 mg fingolimod to RRMS patients

“once-daily fingolimod for up to 24 months.” J.A. 29–30 

¶ 72; J.A. 24724. The district court found Kappos 2006 did 

not meet the negative loading-dose limitation, reasoning

that “[t]he failure to mention a loading dose does not . . . 

indicate that the dose was not present in the trial, but only 

that the presence or absence of a loading dose was not mentioned.” J.A. 30 ¶ 74. A district court’s “internally inconsistent factual findings,” like those here, “are, by definition, 

clearly erroneous.” In re Sentinel Mgmt. Grp., Inc., 728 

F.3d 660, 670 (7th Cir. 2013); see also United States v. 

AT&T, Inc., 916 F.3d 1029, 1033 (D.C. Cir. 2019) (citing, 

e.g., Anderson v. City of Bessemer, N.C., 470 U.S. 564, 575 

(1985)) (“A finding may be clearly erroneous when it is illogical or implausible, [or] rests on internally inconsistent 

reasoning.”). 

The majority’s attempts to distinguish Kappos 2006 

from the ’405 patent fall flat. Maj. at 21–23. To be sure, 

Kappos 2006 does not “say[] the daily fingolimod dosage 

should be ‘initially’ administered.” Id. at 22–23. But neither does the ’405 patent. The ’405 patent uses the word 

initially to describe the length of treatment, not the dosage. 

And it is simply not correct that an issued patent is “presumed to have a complete written description.” Maj. at 21. 

“The presumption of validity includes a presumption the 

patent complies with” the written description requirement. 

Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., 

Inc., 166 F.3d 1190, 1195 (Fed. Cir. 1999). But it does not 

require presuming an issued patent is “complete,” which 

would mean silence presumptively supports a negative limitation in every case. That presumption is contrary to our 

long-standing precedent, which the majority recognizes

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10 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 

(see Maj. at 17), and a gross expansion of the presumption 

of validity. 

This specification is ambivalent as to loading doses in 

a field where, by all expert accounts, loading doses of fingolimod were sometimes used to treat MS. The inventors 

do not get to claim as their invention something they did 

not disclose in the patent. There are no fact findings here 

to defer to—the patent is silent as to loading doses. The 

district court relied upon that silence: “The absence of an 

immediately preceding loading dose from the specification, 

and from the Prophetic Trial, would tell a person of skill 

that loading doses are excluded from the invention.” 

J.A. 26 ¶ 61. This is not a finding of fact; it is a misunderstanding of the law. An inventor cannot satisfy the written 

description requirement through silence. And when the 

majority concludes otherwise, it creates a conflict with our 

long-standing, uniformly-applied precedent including Santarus, Inphi, and Nike. While the negative limitation need 

not be recited in the specification in haec verba, there must 

be something in the specification that conveys to a skilled 

artisan that the inventor intended the exclusion: disadvantages, alternatives, inconsistencies, just something. 

This specification is entirely silent and ambivalent about 

loading doses. These inventors did not disclose treatment 

that must exclude a loading dose, and the district court’s 

finding to the contrary is clearly erroneous. After this case, 

negative limitations are supported by a specification that 

simply never mentions them. 

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