Opinion

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

THERAPEUTICSMD, INC. and MAYNE

PHARMA LLC.,

Plaintiffs, Case No. 2:20-cv-03485 (BRM) (SDA)

(consolidated)

v.

OPINION

TEVA PHARMACEUTICALS USA,

INC.,

Defendant.

MARTINOTTI, DISTRICT JUDGE

Before this Court are competing applications by Plaintiffs TherapeuticsMD Inc. and Mayne

Pharma LLC (collectively, “TherapeuticsMD”) and Defendant Teva Pharmaceuticals USA, Inc.

(“Teva”), to resolve disputes over several claim terms in U.S. Patent Nos. 9,180,091 (“the ’091

patent”), 9,289,382 (“the ’382 patent”), 10,258,630 (“the ’630 patent”), 10,398,708 (“the ’708

patent”), 10,471,072 (“the ’072 patent”), 10,537,581 (“the ’581 patent”), 10,568,891 (“the ’891

patent”), 10,668, 082 (“the ’082 patent”), 10,806,697 (“the ’697 patent”), 10,835,487 (“the ’487

patent”); 10,888,516 (“the ’516 patent”); 11,065,197 (“the ’197 patent”); 11,116,717 (“the ’717

patent”); 11,123,283 (“the ’283 patent”); 11,241,445 (“the ’445 patent”); 11,246,875 (“the ’875

patent”); 11,266,661 (“the ’661 patent”); 11,304,959 (“the ’959 patent”); 11,351,182 (“the ’182

patent”); and 11,497,709 (“the ’709 patent”) (collectively, the “patents in suit”). (ECF Nos. 84,

85.)1 Both TherapeuticsMD and Teva request the Court to find the proper construction of the

following terms:

1) Does Not Include a Hydrophilic Gel-Forming Bioadhesive Agent

2) Does Not Include an amount of a Hydrophilic Gel-Forming Bioadhesive Agent

that Increases the Viscosity Above About 1000 cP at 25º C

3) The “Mean Area Under the Curve (AUC)0-24 of 17β-estradiol of about [X]

pg*hr/ml to about [Y] pg*hr/ml”

4) Corrected Geometric Mean

(Teva’s Op. Br. (ECF No. 84) at 4–5; TherapeuticsMD’s Op. Br. (ECF No. 85) at vii–x.)

The parties each submitted a brief in response to the other’s opening arguments.

(TherapeuticsMD’s First Res. Br. (ECF No. 103); Teva First Res. Br. (ECF No. 104).) The parties

then submitted additional opening briefing to the court requesting two additional terms be

construed:

5) Solvent System

6) Shape of a Tear Drop

(Teva’s Second Op. Br. (ECF No. 179) at 4 & 9; TherapeuticsMD’s Second Op. Br. (ECF No.

180) at 4 & 11.) The Court conducted a Markman hearing on October 5, 2025, where the parties

presented arguments pertaining each of the disputed terms. (Markman Hearing Tr. (ECF No. 206).)

At the close of the hearing, the parties mutually requested leave to file supplemental briefing in

light of the hearing, which the Court granted. (Id. at 76:2–21). The parties timely submitted

supplemental briefing on October 27, 2025, which the Court has considered. (TherapeuticsMD’s

Supp. Br. (ECF No. 208); Teva’s Supp. Br. (ECF No. 207).) For the reasons set forth below in this

Opinion, this Court defines the six disputed terms as follows: (1) “Does Not Include a Hydrophilic

1 Unless otherwise stated, ECF numbers refer to Case No. 2:20-cv-03485.

Gel-Forming Bioadhesive Agent” shall mean “does not include an agent that is hydrophilic,

functions to form a gel, and functions as a bioadhesive;” (2) “Does Not Include an amount of a

Hydrophilic Gel-Forming Bioadhesive Agent that Increases the Viscosity Above About 1000 cP

at 25º C” shall be interpreted to share the same definition as “does not include an agent that is

hydrophilic, functions to form a gel, and functions as a bioadhesive;” (3) the “Mean Area Under

the Curve (AUC)0-24 of 17β-estradiol of about [X] pg*hr/ml to about [Y] pg*hr/ml” shall mean

“corrected geometric mean Area Under the Curve (AUC)0-24 of 17β-estradiol of about [X]

pg*hr/ml to about [Y] pg*hr/ml,” (4) “Corrected Geometric Mean” shall carry its plain and

ordinary meaning, without constraint to a single patient; (5) “Solvent System” means a

“composition of non-toxic, pharmaceutically acceptable solvents, co-solvents, and surfactants

suitable for vaginal delivery or absorption;” and (6) “Shape of a Tear Drop” shall carry its plain

and ordinary meaning, of a shape with a globular form, tapering toward the other end.

I. BACKGROUND

A. Factual Background

TherapeuticsMD is a pharmaceutical company, and the owner of a brand-name vaginal

suppository estradiol supplement named Imvexxy®. (ECF No. 85 at 3). Imvexxy® is used to treat

vulvovaginal atrophy (“VVA”), a condition characterized by dryness, itching, soreness, irritation,

bleeding, and painful sexual activity and is most commonly experienced by post-menopausal

people. (Id. at 2.) VVA is commonly treated by use of topical estrogen-based therapies in the form

of gels, creams, or vaginally-inserted tablets. (Id.) Yet, according to TherapeuticsMD, these

common treatments “suffered from a number of drawbacks,” for instance “gels and creams may

rub, wear or wash off before the estrogen is fully absorbed” and “[t]ablet inserts may not fully

dissolve and lead to unpleasant vaginal discharge.” Id.

Responding to these drawbacks, prior art included “capsule formations” which relied on

“hydrophilic gel-forming bioadhesive agent[s]” to apply the proper dose of hormones. These

agents required “sufficient water/moisture to function properly,” which is not always possible for

women experiencing VAA, because “patients often suffer from vaginal dryness.” (Id.)

TherapeuticsMD contends that Imvexxy® does not rely on these agents and therefore

represents a step forward in the treatment of VVA, because it “overcame the drawbacks of existing

VVA treatments,” and “safely and effectively delivers low doses of estradiol . . . with an improved

pharmacokinetic profile and greater patient compliance.” (Id. at 3.) Under 21 U.S.C. § 355, the

Hatch-Waxman Act, manufacturers are required to inform the FDA by listing in their Orange Book

any patents covering the product, so generic companies can assess whether to challenge

infringement and/or validity of the patents. See 21 U.S.C. § 355(b)(1)(A). TherapeuticsMD

properly registered Imvexxy® with the FDA as covered by twenty (20) patents, which

TherapeuticsMD now seeks to enforce against Teva. (Second Joint Claim Construction Statement

(ECF No. 176) at 1–2.)

Teva is a leading manufacturer of generic drugs. (Compl. (ECF No. 1) ¶ 6; Teva’s Answer

to Complaint (ECF No. 10) ¶ 6.). The Hatch-Waxman requires brand-name manufacturers to list

all patents which cover their products and also requires generic manufacturers insure their products

do not infringe the valid patents of the brand-name manufacturer. F.T.C. v. AbbVie, Inc., 976 F.3d

327, 339 (3d Cir. 2020). Here, Teva filed an abbreviated new drug application, ANDA No. 214137,

on February 18, 2020, which certified its new generic product—despite being therapeutically

similar to Imvexxy®—would not infringe any of the Imvexxy® Patents. (ECF No. 1 ¶ 17; ECF No.

10 ¶ 17.) At the same time, Teva sent a notice letter to TherapeuticsMD, providing notice Teva

was seeking approval of a similar “Estradiol Vaginal Insert . . . before the expiration of the

[Imvexxy® Patents]” on the basis the patents “are invalid, unenforceable, and/or will not be

infringed by . . . Defendants’ ANDA Product.” (Id. ¶¶ 17 & 30.) Under Hatch-Waxman, the filing

of ANDA 214137 is, itself, an act of infringement and TherapeuticsMD timely filed suit requesting

declaratory judgment that “the commercial manufacture, use, offering to sell, or sale within the

United States, and/or importation into the United States, of Teva’s ANDA Product before the

expiration of the [Imvexxy® Patents] would directly and/or indirectly infringe the [patents],”

alongside other forms of relief. (ECF No. 1 ¶¶ A–KK.)

Pursuant to this ongoing litigation, the parties request the Court to construe a series of claim

terms alleged to cover the patents-in-suit. First, pharmaceuticals contain inactive ingredients or

“excipients,” which do not directly treat a given condition but may assist with administration,

uptake, duration, or otherwise benefit the patient, healthcare provider, or manufacturer in some

way. (ECF No. 84 at 2; ECF No. 85 at 8.) The parties contest the meaning of a series of claim

terms governing the meaning of two categories of excipients: “hydrophilic gel-forming

bioadhesive agent[s],” which the patents expressly exclude; and the “solvent system,” which

would solubilize formulation. TherapeuticsMD contends a “hydrophilic gel-forming bioadhesive

agent,” is a functional term—the patent disclaims the presence of an excipient “that actually

functions to form a gel and actually functions as a bioadhesive in the context of the formulation.”

(ECF No. 85 at 8.) Teva disagrees and contends the phrase “hydrophilic gel-forming bioadhesive

agent” refers to a specific set of compounds present in a prior art reference, which the current

patents exclude—and therefore a formulation containing any amount of those compounds falls

outside the scope of the claims. (ECF No. 84 at 9.) As for the “solvent system,” the question is

substantively similar—whether the term “solvent system” is a functional claim. Teva argues this

is a functional claim so the system is a composition “that performs the function of solubilizing the

active ingredient—here, estradiol.” (ECF No. 179 at 10.) Whereas, TherapeuticsMD argues this is

a structural claim that includes “other excipients,” not just the solvents. (ECF No. 180 at 4.)

Second, the parties dispute claim terms governing how the target level of estradiol in

patients should be measured. (ECF No. 84 at 25; ECF No. 85 at 20.) Here, there are a number of

claims referring to the “mean area under the curve” measured after the administration of the

estradiol tablet insert. (ECF No. 84 at 27; ECF No. 85 at 25.) The parties dispute whether “mean”

should be interpreted to carry its plain and ordinary meaning, also known as the “arithmetic mean,”

(ECF No. 84 at 27) or if “mean” instead refers to the “corrected geometric mean.” (ECF No. 85 at

25.) Although other claims expressly refer to the “corrected geometric mean,” Teva argues “mean”

should refer to the corrected geometric mean, which is “calculated based on a single administration

to a single patient.” (ECF No. 84 at 25.)

Finally, the parties dispute the form-factor of the treatment. (ECF No. 179 at 2; ECF No.

180 at 11.) Though the parties agree the U.S. Patent Nos. 10,888,516; 11,065,197; 11,116,717;

and 11,123,283 claim the “shape of a teardrop,” which the parties agree includes a “globular form”

which “taper[s] towards the other end,” Teva contends a teardrop must “taper[] to a point,” whereas

TherapeuticsMD believes that the claims encompass a rounded end, so long as the shape is tapered.

Id.

B. Procedural Background

On April 1, 2020, TherapeuticsMD filed the first of several complaints against Teva,

alleging Teva, in filing ANDA 214137 before the expiration of the Imvexxy® Patents, infringed

five patents under Hatch-Waxman. (ECF No. 1 ¶ 19). Teva answered the complaint on June 15,

2020, and asserted its own counterclaims—seeking a declaration of invalidity on each asserted

patent. (ECF No. 10 ¶¶ 30–92.) Three months later, TherapeuticsMD filed the second action

against Teva, alleging ANDA 214137 infringed two additional patents. TherapeuticsMD, Inc. v.

Teva Pharms. USA, Inc., Civ. A. No. 20-8809 (D.N.J. Aug. 14, 2020). (Civ. A. No. 20-08809,

ECF No. 1 ¶ 1.)

As more of TherapeuticMD’s patents allegedly covering Imvexxy® were granted,

TherapeuticsMD returned to the court and brought five additional actions against Teva for

violation of same. On August 21, 2020, TherapeuticMD filed the third action alleging infringement

of the ’082 Patent. (Civ. A. No. 20-11087, ECF No. 1 ¶ 1.) In November 2020, Therapeutics

brought an action for infringement of the ’697 and ’487. (Civ. A. No. 20-17496, ECF No. 1 ¶ 1.)

In June 2021, TherapueticsMD brought its next complaint, alleging infringement of U.S. Patent

No. 10,888,516. (Civ. A. No. 21-12794, ECF No. 1 ¶ 1.) In 2024, three years later,

TherapeuticsMD brought the last two complaints alleging the full suite of patents currently at issue.

(Civ. A. No. 24-07974, ECF No. 1 ¶ 1); TherapeuticsMD’s Seventh Action Complaint (Civ. A.

No. 24-11161, ECF No. 1 ¶ 1.)

In response to the six additional complaints, Teva put forward substantially similar

answers, alongside counterclaims, requesting a determination that every patent-in-suit be found

invalid. (See, e.g., Civ. A. No. 20-8809, ECF No. 12; Civ. A. No. 20-11087, ECF No. 11; Civ. A.

No. 20-17496 ECF No. 14; Civ. A. No. 24-7974, ECF No. 11.)

After all the applicable patents were granted, the parties jointly moved to consolidate the

seven actions, which the Court granted. (Orders Consolidating Cases (ECF Nos. 33, 43, 51, 149).)

After the actions were consolidated, TherapeuticsMD answered Teva’s counterclaims from the

consolidated suits. (ECF Nos. 52, 56, 152, 153, 158, 159.)

Recently in TherapeuticsMD, Inc., et al. v. Sun Pharmaceutical Industries Ltd., et al., Civ.

A. No. 24-cv-7974 (D.N.J. 2024), TherapeuticsMD moved to consolidate the action against Sun

Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, “Sun”) into

this consolidated action. (Civ. A. No. 24-07974, ECF No. 67 at 1.) TherapeuticsMD accuses Sun

of infringing the same patents through Sun’s own ANDA. (TherapeuticsMD’s Complaint against

Sun (Civ. A. No. 24-07974, ECF No. 1) ¶ 19.) Sun consented to consolidation (Civ. A. No. 24-

07974, ECF No. 70) and adopted Teva’s constructions. (Sun Markman Br. (Civ. A. No. 24-07974,

ECF No. 51) at 1.) Therefore, Sun will be equally bound by the Court’s decision in this Markman

opinion. (Id.)

The parties filed Markman briefs before the court, alongside a joint Markman statement,

clarifying which terms at issue were most important, and laying out the parties’ competing

interpretations. (First Joint Claim Construction Statement (ECF No. 79); ECF Nos. 84, 85.) The

parties each set forth timely response briefs in June 2021 in preparation for a Markman hearing.

(See ECF Nos. 103, 104.) However, before a Markman hearing could be taken, the parties jointly

moved to stay the case on July 26, 2021. (Order Granting a stay of Consolidated Actions (ECF

No. 119).)

Last year, the parties agreed to lift the stay and resume litigation. (ECF No. 139.) However,

in that time, claim terms from newly granted patents came into controversy. (Second Joint Claim

Construction Statement (ECF No. 176) at 5–6.) The parties again put forward Markman briefs,

each arguing for its respective interpretation of the new claim terms. (ECF Nos. 179, 180.) After

the parties filed their respective response briefs (ECF Nos. 185, 186), the Court held a Markman

hearing on October 5, 2025, to consider the parties’ arguments in full. (ECF No. 206.)2 At the

close of the hearing, the Court granted leave for the parties to file supplemental briefing of up to

2 At the Markman hearing, the parties each provided the Court explanatory PowerPoint

presentations, which it considered along with the briefing. (ECF No. 206 at 4.)

five pages. (Id. at 76:2–21). The parties timely submitted supplemental briefing on October 27,

2025. (ECF Nos. 207, 208.)

II. LEGAL STANDARD

Claims define the scope of the inventor’s right to exclude. Phillips v. AWH Corp., 415 F.3d

1303, 1312 (Fed. Cir. 2005). Claim construction determines the correct claim scope and is a

determination exclusively for the court as a matter of law. Markman v. Westview Instruments, Inc.,

52 F.3d 967, 978–79 (Fed. Cir. 1995) (en banc). Indeed, the court can only interpret claims, and

“can neither broaden nor narrow claims to give the patentee something different than what it has

set forth” in the specification. E.I. Du Pont de Nemours v. Phillips Petroleum Co., 849 F.2d 1430,

1433 (Fed. Cir. 1998). A court’s determination “of patent infringement requires a two-step process:

first, the court determines the meaning of the disputed claim terms, then the accused device is

compared to the claims as construed to determine infringement.” Acumed LLC v. Stryker Corp.,

483 F.3d 800, 804 (Fed. Cir. 2007).

This interpretive analysis begins with the language of the claims, which is to be read and

understood as it would be by a person of ordinary skill in the art (“POSA”). Dow Chem. Co. v.

Sumitomo Chem Co., 257 F.3d 1364, 1372 (Fed. Cir. 2001); see also Markman, 52 F.3d at 986

(“The focus [in construing disputed terms in claim language] is on the objective test of what one

of ordinary skill in the art at the time of invention would have understood the term[s] to mean.”);

Phillips, 415 F.3d at 1312–13. In construing the claims, 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 and testimony. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d

1298, 1309 (Fed. Cir. 1999).

The analysis of claim language begins with determining the “ordinary and customary

meaning of a claim term[, which] is the meaning that the term would have to a person of ordinary

skill in the art in question at the time of the invention, i.e., as of the effective filing date of the

patent application.” Phillips, 415 F.3d at 1313. Further, the language should not be read solely in

the context of the claim under review; instead, it should be analyzed “in the context of the entire

patent” and with an understanding of how that language is used in the field from which the patent

comes. Id. In conducting this review, a different interpretation is placed on a term located in an

independent claim than on those located in dependent claims, and it is understood that each claim

covers different subject matter. Saunders Grp., Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1331 (Fed.

Cir. 2007) (quoting Phillips, 415 F.3d at 1315 (holding that the “presence of a dependent claim

that adds a particular limitation gives rise to a presumption that the limitation in question is not

present in the independent claim”)).

To review the language in this manner, “the court starts the decisionmaking process by

reviewing the same resources as would [a person or ordinary skill in the art in question], viz., the

patent specifications and the prosecution history.” Phillips, 415 F.3d at 1313 (quoting Multiform

Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)). When “the ordinary

meaning of claim language as understood by a person of skill in the art [is] readily apparent,”

understanding claim construction “involves little more than the application of the widely accepted

meaning of commonly understood words.” Phillips, 415 F.3d at 1314. “In such circumstances,

general purpose dictionaries may be helpful” to explain the terms used. Id.

However, when the ordinary meaning of a term is not apparent, courts look to “those

sources available to the public that show what a person of skill in the art would have understood

disputed claim language to mean.” Id. Those sources may include “the words of the claims

themselves, the remainder of the specification, the prosecution history, and extrinsic evidence

concerning relevant scientific principles, the meaning of technical terms, and the state of the art.”

Id. Furthermore, claims must be read in view of the claim specification, which is of seminal

importance in providing framework for understanding the claim language. As the Federal Circuit

in Markman explained:

The specification contains a written description of the invention that

must enable one of ordinary skill in the art to make and use the

invention. For claim construction purposes, the description may act

as a sort of dictionary, which explains the invention and may define

terms used in the claims. As we have often stated, a patentee is free

to use his [or her] own lexicographer. The caveat is that any special

definition given to a word must be clearly defined in the

specification. The written description part of the specification itself

does not delimit the right to exclude. That is the function and the

purpose of the claims.

Markman v. Westview Instruments, 52 F.3d 967, 979–80 (Fed. Cir. 1995) (en banc), aff’d,

Markman, 517 U.S. 370.

This Court’s reliance on the specification is appropriate given the Patent and Trademark

Office’s rules, which require:

application claims must ‘conform to the invention as set forth in the

remainder of the specification and the terms and phrases used in the

claims must find clear support or antecedent bases in the description

so that the meaning of the terms in the claims may be ascertainable

by reference to the description

Phillips, 415 F.3d at 1316–17 (quoting 37 C.F.R. § 1.75(d)(1)). During this analysis, however,

courts should not “import limitations from the specifications into the claims.” Innogenetics, N.V.

v. Abbott Labs., 512 F.3d 1363, 1370 (Fed. Cir. 2008) (quoting CollegeNet, Inc. v. ApplyYourself,

Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005)).

The patent’s prosecution history is also of “primary significance in understanding the

claims.” Markman, 52 F.3d at 980. “The prosecution history can often inform the meaning of the

claim language by demonstrating how the inventor understood the invention and whether the

inventor limited the invention in the course of prosecution, making the claim scope narrower than

it would otherwise be.” Phillips, 415 F.3d at 1317. The prosecution history is also relevant to

determining whether the patentee disclaimed or disavowed the subject matter, thereby narrowing

the scope of the claim terms. Seachange Int’l, Inc. v. C-Cor Inc., 413 F.3d 1361, 1372–73 (Fed.

Cir. 2005).

In addition to intrinsic evidence, a court may also rely on extrinsic evidence in interpreting

a claim. Phillips, 415 F.3d at 1317. Extrinsic evidence consists of “all evidence external to the

patent and prosecution history, including expert and inventor testimony, dictionaries, and learned

treatises.” Id. (internal quotation marks omitted). 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.” Id. Extrinsic evidence should be “considered in the

context of the intrinsic evidence,” as there are flaws inhering in the exclusive reliance on extrinsic

evidence, including, inter alia, biases, inadvertent alterations of meanings, and erroneous

contextual translations. Id. at 1318–19. Furthermore, extrinsic evidence should not be relied upon

where “an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim

term.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996).

III. DECISION

A. Does Not Include a Hydrophilic Gel-Forming Bioadhesive Agent

The primary dispute between the parties is whether the terms “hydrophilic gel-forming

bioadhesive agent” and “does not include a hydrophilic gel-forming bioadhesive agent” refer to a

purely structural limitation, or if it encompasses both structural and functional elements. The

claims at issue appear in the ’091, ’581, ’891, and ’697 patents. Teva suggests these limitations

are wholly structural and excludes formulations which contain any amount of an ingredient known

to have these properties. (Teva’s Op. Claim Construction Br. (ECF No. 84) at 6–7.)

TherapeuticsMD contends that the term “agent” connotes a functional limitation, because even if

an ingredient “possesses abstract or potential gel-forming and bio-adhesive properties” it is not an

“agent” if present only in minute quantities or otherwise does not actually function as a gel-forming

or bioadhesive agent “in the context of the formulation.” (TherapeuticsMD’s Op. Claim

Construction Br. (ECF No. 85) at 18–19.)

Before determining the meaning of the claim term, the court must decide whether the terms

are to be construed together, or—as TherapeuticsMD suggests—there should be a separate, albeit

similar, construction for each of the four patents. In theory, this would account for the different

delivery vehicles claimed, such as a vaginal suppository, pessary, or liquid vaginal composition.

(Id. at 17.) Despite this request, TherapeuticsMD “agree[s] that the term should be construed

consistently across all of the asserted patents.” (Id. At 16.) Given that this is a limiting claim, and

there is no indication the absence of a hydrophilic gel-forming bioadhesive agent has a different

effect on different delivery vehicles, there is no additional clarity provided by multiple

constructions. The Court will therefore construe all instances of “hydrophilic gel-forming

bioadhesive agent” or “does not include a hydrophilic gel-forming bioadhesive agent” together.

The parties have agreed to use claim 1 of the U.S. Patent No. 9,180,091 as an example for

construction. It reads:

1. A vaginal suppository comprising:

a. a therapeutically effective amount of estradiol; and

b. a solubilizing agent, wherein the solubilizing agent comprises at least

one C6-C12 fatty acid or a glycol, monoglyceride, diglyceride, or

triglyceride ester thereof;

wherein the vaginal suppository comprises from about 1 micrograms to

about 25 micrograms of estradiol;

wherein estradiol is the only active hormone in the vaginal suppository;

and

wherein the vaginal suppository does not include a hydrophilic gel-

forming bioadhesive agent in the solubilizing agent

(See ECF No. 85 at 3; see also ECF No. 84 at 6–7); ’091 Patent col. 14 ll. 53–65.

Teva contends the plain and ordinary meaning of “does not include” is that certain

substances are entirely absent, namely a series of excipients listed in the specification. (ECF No.

84 at 7.) Despite claim language specifically excluding this category of excipients, formulations

which do contain hydrophilic gel-forming, bioadhesive excipients would be found to infringe if

the Court were to apply a functional reading. To provide an alternative, Teva cites to the

specification of the ’091 patent and the prosecution histories of all patents at issue. (Teva Op. Br.

Exs. 5, 6, & 7 (ECF No. 84-6 at 7, 78, and 181).)

Specifically, Teva cites to the ’091 specification, reciting “carboxyvinylic acid,

hydroxypropylcellulose; carboxymethyl cellulose; gelatin; xanthane gum [sic]; guar gum;

aluminum silicate; or mixtures thereof,” as a list of exemplary agents which are not included in

the formulation. ’091 patent col. 5 ll. 1–5. This list appears across multiple patents and, as Teva

points out, is “the only discussion in the specification about what constitutes a hydrophilic gel-

forming bioadhesive agent in the context of the claimed invention,” and is therefore highly

instructive of the identity of the excipients TherapeuticsMD sought to exclude. (Teva’s Res. Claim

Construction Br. (ECF No. 104) at 12.)

TherapeuticsMD’s argument to the contrary is relatively straightforward—the word “agent

expressly denotes function,” not simply an ingredient. (ECF No. 103 at 3.) This interpretation is

supported by case law, as Courts have often found the term “agent” to claim substances with “a

causal relationship . . . [between the] agent and the act.” Takeda Pharm. Co. v. Teva Pharms. USA,

Inc., 668 F. Supp. 2d 614 (D. Del. 2009), aff'd, 363 F. App’x 34 (Fed. Cir. 2010) (finding

“excipients that facilitate disintegration, but are not known in the art to cause disintegration” were

not “disintegrating agents”). “For a substance to be an ‘agent,’ that substance—what it is, how

much of it is present—must cause a specific result, not merely be capable of doing so if greatly

increased in quantity.” Liqwd, Inc. v. L’Oreal USA, Inc., 720 F. App’x 623 (Fed. Cir. 2018)

(emphasis added). Put simply, for a substance to be an “agent,” quantity and context matter.

The prosecution history of TherapeuticsMD’s patents is not to the contrary. While pursuing

the patents at issue, TherapeuticsMD faced rejection over a prior art reference from U.S. Patent

No. 6,060,077, which the parties refer to as “Meignant.” (ECF No. 84 at 9; ECF No. 85 at 12.) The

Meignant reference also claimed an estradiol therapy for menopausal women. Meignant col. 7 ll.

25–36. Where Meignant differed was that it employed hydrophilic gel-forming bioadhesive agents,

which would interact with the patient’s mucous to adhere to the walls of the treatment area. Id. at

col. 2 l. 13–21 col. 8 ll. 31–35. When TherapeuticsMD faced rejection of its patent application

over Meignant, it amended its claims and specification to disclaim use of the same set of

hydrophilic gel-forming bioadhesive agents Meignant employed in its treatment. (Teva Op. Br.

Ex. 6 (ECF No. 84–6) at 33.)

This point is not dispositive. There is no dispute the claims in question exclude the use of

specific agents, and that these claims were included to distinguish Meignant. (TherapeuticsMD

Res. Br. (ECF No. 103) at 6.) However, Meignant does not compel a structural reading of the term

agent. In a different claim, Meignant has a structural claim for a specific embodiment, including a

specified amount of one of the agents at issue (hydroxypropylcellulose). Meignant col. 8 ll. 10–

20. Despite this, Meignant separately claims an entire category of excipients as potential agents.

See id. col. 7–8, ll. 57–3. However, here the patents do not claim any amount of the alternative

ingredients suggesting instead that it claims whatever amount is necessary for it to serve as an

“agent.” Id. Indeed, the Meignant specification discusses the agents specifically in terms of its

functions within the medicament: to “emulsify, enabling direct passive diffusion” and allowing

“the emulsion to adhere to the mucous membrane with a slight flow.” Id. col. 2 ll. 13–2. The Court

reads this as a functional limitation; Meignant was not claiming the mere presence of the listed

compounds, but enough of those compounds to have the claimed effect.

Notably, Teva has elsewhere recognized that the term “agent” is reserved for a substance

that performs a given function. In the Second Joint Claim Construction Statement the parties

agreed the other agent within the exemplary ’091 claim, the “solubilizing agent,” should be

construed as “an agent or combination of agents that solubilize an active pharmaceutical

ingredient.” (Second Joint Claim Construction Statement (ECF No. 176) at 2); see also, e.g., ’091

Patent col. 14 ll. 55. But if a potential solvent is only present in trace amounts, it cannot actually

solubilize another ingredient and therefore is not a solubilizing agent. “We presume, unless

otherwise compelled, that the same claim term in the same patent or related patents carries the

same construed meaning.” Omega Eng’g, Inc, v. Raytek Corp., 334 F.3d 1314, 1334 (Fed. Cir.

2003).

Consistent with the prior definition of agent within these patents and case law, the Court

adopts TherapeuticsMD’s preferred construction of “does not include a hydrophilic gel-forming

bioadhesive agent,” to mean “does not include an agent that is hydrophilic, functions to form a gel,

and functions as a bioadhesive.”

B. Does Not Include an amount of a Hydrophilic Gel-Forming Bioadhesive

Agent that Increases the Viscosity Above About 1000 cP at 25º C

The Court turns now to the unique claim language of the ’697 Patent, which would—rather

than exclude all hydrophilic gel-forming bioadhesive agents—expressly allow some use of these

gel-forming agents so long as they do not reach a specific viscosity threshold. (ECF No. 85 at 3.)

However, TherapeuticsMD had previously disclaimed any use of hydrophilic gel-forming

bioadhesive agents in order to gain approval over the Meignant reference.

While the Court agrees TherapeuticsMD did not disclaim the mere presence of “immaterial

amounts” of hydrophilic compounds with gel-forming and bioadhesive properties, this amendment

would allow for material amounts of these excipients to be added. (ECF No. 103 at 7.) Though

Meignant did employ these excipients as active agents, they were included as part “liquid or semi-

liquid inner phase,” which encompasses liquids below 1000 cP at 25º C. Meignant col. 2 ll. 31–

33.

TherapeuticsMD’s initial disclaimer before the patent office was absolute—but this

amendment now allows both to use of hydrophilic gel-forming bioadhesive agents. (See Teva First

Markman Br. Ex. 8 (ECF No. 84-6) at 104–05.) These agents may also have substantial effect:

increasing the viscosity of the formulation to its typical target level “between 50 and 1000 cP.”

’697 Patent col 22, ll. 44–45. The specification further makes clear this formulation may make use

of some of the compounds which could potentially serve as gel-forming agents as “thickening

agents,” namely xanthan gum and gelatin. Id. col. 17, ll. 27–30; but see id. col. 21, ll. 19–22

(forbidding the use of these compounds as hydrophilic gel-forming bioadhesive agents).

In short, the ’697 patent is attempting to recapture some of the claim scope surrendered in

prosecution. “Although a disclaimer made during prosecution can be rescinded, permitting

recapture of the disclaimed scope, the prosecution history must be sufficiently clear to inform the

examiner that the previous disclaimer, and the prior art that it was made to avoid, may need to be

re-visited.” Hakim v. Cannon Avent Grp., PLC, 479 F.3d 1313 (Fed. Cir. 2007) (citing Springs

Window Fashions LP v. Novo Indus., L.P., 323 F.3d 989 (Fed. Cir. 2003)); see also Golden Bridge

Tech., Inc. v. Apple Inc., 758 F.3d 1362 (Fed. Cir. 2014) (“Although our precedent allows

applicants to rescind a disclaimer during prosecution [patentee] did not avail itself of this route

and never notified the PTO that it sought a meaning [broader than previously disclaimed] . . . .”).

Here, TherapeuticsMD does not argue it made this disclaimer, rather its argues that such disclaimer

was unnecessary because the patent office ultimately withdrew the objection. (ECF No. 103 at 8.)

The fact the patent office ultimately withdrew its prior art objections over Meignant is

immaterial. (ECF No. 103 at 8.) “[T]here is no principle of patent law that the scope of a surrender

of subject matter during prosecution is limited to what is absolutely necessary to avoid a prior art

reference.” Norian Corp. v. Stryker Corp., 432 F.3d 1356, 1361 (Fed. Cir. 2005).

The Court therefore concludes the term “does not include an amount of a hydrophilic gel-

forming bioadhesive agent that increases the viscosity above about 1000 cP at 25º C” should be

construed identically to “does not include a hydrophilic gel-forming bioadhesive agent,” meaning

it “does not include an agent that is hydrophilic, functions to form a gel, and functions as a

bioadhesive.”

C. The Mean Area Under the Curve (AUC)0-24 of 17β-estradiol of about [X]

pg*hr/ml to about [Y] pg*hr/ml

The parties dispute whether the term “mean” in claims 1, 2, 4, and 5 of U.S. Patent No.

10,835,487 (the ’487 Patent) refers to the arithmetic (ECF No. 84 at 28) or geometric mean (ECF

No. 85 at 25). The arithmetic mean, or the average, is taken by adding a set of data points together,

then dividing by the number of points. The geometric mean is to multiplication what the arithmetic

mean is to addition. For example, the geometric mean of 2 data points is found by multiplying

them together and then taking the square root, if there are 3 data points you multiply and take the

cube root, and so on. (ECF No. 84 at 29; ECF No. 85 at 24.)

Elements of claims 1 and 2 recite the “mean area under the curve (AUC)0-24 of 17β-estradiol

of about 42 pg*hr/ml to about 63 pg*hr/ml,” this precise language appears again in claims 4 and

5, except the range is now “about 16 pg*hr/ml to about 26 pg*hr/ml.” ’487 Patent col. 58 ll. 20–

21, 26–27. Teva contends a POSA reading of the claims would interpret the term “mean” without

further qualification to refer to the arithmetic mean. (ECF No. 84 at 28.) TherapeuticsMD

disagrees, and argues that a POSA having read the specification, where this language appears

verbatim along with “corrected geometric mean,” would understand that the same phrase in other

claims would likewise refer to the geometric mean. (ECF No. 85 at 25.)

As Teva points out, when ordinary people and scientists alike refer to the mean of a data

set, without additional qualifiers, they are typically referring to the arithmetic mean. (ECF No. 84

at 29 (quoting Dawson, Beth, Basic & Clinical Biostatistics, Chapter 3 – Summarizing Data &

Presenting Data in Tables & Graphs (4th ed. 2004)).) Teva further argues TherapeuticsMD’s other

patents do expressly refer to the corrected geometric mean, and therefore the court must presume

“different claim terms . . . have different meanings.” Helmsderfer v. Bobrick Washroom Equip.,

Inc., 527 F.3d 1379, 1382–83 (Fed. Cir. 2008).

These points are persuasive and lend considerable weight to Teva’s preferred construction.

“However, no canon of claim construction is absolute in its application.” ERBE Elektromedizin

GmbH v. Canady Tech. LLC, 629 F.3d 1278, 1286 (Fed. Cir. 2010) (quoting Unique Concepts,

Inc. v. Brown, 939 F.2d 1558 (Fed. Cir. 1991)). “Claim differentiation may be helpful in some

cases, but it is just one of many tools used by courts in the analysis of claim terms.” Id. (citing

Nystrom v. Trex Co., Inc., 424 F.3d 1136, 1142–43 (Fed. Cir. 2005)).

Rather than interpret this claim language in a vacuum, TherapeuticsMD urges the Court to

read the terms in light of the specification, and the Court agrees. The specification of the ’487

Patent contains multiple recitations of the claimed ranges “42 pg*hr/ml to about 63 pg*hr/ml” and

“about 16 pg*hr/ml to about 26 pg*hr/ml,” and each time refers to them as the “corrected

geometric mean area under the curve (AUC)0–24.” ’487 Patent col. 3 ll. 12–14, col. 25 ll. 60–63,

col. 26 ll. 26–28. Construing the term “mean” to refer exclusively to “arithmetic mean” misaligns

the scope of the claimed invention from all embodiment described in the specification. “[A] claim

construction that would exclude the preferred embodiment ‘is rarely, if ever, correct’ and would

require highly persuasive evidentiary support.” Rexnord Corp. v. Laitram Corp., 274 F.3d 1336,

1342 (Fed. Cir. 2001) (quoting Vitronics, 90 F.3d at 1583).

Teva does not cite any intrinsic evidence supporting its preferred construction. Rather,

Teva argues the parallels between the claimed “mean” and the specified “corrected geometric

mean” should be disregarded to avoid “improperly import a limitation from the specification into

the claims.” (ECF No. 84 at 30 (internal quotations omitted) (citing See Cochlear Ltd. v. Oticon

Med. AB, Civ. A. No. 18-6684, 2019 WL 3943014 (D.N.J. Aug. 21, 2019)).) Teva’s concerns are

misplaced. Construing the claims as referring to the “corrected geometric mean” is not more

limiting than if it were the “arithmetic mean.” And while Cochlear is clear that where “a patentee

uses a claim term throughout the entire patent specification . . . with only a single meaning, he [or

she] ha[d] defined that term ‘by implication,’” there is no dispute the specification of the ’487

Patent discusses both the arithmetic and geometric means. Id. at *14 (second alteration in original)

(quoting Homeland Housewares, LLC v. Whirlpool Corp., 865 F.3d 1372, 1377 (Fed. Cir. 2017).

Even so, whenever these specific ranges are discussed in the specification it is uniformly in

reference to the “corrected geometric mean.” ’487 Patent col. 3 ll. 12–14, col. 25 ll. 60–63, col. 26

ll. 26–28.

The Court therefore adopts TherapeuticsMD’s construction that the whole phrase “mean

Area Under the Curve (AUC)0-24 of 17β-estradiol of about [X] pg*hr/ml to about [Y] pg*hr/ml,”

from claims 1, 2, 4, and 5 of the ’487 patent should be construed together and be read as the

“corrected geometric mean Area Under the Curve (AUC)0-24 of 17β-estradiol of about [X]

pg*hr/ml to about [Y] pg*hr/ml.”

D. Corrected Geometric Mean

Though some of TherapeuticsMD’s patents have ambiguous references to the “mean,”

other patents, namely U.S. Patent Nos. 9,289,382 and 10,806,697, expressly refer to the “corrected

geometric mean.” Here, the parties agree “corrected geometric mean” should comport to the

accepted mathematical definition—“the nth root of the product of n observations, adjusted for

baseline.” (ECF No. 103 at 8; ECF No. 84 at 26 (“There is no dispute regarding the mathematical

equation for determining a geometric mean.”).) Though Teva does not contest the standard

definition of geometric mean, it does ask the court to read alongside earlier language to find that

it is the corrected geometric mean of “a single administration to a single patient.” (ECF No. 84 at

25.)

This language comes from the beginning of the claims where the term “corrected geometric

mean” appears:

1. A pessary comprising about 25 μg of 17β-estradiol in a solubilizing

agent comprising a medium chain oil, wherein after a single

administration of the pessary to a patient provides, in a plasma sample

from the patient:

1) A corrected geometric mean peak plasma concentration (Cmax) of

17β-estradiol of about 19 pg/ml to about 29 pg/ml; and

2) a corrected geometric mean area under the curve (AUC)0–24 of about

75 pg*hr/ml to about 112 pg*hr/ml

’382 Patent, col. 56, ll. 2–13 (emphasis added). Teva reads this language as claiming a pessary

where a single blood sample, from a single patient, within one administration has geometric mean

peak plasma concentration with the claimed range. (ECF No. 84 at 25.) The Court is unpersuaded.

Geometric mean is a measure of central tendency, and there is no central tendency within a single

data point.

The Court “may not rewrite a claim even . . . [to avoid] a ‘nonsensical result.’” Source

Vagabond Sys. Ltd. v. Hydrapak, Inc., 753 F.3d 1291, 1301 (Fed. Cir. 2014) (quoting Chef Am.,

Inc. v. Lamb–Weston, Inc., 358 F.3d 1371 (Fed. Cir. 2004)). “But where, as here, the specification

reveals . . . [the] meaning for a term . . . [that] meaning governs, particularly when it also serves to

avoid an inoperable claim construction.” AIA Eng’g Ltd. v. Magotteaux Int’l S/A, 657 F.3d 1264

(Fed. Cir. 2011). Here, no redrafting or special interpretation is required; the Court simply declines

to read in additional limitations from elsewhere in the claim where doing so leads to an illogical

or absurd result.

Teva argues the geometric mean is applied to “multiple measurements from the same

patient,” rather than a mean of data from different patients. (ECF No. 84 at 26.) Although

TherapeuticsMD agrees pharmacokinetic studies require multiple measurements “collected at

various time points post-administration” (ECF No. 85 at 9), this interpretation still fails because it

ignores other claim language and clear evidence in the specification that the geometric mean was

meant to be calculated across multiple patients. First, were the Court to consistently apply Teva’s

reading of the claim language, this data would have to come from “a plasma sample,” not multiple

samples across time, illogically requiring the calculation of the mean of a single data point. ’382

Patent, col. 56, 5. Second, even were the Court to set that issue aside, it would not change the fact

there is only one “peak plasma concentration” or “area under the curve” from a single

administration to a single patient, rendering the claimed corrected geometric mean meaningless.

See Intel Corp. v. Qualcomm Inc., 21 F Ath 801 (Fed. Cir. 2021) (“It is highly disfavored to

construe terms in a way that renders them void, meaningless, or superfluous.” (quoting Wasica

Finance GmbH v. Continental Automotive Systems, Inc., 853 F.3d 1272 (Fed. Cir. 2017))).

The specification confirms TherapeuticsMD’s reading of the claim language. The

specification lists 3 pharmacokinetic studies, demonstrating the effectiveness of the claimed

invention, the first of which discloses “forty eight (48) subjects who completed the study [and]

were included in the primary analysis . . . presented throughout Tables 5, 6, and 7.” °382 Patent,

col. 49, Il. 35-38.

TABLE 5

Safety Results: The descriptive statistics for Day 1

plasma estradiol CL... and T,..., are provided below.

Estradiol 10 ue Placebo

Chaax Tvece Cyricax Tosca

N 24 24 26 26

Mean + 8D 30.7 27AT 2124173 27541726 4.00 + 2.68

Geometric 29.9 — 24,7 —

Mean

Median 20.8 1.00 22.1 6.00

Min, Max 19.7, 52.3 1.00, 6.00 15.1, 90.0 0.00, 6.00

CV % 24.3% 81.3% 62.9% 67.1%

Id. at col. 36 ll. 40 (emphasis added). “Importantly, the person of ordinary skill in the art is deemed

to read the claim term . . . in the context of the entire patent, including the specification,” and

within the specification, the corrected geometric mean clearly refers to the mean of data collected

from different patients. Phillips 415 F.3d at 1314.

A POSA would therefore understand this as claiming a pessary, which on average provided

patients a specific peak plasma concentration and area under curve of B-estradiol after a single

23

administration, as measured by the geometric mean across patients studied. The Court therefore

adopts TherapeuticsMD’s construction that the terms “corrected geometric mean” and “mean”

carry their plain and ordinary meaning, without constraint to a single patient.

E. Solvent System

After the stay was lifted, the parties introduced two additional disputed terms, the first of

which is “solvent system,” which TherapeuticsMD contends refers to “a system of solvent together

with other excipients.” (ECF No. 180 at 4.) Teva asks the Court to apply the following definition

“a composition that solubilizes an active pharmaceutical ingredient.” (ECF No. 179 at 9.) Here,

the parties have essentially switched positions from their prior interpretations of “hydrophilic gel-

forming bioadhesive agent,” and Teva now argues for a construction based on the function of the

solvent system, whereas TherapeuticsMD maintains that this is purely a structural claim.

The parties agree the first claim of the ’487 patent is an appropriate exemplary claim for

“solvent system,” it recites:

1. A method of treating a female patient with a symptom of vulvovaginal

atrophy, the method comprising administering to a female patient in

need thereof, an intravaginal softgel insert, the insert comprising:

a. 10 mcg of estradiol, the estradiol being the only active

pharmaceutical ingredient in the softgel insert; and

b. a liquid solvent system having a viscosity between about 50 cP

and about 1000 cP at 25° C., the solvent system consisting of a

9:1 w/w ratio of (i) one or more C6 to C14 fatty acid mono-, di-

, or triesters of glycerol to (ii) a nonionic surfactant consisting of

PEG-6 stearate, PEG-32 stearate, and ethylene glycol

palmitostearate . . .

(ECF No. 179 at 9; see also ECF No. 180 at 4.) There is no dispute a solvent system contains

“multiple components or ingredients,” rather the parties disagree over the scope of what those

ingredients may be. (ECF No. 180 at 7; Teva’s Second Response Br. (ECF No. 185) at 8.)

According to Teva, the “limitless possibility of other excipients” offered by TherapeuticsMD

would destroy the narrow scope of the claim denoted by the phrase “consisting of.” (ECF No. 185

at 8.)

The Court agrees. It is well understood “consisting of is a closed transition” which

“exclude[s] any elements, steps, or ingredients not specified in the claim.” Yoon Ja Kim v.

Earthgrains Co., 451 F. App’x 922, 926 (Fed. Cir. 2011) (quoting AFG Indus., Inc. v. Cardinal

IG Co., 239 F.3d 1239 (Fed. Cir. 2001)). Therefore, a definition of solvent system encompassing

unclaimed “colorants” would destroy the limiting claim language TherapeuticsMD itself drafted.

(ECF No. 180 at 8.)

In response, TherapeuticsMD cites Amgen Inc. v. Amneal Pharmaceuticals. LLC, 945 F.3d

1368 (Fed. Cir. 2020), as binding authority that purportedly requires the Court to construe the

claim in such a way that it does not “foreclose[e] additional ingredients” in the solvent system,

because the transitional phrase “consisting of” follows the more open-ended transition. (ECF No.

186 at 13.) Teva claims this is an “overread” of Amgen. (ECF No. 207 at 6.) According to Teva,

Amgen stands for the more limited principle that where there is a broad claim covering the “overall

composition,” which comprises multiple limitations, “reciting a ‘consisting of’ phrase” the

“limitations . . . remain closed, [though] the overall composition does not.” Teva makes this

distinction clearer by acknowledging “other excipients may be included in [a vaginal] ‘insert’” and

still practice the patent, only “the solvent system is closed.” (Id.)

Amgen did not change the well-understood rules of patent interpretation, rather it provided

guidance on how courts should interpret the limiting language of Markush groups as part of

broader, open claim. See Amgen Inc. 945 F.3d at 1376. “A Markush claim is a particular kind of

patent claim listing alternative species or elements that can be selected as part of the claimed

invention.” Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350,

1357 (Fed. Cir. 2016). Where the term Markush claim refers to the claim as a whole, “[a] Markush

group lists specified alternatives in a patent claim.” Id. at 1358.

Teva’s reading is consistent with binding Federal Circuit precedent. Amgen addressed the

question of when a claim is “compris[ed]” of a Markush group of alternative “binders and

disintegrants,” if the presence of an “additional . . . functionally similar [component,]” to the

Markush group would defeat a claim of infringement. Amgen Inc. 945 F.3d at 1379. The Federal

Circuit held that since the overall claim “uses a ‘comprising’ transition phrase” one may still

infringe the patent “when an accused product contains a component that is from the Markush group

and that meets the limitation’s requirements.” Id. Put more simply, if a patent claims at least

elements (A), (B), and (C)—where (C) is one of three options—an accused product that contains

(A), (B), (C), and (D) still infringes, even if (D) serves a similar purpose to the options in (C). Id.

But if the accused product only contains (A), (B), and (D), it would not infringe, unless it fell under

the doctrine of equivalents or similar doctrine. Id.

The circumstances of Amgen differ in two parts. First, though “[n]o precise linguistic

formula is required to create a Markush claim” or group, there is little doubt the claim at issue does

not qualify. Id. at 1357 n.2. The term “liquid solvent system” may have two claimed subparts, but

these parts are not alternatives to each other. ’487 patent col. 57 ll. 51–65. Indeed, it is clear from

the plain meaning of the claim, both elements must be present in the “solvent system . . . [in] a 9:1

w/w ratio,” rather than as a list of two alternative elements. Id. Second, unlike the additional

“binders and disintegrants” in Amgen, 945 F.3d at 1379, the additional “other excipients” at issue

include “surfactants, lubricants, antioxidants, colorants, and preservatives.” (ECF No. 180 at 8.)

Of these, only the surfactants are arguably “functionally similar” to elements of the solvent system.

Amgen Inc. 945 F.3d at 1379. The specification, again, provides guidance, as it shows the first

element, the “esters of glycerol” are “solubilizing agents,” whereas “PEG-6 palmitostearate,” and

other stearates, play multiple different roles, reducing the surface tension of the system, i.e. being

a “surfactant,” is “capable of dissolving or solubilizing relatively high amounts of hydrophobic

drug compounds,” and acting as “a thickening agent.”’487 Patent col. 15–17 ll. 48–25. None of

these are “functionally similar” to the “lubricants, antioxidants, colorants, and preservatives”

present in the tablet TherapeuticsMD seeks to have covered as part of the “solvent system.” (ECF

No. 180 at 8.) Amgen’s relevance is only for the point that claim 1 of the ’487 Patent may still be

infringed by inserts which contain other excipients—an issue the parties do not actually contest.

(ECF No. 207 at 5); see also Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 972 (Fed.

Cir. 1999) (“[L]imitations stated in dependent claims are not to be read into the independent claim

from which they depend . . .”).

For this reason, the Court will interpret the phrase “dependent claims are not to be read into

the independent claim from which they depend.”).consisting of” as a traditional closed transitional

phrase. Though TherapeuticsMD does not go so far as to claim that the presence of the preceding

“comprising” language negates the meaning of the closed “consisting of” transition, it does argue

the solvent system should be permitted to cover additional components outside the closed claim

language. (ECF No. 186 at 9.) But the Federal Circuit is clear, “use [of] the phrase ‘consisting of’

. . . creates a very strong presumption that that claim element is closed and therefore excludes any

[other] elements.” Shire Dev., LLC v. Watson Pharms., Inc., 848 F.3d 981, 984 (Fed. Cir. 2017)

(internal quotation omitted) (citing Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics

Corp., 831 F.3d 1350, 1368 (Fed. Cir. 2016)). “[T]o overcome the exceptionally strong

presumption that a claim term set off with ‘consisting of’ is closed to unrecited elements, the

specification and prosecution history must unmistakably manifest an alternative meaning.” Id. at

1359.

TherapeuticsMD appears to contend, though does not expressly state, that because the

patent specification “expressly contemplates the presence of other excipients” it is an unmistakable

manifestation of an alternate meaning. (ECF No. 186 at 9.) To support its interpretation,

TherapeuticsMD emphasizes a line of the specification discussing how in the “embodiments, the

solvent system that solubilizes the estradiol are medium chain fatty acid-based solvents, together

with other excipients.” ’487 Patent col. 13 ll. 12–19; see also ’709 Patent col. 13 ll. 10–17. Yet,

the very next section of the ’487 Patent defining the meaning of “other excipients,” shows this is

an incomplete account. Id. col. 15 ll. 36. The primary “other excipient” discussed in this section is

“a surfactant,” which “includes PEG-6 palmitostearate and ethylene glycol palmitostearate.” Id.

The second element is the claimed solvent system. Id. col. 16 ll. 48. There is, therefore, significant

ambiguity as to the meaning of “other excipients” within the context of the specification, and

whether those excipients are already represented within the claim language, it does not

“unmistakably manifest an alternative meaning,” to the standard definition of “consisting of.”

Multilayer Stretch Cling Film Holdings, 831 F.3d at 1368. As to the prosecution history,

TherapeuticsMD provides the Court no evidence the history supports its favored interpretation.

(See e.g., ECF Nos. 180, 186, 208.) The Court cannot diverge from the well-established

understanding of “consisting of” based on limited and ambiguous evidence.

Though other parts of the specification do suggest the term “solvent system” was intended

to contain excipients beyond the claimed surfactants, this alone cannot change the plain meaning

of the claim terms. “[T]he claims measure the invention. They may be explained and illustrated by

the description. They cannot be enlarged by it.” Cont’l Paper Bag Co. v. E. Paper Bag Co., 210

U.S. 405, 419 (1908) (citing Yale Lock Mfg. Co. v. Greenleaf, 117 U.S. 554 (1886)); see also

Brumfield , Tr. for Ascent Tr. v. IBG LLC, 97 F.4th 854 (Fed. Cir. 2024) (same).

Despite this, the Court does not agree with Teva’s proposed construction. Unlike the term

“hydrophilic gel-forming bioadhesive agent” above, there is nothing within the claim language or

specification which compels a functional reading of this claim, much less one which limits the

“solvent system” to “solubiliz[ing] an active pharmaceutical ingredient,” without consideration of

other excipients—even if those excipients are not themselves part of the solvent system. See Kara

Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341 (Fed. Cir. 2009) (“The patentee is entitled to the full

scope of his claims.”) (citing Phillips, 415 F.3d at 1323.); see also Ecolab, Inc. v. Envirochem,

Inc., 264 F.3d 1358, 1367 (Fed. Cir. 2001) (“Where the function is not recited in the claim itself

by the patentee, we do not import such a limitation.”).

Unlike the prior gel-forming claim, there is no term such as “agent” which either party

claims to create a functional language. ’487 Patent col 58 ll. 20–21, 26–27. Indeed, the remaining

claim language pushes against a functional interpretation. The claimed element has language

defining the solvent system in terms of its composition, the precise ratio of components, a favored

temperature, and a specified range of viscosities—other than being referred to as a “solvent

system” there is no other reference to the function of the system, nor language which typically

connotes a functional limitation. Id.

Teva argues its “proposed construction [does not] transform[] this term into a functional

term,” but instead “defin[es] an excipient according to its function.” (ECF No. 185 at 10.) There

is no doubt, even for structural claims, that “it is entirely proper to consider the functions of an

invention in seeking to determine the meaning of particular claim language.” See ICU Med., Inc.

v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1375 (Fed. Cir. 2009). But that does not mean the Court

can impose a functional limitation on a structural claim, even where the specific function is

uncontested.

Defining “solvent system” as “a composition that solubilizes an active pharmaceutical

ingredient” would also run counter to the doctrine of claim differentiation, as it is essentially the

same definition given to the term “solubilizing agent.” (ECF No. 176 at 2, 12 (defining

“solubilizing agent” as “an agent or combination of agents that solubilize an active pharmaceutical

ingredient”).) Claim differentiation “stems from the common sense notion that different words or

phrases used in separate claims are presumed to indicate that the claims have different meanings

and scope.” Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1368 (Fed. Cir. 2005) (quotation

omitted) (citing Karlin Tech. Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971–72 (Fed. Cir.

1999))).

Though the ’487 Patent does not contain claim language regarding solubilizing agents,

other patents such as the U.S. Patent No. 11,123,283 has claims encompassing both “a solubilizing

agent” in claims 1, 8, and 23 alongside a “solvent system” in claim 15. ’283 Patent col. 19–20, ll.

2– 45. Even within the ’487 Patent, the specification is clear that the “solvent system” includes not

only “solubilizing agents,” id. col. 13 ll. 20–22, but also “non-ionic surfactants” that also serve as

“thickening agents,” id. col. 15, ln. 20–36; id. col. 17, ll. 22–25. In order to avoid the solvent

system having an identical definition to its individual ingredients, the Court will provide a

structural definition of “solvent system” consistent with Teva’s position regarding “other

excipients.”

“The trial judge has an independent obligation to determine the meaning of the claims,

notwithstanding the views asserted by the adversary parties.” Exxon Chem. Pats., Inc. v. Lubrizol

Corp., 64 F.3d 1553, 1555 (Fed. Cir. 1995). The Court will therefore apply the following

construction: a “solvent system” is a “composition of non-toxic, pharmaceutically acceptable

solvents, co-solvents, and surfactants suitable for vaginal delivery or absorption.”

F. Shape of a Tear Drop

Finally, the parties dispute the definition of the “shape of a teardrop” which is the claimed

shape of the vaginal insert of U.S. Patent Nos. 10,888,516; 11,065,197; 11,116,717; and

11,123,283. The disagreement boils down to a single point. Teva insists a tear drop must have one,

whereas TherapeuticsMD believes any shape “having a globular form at one end tapered towards

the other end,” is a tear drop.

Teva points out, correctly, as constructed, the TherapeuticsMD’s definition would

encompass shapes that the average person is not likely to draw if asked to draw a tear drop, and

which are not shown in the specification. (Teva Second Res. Markman Br. (ECF No. 185) at 6.)

However, the question is not what the average person expects in a vacuum, but whether the shape

would be identified as a tear drop by a POSA. Markman, 52 F.3d at 986. Teva points to a series of

shapes TherapeuticsMD’s expert, Dr. Khan, testified were tear drops as evidence of

TherapeuticsMD’s unreasonable position. (ECF No. 185 at 6.)

6 6 0 8 175A OE

SHPEHKHANYY

55 twa

56

TUBE

mcm 17 8935 aD

==

oo

Figure 1 Tear Drop Shapes in Dispute (ECF No. 185 at 6)

31

Though Dr. Khan’s opinion 1s extrinsic evidence and is not being considered, the Court finds these

shapes instructive as to the parties positions. TherapeuticsMD’s attorney argued at the hearing that

all of the above shapes are in fact tear drops (ECF No. 206 at 61), whereas Teva contended only

“one or two are actually teardrops.” (U/d. at 60). Each of the shapes vary in a number of ways, but

all have a globular bottom section, and a narrower, yet rounded top. (ECF No. 185 at 6.) Despite

Teva’s objections, its own construction would similarly encompass every one of these shapes, so

long as the tapered side ended in a point.

This contradiction was evident at the hearing where Teva, at times, appeared to abandon

the issue of whether the tear-drops tapered to a point, and instead highlighted that “taper is

generally understood to have gradual narrowing,” whereas many of these shapes narrow quite

suddenly. (ECF No. 206 at 59-60.) Fundamentally, this dispute demonstrates the inherent

difficulties of rigidly defining visual information.

Instead, the Court looks to the specification and the purpose of the invention to determine

the proper construction. Here, the specification begins with a figure detailing the approximate

dimensions of the insert:

ooo 208

□□□ —— 206-——!

See °197 Patent Fig. 2. This shape matches TherapeuticsMD’s preferred definition, “having a

globular form at one end tapered towards the other end,” and could fairly be described as

possessing the “shape of a tear drop.” (ECF No. 180 at 11.) Teva argues this shape is not a reference

to the tear drop specifically “in accordance with various embodiments of the invention,” and may

32

be “a cylinder with a larger ‘cap’ section,” but is “equally likely to be showing the shape of an

avocado or pear as it is a teardrop.” (ECF No. 185 at 3.)

First, there is no apparent cylindrical element in the figure. Second, avocados and pears

have been considered “tear drop” shapes, and the terms are sometimes used interchangeably. See

e.g. Optical Disc Corp. v. Del Mar Avionics, 45 F. App’x 887, 889 (Fed. Cir. 2002) (noting that

heating and cooling of a disc resulted in an asymmetric “‘pear-shaped’ or ‘teardrop-shaped’

surface”). Therefore, a POSA would likely interpret the claimed shape to be referring to an insert

matching this figure, even with the potential ambiguity of the specification.

To TherapeuticsMD, the claimed tear drop shape should be read in light of its therapeutic

intent, the insert’s “shape[ must] be suitable for insertion into the vagina” of people specifically

prone to vaginal discomfort—a pointed shape would not be suitable for this purpose. The ’197

Patent col. 18–19 ll. 66–2. Teva agrees a tear drop suppository with “a sharp end would be

impractical,” so the tapered end would be rounded “so that it would not be dangerous or

uncomfortable for the patient.” The parties therefore agree a tear drop with a rounded, tapered end

is appropriate, and, despite Teva’s objection, the Court cannot discern the practical difference

between a shape that tapers to this rounded point and TherapeuticsMD’s definition.

The Eastern District of Pennsylvania faced a similar claim construction of a “generally tear

drop shape” element of a surgical device in Bausch & Lomb Inc. v. Moria S.A. 222 F. Supp. 2d

616, 653 (E.D. Pa. 2002). The Pennsylvania Court determined “the claim is not limited by a

pointed top,” so long as it has “a globular form at the bottom, tapering to a narrower portion at the

top.” Id.

The Court agrees and therefore adopts TherapeuticsMD’s construction that the “shape of a

teardrop” carries the plain and ordinary meaning “having a globular form at one end tapered

towards the other end.” In adopting this definition, the Court makes no determination as to the

credibility of Dr. Khan’s opinions or whether all the shapes he testified constitute tear drops, in

fact, qualify.

IV. CONCLUSION

For the reasons set forth above, the Court defines the claim terms as follows: (1) “Does

Not Include a Hydrophilic Gel-Forming Bioadhesive Agent” shall mean “does not include an agent

that is hydrophilic, functions to form a gel, and functions as a bioadhesive;” (2) “Does Not Include

an amount of a Hydrophilic Gel-Forming Bioadhesive Agent that Increases the Viscosity Above

About 1000 cP at 25º C” shall be interpreted to share the same definition as “does not include an

agent that is hydrophilic, functions to form a gel, and functions as a bioadhesive;” (3) the “Mean

Area Under the Curve (AUC)0-24 of 17β-estradiol of about [X] pg*hr/ml to about [Y] pg*hr/ml”

shall mean “corrected geometric mean Area Under the Curve (AUC)0-24 of 17β-estradiol of about

[X] pg*hr/ml to about [Y] pg*hr/ml,” (4) “Corrected Geometric Mean” shall carry its plain and

ordinary meaning, without constraint to a single patient; (5) “Solvent System” means a

“composition of non-toxic, pharmaceutically acceptable solvents, co-solvents, and surfactants

suitable for vaginal delivery or absorption;” and (6) “Shape of a Tear Drop” shall carry its plain

and ordinary meaning, of a shape with a globular form, tapering toward the other end.

Date: January 8th, 2026 /s/ Brian R. Martinotti ______

HON. BRIAN R. MARTINOTTI

UNITED STATES DISTRICT JUDGE