Court Opinion

ID: 3217049
Source: CourtListenerOpinion
Date Created: 2016-06-24 20:01:10.988494+00
Date Added: 2024-06-11T09:19:15.319197
License: Public Domain

Case: 15-12996       Date Filed: 06/24/2016       Page: 1 of 20

                                                                                   [PUBLISH]

                  IN THE UNITED STATES COURT OF APPEALS

                            FOR THE ELEVENTH CIRCUIT
                              ________________________

                                     No. 15-12996
                               ________________________

                       D.C. Docket No. 3:13-cv-00859-TJC-MCR

RANBAXY LABORATORIES INC.,

                                                                         Plaintiff-Appellant,

                                             versus

FIRST DATABANK, INC.,

                                                                         Defendant-Appellee.

                               ________________________

                      Appeal from the United States District Court
                          for the Middle District of Florida
                             _______________________

                                       (June 24, 2016)

Before WILLIAM PRYOR, ANDERSON, and PARKER, * Circuit Judges.

PARKER, Circuit Judge:

*
 Honorable Barrington D. Parker, Jr., United States Circuit Judge for the Second Circuit, sitting
by designation.
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      Plaintiff-Appellant, the pharmaceutical company Ranbaxy Laboratories Inc.,

seeks money damages and injunctive relief for alleged misrepresentations made by

Defendant-Appellee First Databank, Inc. (“FDB”), a company that publishes a

drug information database for use by pharmacies across the United States.

Ranbaxy alleges that FDB’s database, MedKnowledge, falsely represents that

Ranbaxy’s acne drug Absorica is non-unique. After expedited discovery on the

issue of falsity, the district court granted summary judgment in favor of FDB,

concluding that FDB did not publish any false statements about Absorica. Because

we agree that Ranbaxy has not raised a genuine issue of material fact with regard

to falsity, we affirm the order and judgment of the district court.

                                 I. BACKGROUND

                                      A. Absorica

      Ranbaxy is the manufacturer of Absorica, an Isotretinoin-based product used

to treat serious acne and other skin diseases. Although Absorica shares many

features with other generic acne treatments, it is unique in that it is effective even if

taken without meals (in a “fasted state”).

      The FDA issues a publication called the “Orange Book,” which is used by

pharmacists in many states to help identify which drugs are interchangeable with

other drugs. The Orange Book provides a wide range of information about drugs

approved by the FDA, but only two metrics are relevant here: pharmaceutical

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equivalence and therapeutic equivalence. Two drugs are pharmaceutical

equivalents if “they contain the same active ingredient(s), are of the same dosage

form, route of administration and are identical in strength or concentration.” App.

74-8 at vi–vii. The Orange Book designates Absorica as pharmaceutically

equivalent to several other Isotretinoin-based acne medications. By contrast, two

drugs are therapeutic equivalents if “they are pharmaceutical equivalents and if

they can be expected to have the same clinical effect and safety profile when

administered to patients under the conditions specified in the labeling.” App. 74-8

at vii. Because of Absorica’s unique effectiveness when taken in a fasted state, the

Orange Book has given Absorica a “BX” rating, which indicates that no drugs are

therapeutically equivalent to Absorica.

      The Orange Book is used in many states as the authoritative source for

determining whether a pharmacist may substitute a prescribed drug with a cheaper

generic version. In “Orange Book states,” pharmacists may only substitute a drug

for another if the two drugs are designated by the Orange Book as being

therapeutic equivalents. However, in “non-Orange Book states,” pharmacists are

not required to consult the Orange Book (though they may choose to do so), and

instead make substitution decisions by relying on their own professional judgment

and the information provided by their companies’ software programs.

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                            B. MedKnowledge Database

      FDB publishes the MedKnowledge database, which is a collection of

information about various drugs for use by pharmacies when they fill prescriptions.

MedKnowledge is a raw data file—it is not organized in a way that is meaningful

or useful to pharmacists at local drug stores. Instead, FDB sells subscriptions to

the MedKnowledge database to customers who then develop software that sorts

and organizes the raw data into a display format usable by pharmacists.

MedKnowledge provides thousands of fields for each drug, with each field

populated with a coded piece of information. For example, in one field that relates

to the Orange Book’s therapeutic equivalence designation, Absorica is marked as

“BX,” indicating it has no therapeutic equivalent. FDB’s customers choose which

data to display to pharmacists and how to display it. FDB has no control over how

the information is displayed to the pharmacists issuing prescriptions.

      Because MedKnowledge is merely a collection of thousands of coded data

fields, FDB provides its customers with access to the MedKnowledge user

documentation. Reference to the documentation is necessary to understand the

various fields of coded data, many of whose meaning is not self-evident. FDB

customers can retrieve the documentation, which is nearly 4,000 pages long, by

either requesting a CD of the documentation or downloading it from FDB’s

website.

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      Ranbaxy’s complaint concerns two pieces of data published in the

MedKnowledge database. First, each drug is assigned a 5-digit Clinical

Formulation ID. Several drugs may be assigned the same Clinical Formulation ID

if they have the same active ingredients, route, dosage form, and strength (the same

factors considered in determining pharmaceutical equivalence). The

MedKnowledge documentation indicates that “[a]lthough the Clinical Formulation

ID . . . can be used to develop a list of candidates for substitution, these candidates

are only pharmaceutically equivalent; it is not sufficient to determine therapeutic

substitutability.” App. 74-2 at 5. Elsewhere, however, the documentation

indicates that FDB may assign a unique Clinical Formulation ID to a drug with

pharmaceutical equivalents if the drug has a clinically unique dosage form that is

not accounted for in the Orange Book. For example, while the Orange Book

groups all drugs taken as a tablet under a single dosage form, FDB has twenty-five

different dosage forms for tablets. Thus, two drugs identified as pharmaceutically

equivalent by the Orange Book might still have different Clinical Formulation IDs

if their dosage forms differ in a way recognized by FDB, but not the FDA.

Although FDB employs substantially more dosage forms than the FDA, it does not

have a dosage form relating to whether a drug may be taken in a fasted state.

Absorica thus shares its Clinical Formulation ID with several other Isotretinoin-

based acne medications.

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      Ranbaxy protests that because the MedKnowledge documentation indicates

that “new dosage forms are added when the clinical uniqueness of a novel dosage

form has been established,” App. 74-2 at 3, the assignment of a non-unique

Clinical Formulation ID to Absorica falsely represents that Absorica does not have

a clinically unique dosage form, thereby misleading pharmacists into believing that

Absorica is substitutable with other acne medications. Ranbaxy specifically points

to testimony from FDB’s corporate representative that “differences in absorption

when a product is taken in the fed or fasted state” may be a sign of clinical

uniqueness. App. 74-11 at 27.

      The second piece of data challenged by Ranbaxy is Absorica’s designation

in the Multi-Source/Single Source Indicator (NDCGI1) field as a “multi-source”

drug. The MedKnowledge documentation explains that this field “specifies

whether a product’s clinical formulation (i.e., its particular active ingredient,

dosage form, route of administration and strength) is only available from a single

labeler [(single source)] or from multiple labelers [(multi-source)].” App. 74-2 at

6. The documentation goes on to state that “[p]roducts that have the same clinical

formulation are not necessarily therapeutically equivalent.” App. 74-2 at 6. But

Ranbaxy’s expert testified that, contrary to the definition offered in the

MedKnowledge documentation, “multi-source” is a term of art in the

pharmaceutical industry used to indicate that a drug has a therapeutic equivalent.

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Thus, a pharmacist who sees Absorica designated as “multi-source” may

erroneously conclude that Absorica has therapeutic equivalents that may be offered

as cheaper substitutes.

      Ranbaxy admits that, in Orange Book states, there is no risk of confusion

because pharmacists there are required to consult the Orange Book code before

offering a substitute for a drug, and Absorica’s BX rating, accurately notated in the

MedKnowledge database, indicates that it has no therapeutic equivalent. Ranbaxy

contends, however, that in non-Orange Book states, a pharmacist might not consult

the Orange Book code for Absorica, and instead will see its non-unique Clinical

Formulation ID or its multi-source designation and wrongly conclude that other

generic acne drugs may be safely substituted for Absorica.

                               C. Procedural History

      After Ranbaxy brought this action, FDB moved to dismiss the complaint,

transfer venue, and strike the complaint pursuant to California’s anti-SLAPP

statute, which allows courts to dismiss actions seeking to restrain speech unless the

plaintiff demonstrates a probability of success on the merits. The district court

denied all three motions. The parties then agreed on an expedited discovery

schedule limited to the issue of falsity. Following completion of limited discovery,

FDB moved for summary judgment on the ground that there was no genuine issue

of material fact as to falsity. The district court granted the motion, reasoning that

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“[n]o reasonable reader of MedKnowledge’s data would consider these statements

‘false’ or ‘reasonably capable of a defamatory interpretation.’” Ranbaxy Labs. Inc.

v. First Databank, Inc., No. 3:13-cv-859, 2015 WL 3618429, at *12 (M.D. Fla.

June 9, 2015). The court agreed with FDB that “this is just a disagreement

between Ranbaxy and FDB about the proper characterization and placement of

Absorica in the MedKnowledge database. But such a disagreement is not the stuff

of a trade libel claim.” Id. Ranbaxy appealed.

                          II. STANDARD OF REVIEW

      We review a district court’s ruling on summary judgment de novo. Skritch

v. Thornton, 280 F.3d 1295, 1299 (11th Cir. 2002). A court may grant summary

judgment only if it determines that “there is no genuine dispute as to any material

fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P.

56(a). In reviewing the record, we must “construe the facts and draw all inferences

in the light most favorable to the nonmoving party.” Mathews v. Crosby, 480 F.3d

1265, 1269 (11th Cir. 2007).

                                III. DISCUSSION

                                   A. Jurisdiction

      Before we examine the merits of this case, we must first consider whether

we have subject-matter jurisdiction. This case comes before us as an appeal from a

final decision of the District Court for the Middle District of Georgia. See 28

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U.S.C. § 1291. The district court exercised diversity jurisdiction pursuant to 28

U.S.C. § 1332(a)(1). A district court may exercise diversity jurisdiction only if

there is complete diversity between the parties, that is, no two adverse parties are

citizens of the same state. See Owen Equip. & Erection Co. v. Kroger, 437 U.S.

365, 373 (1978). A corporation is a citizen of any state in which it is incorporated

and of the state “where it has its principal place of business.” 28 U.S.C.

§ 1332(c)(1).

      The parties agree that FDB is a Missouri corporation with its principal place

of business in California, but they disagree as to whether Ranbaxy, a Delaware

corporation, has its principal place of business in Florida or New Jersey. However,

“a party need not always prove the exact location of a corporation’s principal place

of business . . . . If it can be shown, for example, that the company’s principal

place of business is one of two states, and the opposing party is not a citizen of

either of them, subject matter jurisdiction will be upheld.” 13F Charles Alan

Wright et al., Federal Practice & Procedure § 3625 (3d ed. April 2016 update).

Though we have not explicitly adopted this principle, we have acknowledged its

logic in other circumstances, see Cabalceta v. Standard Fruit Co., 883 F.2d 1553,

1560 (11th Cir. 1989) (discussing, without criticizing, decision of district court to

exercise jurisdiction without determining corporation’s place of business), and we

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agree with the parties that its application is appropriate here. We are therefore

satisfied that the district court had jurisdiction over this case.

                                        B. Falsity

      We now turn to the question of whether Ranbaxy has raised a genuine issue

of material fact with regard to the alleged falsity of FDB’s statements in the

MedKnowledge database. We conclude that it has not.

      The parties disagree as to whether Florida, California, or New Jersey law

controls this dispute. The district court concluded that Florida or New Jersey law

likely applies, but that there was no conflict between the two. We agree with the

district court that the question of which state’s law applies is immaterial.

      Ranbaxy has brought claims for trade libel and tortious interference with

business relations. Under both Florida and New Jersey law, FDB is only liable for

those claims if it published false information. Compare Border Collie Rescue, Inc.

v. Ryan, 418 F. Supp. 2d 1330, 1348 (M.D. Fla. 2006) (trade libel), and Cherestal

v. Sears Roebuck & Co., No. 6:12-cv-1681, 2014 WL 644727, at *4 (M.D. Fla.

Feb. 19, 2014) (tortious interference), with Arista Records, Inc. v. Flea World, Inc.,

356 F. Supp. 2d 411, 427–28 (D.N.J. 2005) (trade libel), and E. Penn Sanitation,

Inc. v. Grinnell Haulers, Inc., 682 A.2d 1207, 1218 (N.J. Super. Ct. App. Div.

1996) (tortious interference). The operative question is thus whether FDB’s

published statements regarding Absorica are false.

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       In determining falsity, we analyze how a “reasonable reader” would

understand the disputed material. Dunn v. Air Line Pilots Ass’n, 193 F.3d 1185,

1193 (11th Cir. 1999) (citing Masson v. New Yorker Magazine, Inc., 501 U.S. 496

(1991); Nat’l Ass’n of Letter Carriers v. Austin, 418 U.S. 264 (1974)). We

consider the context of the statements and the commonly understood meaning of

terms. Id. at 1193. The plaintiff in a trade libel case bears the burden of proving

that the statements in question are false. See Bothmann v. Harrington, 458 So. 2d

1163, 1168 (Fla. Dist. Ct. App. 1984).

       We now turn to the two claims made by Ranbaxy: (1) that FDB’s

assignment of a non-unique Clinical Formulation ID to Absorica is false, and (2)

that FDB’s designation of Absorica as “multi-source” is false. 1

1
  Both parties reference a case in the Northern District of California, Schering Corp. v. First
Databank Inc., wherein the plaintiff made similar allegations against FDB to those made here.
FDB points out that the plaintiff in that case moved for a preliminary injunction, but the court
denied the motion, finding that the plaintiff had not established a likelihood of success on the
merits because “[n]othing in First DataBank’s . . . database actually states that the . . . products
are therapeutically equivalent.” Schering Corp. v. First Databank Inc., No. C 07-01142, 2007
WL 1068206, at *5 (N.D. Cal. Apr. 10, 2007). But Ranbaxy points out that just days later, the
same court denied FDB’s motion to strike the complaint under California’s anti-SLAPP statute
because, among other reasons, the plaintiff had made “a prima facie showing of facts to sustain a
favorable judgment.” Schering Corp. v. First Databank Inc., No. C 07-01142, 2007 WL
1176627, at *9 (N.D. Cal. Apr. 20, 2007). Whatever the meaning of these apparently
contradictory statements, we note only that these unpublished decisions, rendered by a district
court in another circuit, offer limited persuasive value, as the court there was operating under a
different set of facts and the parties there had not yet engaged in discovery.

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                             1. Clinical Formulation ID

      Ranbaxy argues on appeal that the assignment of a non-unique Clinical

Formulation ID to Absorica falsely represents that Absorica is not clinically

unique, thereby misleading pharmacists into believing they may safely substitute

generic acne medications for Absorica. At the outset, FDB correctly notes that this

is not the theory Ranbaxy pursued in its complaint. There, Ranbaxy alleged that

“[b]y assigning the same [Clinical Formulation ID] to Absorica and all other

Isotretinoin-based products . . . , FDB falsely and incorrectly indicates to FDB

Subscribers that Absorica is therapeutically equivalent to, and may be safely

substituted for, other branded or generic Isotretinoin-based products.” App. 1 at 7.

It was only after discovery that Ranbaxy advanced the theory that FDB falsely

represented the clinical uniqueness of Absorica.

      In any event, however, the district court was correct in concluding that there

is no genuine issue of material fact because no reasonable reader would understand

Absorica’s Clinical Formulation ID to mean that Absorica had therapeutic

equivalents or that it could be substituted for other drugs.

      Ranbaxy first argues that because the MedKnowledge documentation

indicates that unique Clinical Formulation IDs may be assigned when a drug’s

dosage form is “clinically unique,” Absorica should have its own Clinical

Formulation ID. Ranbaxy points to testimony from MedKnowledge’s corporate

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representative explaining that clinical uniqueness may include “differences in

absorption when a product is taken in the fed or fasted state in clinical trials.”

App. 74-11 at 27. But there is no evidence that FDB has ever assigned a unique

Clinical Formulation ID merely because a drug may be taken in a fasted state.2

And despite an extensive list of dosage forms, nothing in the MedKnowledge

documentation suggests that such a metric is relevant to FDB’s determination of

clinical uniqueness. That an FDB corporate representative admitted that a drug’s

ability to be taken in a fasted state may be a sign of clinical uniqueness has no

impact on what a reasonable reader would glean from the database and the

accompanying documentation. The MedKnowledge documentation belies any

claim that the assignment of a non-unique Clinical Formulation ID to Absorica is

misleading to a reasonable reader: the documentation makes clear that the Clinical

Formulation ID “is not sufficient to determine therapeutic substitutability,” and

nothing in the documentation suggests that a drug’s effectiveness in a fasted state

is a metric that warrants a new dosage form. App. 74-2 at 5.

       Ranbaxy protests that the MedKnowledge documentation is so lengthy and

cumbersome that no representative from FDB could even say they read the entire

manual, and there is no evidence that any customers have actually done so.

2
  Even Ranbaxy’s expert seemed unconvinced by this argument: “Q: And is it your testimony
that FDB is required to create a new dosage form for Absorica? . . . A: I – I can’t – I can’t –
that’s up to them.” App. 74-13 at 38 (deposition testimony).
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Ranbaxy’s insistent reference to the size of the documentation is of no help. The

user documentation is not a novel to be read cover-to-cover; it is a reference

manual, designed to be consulted and searched as needed. The very passages cited

by the parties in this litigation can be found simply by referencing the Table of

Contents, Index, or other search function. And as explained above, the

MedKnowledge documentation, which is made available to all MedKnowledge

subscribers, is necessary to understand the data provided in the coded fields. It

strains credulity to suggest that FDB’s customers, responsible for designing

software to make prescription decisions for ailing patients, would simply neglect to

consult the authoritative guide explaining the various data fields. Tellingly,

Ranbaxy’s argument regarding clinical uniqueness makes sense in the first place

only if we assume that customers read the portion of the documentation explaining

that clinical uniqueness may be a basis for developing new dosage forms.

      Nor is it appropriate to call the detailed explanations in the MedKnowledge

documentation “disclaimers.” Unlike in the cases cited by Ranbaxy, this is not a

situation in which FDB has made false statements and has attempted to insulate

itself from liability by disclaiming responsibility for their accuracy. See Off Lease

Only, Inc. v. Carfax, Inc., No. 12-80193-cv, 2012 WL 1966372, at *3 (S.D. Fla.

May 31, 2012) (defendant provided disclaimer that “in no event [are] the [reports]

warranted as being error free” (alterations in original)); Harcrow v. Struhar, 511

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S.E.2d 545, 546 (Ga. Ct. App. 1999) (defendant implied that plaintiff was guilty of

a crime, but added that “I’m not saying that they are responsible for this atrocious

act”).3 FDB does not disclaim responsibility for the accuracy of its data in the

documentation; it provides explanations for each of the coded fields so that its

customers can translate those fields into usable data for pharmacists.

       Ranbaxy next points to two publications outside the MedKnowledge

database that it claims give rise to an issue of fact. Like the district court, we are

uncertain whether these separate publications are germane to our analysis of the

falsity of the MedKnowledge database. Nevertheless, we conclude that these

publications do not create a genuine issue of material fact. Ranbaxy cites language

in a series of “MEDITECH Customer Connection” newsletters, sent to a subset of

FDB’s customers, explaining that “because FDB’s Clinical Form ID classification

groups identical products under a shared numerical value (ID), users are able to

easily identify a replacement [National Drug Code] for a pharmaceutically

substitutable product.” App. 74-24 at 6. Though Ranbaxy is correct that these

newsletters describe Clinical Formulation IDs as identifying “identical products,”

it ignores the rest of the sentence, which plainly states that the codes merely

identify “pharmaceutically substitutable product[s].” And a table produced just

3
  A third case cited by Ranbaxy, Machleder v. Diaz, 538 F. Supp. 1364 (S.D.N.Y. 1982), is
inapposite. There, the “disclaimer” ignored by the court was a statement made by the plaintiff,
explaining that he was not responsible for the acts improperly attributed to him by the defendant.
538 F. Supp. at 1372–73.
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one page earlier in the same document makes clear that Clinical Formulation IDs

group together products with the same “Ingredients, Strengths, Dosage Forms, and

Routes.” App. 74-24 at 5. Ranbaxy is not permitted to make its case by taking

terms out of context and ignoring the plain meaning of the immediate context. A

reasonable reader does not read terms in isolation, but puts them in the context in

which they were published. See, e.g., Fid. Warranty Servs., Inc. v. Firstate Ins.

Holdings, Inc., 74 So. 3d 506, 515 (Fla. Dist. Ct. App. 2011); Ward v. Zelikovsky,

643 A.2d 972, 980 (N.J. 1994).

      Ranbaxy also cites to a “Monthly Interest” newsletter in which FDB

discussed, as an example of clinical uniqueness, two drugs, one that needed to be

taken in the evening with dinner and one that needed to be taken in the morning

without regard to meals. Accepting, as we must at this stage, that a reasonable

reader would interpret this newsletter to mean that FDB assigns a unique Clinical

Formulation ID to drugs that can be taken in a fasted state, there is no basis upon

which to assume that a reasonable reader would ignore the numerous explanations

that “[t]he purpose of the [Clinical Formulation ID] is to allow grouping of

pharmaceutically equivalent products,” and that “[a] good rule of thumb to follow

is to use the [Clinical Formulation ID] plus the Orange Book code to identify

possible generic equivalents.” App. 74-25 at 4–5. These passages inform readers

that the fact that two drugs share a Clinical Formulation ID is only sufficient to

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show pharmaceutical equivalence, and that substitution decisions should be made

by consulting the Orange Book. No reasonable reader would understand that

assignment of a non-unique Clinical Formulation ID indicated therapeutic

equivalence or substitutability. Again, Ranbaxy seeks to remove small portions of

text from their plain context; such a strategy does not create a genuine issue of

material fact.

      The last piece of evidence relied upon by Ranbaxy is a set of FDB customer

inquiries. These inquiries questioned why Absorica shares a generic code (its

Clinical Formulation ID) with other Isotretnoin-based medications, even though

Absorica is not generally substitutable with other drugs. Although we have

acknowledged that in the context of a Lanham Act claim, “evidence of actual

confusion” is the “best evidence of likelihood of confusion,” Amstar Corp. v.

Domino’s Pizza, Inc., 615 F.2d 252, 263 (5th Cir. 1980), we are assessing falsity,

not likelihood of confusion. And the inquiries are not evidence of actual

confusion, but are instead targeted questions about how FDB organizes its data.

Moreover, deferring to the judgment of actual customers would require us to

ignore the Supreme Court’s direction that falsity is viewed from a reasonable

reader’s perspective—the inquiry is an objective, not a subjective, one. In the face

of the plain language of the MedKnowledge documentation, which provides clear

and ample explanation of how Clinical Formulation IDs are generated and used,

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five isolated instances of customers inquiring about the Clinical Formulation ID

are insufficient to raise a genuine issue of material fact.

      The MedKnowledge documentation, which is necessary to understanding

the vast fields of data provided by FDB, dispels any notion that FDB has published

false information about Absorica by assigning it a non-unique Clinical Formulation

ID. There is nothing in the MedKnowledge database or the accompanying

documentation that would lead a reasonable reader to believe that every drug that

may be taken in a fasted state is assigned a unique Clinical Formulation ID.

                             2. Multi-Source Designation

      Ranbaxy’s second ground for liability is that the MedKnowledge database

falsely represents that Absorica is a multi-source drug despite the fact that,

according to Ranbaxy’s expert, “multi-source” is a pharmaceutical term of art

understood in the industry to mean that a drug has therapeutic equivalents.

Although Ranbaxy’s expert is unable to cite any treatise, journal, or other authority

for this contention, we must assume at summary judgment that his characterization

of the term is accurate.

      However, we need not ignore the plain reality that “multi-source” is

susceptible to multiple meanings, as evidenced by the Orange Book’s use of the

term, which is consistent with the definition employed by FDB in the

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MedKnowledge documentation.4 Ranbaxy argues that where a statement is

susceptible to multiple meanings, a jury or other finder of fact must decide whether

the statement was understood in a defamatory sense. See Smith v. Cuban Am. Nat’l

Found., 731 So. 2d 702, 705 (Fla. Dist. Ct. App. 1999). But that is not the case

where, as here, the publisher has offered clear and unambiguous guidance as to

how the term should be understood. FDB did not leave interpretation of the term

“multi-source” to the discretion of the reader, but rather provided a detailed

explanation of how the term is employed in the MedKnowledge database.

       Ranbaxy protests again that mere “disclaimers” do not absolve FDB from

liability. As set forth above, the explanations in the MedKnowledge

documentation are not disclaimers; they are guides for understanding the fields of

data that FDB publishes and are a necessary reference for all of FDB’s customers.

In particular, the data field indicating whether a drug is multi-source or single

source contains only a “1” or a “2”; users have to reference the documentation to

understand that “1” corresponds to multi-source and “2” corresponds to single

source.5

4
  Ranbaxy’s expert admitted that “the FDA did not consider Absorica a single-source product, at
least in how they used the terms.” App. 74-13 at 31.
5
  Ranbaxy suggests that users could learn the meaning of the MedKnowledge codes orally from
more experienced users without referencing the user documentation. Again, in the absence of
any evidence to the contrary, we find it implausible that FDB’s customers, who are responsible
for developing software for dispensing medication to patients, would eschew the clear
explanations provided in the MedKnowledge documentation in favor of word-of-mouth
explanations by other users.
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         Moreover, not only does FDB indicate in a separate field that Absorica has

no therapeutic equivalents, it also indicates in another field that Absorica is single

source pursuant to the definition suggested by Ranbaxy’s expert. Any reasonable

reader viewing the database in context would understand that multi-source and

single source are susceptible to different interpretations, and that reference to the

user documentation was necessary to understand the meaning employed by each

field.

                                 IV. CONCLUSION

         There is little dispute that the MedKnowledge documentation directly

undercuts each of Ranbaxy’s claims. We are not persuaded that the sheer volume

of the documentation undermines FDB’s reliance on it. Because FDB provides

ample explanation of the information and terms in its database, no reasonable

reader would conclude that Absorica was therapeutically equivalent to or

substitutable for other drugs.

         Accordingly, we AFFIRM the order and judgment of the district court.

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