VIFOR (INTERNATIONAL) AG v. MYLAN LABORATORIES LTD.

NOT FOR PUBLICATION*

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

VIFOR (INTERNATIONAL) AG and

AMERICAN REGENT, INC.,

Plaintiffs, Civil Action No. 19-13955 (FLW)

v. OPINION

MYLAN LABORATORIES LTD. and SANDOZ

INC.,

Defendants.

WOLFSON, Chief Judge:

In this claim construction Opinion, the Court construes disputed claim terms across two

families of United States Patents, which disclose specific formulations of ferric carboxymaltose,

an injectable iron carbohydrate complex, and methods of using those formulations to treat iron

deficiency anemia. After reviewing the parties’ briefings and exhibits, and holding a Markman

hearing, the Court construes the disputed claim terms in accordance with the intrinsic and extrinsic

evidence, as set forth herein.

I. BACKGROUND

Plaintiffs Vifor (International) AG (“Vifor”) and American Regent, Inc. (“American

Regent”) (collectively, “Plaintiffs”) brought the instant patent infringement suit against

Defendants Mylan Laboratories Ltd. (“Mylan”) and Sandoz Inc. (“Sandoz”) (collectively

“Defendants”).1 At issue in this claim construction dispute are five patents which share a common

1 This matter consisted of four separate cases, see 3:19-cv-13955; 3:19-cv-16305; 3:20-cv-

01647; 3:20-cv-01649, which were consolidated for all purposes, including discovery, case

specification: U.S. Patent Nos. 7,612,109 (“the ’109 patent”); 7,754,702 (“the ’702 patent”);

8,895,612 (“the ’612 patent”); 9,376,505 (“the ’505 patent”); and 10,519,252 (“the ’252 patent”)

(collectively, the “patents-in-suit”). (Pls. Opening Br. 1.) Plaintiffs are the assignees of the

patents-in-suit. (Mylan FAC at ¶¶ 19-23; Sandoz FAC at ¶ 27.) The patents-in-suit are listed in

the Food and Drug Administration’s (“FDA”) Orange Book for Injectafer (ferric carboxymaltose

injection), and they cover an iron replacement product suggested for the treatment of iron

deficiency anemia in adult patients. (Pls. Opening Br. 1.)

Specifically, iron deficiency anemia (“IDA”) is a condition that develops when body stores

of iron drop too low to support normal red blood cell production. (Id. at 2.) Prior to the invention

of Injectafer (ferric carboxymaltose), intravenous iron therapies for IDA had drawbacks for

patients and their healthcare providers because the early infusion products were associated with an

elevated risk of unfavorable consequences. Later infusion therapies were generally considered

safer, but typically required multiple administrations to deliver the necessary doses of iron. (Id.)

According to Plaintiffs, this changed, however, with the invention of ferric carboxymaltose, the

active ingredient in Injectafer, by Peter Geisser and his team of co-inventors, which is captured in

the ’109, ’505, and ’252 patents (“Geisser Family Patents”). Thereafter, Mary Jane Helenek and

her colleagues further discovered that ferric carboxymaltose can be administered to patients in a

higher dose and in a shorter amount of time than had been deemed advisable at the time.

Accordingly, the inventors of the ’612 and ’702 patents (“Helenek Family Patents”) discovered

the combination of properties that make the claimed methods of administration possible, to the

benefit of IDA patients.

management, and trial, into one action by Orders dated February 6, 2020 (ECF No. 34) and

February 24, 2020. (ECF No. 39).

The instant litigation arose because Defendants filed an Abbreviated New Drug

Application (“ANDA”) with the FDA to market generic versions of Injectafer. (See, e.g., Compl.)

In response, Plaintiffs filed the present infringement suit under the Hatch-Waxman Act. (Id.)

Plaintiffs allege that Defendants’ generic product has, or will, infringe certain composition and

process claims of the patents-in-suit. (Id.) Defendants, on the other hand, have asserted that the

patents-in-suit are not infringed, and in that regard, Defendants advanced invalidity theories for

each of the asserted claims.

Initially, the parties disputed seven claim terms contained within the patents-in-suit. Prior

to the Markman Hearing, however, the parties reached an agreement on one of those terms: “iron-

carbohydrate complex comprising the reaction product of,” and therefore, the Court will not

address that term in this Opinion. (See ECF No. 97.) The remaining six terms in dispute are divided

into two patent families: the Geisser Family Patents and the Helenek Family Patents. Under the

Geisser Family Patents, there are three terms in dispute: (1) “maltodextrin,” (2) “one maltodextrin”

/ “each individual maltodextrin,” and (3) “subject.”2 The first two disputed claims—those related

to maltodextrin—will be construed together, as they turn on the same evidence, and the parties

have so argued for purposes of the Markman Hearing. As for the Helenek Family Patents, there

are also three disputed terms: (1) “the iron carbohydrate complex has a substantially non-

immunogenic carbohydrate component,” (2) “the iron carbohydrate complex has […] substantially

no cross reactivity with antidextran antibodies,” and (3) “subject.” The following chart provides

2 On June 25, 2021, Plaintiffs advised the Court that they were “no longer asserting any

claims of U.S. Patent No. 10,519,252[, and therefore,] “the claim term ‘subject’ as used in the ‘252

patent no longer needs to be construed by the Court as part of the Court’s claim construction

decision.” (ECF No. 186.) Accordingly, the Court will only construe the “subject” term with

respect to the Helenek Family Patents.

a summary of the disputed claim terms, and the parties’ respective proposed construction for each

term:

Disputed Term Patents/Claims Plaintiffs’ Construction Defendants’ Construction

“maltodextrin” ’109 Patent, Claims “starch hydrolysate composed “saccharide(s) of variable

1-16, 19-21, 23-27 of a mixture of saccharides of length composed of chains of

variable length consisting of D-glucose units connected

’505 Patent, Claims chains of D-glucose units primarily by α-(1→4)

1-6, 8-24, 26-36 connected primarily by α- glycosidic bonds”

(1→4) glycosidic bonds”

’252 Patent, Claims

1-4, 6-8, 10-16, 18-

26

“one maltodextrin” ’109 Patent, Claims one/each “maltodextrin,” as Indefinite under 35 U.S.C. §

/ “each individual 1-16, 19-21, 23-27 that term is defined above 112

maltodextrin”

’505 Patent, Claims

1-6, 8-24, 26-36

’252 Patent, Claims

1-4, 6-8, 10-16, 18-

26

“the iron ’702 Patent, Claims “the iron carbohydrate complex Indefinite under § 112.

carbohydrate 4-6, 17-19, 21-22, has a carbohydrate component

complex has a 24, 31-38, 44-47, resulting in a low risk of To the extent a construction

substantially non- 53-54 anaphylactoid/hypersensitivity is possible, it should be

immunogenic reactions, wherein a low risk is construed as a carbohydrate

carbohydrate ’612 Patent, Claims an incidence of adverse events component resulting in a low

component” 1-5, 10-11, 15-18 associated with the iron risk of anaphylactoid/

carbohydrate complex lower hypersensitivity reactions,

than iron dextran” wherein a low risk is an

incidence of adverse events

lower than dextran.

“the iron ’702 Patent, Claims “the iron carbohydrate complex Indefinite under § 112.

carbohydrate 4-6, 17-19, 21-22, … does not exhibit a substantial

complex has […] 24, 31-38, 44-47, antibody/antigen immune To the extent a construction

substantially no 53-54 response with antidextran may be possible, it must be

cross reactivity antibodies in a clinical setting” construed as not limited to

with antidextran ’612 Patent, Claim requiring cross reactivity

antibodies” 2 with anti-dextran antibodies

in a clinical setting.

“subject” ’702 Patent, Claims “human” “Mammal to whom the

4-6, 17-19, 21-22, carbohydrate complex is

24, 31-38, 44-47, administered”

53-54

’612 Patent, Claims

1-5, 10-11, 15-18

II. LEGAL STANDARD

A. Claim Construction

The claims of a patent define an inventor’s right to exclude. Philips v. AWH Corp., 415

F.3d 1303, 1312 (Fed. Cir. 2005). The court has the exclusive authority to construe patent terms

and determine the correct scope of disputed claims as a matter of law. Markman v. Westview

Instruments, Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995). The purpose of claim construction is to

objectively determine how a person of ordinary skill in the art would understand a claim at the

time of the invention. Phillips, 415 F.3d at 1313. In construing a claim, the court may examine

both intrinsic evidence (e.g., the patent, its claims, the specification, and the prosecution history)

and extrinsic evidence (e.g., expert reports, testimony, and anything else). Vitronics Corp. v.

Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

It is well established that claim construction analysis begins with consideration of the

intrinsic evidence. Id. Intrinsic evidence is considered “the most significant source of the legally

operative meaning of disputed claim language.” Id. In this regard, the court first looks to the

words of the claims themselves. Id. Claim terms “are generally given their ordinary and customary

meaning.” Id. However, “a patentee may choose to be his own lexicographer and use terms in a

manner other than their ordinary meaning.” Id. Therefore, it is important that courts examine

other components of the intrinsic evidence to determine whether the patentee has given a term an

unconventional meaning. Id.

The court should then review the patent specification to determine whether the inventor

uses terms inconsistent with their ordinary meaning, or explicitly or implicitly defines terms.

Markman, 52 F.3d at 979. The specification has long been emphasized as “the single best guide

to the meaning of a disputed term,” and is usually dispositive in claim construction analyses.

Phillips, 415 F.3d at 1315. The specification “acts as a dictionary when it expressly defines terms

used in the claims or when it defines terms by implication.” Dow Chem. Co. v. Sumitomo Chem.

Co., 257 F.3d 1364, 1373 (Fed. Cir. 2001). Indeed, if the specification “reveal[s] a special

definition given to a claim term by the patentee that differs from the meaning it would otherwise

possess,” “the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316.

In addition to the claims and specification, the court can consider the patent’s prosecution

history, which, if in evidence, can inform the meaning of a claim term. Id. at 1317. “The

prosecution history provides evidence of how the PTO3 and the inventor understood the patent.”

Id. However, “because the prosecution history represents an ongoing negotiation between the PTO

and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the

specification and thus is less useful for claim construction purposes.” Id.

Finally, a court may consider extrinsic evidence, which “consists of all evidence external

to the patent and prosecution history, including expert and inventor testimony, dictionaries, and

learned treatises.” Markman, 52 F.3d at 980. “However, while extrinsic evidence ‘can shed useful

light on the relevant art,’ ... it is ‘less significant than the intrinsic record in determining ‘the legally

operative meaning of claim language.’” Philips, 415 F.3d. at 1317 (quoting Vanderlande Indus.

Nederland BV v. Int’l Trade Commc’n, 366 F.3d 1311, 1318 (Fed. Cir. 2004)). Extrinsic evidence

should therefore be considered only where the intrinsic evidence does not provide a sufficient

description to resolve ambiguities in the scope of the claim. See Vitronics, 90 F.3d at 1583.

B. Indefiniteness

“[A] patent is invalid for indefiniteness if its claims, read in light of the specification

delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those

skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572

3 The United States Patent and Trademark Office.

U.S. 898, 901 (2014). “[D]efiniteness is measured from the viewpoint of a person skilled in [the]

art at the time the patent was filed.” Id. at 908 (citation omitted). “[A] patent must be precise

enough to afford clear notice of what is claimed, thereby ‘appris[ing] the public of what is still

open to them.’” Id. at 909 (alteration in original) (citation omitted). At the same time, the

definiteness requirement “take[s] into account the inherent limitations of language,” and therefore,

“some modicum of uncertainty” is permitted. Id. (citation omitted). Patents are presumptively

valid, and to overcome the presumption of validity, an accused infringer must “show[ ] by clear

and convincing evidence that a skilled artisan could not discern the boundaries of the claim based

on the claim language, the specification, and the prosecution history, as well as her knowledge of

the relevant art area.” Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238, 2339 (2011); Halliburton

Energy Sen’s., Inc. v. M-I LLC, 514 F.3d 1244, 1249-50 (Fed. Cir. 2008).

III. DISCUSSION

A. The Geisser Family Patents

The parties dispute the meaning of “maltodextrin” and “one maltodextrin” / “each

individual maltodextrin” found within dependent Claims 1-16, 19-21, 23-27 of the ’109 patent;

dependent Claims 1-6, 8-24, 26-36 of the ’612 patent; and dependent Claims 1-4, 6-8, 10-16, 18-

26 of the ’252 patent.

1. “Maltodextrin”

As to “maltodextrin,” Plaintiffs propose that term means a “starch hydrolysate composed

of a mixture of saccharides of variable length consisting of chains of D-glucose units connected

primarily by α-(1→4) glycosidic bonds.” (Pl. Opening Br. at 12.) Defendants, on the other hand,

contend that “maltodextrin” means: “saccharide(s) of variable length composed of chains of D-

glucose units connected primarily by α-(1→4) glycosidic bonds.”

At the outset, because noticeable similarities exist between the parties’ competing claim

constructions, relating to chains of D-glucose units connected by glycosidic bonds, and they refer

to saccharides, I note that the dispute turns on three aspects. First, the parties dispute whether

“maltodextrin” is a mixture of saccharides of variable length. Second, whether maltodextrin is a

starch hydrolysate. Third, whether “maltodextrin” either “consists of” or is “composed of” chains

of D-glucose units connected by glycosidic bonds. I will address each of these disputes, in turn.

i. Maltodextrin Refers to a Mixture of Saccharides of Variable Chain Lengths

First, after reviewing the intrinsic and extrinsic evidence, I reject Defendants’ proposed

construction that “maltodextrin” refers to one or more saccharides. Rather, I adopt Plaintiffs’

portion of the term’s construction, namely that “maltodextrin” refers to a “mixture of saccharides

of variable chain lengths.”

Here, relying on the expert opinion of Dr. Geert-Jan Boons, Plaintiff claims that the term

“maltodextrin,” as used in both the art and the Geisser patents, refers to the carbohydrate produced

by the partial hydrolysis of starch, and is thus a “starch hydrolysate.” (Pl. Opening Br. at 13-14.)

According to Plaintiffs, when hydrolyzed, the starch breaks down to produce a mixture of

saccharides of varying chain lengths. (Id.) Thus, a POSA would have known that the term

“maltodextrin” refers to a mixture of saccharides of varying chain lengths, consisting of chains of

D-glucose units connected primarily by α-(1→4) glycosidic bonds, that is formed by the partial

hydrolysis of starch. (Id.) In support of their construction, Plaintiffs further rely on the

specification, arguing that it teaches that “the iron preparation is to be producible from easily

obtainable starting products and without great effort.” (Id. at 14) (citing Declaration of M. David

Weingarten in Support of Plaintiffs’ Opening Markman Brief (“Weingarten Decl.”), Ex. 1 at 1:42-

44.) According to Plaintiffs, the specification emphasizes that an advantage of the claimed

complex is the “high degree” of commercial availability of the maltodextrin starting material, and

as Dr. Boons opines, commercially available maltodextrins as of October 2002 were starch

hydrolysates composed of a mixture of saccharides of variable length. (Id.) Defendants, on the

other hand, submit that their construction is consistent with the claim language chosen by the

inventors. (Def. Opening Br. at 10.) Defendants note that claim 1 of the ’109 patent and claim 1

of the ’505 patent expressly require “at least one maltodextrin,” and claim 1 of the ’252 patent

introduces “maltodextrin” without a modifier, implying it is not limited to the plural. (Id.) As

such, Defendants rely on Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999), for the

principle that “[u]se of the phrase ‘at least one’ means that there could be only one or more than

one.” See also Kistler Instrumente AG v. United States, 628 F.2d 1303, 1318 (Ct. Cl. 1980)

(“Anyone with even the most rudimentary understanding of the English language understands ‘at

least one piezo-electric crystal’ . . . to mean one or more crystals.”). Defendants further claim that

their construction comports with the specifications of the asserted patents, which use both the

singular “maltodextrin” and plural “maltodextrins.” (Id. at 11.)

The “starting point for any claim construction must be the claims themselves.” Pitney

Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298 (Fed. Cir. 1999). Here, in the Geisser Family

Patents, the term “maltodextrin” refers to the starting material used to form the claimed iron

carbohydrate complex. Indeed, each of the asserted claims of the Geisser patents recites a product

comprising oxidized maltodextrin, wherein the maltodextrin, prior to oxidation, possesses a

specific dextrose equivalent value. (See, e.g., Weingarten Decl., Ex. 1 at Claim 1.) As it relates

to whether “maltodextrin” refers to “one or more saccharides,” or whether it refers to a “mixture

of saccharides of variable chain lengths,” however, the Court finds the claims to be silent. Thus,

like the parties, the Court acknowledges that the inventors did not “act as their own lexicographer,”

on the definition of maltodextrin. Put simply, neither the claims nor the specifications provide any

context or guidance as to this portion of the definition of “maltodextrin,” a fundamentally scientific

word. Accordingly, “[i]t is permissible, and often necessary, to receive expert evidence to

ascertain the meaning of a technical or scientific term or term of art so that the court may be aided

in understanding ... what [the instruments] actually say.” Markman, 52 F.3d at 981 (quoting U.S.

Indus. Chems., Inc. v. Carbide & Carbon Chems. Corp., 315 U.S. 668, 678 (1942)).

Here, the extrinsic evidence, specifically the unrebutted expert testimony offered by Dr.

Boons, supports Plaintiffs’ construction of this portion of the claim. York Prods., Inc. v. Central

Tractor Farm & Family Center, 99 F.3d 1568, 1572 (Fed. Cir. 1996). Significantly, Defendants

did not provide an expert opinion with respect to the Geisser Patent Family terms; rather, the only

expert opinion the Court had to assist it in evaluating the plain and ordinary meaning of

“maltodextrin” and “one maltodextrin” / “each individual maltodextrin” was that of Dr. Boons. In

that connection, Dr. Boons opined that when hydrolyzed, the starch breaks down to produce a

mixture of saccharides of varying chain lengths. (Declaration of Dr. Boons (“Boons Decl.”) at ¶¶

40-44.) Indeed, the Court finds that Dr. Boons’ testimony is supported by several reference

materials available at the time of invention, including Starch: Chemistry and Technology (2nd

Ed.), dated before the effective filing date of the Geisser patents, which defines maltodextrin as “a

mixture of purified nutritive saccharides obtained by the hydrolysis of starch having a DE[4] of

less than 20.” (Weingarten Decl., Ex. 22 at 612) (emphasis added). Similarly, the Handbook of

4 The abbreviation “DE” refers to “dextrose equivalent.” The parties have agreed that with

respect to the Geisser patents, “dextrose equivalent,” is defined as the “amount of reducing sugar

relative to amount of sugar product, expressed as a dry percentage basis.” (Boons Decl. at ¶ 29.)

According to Dr. Boons, “the dextrose equivalent value reflects the reducing power of a

carbohydrate (i.e. the potential for the carbohydrate to reduce another compound and in turn be

oxidized to a carboxyl group).” (Id. at ¶ 41.)

Pharmaceutical Excipients, identified by Defendants in their Joint Claim Construction and

Prehearing Statement, also defines “maltodextrin” as “a nonsweet nutritive saccharide mixture of

polymers that consist of D-glucose units, with a dextrose equivalent (DE).” (ECF No. 81-66,

Defendants’ Joint Claim Construction and Prehearing Statement, Ex. 62 at 317; see also ECF No.

81-31, Ex. 27 at 2577 (same).) Further, the Court notes that additional statements offered by

Defendants in this case have referred to “maltodextrin” as a mixture of saccharides of variable

length. (See Declaration of M. David Weingarten in Support of Plaintiffs’ Responsive Markman

Brief (“Weingarten Resp. Decl.”), Ex. I at SANDOZ-FCM000001271; see also Weingarten Resp.

Decl., Ex. M at Formula 1, ¶ 14, Example 1, Claim 1 (depicting maltodextrin as a mixture of

saccharides of variable length); see also Weingarten Resp. Decl., Ex. L, MYL-FCARB_0095425.)

Finally, Dr. Boons certified that he is unaware of any commercially available maltodextrin not

sold as a mixture of saccharides of variable length as of October 2002. (Boons Decl. at ¶ 55.).

Accordingly, the Court adopts Plaintiffs’ construction with respect to the first disputed

portion of the “maltodextrin” term, specifically it refers to a “mixture of saccharides of variable

chain lengths.”

ii. The Intrinsic Evidence Does Not Support Inserting a Starch Hydrolysis

Requirement into “Maltodextrin”

Next, the parties dispute whether to include “starch hydrolysate” in the definition of

maltodextrin. In that regard, Plaintiffs argue that although the claims are silent regarding the

process for manufacturing maltodextrin, the prior art consistently defines “maltodextrin” as a

product of starch hydrolysis, and therefore, it should be given that meaning. On the other hand,

Defendants argue that there is no basis in the claims, specifications, or prosecution history for

“importing the additional ‘starch hydrolysate’ limitation Plaintiffs seek,” and therefore, the Court

cannot read a limitation into the term that does not exist.

After reviewing the intrinsic evidence, I reject Plaintiffs’ proposed construction, and adopt

Defendants’ construction. Again, the “starting point for any claim construction must be the claims

themselves.” Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298. Here, reviewing the plain

and ordinary meaning of “maltodextrin” in the context of the claims, there is simply no indication

that the claims themselves insert a specific manufacturing process, or any other limitations, into

the definition of the term. Instead, as Defendants point out, Plaintiffs cannot cite a single portion

of the claim language or the specifications that limits maltodextrin to production only through the

partial hydrolysis of starch. In other words, the claims relate to “maltodextrin,” without express

limitation on how it is made, and courts are typically reluctant to read into claims particular

methods of manufacture where no such process limitations appear in the claims. See Vanguard

Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2000) (“The method of

manufacture, even when cited as advantageous, does not of itself convert product claims into

claims limited to a particular process. . . . A novel product that meets the criteria of patentability

is not limited to the [unclaimed] process by which it is made.”); see also Southwall Technologies,

Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed.Cir. 1995) (finding a product claim limited to a

particular process because the patentee had specifically restricted its claim to a method of

manufacture in order to avoid rejection for obviousness); Orexo, AB v. Mylan Pharm., Inc., No.

11-3788, 2014 WL 1302056, at *6 (D.N.J. Mar. 31, 2014) (rejecting a plaintiff’s claim

construction where neither the language of the patent nor the prosecution history supported the

idea that the invention must be limited to a water-free manufacturing process).

Notwithstanding the language of the claims, it is necessary to look to other intrinsic

evidence, including the specifications. Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir.

2005). The specification has long been emphasized as “the single best guide to the meaning of a

disputed term,” and is usually dispositive in a claim construction analysis. Id. The specification

“acts as a dictionary when it expressly defines terms used in the claims or when it defines terms

by implication.” Dow Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364, 1373 (Fed. Cir. 2001).

In the instant case, the specifications of the Geisser Family Patents, like the claims, are silent as it

relates to how maltodextrin is prepared or manufactured. Indeed, Plaintiffs point to only the ’109

patent specification’s statement that “[t]he usable maltodextrins are easily obtainable starting

products, and they are commercially available” and that they have a “high degree of availability .

. ., e.g., commercially available additives in the food processing industry.” (See ’109 patent, 2:4-

5, 4:62-65.) While Dr. Boons opines that Plaintiffs’ construction is appropriate because

commercially available maltodextrins as of October 2002 were starch hydrolysates composed of a

mixture of saccharides of variable length, courts generally “will not narrow a claim term beyond

its plain and ordinary meaning unless there is support for the limitation in the words of the claim,

the specification, or the prosecution history.” Wasica Fin. GmbH v. Cont’l Auto. Sys., 853 F.3d

1272, 1281 (Fed. Cir. 2017). Moreover, although the Court need not consider extrinsic evidence,

the extrinsic evidence appears to suggest that maltodextrin, at the time of the claimed invention,

was not made exclusively via the hydrolysis of starches, but rather synthetic methods were

available for producing saccharides like maltodextrin. (See Declaration of Dennis Gregory, Esq.

in Support of Defendants’ Opening Markman Br. (“Gregory Decl.”), Ex. 34 at 23; Gregory Decl.,

Ex. 36 at 72.)

Accordingly, the Court does not find it appropriate to limit the method in which

maltodextrin is manufactured by inserting a process that does not exist in the patent claim

language, specifications, or prosecution history.

iii. Maltodextrin is “composed of” chains of D-glucose units connected by

glycosidic bonds.

Finally, despite the parties’ dispute, the Court does not find a meaningful difference

between “consisting of” and “composed of,” as it pertains to this specific term. Here, Plaintiffs

argue that “maltodextrin” be construed as a “starch hydrolysate composed of a mixture of

saccharides of variable length consisting of chains of D-glucose units connected primarily by α-

(1→4) glycosidic bonds,” whereas Defendants submit that the term should mean “saccharide(s) of

variable length composed of chains of D-glucose units connected primarily by α-(1→4) glycosidic

bonds.” Specifically, Plaintiffs rely on prior art, arguing that the phrase “consisting of” is

“frequently repeatedly” and often used. (Pl. Resp. Br. at 9.) In response, Defendants contend that

Plaintiffs’ attempted insertion of “consisting of” is improper because that phrase is a term of art in

patent law that excludes any unrecited elements. According to Defendants, the asserted claims of

the Geisser Family Patents use the open term “comprising,” which means that the recited elements

are essential, but other elements may be added. (Def. Opening Br. at 15-16) (citing Genentech,

Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997)).

That said, because neither the intrinsic nor the extrinsic record convincingly supports either

construction, the Court adopts Defendants’ use of the phrase “composed of” to avoid unfairly

narrowing the term. See Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331 (Fed. Cir. 2004)

(explaining that “‘[c]onsisting of’ is a term of patent convention meaning that the claimed

invention contains only what is expressly set forth in the claim.”).5 As explained in Multilayer

5 The Court notes that this principle of patent law is well supported. See, e.g., CIAS, Inc. v.

All. Gaming Corp., 504 F.3d 1356, 1361 (Fed. Cir. 2007) (“It is ... well understood in patent usage

that ‘consisting of’ is closed-ended and conveys limitation and exclusion. ... For patent claims the

distinction between “comprising” and “consisting” is established....”); Conoco, Inc. v. Energy &

Envtl. Int’l, 460 F.3d 1349, 1359 (Fed. Cir. 2006) (“‘[C]onsisting of’ is a term of art in patent law

with its own construction....”); Vehicular Techs. Corp. v. Titan Wheel Int’l, Inc., 212 F.3d 1377,

Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016),

“consisting of,” is a “term of art in patent law with a distinct and well-established meaning.”

(Internal quotations omitted). Thus, “[u]se of the transitional phrase ‘consisting of’ to set off a

patent claim element creates a very strong presumption that that claim element is ‘closed’ and

therefore ‘exclude[s] any elements, steps, or ingredients not specified in the claim.’” Id. (quoting

AFG Indus., Inc. v. Cardinal IG Co., Inc., 239 F.3d 1239, 1245 (Fed. Cir. 2001)). For example,

“if a patent claim recites ‘a member selected from the group consisting of A, B, and C,’ the

‘member’ is presumed to be closed to alternative ingredients D, E, and F.” Id. On the other hand,

“the alternative transitional term ‘comprising’ creates a presumption that the recited elements are

only a part of the device, that the claim does not exclude additional, unrecited elements.” Id.

(quoting Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l, Inc., 246 F.3d 1336, 1348

(Fed. Cir. 2001)).

In sum, the Court finds “maltodextrin” to mean a “mixture of saccharides of variable length

composed of chains of D-glucose units connected primarily by α-(1→4) glycosidic bonds.”6

2. “one maltodextrin” / “each individual maltodextrin”

Next, the parties dispute the meaning of “one maltodextrin” / “each individual

maltodextrin.” Like their proposed construction of “maltodextrin,” Plaintiffs assert that their

construction of “one maltodextrin” / “each individual maltodextrin,” is consistent with the intrinsic

record and is supported by prior art. (Pl. Opening Br. at 16-18.) Plaintiffs maintain that the term

should be construed using their definition of “maltodextrin,” as Plaintiffs defined it above. (Id. at

1382–83 (Fed. Cir. 2000) (“The phrase ‘consisting of’ is a term of art in patent law signifying

restriction and exclusion, while, in contrast, the term ‘comprising’ indicates an open-ended

construction.... In simple terms, a drafter uses the phrase ‘consisting of’ to mean ‘I claim what

follows and nothing else.’” (citations omitted)).

6 The Court notes that the claim does not foreclose the possibility that there could be other

ingredients in maltodextrin.

16.) Applying that previous definition, which the Court only partially adopted, Plaintiffs argue

that based on the claim language contained in Claim 1 of the ’109 patent, a POSA would

understand that “one maltodextrin” / “each individual maltodextrin” refers to a “single starch

hydrolysate composed of a mixture of saccharides of variable length consisting of chains of D-

glucose units connected primarily by α-(1→4) glycosidic bonds.” (Id.) (citing Boons Decl. at ¶

66.) Specifically, they emphasize that Claim 1 of the ’109 patent provides that “when one

maltodextrin is present [in the reaction], the maltodextrin has a dextrose equivalent of between 5

and 20, and wherein, when a mixture of more than one maltodextrin is present [in the reaction],

the dextrose equivalent of each individual maltodextrin is between 2 and 40, and the dextrose

equivalent of the mixture is between 5 and 20.” (See Weingarten Decl., Ex. 1 at Claim 1.)

Plaintiffs further highlight that the specification provides examples of iron carbohydrate

complexes derived from the reaction product of iron (III) salt and the oxidation of “one

maltodextrin” compared to iron carbohydrate complexes derived from the reaction product of iron

(III) salt and the oxidation of “a mixture of more than one maltodextrin.” Compare Ex. 1 at

Example 1 (“100 g maltodextrin (9.6 dextrose equivalent measured gravimetrically)”), with id. at

Example 4 (“A mixture of 45 g maltodextrin (6.6. dextrose equivalent measured gravimetrically)

and 45 g maltodextrin (14.0 dextrose equivalent measured gravimetrically)”). According to

Plaintiffs, the starting maltodextrin of Example 1 is “one maltodextrin” as recited in the Geisser

patents, while in Example 4, the maltodextrin with a dextrose equivalent of 6.6 and the

maltodextrin with a dextrose equivalent of 14.0 are “each individual maltodextrin,” that, when

combined, constitute “a mixture of more than one maltodextrin.” Id. While Plaintiffs propose a

definition, Defendants, on the other hand, argue that the term is indefinite. (Def. Opening Br. at

16-17.)

Here, I decline Defendants’ invitation to find the term indefinite at this juncture. Horizon

Pharma, Inc. v. Dr. Reddy’s Lab’ys, Inc., No. 15-3324, 2017 WL 5451748, at *5 (D.N.J. Nov. 14,

2017) (finding that the court need not consider indefiniteness arguments at claim construction, as

they are better served for summary judgment or trial). While the Court appreciates Defendants’

argument that a person of ordinary skill might not be able to determine with reasonable certainty

when “one maltodextrin” or “each individual maltodextrin” meets the claimed parameters without

first understanding how dextrose equivalent values are determined, the Court also agrees with

Defendants’ observation that the parties’ claim construction dispute for this term is merely a

“subset” of the dispute over the “maltodextrin” term. In that regard, the Court finds the term “one

maltodextrin” / “each individual maltodextrin” to refer to a single maltodextrin, as that term has

been defined above. Moreover, while Defendants argue that Plaintiffs’ proposed construction is

incorrect because “one maltodextrin” / “each individual maltodextrin” could be construed as

having the same meaning as “mixture of more than one maltodextrin,” I disagree. When analyzed

in connection with the term “maltodextrin” above, “one maltodextrin” would mean a single

mixture of saccharides of variable length composed of chains of D-glucose units connected

primarily by α-(1→4) glycosidic bonds, whereas a “mixture of maltodextrin” refers to a mixture

of two or more maltodextrins. As such, I adopt Plaintiffs’ construction, using the Court’s

definition of “maltodextrin” recited above.

B. The Helenek Family Patents

1. “the iron carbohydrate complex has a substantially non-immunogenic

carbohydrate component”

With respect to the Helenek Family Patents, the parties first dispute the meaning of “the

iron carbohydrate complex has a substantially non-immunogenic carbohydrate component” found

within dependent Claims 4-6, 17-19, 21-22, 24, 31-38, 44-47, 53-54 of the ’702 patent and

dependent Claims 1-5, 10-11, 15-18 of the ’612 patent. Specifically, the parties disagree regarding

the meaning of “substantially non-immunogenic” and whether the immunogenicity is assessed for

the entire iron carbohydrate complex (i.e., iron and carbohydrate components together), as opposed

to just the carbohydrate component. (Pl. Opening Br. at 23.)

Plaintiffs’ proposed construction is “the iron carbohydrate complex has a carbohydrate

component resulting in a low risk of anaphylactoid/hypersensitivity reactions, wherein a low risk

is an incidence of adverse events associated with the iron carbohydrate complex lower than iron

dextran.” (Pl. Opening Br. at 22.) In support of their position, Plaintiffs argue that their

construction is supported by the claims and specifications of the ’612 and ’702 parents and the

state of the art. Plaintiffs explain that the Helenek patent claims concern methods of treatment,

including “administering to a subject in need thereof an iron-carbohydrate complex.” (Id. at 24)

(citing Weingarten Decl., Ex. 2 at Claim 1; Weingarten Decl., Ex. 3 at Claim 1.) Therefore,

because it is Plaintiffs’ view that the Helenek patent claims are directed to clinicians and healthcare

providers, they contend a POSA would understand this claim limitation from a clinical perspective.

(Id.)

Defendants, on the other hand, assert that this term is indefinite under 35 U.S.C. § 112, but

to the extent construction is possible, the term should mean: “a carbohydrate component resulting

in a low risk of anaphylactoid/ hypersensitivity reactions, wherein a low risk is an incidence of

adverse events lower than dextran.” (Def. Opening Br. at 18-19.) Defendants first argue that the

asserted claims of the Helenek Family Patents require that the carbohydrate component must be

“substantially non-immunogenic,” however the specifications of the Helenek Family Patents do

not provide an explanation of what it means to be “substantially non-immunogenic.” (Id. at 19-

20.) Specifically, Defendants claim that there is a distinction between a “non-immunogenic”

carbohydrate component and a “substantially non-immunogenic” carbohydrate component, but the

intrinsic record does not articulate, nor quantify, that distinction. (Id.) (Emphasis added).

According to Defendants, the intrinsic record’s silence is especially problematic because the term

“substantially non-immunogenic” does not have an ordinary meaning in the art. Defendants claim

that although “immunogenic” is well understood in the art, “substantially non-immunogenic” does

not have an established meaning. (Id. at 20.) Therefore, because “substantially non-

immunogenic” does not have an ordinary meaning in the art, and the specification does not provide

insight for a POSA to understand the meaning, the claim is indefinite. (Id.) (citing In re Mobile

Telecommc’ns Techs. LLC, 265 F. Supp. 3d 454, 474 (D. Del. 2017)) (“Because ‘substantially’ is

a term of degree, the patent must provide ‘some standard of measuring that degree’ such that the

claim language provides ‘enough certainty to one of skill in the art when read in context of the

invention.’”).

Moreover, Defendants argue that even if “substantially non-immunogenic” is subject to

construction, the Court should adopt the Patent Trial and Appeal Board’s (“PTAB” or the “Board”)

prior construction that “the term ‘substantially non-immunogenic carbohydrate component’ only

requires an assessment of the immunogenicity of the carbohydrate component.” (Id. at 21) (citing

Pharmacosmos A/S v. Luitpold Pharms., Inc., IPR2015-1490, 2017 Pat. App. Lexis 3422, at *4

(PTAB Jan. 4, 2017)). According to Defendants, in that decision, the Board “expressly disagreed

‘with Patent Owner that the claims require an assessment of the immunogenicity of the iron

carbohydrate complex as a whole.’” (Id. at 21-22.) Thus, Defendants urge this Court to disregard

Plaintiffs’ attempt to re-argue this failed position. Finally, Defendants also highlight that Plaintiffs

have prosecuted additional patents in the Helenek Patent Family that include claims requiring

“substantially non-immunogenic iron carbohydrate complex,” and that this Court may consider

these later prosecutions in deciding claim construction here. (Id. at 22.)

At the outset, I address Defendants’ contention that the term is indefinite based on its use

of the word “substantially.” The word “substantially” is not “inherently indefinite.” Elm 3DS

Innovations, LLC v. Samsung Elecs. Co., No. 14-1430, 2020 WL 1850657, at *6 (D. Del. Apr. 13,

2020). “Substantially” can be used “when warranted by the nature of the invention, in order to

accommodate the minor variations that may be appropriate to secure the invention.” Verve, LLC

v. Crane Cams, Inc., 311 F.3d 1116, 1120 (Fed. Cir. 2002). However, when substantially is used

as “a word of degree,” the court has to “determine whether the patent provides some standard for

measuring that degree.” Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir.

2010) (quotation omitted). Otherwise, the patent fails to allow a person skilled in the art to

compare potentially infringing products and determine “whether interference ... is substantial.”

Sonix Tech. Co. v. Publications Int’l, Ltd., 844 F.3d 1370, 1377 (Fed. Cir. 2017) (quoting Enzo,

599 F. 3d at 1336). Here, the specification accomplishes that purpose. The specification identifies

iron dextran as an objective benchmark against which to assess immunogenicity. (See Responsive

Declaration of Dr. Coyne (“Coyne Resp. Decl.”) at ¶¶ 22-27.) The specification teaches that the

focus of the claimed invention is obtaining an iron carbohydrate complex that is less immunogenic

(i.e., results in a lower incidence of anaphylactoid/hypersensitivity reactions) than iron dextran.

Therefore, as explained by Dr. Coyne, a POSA would understand an iron carbohydrate complex

with a “substantially nonimmunogenic carbohydrate component” to be less immunogenic than iron

dextran as assessed by a lower incidence of anaphylactoid/hypersensitivity adverse events. (Coyne

Resp. Decl. at ¶ 25.) Accordingly, I do not find this term to be indefinite on its face. That said,

“[w]hile the court recognizes that a determination of indefiniteness is necessarily intertwined to

some degree with claim construction, it is clear that the court must first attempt to determine what

a claim means before it can determine whether the claim is invalid for indefiniteness.”

Pharmastem Therapeutics, Inc. v. Viacell, Inc., No. 02-148, 2003 WL 124149, at *1 (D. Del. Jan.

13, 2003) (citing ASM America, Inc. v. Genus, Inc., 2002 WL 1892200, *15 (N.D.Cal. Aug. 15,

2002)) (recognizing that claim construction must proceed before an indefiniteness challenge); see

also Intervet America, Inc. v. Kee–Vet Labs., 887 F.2d 1050, 1053 (Fed.Cir.1989). Thus, the

Court’s position at this time does not, however, represent an actual adjudication on Defendants’

indefiniteness defense. Rather, the Court simply finds that the claim is sufficiently definite to

survive claim construction. Defendants may pursue this defense at trial.

Turning to the substance of the term’s construction, it is clear that the parties agree that in

the context of the ’612 and ’702 patents, “substantially nonimmunogenic” requires a “low risk of

anaphylactoid/hypersensitivity reactions,” measured by relative incidence rates of adverse events.

Thus, that portion is not disputed. However, the parties disagree on whether immunogenicity

should be assessed for the entire iron carbohydrate complex (i.e., iron and carbohydrate

components together), as opposed to the carbohydrate component alone.

Here, I find that Plaintiffs’ construction is inconsistent with the intrinsic evidence,

including the Helenek Family Patent claims and specification,7 and therefore, I adopt Defendants’

construction. GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1317 (Fed. Cir. 2014)

(refusing to “import[] an extraneous adjectival modifier into the claim, which, in effect,

impermissibly rewrites the patent’s claims”); see also Nike Inc. v. Wolverine World Wide, Inc., 43

F.3d 644, 647 (Fed. Cir. 1994) (rejecting patentee’s proposed claim construction that would, “in

7 The ’612 and ’702 patents share a common specification. For simplicity and consistency,

all citations to the specification refer to the ’702 patent, attached to the Weingarten Decl. as Exhibit

2.

effect, rewrite its patent claims to suit its needs in this litigation”). In that regard, I agree with the

findings of the PTAB in Pharmacosmos A/S v. Luitpold Pharms., Inc., IPR2015-1490, 2017 Pat.

App. Lexis 3422, at *4 (PTAB Jan. 4, 2017). There, the PTAB construed the same claim term in

the ’702 patent, and it rejected the identical construction proposed by Plaintiffs in this case. To be

clear, the PTAB agreed with the petitioner that “the language of the term “substantially non-

immunogenic carbohydrate component” itself only requires an assessment of the immunogenicity

of the carbohydrate component,” and disagreed with the patent owner that “the claims require an

assessment of the immunogenicity of the iron carbohydrate complex as a whole.” Id. (emphasis

added.) In adopting the construction proposed by Defendants, here, the PTAB reasoned that the

specification of the ’702 patent also supports a finding that the term “substantially non-

immunogenic carbohydrate component” is limited to the carbohydrate component as opposed to

the iron carbohydrate complex as a whole. Id. Specifically, the specification teaches that

“previously available iron dextran products suffered from a ‘high incidence of anaphylactoid

reactions ... believed to be caused by the formation of antibodies to the dextran moiety,’” while

“‘[o]ther parenteral iron products (e.g., iron sucrose and iron gluconate) do not contain the dextran

moiety, and the incidence of anaphylaxis with these products is markedly lower.’” Id. (citing

Weingarten Decl., Ex. 2, ’702 Patent at 1:53–57 and 11:3–4) (“non-immunogenic carbohydrate

component; no cross reactivity with anti-dextran antibodies”). Moreover, the PTAB emphasized

that “the language of independent claim 1 itself does not require a non-immunogenic complex, but

only specifies that the ‘iron carbohydrate complex has a substantially non-immunogenic

carbohydrate component.’” Id.

Accordingly, consistent with the findings of the PTAB, I find that the plain language of the

claims, as supported by the specification, unambiguously requires that only the carbohydrate

component of the iron-carbohydrate complex must be substantially nonimmunogenic. Therefore,

there is no need to rewrite the claim language as requested by Plaintiffs. The Court need not

consider extrinsic evidence and construes this term in accordance with Defendants’ proposed

construction: “the iron carbohydrate complex has a carbohydrate component resulting in a low risk

of anaphylactoid/hypersensitivity reactions, wherein a low risk is an incidence of adverse events

associated with the iron carbohydrate complex lower than iron dextran.”

2. “the iron carbohydrate complex has […] substantially no cross reactivity with

antidextran antibodies”

Next, the parties dispute the meaning of “the iron carbohydrate complex has […]

substantially no cross reactivity with antidextran antibodies” found within dependent Claims 4-6,

17-19, 21-22, 24, 31-38, 44-47, 53-54 of the ’702 patent and dependent Claim 2 of the ’612 patent.

Plaintiffs’ proposed construction is “the iron carbohydrate complex … does not exhibit a

substantial antibody/antigen immune response with antidextran antibodies in a clinical setting.”

Plaintiffs contend that this construction is supported by the claims, the specification of the ’612

and ’702 patents, the state of the art, and the prosecution history. (Pl. Opening Br. at 27.) As

discussed above, Plaintiffs argue that a POSA would understand these claim limitations from the

clinical perspective. (Id.) Therefore, Plaintiffs emphasize that a POSA reading the claims would

understand that an iron carbohydrate complex that has “substantially no cross reactivity with anti-

dextran antibodies” means that the iron complex will not induce a clinically relevant

antibody/antigen immune response in the patient. (Id.) (emphasis added.) Plaintiffs further argue

that “cross reactivity” was defined during prosecution, and therefore, Plaintiffs’ construction is

supported by the prosecution history. (Id. at 28-29.)

Defendants assert that the proper construction of this term is indefinite under 35 U.S.C. §

112, because a POSA would not understand what it means for there to be “substantially” no cross-

reactivity. (Def. Opening Br. at 22-25.) Similar to its argument above regarding “non-

immunogenic,” Defendants argue that a substance either has cross-reactivity or it does not. (Id.)

Defendants posit that the term “cross reactivity” has an established meaning in the art, i.e.,

“[r]eaction of antisera or sensitized cells with different antigens due to some shared antigenic

determinants or shared structures within the determinant,” and that the use of that term in the

Helenek Patents’ specification is consistent with the term’s ordinary meaning. (Id. at 23.)

Defendants contend, however, that “substantially no cross-reactivity” has no established meaning

in the art, nor is it defined by the specification. (Id. at 23-24) (emphasis added.) Put simply,

Defendants argue that a POSA understands that antibodies either cross-react with antigens or they

do not cross-react at all. (Id. at 23.) Moreover, Defendants argue that to the extent a construction

may be possible, it must be construed as not limited to requiring cross reactivity with anti-dextran

antibodies in a clinical setting. (Id. at 26.) Defendants state that cross reactivity does not require

a clinical, i.e., human, response, and as argued, infra, the term “subject” as used in the Helenek

Patents is not limited to humans. (Id.)

First, I find that this term, on its face, is definite. Again, “substantially,” in this context, is

used to communicate degree, and therefore, the Court’s analysis turns on whether “the patent

provides some standard for measuring that degree.” Enzo Biochem, Inc, 599 F.3d at 1332. In that

regard, I find that it does. As discussed above with respect to “substantially non-immunogenic

carbohydrate component,” Plaintiffs reason that the specification discloses to a POSA an objective

guidepost—immune responses observed with iron dextran. Thus, it appears, for the purposes of

claim construction, that a POSA would understand how to determine whether an iron-carbohydrate

complex exhibited fewer immunologic adverse events than iron dextran, therefore exhibiting

“substantially no cross-reactivity with anti-dextran antibodies.” To reiterate, because the term is

not indefinite on its face, it is capable of construction; however, Defendants’ indefiniteness

argument remains ripe for trial. See Forta Corp. v. Surface-Tech, LLC, No. 13-1608, 2015 WL

3756187, at *2 (W.D. Pa. June 11, 2015) (finding that “[s]ince Nautilus[, Inc. v. Biosig Instr., Inc.,

572 U.S. ––––, 134 S.Ct. 2120, 189 L.Ed.2d 37 (2104)] held that a lesser standard must be met to

show indefiniteness, it stands to reason that a court may construe a claim term and then later

determine that the patent’s ‘claims, read in light of the specification delineating the patent, and the

prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope

of the invention.’”); see also Ansell Healthcare Prod. LLC v. Reckitt Benckiser LLC, No. 15-915,

2017 WL 1021844, at *2 (D. Del. Mar. 16, 2017) (finding that a defendant was “free to renew its

indefiniteness arguments,” specifically those related to a term’s use of the word “substantially,”

later in the case). In addition, I note that besides contesting the term’s definiteness, Defendants do

not appear to take issue with Plaintiffs’ proposed construction other than their inclusion of “clinical

setting” and “immune response,” which the Court addresses below.

Here, I construe the term as: “the iron carbohydrate complex … does not exhibit a

substantial antibody/antigen immune response with antidextran antibodies.” First, upon review of

the intrinsic evidence, I find no support in the claims themselves for Plaintiffs’ position that the

term requires a clinical response. Indeed, the claims do not expressly use the term “clinical” or

“clinically” such that a limitation in this respect would be appropriate. Regardless, even if some

ambiguity existed, the Court finds the teachings of the specifications instructive. In that regard,

the specifications discuss a “dextran antigenicity test” of VIT-45, which is an early name used for

Injectafer®. (See ’702 patent, 13:14-15.) The information in the specifications regarding that

testing appears to be derived from an Investigational New Drug Application (“IND”) submitted to

the FDA in January 2004. (See Gregory Decl., Ex. 29.) The IND states, for example, that “VIT-

45 does not contain dextran and does not cross-react with dextran antibodies,” id. at 623, and that

“[t]here were no specific responses to VIT-45 in a dextran antigenicity text.” Id. at 616. Notably,

the underlying basis for these statements appears to be study VFR043, which is described as

“antibody induction,” see id. at 627, and as explained by Defendants’ expert, Dr. Anthony

DeFranco, this study involved a preclinical method of assessing cross-reactivity, and the cross-

reaction was studied in guinea pigs—not human patients. (See Declaration of Dr. Anthony

DeFranco (“DeFranco Decl.”) at ¶¶ 146-151; Gregory Decl., Ex. 30 at 233.) Thus, the Court is

satisfied that a POSA would understand that this term is not limited to outcomes only in humans,

and cross-reactivity does not require a clinical response.8

While Plaintiffs argue that insertion of the phrase “clinical setting” in the claim

construction is supported by the prosecution history, I disagree. (Pl. Opening Br. at 28-29.)

Plaintiffs submit that during prosecution of the ’549 patent (a patent in the same family as the

Helenek patents but not asserted in this litigation), the Applicant argued, and the Examiner

accepted, an express definition of “cross reactivity” that focuses on clinical immune response.

(Id.) Specifically, Plaintiffs explain that the Examiner initially rejected the claims because, based

on a prior art reference, “one of skill in the art would expect anti-dextran antibodies to cross react

with polyisomaltose.” (Weingarten Decl., Ex. 39 at 4.) The Applicant responded, however, with

the declaration of co-inventor, Richard Lawrence, who clarified:

Based on my experience, cross-reactivity at the time of filing was

understood as a reaction between an antibody and an antigen (that

differs from an immunogen) resulting in an immune response. In

other words, mere binding of an antibody and an antigen was not

8 The Court also notes that as explained below, infra, it does not find that the disputed term

“subject,” as used in the Helenek patents, is limited to humans, and therefore, if the Court were to

adopt Plaintiffs’ construction related to this term, it would be inconsistent with its broad

construction of the “subject” term, as I have defined it.

understood as “cross-reactivity” in the absence of an immune

response.

(See id. at Ex. 37, Lawrence Declaration at 2.) The Applicant then further explained that although

the prior art disclosed binding to anti-dextran antibodies, “the Office . . . failed to establish that

any such binding results in an immune reaction and, as such, the Office . . . failed to show cross-

reactivity.” (Id. at 9-10.) The Examiner subsequently withdrew the rejection following this

information. Therefore, according to Plaintiffs, here, by distinguishing the prior art based on its

definition that “cross reactivity” does not mean binding absent an immune response, the Applicant

demonstrated that, regardless if binding occurs, it is the absence of a clinical immune response that

the claim requires. (Pl. Opening Br. at 29.) However, while I agree that this prosecution history

supports inclusion of the phrase “immune response” in the definition of the disputed term, the

Declaration of Richard Lawrence relied on by Plaintiffs does not provide any clinical limitations

as Plaintiffs advocate. Nowhere in the explanation does the Applicant or the co-inventor suggest

that the immune response had to occur in a clinical setting.

Accordingly, the Court adopts the following construction without the need for extrinsic

evidence: “the iron carbohydrate complex … does not exhibit a substantial antibody/antigen

immune response with antidextran antibodies.”

3. “subject”

Finally, the parties dispute the meaning of “subject” found within dependent Claims 4-6,

17-19, 21-22, 24, 31-38, 44-47, 53-54 of the ’702 patent and Claims 1-5, 10-11, 15-18 of the ’612

patent. Specifically, the parties disagree as to whether this term should be limited to mean humans

or rather if the term should mean mammals.

Plaintiffs’ proposed construction for the term “subject” is “human.” (Pl. Opening Br. at

18, 29.) In support, Plaintiffs argue that their proposed construction is consistent with the patent

itself and the doctrine of claim differentiation, which “presume[s] that different words used in

different claims result in a difference in meaning and scope for each of the claims.” (Id. at 18)

(citing Clearstream Wastewater Sys., Inc. v. Hydro-Action, Inc., 206 F.3d 1440, 1446 (Fed. Cir.

2000); see also TQ Delta, LLC v. 2WIRE, Inc., No. 13-01835, 2017 WL 6435334, at *4, n.2 (D.

Del. Dec. 18, 2017) (“The Federal Circuit has applied the doctrine of claim differentiation both

within a single patent and within a family of patents.”)). Specifically, Plaintiffs highlight that the

shared specification of the Geisser Family Patents states that the claimed complexes can serve as

medicaments to be “used in human or veterinary medicine.” (Id. at 19) (citing Weingarten Decl.,

Ex. 4 at 4:61-62; Weingarten Decl., Ex. 5 at 4:57-58.) As such, the specification provides support

for administration in all “animals,” which is recited in the claim of the ’505 patent. (Id. at 19)

(citing Weingarten Decl., Ex. 4 at Claims 5, 6, 9, 23, 27.) But the specification also describes

advantages of the claimed iron carbohydrate complexes compared to other complexes used as

human medicaments. For example, the specification explains that the present invention is

advantageous over prior complexes. Therefore, Plaintiffs argue that applying the doctrine of claim

differentiation, the use of “animal” in the ’505 patent claims must have a different scope from that

of “subject” used in the claims of the ’252 patent. (Id.) (Compare Weingarten Decl., Ex. 4 at

Claims 5, 6, 9, 23, 27, with Weingarten Decl., Ex. 5 at Claim 18.) Put simply by Plaintiffs,

“animal” is broad enough to correspond with the specification’s disclosure of medicaments used

in “human or veterinary medicine,” while the term “subject” narrows that definition to only mean

“human.” (Id. at 19.) Moreover, narrowing “human or veterinary medicine” to only “human” is

appropriate because the specification emphasizes administration to humans, not animals. (Id.)

Defendants assert that the proper construction of this term is “Mammal to whom the

carbohydrate complex is administered.” (Def. Opening Br. at 27.) In support, Defendants argue

that a POSA would understand the term “subject” in the context of the claims and intrinsic record

of both the Geisser Family Patents and the Helenek Family Patents to refer to mammals generally,

and not just “humans.” (Id.) According to Defendants, while Plaintiffs may isolate certain portions

of the specification that use “subject” in the context of human clinical trials, the specifications also

differentiate between “human subjects” and “non-human mammals.” (Id. at 28-29.)

I construe “subject” to match Defendants’ construction: “Mammal to whom the

carbohydrate complex is administered.” As a preliminary matter, while Plaintiffs have advised

that the Court need not construe the “subject” term in connection with the ’252 patent, the Court

may nonetheless reference that term’s use in the ’252 patent to the extent it assists construction of

the Helenek Family Patents. That said, the Court also acknowledges Plaintiffs’ concern regarding

this term; that is the Geisser Family Patents and the Helenek Family Patents are two separate patent

families, with different inventors, different priority dates, and different POSAs.

Here, the intrinsic evidence cited by Defendants, including the claim language and the

specification language, reveals that the term “subject” should not be limited to only humans. In

that regard, the Court is not persuaded by Plaintiffs’ argument that the term “subject” must be

construed to mean “human” simply because the patents, specifically the Helenek Family Patents,

are clinical patents. As explained by Defendants, the term “subject” is common to both the

Helenek Family’s ’612 and ’702 patents and the Geisser Family’s ’252 patent. With respect to the

’252 patent, dependent Claim 18 is directed to “[a] method for treating an iron deficiency condition

comprising the step of administering to a subject in need thereof a pharmaceutically effective

amount of the medicament of [a prior claim].” Although “subject” does not appear in the

specification of the ’252 patent, the specification does unambiguously state that the “medicaments”

containing the disclosed carbohydrate complexes “can be used in human and veterinary medicine.”

Because claim interpretations that are contrary to the usage in the specification are erroneous, Wi-

Fi One, LLC v. Broadcom Corp., 887 F.3d 1329, 1346 (Fed. Cir. 2018), cert. denied, 139 S. Ct.

826 (2019), I find that the “medicament” of Claim 18 must be construed consistent with

Defendants’ position—as one that can be used in human or veterinary medicine. As such,

Plaintiffs’ attempt to limit the term “subject” to only humans is not supported by the intrinsic

evidence.

Similarly, as it pertains to the Helenek Family Patents, Claim 1 of the ’612 and ’702 patents

states:

A method of treating a disease, disorder, or condition characterized

by iron deficiency or dysfunctional iron metabolism resulting in

reduced bioavailability of dietary iron, comprising administering to

a subject in need thereof an iron carbohydrate complex . . . .

The Court agrees with Defendants that this claim language may be directly attributed to the

following passage of the specification:

methods of treating a disease, disorder, or condition characterized

by iron deficiency or dysfunctional iron metabolism through the

administration of at least 0.6 grams of elemental iron via a single

unit dosage of an iron carbohydrate complex to a subject that is in

need of such therapy.

(See ’702 patent, 2:32-37; ’612 patent, 2:37-43.) That same specification goes on to state that the

invention applies to the treatment of a “state, disease, disorder, or condition” by preventing or

delaying the appearance of clinical symptoms “in a mammal[.]” Accordingly, like the ’612 and

’702 patents, I find that a POSA would understand the term “subject” to mean something broader

than just humans, i.e., “mammals.”

In addition, recent prosecution activity in related patent applications supports Defendants’

construction. Actelion Pharm., Ltd. v. Sun Pharm. Indus., No. 17-5015, 2019 WL 653149, at *6

(D.N.J. Feb. 15, 2019) (“[S]tatements made by the inventor during continued prosecution of a

related patent application can, in some circumstances, be relevant to claim construction.”). For

example, the recently filed patent application in U.S. Patent Application No. 16/825,337, which is

related to the ’612 patent, includes the phrase “adult human subject.” Clearly, the decision to

incorporate “human” in the application signals the potential for non-human subjects. As

Defendants correctly articulate, if “subject” was limited to mean “human,” as Plaintiffs claim here,

Plaintiffs would have stated “adult subject” instead of “adult human subject” in the later

applications. (Def. Opening Br. at 29.) Thus, adopting Plaintiffs’ proposed construction would

make the use of “human” in the phrase “adult human subject” redundant—i.e., “adult human

human.” See Pfizer Inc. v. Teva Pharm. USA, Inc., 855 F. Supp. 2d 286, 298 (D.N.J. 2012)

(rejecting proposed construction because it “would thus render portions of the patents

superfluous”).

Because the construction is sufficiently clear based on the intrinsic evidence, I need not

consider extrinsic evidence. See Vitronics, 90 F.3d at 1584. Accordingly, I construe the term

“subject” to mean “mammal to whom the carbohydrate complex is administered.”

IV. CONCLUSION

In light of the foregoing reasons, the Court construes the disputed claim terms as

represented in the chart below:

Disputed Term Construction

“maltodextrin” “a mixture of saccharides of variable length composed of

chains of D-glucose units connected primarily by α-(1→4)

glycosidic bonds”

“one maltodextrin” / one/each “maltodextrin,” as that term is defined by this

“each individual Opinion, i.e., one mixture of saccharides of variable length

maltodextrin” composed of chains of D-glucose units connected primarily by

α-(1→4) glycosidic bonds

“the iron carbohydrate “a carbohydrate component resulting in a low risk of

complex has a anaphylactoid/ hypersensitivity reactions, wherein a low risk is

substantially non- an incidence of adverse events lower than dextran”

immunogenic

carbohydrate

component”

“the iron carbohydrate “the iron carbohydrate complex … does not exhibit a

complex has […] substantial antibody/antigen immune response with

substantially no cross antidextran antibodies”

reactivity with

antidextran antibodies”

“subject” “Mammal to whom the carbohydrate complex is administered”

Dated: June 28, 2021 /s/ Freda L. Wolfson

Freda L. Wolfson

U.S. Chief District Judge