Functionality and secondary meaning in the trade dress of brand name prescription drug products

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Title:
Functionality and secondary meaning in the trade dress of brand name prescription drug products
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Brand name prescription drug products
Trade dress of brand name prescription drug products
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viii, 136 leaves : ill. ; 29 cm.
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Shapiro, Larry Jack, 1955-
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Drug Labeling   ( mesh )
Drug Packaging   ( mesh )
Pharmaceutical Preparations -- nomenclature   ( mesh )
Therapeutic Equivalency   ( mesh )
Pharmacy thesis Ph.D   ( mesh )
Dissertations, Academic -- Pharmacy -- UF   ( mesh )
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Thesis:
Thesis (Ph.D.)--University of Florida.
Bibliography:
Bibliography: leaves 130-135.
Statement of Responsibility:
by Larry Jack Shapiro.
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Photocopy of typescript.
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Vita.

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University of Florida
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FUNCTIONALITY AND SECONDARY MEANING
IN THE
TRADE DRESS OF BRAND NAME
PRESCRIPTION DRUG PRODUCTS











By

LARRY JACK SHAPIRO


A DISSERTATION PRESENTED TO THE GRADUATE COUNCIL OF
THE UNIVERSITY OF FLORIDA
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE
DEGREE OF DOCTOR OF PHILOSOPHY


UNIVERSITY OF FLORIDA


1982


































Copyright 1982

by

Larry Jack Shapiro




































To my parents, my brothers, and Dora,
for being there when I needed them.

















ACKNOWLEDGEMENTS

I would like to express my gratitude to Dr. William C. McCormick,

whose counsel and advice were invaluable throughout this investigation

and my graduate education.

Special thanks are extended to Dr. Richard A. Angorn, whose

influence and direction during my stay at the University will always be

remembered.

I would like to acknowledge the other members of my supervisory

committee, Dr. Oscar Araujo, Dr. Douglas Bradham, Dr. Carole Kimberlin,

Mr. Max Lemberger, Dr. Ronald Marks and Dr. Pejaver Rao for their

guidance.

I would like to acknowledge Harriet Douglas for her patience and

assistance in the preparation of this document and Bob Curtis for his

continuous support.

Finally, I wish to thank the Purepac Company for its assistance and

those pharmacies and pharmacists who cooperated in the study and made

this research possible.
















TABLE OF CONTENTS

Page


ACKNOWLEDGEMENTS . . . iv

TABLE OF CONTENTS. . . . v

ABSTRACT . . . vii

CHAPTER I INTRODUCTION . . 1

The Context of the Problem . . 1
The Purpose of the Study . . 4
Methodologic Framework . . 5
The Questions Addressed by the Study . 8
The Objectives of the Study . . 10
Statement of Hypotheses . . 11

CHAPTER II LEGAL BACKGROUND . . 14

Trademark and Unfair Competition Law . 14
Drug Product Copying Cases Prior to Ives v. Darby. 16
Ives v. Darby and Related Law . . 19

CHAPTER III REVIEW OF THE LITERATURE . 26

The Issue of Secondary Meaning . 26
The Issue of Functionality . . 29
Theoretical Foundations . . 33

CHAPTER IV METHODOLOGY . . 40

Overview . . . 40
The Survey Population . . 42
Selection of the Sample . .. 43
Laboratory Procedures . . 45
Instrumentation and Pilot Study . 46
Variables of Interest and Data Collection Procedures 47
Part I--The Personal Interview . 47
Part II--The Controlled Experiment . 50
Part Ill--The Self-administered Questionaire 53
Data Processing and Preparation . 55
Major Limitations of the Study . 55














Page

CHAPTER V RESULTS AND ANALYSES . . 57

The Findings of the Study . . 57
Part I--The Personal Interview . 57
Part II--The Controlled Experiment . 69
Part III--The Self-administered Questionnaire 77

CHAPTER VI CONCLUSIONS . . 93

Summary and Discussion . . 93
Part I--The Personal Interview . 93
Part II--The Controlled Experiment . 96
Part Ill--The Self-administered Questionnaire 98
Implications and Recommendations . 100
Topics for Future Research . . 102

GLOSSARY . . . 105

APPENDICES

A THE APPEARANCE OF THE DRUG PRODUCTS SELECTED
FOR THE INVESTIGATION . . 108

B PHARMACIES INCLUDED IN THE STUDY AND THEIR
LOCATIONS . . 112

C INFORMED CONSENT FORM . . 114

D THE INTERVIEW/QUESTIONNAIRE INSTRUMENT . 116

E VISUAL PROMPT DRUG FIRMS . . 122

F VISUAL PROMPT DRUG PRODUCT NAMES . 124

G DATA CODING SHEET . . 126

REFERENCES . . . 130

BIOGRAPHICAL SKETCH . . 136













Abstract of Dissertation Presented to the Graduate Council of
the University of Florida in Partial Fulfillment of the Requirements
for the Degree of Doctor of Philosophy


FUNCTIONALITY AND SECONDARY MEANING
IN THE
TRADE DRESS OF BRAND NAME
PRESCRIPTION DRUG PRODUCTS

By

Larry Jack Shapiro

December 1982

Chairman: William C. McCormick
Major Department: Pharmacy

A study was undertaken to examine several issues regarding the

functionality and secondary meaning of the appearance of brand name

prescription drugs.

A survey of 240 patients who were identified as chronically

taking at least one of 25 single-source, branded prescription drugs

was conducted in six community pharmacies in Gainesville, Florida.

The survey was accomplished utilizing a structured three-part inter-

view/questionnaire instrument.

In Part I, patients were shown samples of their prescription

drugs. A structured interview was conducted to determine by what

manner patients identify their medications and to ascertain whether

the patients were knowledgeable of the trademark name and source of

their drug products.

In Part II, a controlled experiment was conducted to determine

if patient acceptance of less expensive generic drug substitutes for

their brand name drugs is related to the look-alike appearance of

these substitute products.


vii











In Part III, a self-administered questionnaire was utilized to

collect demographic data and other information related to the patients'

knowledge of their drug products.

In regard to secondary meaning, the results showed that signi-

ficantly more than a majority of patients recognized and initially

identified their drug product by its trademark name. Less than

one-fourth of the patients initially identified their medication by its

colors, functions, or effects. However, of those patients who were

knowledgeable of the trademark name, significantly less than a majority

associated that name with a specific company's product. Very few

patients were knowledgeable of their drug product's source of manufac-

ture. The findings support the claim that a majority of patients do not

associate the trade dress of their prescription drugs with a unique

product source.

In regard to functionality, there was insufficient evidence to

conclude that the trade dress colors of prescription drugs significantly

affect patients' choice among their brand name drugs and less expensive

generically equivalent drugs. This finding and additional results

regarding patients' attitudes toward drug product appearance refute the

claim that trade dress colors of brand name drugs are functional to

consumers for the reason that patients are less likely to accept non-

look-alike generic drug substitutes.


viii
















CHAPTER I

INTRODUCTION

The Context of the Problem

The widespread adoption of state drug substitution laws during

the past decade, coupled with the increased availability and market

acceptance of less expensive generic versions of formerly patent-

protected prescription drugs, has substantially increased the demand for

generic drug products [1]. However, the rapid growth of the generic drug

market has rekindled a number of hitherto dormant public policy and legal

controversies. One such controversy is exemplified by the recent rash

of unfair competition suits brought by certain brand name drug

manufacturers against other drug manufacturers who manufacture and sell

"look-alike" generic drugs which simulate the trade dress appearance of

their brand name products [2-3]. The issue for resolution is whether it

is legal to allow generic drug manufacturers to copy the nonpatented

features of color, shape, and size of brand name prescription drug

products which have become familiar to health care practitioners and

patients, or whether such copying results in sufficient public deception,

market misrepresentation, and false designation of origin as to consti-

tute unfair competition under both the common law and the various state



For a discussion of the original generic drug "substitution" problems,
see Galbally, J.J., "Substitution as Gross Immorality," Food Drug
Cosmetic Journal, 12:758, 1958; and Stamler, J.H., "Some Legal Aspects
of the Substitution Problem," Food Drug Cosmetic Journal, 8:643, 1953.










laws and to constitute unfair competition and contributory infringement

under the Lanham Act [4].

The drug product copying cases which were litigated prior to the

current trend which favors generic drug substitution clearly indicate

that the imitation by a drug manufacturer of the "nonfunctional" trade

dress features of another manufacturer's drug product constitutes unfair

competition if those features are shown to have acquired a "secondary

meaning"[4:5-6].

In order for nonfunctionality to exist, the drug product's trade

dress features could have no functional purpose or utility aside from

identifying the product and its source [5]. If certain colors or other

distinguishing features were found to have therapeutic value, or if those

features could be shown to aid in the solubility, dispensing, or

commercial success of the drug product, then such characteristics could

be found to be functional and are therefore copyable [4:5].

In order for secondary meaning to exist, the drug product's trade

dress features must be shown to have acquired a new significance to a

substantial number of patient-consumers as an indication of the product's

source or uniqueness in the marketplace in a "trademark" sense

[5:516-22]. Once a nonfunctional drug product color or feature was shown

to have acquired a secondary meaning, it could be protected from copying

on the basis of common-law trademark [6].

In the 1980 case of Ives Laboratories, Inc. v. Darby Drug Co. et
2
al., a Second Circuit trial court refused to enjoin defendant

pharmaceutical firms from copying the trade dress coloring of plaintiff's



2488 F.Supp. 394 (E.D. N.Y. 1980).










drug product CYCLOSPASMOL [7]. The court found that the plaintiff did

not meet its burden proving nonfunctionality and secondary meaning in the

trade dress color appearance of its drug capsules.

Testimony by several of defendants' physician witnesses claiming

that patients were more likely to associate the drug product's colors

with the drug itself or its therapeutic effect, rather than its source,

was accorded substantial weight. In addition, the court was persuaded by

defendants' arguments suggesting that the capsules' trade dress colors

were copyable because they had functions aside from source identifi-

cation. The defendants claimed that their use of the identical blue and

red color combination of CYCLOSPASMOL aided in the identification of the

drug entity in emergency medical situations and facilitated consumer

acceptance at the retail level which was necessary for the drug product's

commercial success. No hard data, however, were presented to support the

claims of functionality or claims of secondary meaning in the trade dress

colors of CYCLOSPASMOL.

In sharp contrast to Ives, a Court of Appeals for the Third Circuit

affirmed the lower court's decision in SK&F Co. v. Premo Pharmaceutical
3
Laboratories, and enjoined defendant drug firm from manufacturing and

distributing trade dress copies of plaintiff's drug product DYAZIDE [8].

Here, the court expressly rejected similar arguments that the appearance

of plaintiff's capsules was functional with respect to patients or to

health professionals. In addition, substantial weight was accorded to

plaintiff's contention which suggested that the capsule's appearance was

"arbitrary" and "distinctive" and that consumer recognition of DYAZIDE



625 F.2d 1055 (3rd Cir. 1980).










was sufficiently "widespread" to establish secondary meaning. As in

Ives, no hard data were presented in support of the claims of secondary

meaning or the claims of functionality in the trade dress of DYAZIDE.

The conflicting decisions in Ives and SK&F highlight the failure of

the judiciary to bring about uniformity in unfair competition law as it

relates to drug product copying and generic drug product substitution.

Inasmuch as the elements of unfair competition are not susceptable to

precise definition, and that a balance relative to drug substitution

laws, generic drug copying, and unfair competition has yet to be struck,

it appears that the outcome of "look-alike" drug product litigation is

less predictable than for other types of unfair competition cases.

Nevertheless, the records in Ives and SK&F reveal that the legal

conclusions on the issues of functionality and secondary meaning were

based on the tenuous opinion testimony of litigants' witnesses, circum-

stantial evidence, and uncontrolled studies rather than on any impartial

scientific research.



The Purpose of the Study

The principal purpose of the study was two-fold. First, in regard

to the issue of secondary meaning, the purpose was to investigate the

manner by which patients identify their brand name prescription drugs

when they are shown only the product's size, shape, and color trade dress

appearance and to ascertain whether patients have knowledge of their drug

product's trademark name and source. Second, in regard to the issue of



4Id. at 1059.










functionality, the purpose was to discover whether the trade dress

colors) of prescription drug products significantly impact on the

patients' choice between their brand name drugs and less expensive

generically equivalent drug substitutes.5

The issues of functionality and secondary meaning in drug product

trade dress encompass a substantial part of the legal questions posed in

the "look-alike" drug product cases. While the scope of this investi-

gation is not intended to cover every aspect related to the issues of

functionality and secondary meaning, it was undertaken to better clarify

several major points of contention and, perhaps, set the stage for

studies broader in character and in scope.



Methodologic Framework

Frequently at issue in cases of trademark infringement and unfair

competition are the subjective mental associations, perceptions, or

reactions of a class of purchasers in regard to an alleged trademark [9].

Consequently, the parties in litigation have the burden of establishing

the "true" state of mind of purchasers so that the judge or jury can make

a decision based on the facts of the case [10].

The use of survey evidence in unfair competition cases as a means of

substantiating claims raised in the pleadings has become increasingly

popular for trademark owners [11]. Such evidence, however, is considered


S
It appears that the duplication of colors) is at the heart of the
functionality issue, rather than the copying of the product's size and
shape. This can be pointed out by the fact that brand name
manufacturers have not pursued unfair competition suits against generic
drug manufacturers who have changed the trade dress colors of their
products.










heresay. Since its admittance would result in the introduction into

evidence of statements made by interviewees who are not sworn or subject

to cross examination, the courts are careful in examining their technical

adequacy and prudently accord them weight [12].

The sample surveys introduced in trademark litigation have primarily

been accomplished through personal interviews, telephone calls, and mail

questionnaires [13]. They have incorporated various research techniques,

including flash-card experiments and observations at the point of sale

[14]. However, the cases clearly indicate that the most broadly appli-

cable and reliable survey format for use in trademark litigation is one

which employs a fixed form of interview seeking the unbiased reactions of

a representative sampling of relevant purchasers [14:156].

Although survey evidence may be admitted in court and given

substantial weight, there are no fixed requirements in trademark law as

to the number or percentage of purchasers who must be shown to think or

react in a specified manner in order to constitute adequate proof. The

cases indicate that a "substantial" or "appreciable" number of relevant

purchasers are necessary [15]. However, a "substantial" or "appreciable"

number do not necessarily mean a majority of purchasers, and in a given

trademark case a showing of less than a majority may suffice [15:512].

As a general rule, a survey which shows that at least a majority of

purchasers (majority test) think or react in a specified manner will



Prior to the 1950's, survey evidence was frequently barred from use in
the courts by the hearsay rule. Several cases during the 50's set
precedent allowing the introduction of such evidence in court as an
exception to the hearsay rule. For an in-depth discussion of this
issue, see Licht, L., "Public Opinion Polls as Evidence in Unfair
Competition Cases," The Trademark Reporter, 46:1462-68, 1956.










usually suffice as proof as long as the survey is found to be technically

adequate [15:513-14].

Social scientists have recorded a number of fundamentals of

designing and conducting surveys which, if adhered to, increase their

reliability and validity and thus promote their technical adequacy in

litigation [16-18]. These fundamentals include

(1) selecting an unbiased, representative sample from the relevant

population;

(2) surveying the subjects in the proper setting and context;

(3) utilizing an unbiased and reliable measuring instrument;

(4) employing a fair and uniform method of questioning the

interviewees;

(5) gathering, processing, and tabulating the data accurately and

uniformly;

(6) applying accepted statistical procedures; and

(7) expressing and explaining the results and all relevant terms in

clear and unambiguous language.

Because of the nature of the issues to be examined in this

investigation, the research questions were framed in compliance with the

requisites of the majority test. In addition, the survey fundamentals

listed above were used as a framework for the design and implementation

of this study.










The Questions Addressed by the Study

This study was designed to provide answers to the following

questions related to the issues of functionality and secondary meaning in

drug product trade dress:7

1. (a) Do a majority of patients, who are shown only the trade

dress features of size, shape, and color of their prescrip-

tion drugs, initially identify their drug product by its

trademark name or source of manufacture in a trademark

sense?

(b) Do less than a majority of patients initially identify

their drug product by its colors, functions, or effects (e.g.,

"my red heart pill") without regard to trademark?

2. Is there a difference between the percentage of patients who

initially identify their drug in a trademark sense and the

percentage of patients who initially identify their drug in a

functional sense without regard to trademark?

3. If patients do not initially identify their drug product by its

trademark name, are a majority of patients knowledgeable of its

trademark name after verbal probing and visual prompting?

4. If patients do not initially identify their prescription drug

by its source of manufacture, are a majority of patients

knowledgeable of its source after verbal probing and visual

prompting?



Questions one and two relate to both issues of functionality and
secondary meaning, questions three through six relate specifically
to secondary meaning, and question seven relates specifically to
functionality.










5. (a) Given those patients who are knowledgeable of their drug

product's trademark name, do less than majority associate that

name with the trademark of a specific company's product?

(b) Do a majority of patients associate that name with the drug

entity itself without regard to the trademark of a specific

company's product?

6. Is there a difference between the percentage of patients who

associate the trademark name with the trademark of a specific

company's drug product and the percentage of patients who

associate the name with the drug itself?

7. If patients are offered less expensive generically equivalent

drug substitutes in place of their brand name drugs, is there a

difference between the percentage of patients who choose

"look-alike" generic drug substitutes and the percentage of

patients who choose "nonlook-alike" generic drug substitutes?



In the context of this study, "look-alike" means a drug product of the
same size, shape, and color as the brand name drug. "Nonlook-alike"
means a drug product of the same size and shape but different color.











The Objectives of the Study

In attempting to answer the research questions, the following

objectives identified for the study were

1. To ascertain the percentage of patients who initially identify

their prescription drug by its trademark name or source of

manufacture in a trademark sense.

2. To ascertain the percentage of patients who initially identify

their prescription drug in a functional, nontrademark sense.

3. To discover whether the percentage of patients who initially

identify their prescription drug in a trademark sense is

significantly different from the percentage of patients who

initially identify their prescription drug in a functional

sense without regard to trademark.

4. To ascertain the percentage of patients who can identify the

trademark name of their drug product after assistance through

verbal probing or visual prompting.

5. To ascertain the percentage of patients who can identify the

source of manufacture of their drug product after assistance

through verbal probing or visual prompting.

6. To ascertain the percentage of patients who are knowledgeable

of their drug product's trademark name and who associate it

with the trademark of a specific company's product.

7. To ascertain the percentage of patients who are knowledgeable

of their drug product's trademark name but who associate it

with the name of the drug itself.










8. To discover whether the percentage of patients who are

knowledgeable of their drug product's trademark name and who

associate it with a trademark of a specific company's product

is significantly different from the percentage of patients who

are knowledgeable of their drug product's trademark name but

who associate it with the name of the drug itself.

9. To discover whether there is a significant difference between

the percentage of patients who would switch to a look-alike

generic drug substitute and the percentage of patients who

would switch to a nonlook-alike generic drug substitute.



Statement of Hypotheses

The following nine research hypotheses were formulated to address

the aforementioned research questions related to functionality and

secondary meaning in prescription drug product trade dress:



1. More than 50 percent of the patients initially identify their

drug product by its trademark name or source of manufacture in

a trademark sense.

2. Less than 50 percent of the patients initially identify their

drug product by its colors, functions, or effects without

regard to trademark.

3. There is a significant difference between the percentage of

patients who initially identify their drug product in a

trademark sense and the percentage of patients who initially

identify their drug product by its colors, functions, or

effects without regard to trademark.










4. More than 50 percent of the patients who do not initially

identify their drug product by its trademark name are

knowledgeable of its trademark name after verbal probing and

visual prompting.

5. More than 50 percent of the patients who do not initially

identify their drug product by its source of manufacture are

knowledgeable of its source of manufacture after verbal probi

and visual prompting.

6. Less than 50 percent of the patients who are knowledgeable of

their drug product's trademark name associate that name with

the trademark of a specific company's product.

7. More than 50 percent of the patients who are knowledgeable of

their drug product's trademark name associate that name with

the drug entity itself without regard to the trademark of a

specific company's product.

8. There is a significant difference between the percentage of

patients who associate the trademark name with the trademark

a specific company's drug product and the percentage of

patients who associate the trademark name with the name of th

drug entity itself.

9. There is a significant difference between the percentage of

patients who choose "look-alike" generically equivalent drug

products and the percentage of patients who choose

"nonlook-alike" generically equivalent drug products when

offered a less expense generic drug substitute in place of

their brand name drug.


ng


of



e















Content of the Remaining Chapters



Chapter II presents the background information on trademark and

unfair competition law, the relevance of the drug product copying cases

litigated prior to Ives v. Darby, and the evolution of the Ives v. Darby

cases.

Chapter III presents the literature review regarding the secondary

meaning and functionality issues and provides the theoretical foundation

of the study.

Chapter IV constitutes the methodology utilized to conduct the

study.

Chapter V gives the results and statistical analyses of the study in

respect to the objectives and the specific research hypotheses outlined

in Chapter I.

Chapter VI, the final chapter, presents a summary and discussion of

the study results, the implication of the findings, and suggestions for

future research.
















CHAPTER II

LEGAL BACKGROUND

Trademark and Unfair Competition Law

Protection of ownership interests in diverse forms of intangible

personal property has long been recognized under the common law [19]. In

addition, Congress, under authority of Article I, Section 8, Clauses 3

and 8 of the Constitution of the United States, has accorded legal

protection in the ownership rights of inventions, artistic works, and

trade symbols by enacting patent, copyright, and trademark laws which

protect these rights and reserve to the owners the exclusive use of their

business property [5:121-45].

Commercial excesses in the deliberate copying of a competitor's

product or packaging in order to achieve a greater quantum of success in

the marketplace date back many centuries [6:361]. While this practice

has to some degree been controlled by our patent laws, it is primarily

the laws of trademarks and unfair competition, based on common law

rights, which are most relevant to the drug product copying cases [20].

Historically, Anglo-American trademark law arose from a series of

court cases which over the years established common law protection of

trademark property [19:310-26]. Recovery for trademark infringement

was recorded in England [21] as far back as 1824 in Sykes v. Sykes.I



3 B. & C. 541 (1824). This English chancery court held in favor of
trademark protection because of defendant's conduct in palming off his
goods as those of the plaintiff.










Modern trademark law in the United States is derived partly from its

common law basis and partly from specific statutory enactments, most

notably the Lanham Trademark Act of 1946 [22]. Under the modern common

law concept, trademark infringement has come to be viewed, in effect, as

unlawful trading on the goodwill and reputation established by another

seller [23].

The law of unfair competition emerged out of the common law

protection accorded to trademarks [19:336]. In the earliest case law,

unfair competition was recognized when a seller was shown to have "passed

off" or "palmed off" goods of his own manufacture when the goods of

another manufacturer were requested by the purchaser [15:170]. The act

of palming off was most often facilitated by defendant's intentional

copying of the plaintiff's product labels, product features, or overall

product appearance [24].

An action for unfair competition was inherently broader in scope

than an action solely for trademark infringement [5:44-45]. Every

physical feature of the defendant's goods could be relevant, including

the product's packaging, labeling, trademark, configuration, features and

colors [5:45]. Consequently, in a suit for unfair competition, the court

had no need to focus only on one aspect of the plaintiff's product as it

did in the case for trademark infringement. However, in both trademark

infringement and unfair competition suits the keystone legal objective

was the same; it was to prevent commercial deception due to confusion or

a likelihood of confusion in the minds of the purchasing public [5:46].










Drug Product Copying Cases Prior to Ives v. Darby

The United States Supreme Court in 1924 rendered its decision in the

leading drug product copying case of William R. Warner & Company v. Eli
2
Lilly [25]. The case involved defendants' imitation of Lilly's

nonpatented chocolate-flavored quinine product COCO-QUININE which was

first marketed in 1899. The Court found that Lilly had no right to the

exclusive use of chocolate in its quinine preparation on the grounds that

chocolate was functional as a flavoring and suspending agent, aside from

imparting a distinctive color, and thus free for any manufacturer to

incorporate in its products.

Testimony in the case revealed that several of the defendants'

selling agents made statements to pharmacy retailers suggesting that

Warner's less expensive drug product could be substituted for the Lilly

product without danger of detection. In addition, deceptive

substitutions by druggists were shown to have occurred on numerous

occasions. The evidence of passing off and predatory marketing tactics

practiced by defendants' selling agents were sufficient to find Warner

and codefendants contributorially liable for the unfair competition

practiced by pharmacy retailers.

The Court granted Lilly limited relief. It enjoined defendants'

selling agents from suggesting to pharmacy retailers that they could

substitute without notice and required the defendants to place a

disclaiming statement on its drug product packages indicating that their

preparation was "not to be sold or dispensed" as those of Lilly. The



2265 U.S. 526 (1924).

31d. at 533.










Court, however, expressly refused to enjoin the manufacture and sale of

defendant's quinine preparation which was similar in appearance to the

Lilly product.

The drug product copying cases which followed Warner v. Lilly

generally relied on its rulings and adhered to its remedies,4-7 but with

some variations. If the copied features of the drug product were found

to be both nonfunctional and to have acquired a secondary meaning, and if

defendants were found to be contributorially liable for encouraging or

inducing "passing off" activities practiced by pharmacy retailers, then



Smith, Kline & French Laboratories v. Clark & Clark et al., 157 F.2d 725
(2nd Cir. 1946).

Smith, Kline & French Laboratories V. Waldman, 60 F.Supp. 646 (E.D.
Penn. 1946).

Upjohn Company v. Schwartz, 246 F.2d 254 (2nd Cir. 1957).

Norwich Pharmacal Company v. Sterling Drug, Inc., 271 F.2d 569 (2nd Cir.
1959).










the courts would enjoin the manufacture and sale of the drug product

similar in appearance to that of the plaintiff. 812

In some courts an exception to the traditional rules was recognized.

If the plaintiff, in seeking relief, could show actual passing off or a

likelihood of consumer deception as a result of defendant's copying and

predatory marketing tactics, then the plaintiff was freed from having to

meet the requirements of secondary meaning and/or nonfunctionality in its

drug product trade dress features.13-16 The cases indicate that such

predatory marketing tactics or inducements to illegally substitute could

exist in the form of salesmens' statements, postcard advertisements,

deceptive packaging and labeling, and comparison promotional literature

[26]. However, in Marion Laboratories Inc. v. Michigan Pharmacal


8
Smith, Kline & French Laboratories v. Heart, 90 F.Supp. 976 (S.D. N.Y.
1950).
9
Smith, Kline & French Laboratories v. Lipton, 89 U.S.P.Q. 418 (N.D. Ohio
1951).

10Ross-Whitney Corp. v. Smith, Kline & French, 207 F.2d 190 (9th Cir.
1953).

1Smith, Kline & French Laboratories v. Broder, 125 U.S.P.Q. 298 (S.D.
Texas 1959).
12
2Smith, Kline & French Co. v. Premo Pharmaceutical Laboratories, Inc.,
625 F.2d 1055 (3rd Cir. 1980).

13Martin H. Smith Company v. American Pharmaceutical Co., Inc. et al.,
200 N.E. 779 (C.A. N.Y. 1936).

14E.R. Squibb & Sons, Inc. v. Premo Pharmaceutical Labs, Inc., 195
U.S.P.Q. 545 (S.D. N.Y. 1977).

15Merrell-National Laboratories, Inc. v. Zenith Laboratories, Inc.
et al., 194 U.S.P.Q. 157 (D.C. N.J. 1977).

16Pennwalt Corporation v. Zenith Laboratories, Inc., 472 F.Supp. 413
(E.D. Mich. 1979).










Corporation,17 the defendant's sales catalog which compared plaintiff's

drug product to its own product was ruled not to constitute contributory

unfair competition because it was found not to have induced pharmacists

to engage in deceptive substitution.



Ives v. Darby and Related Law

In 1978, Ives brought its first suit against Darby Drug Company and

other drug firms for trademark infringement of its registered mark

CYCLOSPASMOL. The action also charged contributory trademark

infringement and unfair competition under the Lanham Act, and unfair

competition under New York state law due to defendant's sale of

identically colored generic imitations of cyclandelate capsules [27).

Aside from the traditional claim of common law unfair competition, Ives

claimed that defendants should be liable for contributory infringement

and unfair competition under the Lanham Act on the ground that

defendant's "look-alike" capsules and promotional catalogs encouraged

retail pharmacists to illegally substitute or deceptively label generic

cyclandelate with the CYCLOSPASMOL trademark. Apart from the pleadings,

New York's drug product selection law, which mandated generic drug

substitution, opened up a public policy issue for which a balance between

unfair competition and drug product copying had to be struck.

The remedies for infringement of a registered trademark under the
18
Lanham Act appear in section 32.18 The Act prohibits the use in commerce

of any reproduction, counterfeit, copy, or colorable imitation



17338 F.Supp. 762 (E.D. Mich. 1972).

1815 U.S.C. 1114.










of a registered mark without the consent of the registrant. Infringement

exists if defendant's use of the mark is likely to cause confusion,

mistake, or deceive consumers [27:235]. This section has also been

construed so as to make any party contributorially liable for the

infringing action of another party if he supplies the means by which a

consumer may be deceived [27:235]. The contributing infringer, however,

must be shown to have deliberately induced, encouraged, or knowingly

facilitated the infringing action of another party in order for liability

to attach [26:39-42].

Under section 43(a) of the Act, false designations of origin and
19
false descriptions are .forbidden.19 This section has become recognized

as the federal law of unfair competition [281. Claims made under this

section frequently stem from a competitor's copying either a prominent

product feature or the product's overall appearance, apart from any

claims of trademark infringement [27:236]. However, to sustain an unfair

copying claim under section 43(a), the plaintiff must show existence of

secondary meaning under the common law because he lacks the presumptive

source association of a registered trademark [27:237]. That is, the

plaintiff must establish "trademark" significance in the product's

contested feature in order to show a likelihood that consumers can be

confused. In addition, the product feature alleged to have trademark

significance must meet the requirement of nonfunctionality [27:237].



1915 U.S.C. 1125a.










In Ives, the lower court refused to grant a preliminary injunction
20
against defendant's drug product copying.20 In regard to the unfair

competition claim under section 43(a), the court found that Ives did not

unequivocally establish that the colors of its CYCLOSPASMOL capsules were

nonfunctional or had acquired a secondary meaning. In addition, it found

insufficient evidence that defendants had conspired with pharmacists or

suggested that they improperly substitute or label generic cyclandelate

with Ives' registered trademark CYCLOSPASMOL in violation of federal or

state unfair competition law. The lower court indicated that the Lanham

Act could not be employed to prevent manufacturers of generic drugs from

copying the colors of brand name drugs and that granting a monopoly in

the colors of plaintiff's drug product would "inhibit legitimate

substitutions which the New York legislature has found in the public

interest."21

On the appeal from the denial of preliminary relief, the Second
22
Circuit refused to overturn the lower court's decision.22 However, it

differed as to the criteria required to establish contributory

infringement claims under section 32 of the Lanham Act. The court held

that a drug product imitator may be liable for contributory infringement

if he suggested, even if only by implication, that a retailer fill a

bottle with generic capsules and apply Ives' nark CYCLOSPASMOL to the



20
20Ives Laboratories, Inc. v. Darby Drug Co. Inc. et al., 455 F.Supp. 939
(E.D. N.Y. 1978).

1Id. at 951.

22601 F.2d 631 (2nd Cir. 1979).
601 F.2d 631 (2nd Cir. 1979).









23
label.23 Nevertheless, the appellate court was constrained to agree with

the lower court's findings of fact that Ives had failed to provide that

quantum of evidence necessary to sustain a preliminary injunction under

either section 43(a) or section 32. It remanded the case to trial under

its analysis and indicated that if defendants could show evidence which

would suggest that copying was an essential function to the commercial

success of the generic drug, then that evidence would be especially

pertinent.24

On remand, the trial court rejected Ives' argument that defendant's

"look-alike" drugs and promotional catalogs suggested, even by

implication, that pharmacists fill bottles with defendant's generic

cyclandelate and apply Ives registered trademark CYCLOSPASMOL.25 In

regard to Ives' unfair competition claim under section 43(a), the court

once again found that Ives did not meet the traditional requirements of

secondary meaning or nonfunctionality. On the contrary, it found that

the color of Ives' capsules might have identification functions in

medical emergencies and commercial success functions. The court also

indicated that consumers associate the drug colors more often with the

drug itself or its effect, rather than a particular source or in a
,26
trademark sense.26



23Id. at 636.

4Id. at 644.

25488 F.Supp. 394 (E.D. N.Y. 1980).

26Id. at 400.










Additional evidence presented by Ives indicated that of 35 pharma-

cists who substituted a generic cyclandelate product in place of CYCLO-

SPASMOL, 10 labeled the prescription with the CYCLOSPASMOL trademark in

27
some manner.27 However, only one pharmacist was found to have passed off

the generic drug as CYCLOSPASMOL and to have charged the brand name

price. The court dismissed the mislabeling evidence as instances where

"druggists have misunderstood the precise requirements of New York drug

substitution laws" and stated that pharmacists "appear not deliberately

to have been attempting to pass off the generic drug product as

CYCLOSPASMOL."28

The trial court's decision on the claim of contributory infringement

was appealed on the ground that defendant's drug copying, comparison

catalogs, and additional evidence of mislabelings did, undisputedly,

establish a violation of section 32 of the Lanham Act. On the second

appeal, the Second Circuit concluded (in a 2 to 1 decision) that the

evidence clearly established defendant's liability for contributory
29
infringement.29 The court reasoned that defendants should have

anticipated that the use of "look-alike" capsules and comparison catalogs

would result in illegal substitutions and trademark mislabelings by a

substantial number of pharmacy retailers. No judgments were reached on

Ives' unfair competition claims under section 43(a) of the Act. The

court was of the opinion that the simplest way to reduce illegal



7Id. at 397.

28
Id.

29638 F.2d 538 (2nd Cir. 1981).










substitutions and mislabelings would be to require defendants to sell

their drug products in capsules which did not resemble CYCLOSPASMOL.30

Defendants appealed to the Supreme Court on the ground that the

Appellate Court erred in finding them in violation of section 32 of the

31
Lanham Act given the evidence at trial.31 Certiorari was granted and the

case was heard in February, 1982. The key questions presented to the

Court in defendant's petitions for certiorari are summarized below.32

1. Can the trade dress appearance of a pharmaceutical firm's

nonpatented drug product gain sufficient "trademark"

significance in the marketplace to grant pharmaceutical firms

an exclusive property right in size, shape, and color?

2. Does the intentional trade dress copying of an innovator

pharmaceutical firm's nonpatented drug product constitute

sufficient market misrepresentation and contributory

infringement, false designation of origin, and unfair

competition under federal and state law to preclude generic

pharmaceutical firms from the manufacture and sale of generic

drug product "look-alikes" in light of drug product selection

laws and public policy which fosters generic substitution?

33
The opinion of the Court was delivered on June 1, 1982.33 The Court

did not address the broader issues related to drug product copying as

presented in the defendants' petitions for certiorari. Instead, it

unanimously reversed the Court of Appeals on the narrow issue of



0Id. at 545.
31
31BNA's Patent Trademark & Copyright Journal, 568:A-1, February, 1981.

3250 U.S.L.W. 3266 (October 1981).

33BNA's Patent Trademark & Copyright Journal, 582:103, June, 1982.
BNA's Patent Trademark & Copyright Journal, 582:103, June, 1982.










contributory infringement (section 32) and remanded the case back for

review of Ives' section 43(a) claim (false designation of origin) which

was not reached at the appellate level.

The Court ruled that the Court of Appeals made a procedural error by

setting aside the lower court's findings of fact without showing them to

be clearly erroneous. The majority opinion indicated that (1) the lower

court's findings were not unreasonable; and (2) that the Court of Appeals

had unjustifiably diluted the test for contributory infringement under

section 32.

Unless the Court of Appeals finds the lower court's findings clearly

erroneous, it appears that Darby and codefendants will be exonerated of

all charges. Nevertheless, the Supreme Court ruling clearly indicates

that brand name drug manufacturers can still seek to prevent copying of

their products under section 43(a) of the Lanham Act, as well as state

unfair competition law, if they can present stronger evidence in support

of nonfunctionality and secondary meaning in their drug products' trade

dress. Since functionality claims and secondary meaning claims will

continue to be debated by drug manufacturers in future "look-alike"

cases, this research may be valuable to the parties because it

constitutes an evaluation of the issues based on objective, controlled

study.
















CHAPTER III

REVIEW OF THE LITERATURE

The Issue of Secondary Meaning

One undisputed consequence of state generic drug substitution

legislation has been the increased frequency with which generic drug

look-alikes have entered the market. The benefits, drawbacks, and legal

actions resulting from the marketing of such products have been widely

discussed in the literature [2,3,6,29-36].

Two fundamental legal issues regarding look-alike prescription drugs

are examined in this study. The first is whether the size, shape, and

color appearance of brand name drugs are sufficiently distinctive to

identify medications in the same way a trademark aids a consumer in

recognizing a specific product. In trademark law, the proof of

distinctiveness is equated with the finding that the product's colors and

features have acquired a secondary meaning to consumers thereby

identifying a unique product source.

As might be expected, brand name drug manufacturers claim that drug

product colors and shapes develop a secondary meaning to patients with

extended use of the medication. Generic drug manufacturers, on the other

hand, claim that such features identify only the drug entity to patients

rather than a drug product produced by a specific company. If generic

drug manufacturers' claims are upheld, features such as size, shape, and

color will have no trademark protection and may be copied at will.










The literature reveals a lack of empirical research regarding the

manner in which patients primarily identify their prescription drugs or

how patients perceive prescription drug brand names. The lack of studies

in this area may be due to pharmaceutical companies' hitherto traditional

practice of refraining from advertising or promoting prescription brands

directly to the public [37]. Nevertheless, the subject of brand

awareness, brand perception, and brand preference has been extensively

studied in respect to other consumer goods.

The marketing literature indicates that an individual's awareness

and knowledge of brands is correlated with the nature of the product, its

purchase frequency, mass media exposure (advertising and promotion) and

opinion leadership [38-40]. In addition, predispositional factors such

as sex, age, education, income, and social class have been found to be

associated with an individual's awareness, knowledge, and perception of

specific brands [41-42].

A common methodology used to evaluate the ability of consumers to

identify and distinguish brand products is controlled experimentation.

Allison and Uhl tested 326 beer drinkers with unlabeled beer products in

order to determine if they could identify and distinguish by taste

specific brands with which they were familiar [43]. Charton and

Ehrenberg used a consumer panel of 180 housewives to examine brand

identification and brand loyalty of frequently purchased consumer goods

[44]. Participants were asked to purchase once a week one brand of four

unmarked detergent products and one brand of three unmarked tea products

which were priced at different levels but which did not differ in

formulation.










Another method used to evaluate consumer knowledge and perception of

branded goods incorporates self-administered questionnaires. Keiser used

a questionnaire instrument which incorporated visual prompting with

product brand names [45]. Subjects were asked to indicate the type of

product which was associated with a specific brand name. Peter and

Tarpey used questionnaires on 217 college students to measure brand

identification, perception, and preference of automobiles [46]. The

subjects were prompted with profile cards of automobiles that contained

different kinds of information on each brand and asked to indicate their

opinions on seven point semantic differential scales.

In addition to controlled experiments and questionnaires, personal

interviews have frequently been used to measure consumer brand knowledge.

Woodside and Fleck conducted in-depth interviews with consumers at their

homes to evaluate brand knowledge and brand choice of beer [47]. Rao

conducted interviews with 50 subjects to examine whether profile

information of automobiles affected brand perception and brand preference

[48]. Bogart and Lehman interviewed 400 housewives in their homes to

evaluate brand awareness of goods [49]. The subjects were paid five

cents for every brand they could recall in a product class without aid or

prompting. It is interesting to note that brand name recalls for

pharmaceuticals (prescriptions and otc) represented only 1 percent of all

brands mentioned by the subjects.

In summary, a review of the literature indicates that very little

empirical research has been conducted in regard to consumers' brand

awareness, brand knowledge, or brand perceptions of prescription drugs.

Nevertheless, the marketing literature reveals that the subject has been










studied extensively for other types of consumer goods. Methodologies

incorporating either controlled experiments, questionnaires, and personal

interviews are used most often to study consumer knowledge and perception

of branded products. Apparently, most studies utilize a combination of

two or more of the methods.

Even though pharmaceutical companies have not traditionally

advertised and promoted prescription brands directly to the public, at

least one manufacturer has broken tradition and started to do so with one

of its prescription drugs [50]. Recent literature indicates that this

practice may become more prevalent in the near future [51-52]. As a

consequence, an increase in reported research related to patients'

knowledge and perception of brand names of prescription drugs can be

expected in the literature.



The Issue of Functionality

The second legal issue examined in this study is that of

functionality in the trade dress colors of brand name drugs. Generic

drug manufacturers contend that drug product colors are functional and

therefore are copyable because patients would be less likely to purchase

a less expensive generically equivalent drug product which looks

different from the brand name drug. Brand name drug manufacturers rebut

this argument by contending that drug product colors are arbitrary,

inherently nonfunctional, and do not affect a patient's willingness to

purchase a generic drug. If generic drug manufacturers' claims of

functionality are upheld, they will then be free to market "look-alike"

generic versions of patent-expired brand name drugs.










There have been relatively few studies reported in the literature

regarding consumer attitudes and acceptance of generic drug products.

Nelson and Gagnon mailed out questionnaires to 1000 housewives and

reported that only 20 percent of the respondents absolutely preferred

that the pharmacist not substitute a generic drug [53]. More than 65

percent of the respondents indicated they would accept a less expensive

generic substitute on most prescriptions unless the physician had

specifically ordered a certain brand name be dispensed. The

investigators also found that willingness to accept a generic product

increased with the individual's income and education but decreased with

age. In a separate study, the same investigators found that a majority

of consumers were willing to accept a generic drug product if the savings

were as little as 5 percent [541.

Mason and Bearden conducted interviews and questionnaire studies

with pharmacists, physicians, and consumers in order to determine salient

factors of generic drug product prescribing and acceptance [55]. The

interviews revealed that dimensions of quality, price, and effectiveness

were important to consumers. The dimensions of safety, side effects,

reputation of manufacturer and efficacy were found to be most important

to health practitioners.

In another study, Bearden, Mason and Smith found that willingness to

accept a generic drug substitute in an elderly population was associated

with the perceived risk [56]. Older patients were found to perceive more

overall risk toward generic drug prescribing than younger patients.

Lambert, Doering, Goldstein, and McCormick used a questionnaire

instrument to measure the impact of two levels (high and low) of brand











name drug prices on generic drug acceptance [57]. They found that

approximately one-third of the 510 respondents were willing to accept a

generic substitute for either high priced or low priced brand name drugs.

Age and perceived drug effectiveness were linked most consistently with

drug choice. In addition, generic drug rejection was found more likely

to be associated with females, with persons having lower annual incomes,

with persons having low general drug knowledge, and with persons having

beliefs that serious consequences could result from the use of less

expensive drugs.

In an exploratory study, Carroll and Jang reported that 66 percent

(35 of 53 patients) of their sample preferred to have a generic drug

[58]. About 77 percent of the subjects felt that generics were the same

as brand names in terms of effectiveness, 75 percent felt they were the

same in terms of safety, and 95 percent felt they were less expensive

than the brand name drug.

LaBarbera conducted a questionnaire study to examine the acceptance

of generic foods and generic drugs and found that approximately 60

percent of the respondents were willing to accept generic products [59].

She reported that 41 percent of respondents had purchased generic foods

or drugs in the past. Of those subjects who had not purchased generics,

52 percent indicated they were willing to try generics in the future.

White and Geiger used a questionnaire instrument to measure consumer

attitudes and behavior toward drug product substitution [60]. The

results from 448 respondents indicated that the subjects' beliefs about

the quality of the generic drug, their years of education, the number of

prescriptions they purchased annually, and their annual expenditure for










drugs were most associated with their willingness to purchase generic

drug products. No significant relationships were found between willing-

ness to accept generic drugs and predispositional factors such as age,

income, and who paid for the prescription. Approximately 40 percent of

the sample indicated they had purchased a generic drug sometime in the

past.

Baldwin and Berger used a cartoon technique to evaluate consumer

acceptance of drug product substitution activities of pharmacists [61].

Subjects were asked to supply the speech of a patient (cartoon) character

responding to four different versions of a pharmacist suggesting a

generic drug substitute. The results from 528 subjects indicated that

slightly over 50% would have accepted the generic drug substitute.

Perceptions of quality, equivalency, and price were most associated with

generic drug acceptance. Demographic factors were not studied in this

investigation.

The differences in results of the cited studies can be partially due

to the diverse designs and techniques used to measure generic drug

acceptance. A basic methodological problem addressed by several of the

investigators was the manner in which "generic drug" was defined.

Carroll and Jang reported that only 59 percent of their sample understood

the term "generic" [58]. LaBarbera reported that only 50 percent of her

sample were actually knowledgeable of generic drugs although 58 percent

had indicated they thought they knew the meaning [59].

In summary, the literature indicates that perceptions of quality,

price, and effectiveness may be the most important factors related to

patient willingness to accept generic drugs. In addition, the studies










indicate that predispositional factors such as an individual's sex, age,

income, education, drug product consumption, drug expenditures, and

previous experiences with generic products may affect acceptance of

generic drugs. Research related to the impact of drug product appearance

on the acceptance of generic drug substitutions was not, however,

investigated in any study. In considering the legal debate regarding the

functionality issue and the lack of information on this subject, the

investigator felt this issue was important to address through controlled

study so that the results might be useful to decision makers.



Theoretical Foundations

The purposes of this study are to examine how patients identify

their prescription drug products, to ascertain whether patients are

knowledgeable of their drug product's name and source, and to evaluate

patients' choices between their brand name drugs and less expensive

generically equivalent look-alike and nonlook-alike drugs. The

theoretical foundations of the study arise from psychology, behavioral

science, and in particular from consumer behavior.

Two fundamental theoretical positions underlying consumer behavioral

research have achieved prominence. The first is termed "drive-habit"

theory, which is adapted from the classic work of stimulus-response

learning theorists such as Thorndike, Pavlov, Skinner, and Hull [62].

Drive-habit models of consumer behavior posit that consumer purchasing is

more or less a learned response. The interplay of internal drives

(needs), external stimuli (cues), and rewards (reinforcements) are

assumed to play major roles in determining purchase behavior [63]. A










variety of stochastic models of brand choice based on learning theory are

present in the literature [64].

The second theoretical position is termed "expectancy-value" theory

and is associated with the work of psychologists such as Tolman and

Lewin [62]. According to the general theory, man is seen as responding

to the expected consequences of a given behavior [62]. Expectancy-value

models of consumer behavior emphasize goal-directed action tendencies.

The action tendency is defined to be a function of the perceived

magnitude or utility of the goal object and its probability of

attainment. One model which has received a great deal of attention in

the marketing literature is the expectancy-value model adapted from a

formulation proposed by Fishbein [65]. The "extended" version of

Fishbein's behavioral model as adopted by Ryan and Bonfield [66] is

illustrated conceptually in Figure I.

According to this theory, an individual is assumed to form a

specific behavioral intention which directly determines his subsequent

overt behavior. Two major factors are assumed to determine behavioral

intention: (1) the individual's attitude towards the behavior, and (2)

the individual's subjective norm (social influence) towards the behavior.

The attitude component is defined to be a function of the individual's

beliefs about the consequences of performing the behavior and the

individual's evaluation (e.g., goodness or badness) of the expected

consequences. The subjective norm is defined to be a function of the

individual's normative beliefs (e.g., the person's belief that a referent

group or individual thinks he should or should not perform the behavior)

and the individual's motivation (e.g., desire or lack of desire) to

comply with those beliefs.














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The Fishbein model has been extensively investigated and found

useful in explaining and predicting an individual's brand preference

[66-70]. In a consumer behavior context, the model takes the form as

illustrated in Figure II.

The assumption underlying the application of the model to consumer

purchasing behavior is that an individual develops purchase attitudes

towards specific brands of products which determine his purchase

intention [71]. The individual's purchase intention is then assumed to

direct his purchase behavior.

According to the model, an individual will process information in

forming specific beliefs about salient product attributes (e.g., style,

appearance, price, texture, taste, etc.) to arrive at a purchase attitude

toward each known brand. The strength or magnitude of the attitude

formed towards each brand is assumed to shape purchase intention and

thus, direct purchase behavior. In addition to attitude, the theory

holds that the individual's social or subjective norm (e.g., the strength

of beliefs regarding brand choice of referent individuals or groups) will

shape his purchase intention. However, there is some disagreement about

the usefulness and predictive power of this component of the model [72].

It is clear from the literature that attitudes and even purchase

intentions are not completely reliable predictors of actual buying

behavior. Predispositional factors, such as demographic variables [73]

(e.g., age, sex, education, income, social class) and personality

variables [74] (e.g., traits and life-styles) have been found to be

associated with brand choice. In addition, situational factors (e.g.,

importance of purchase, financial state, product availability) are known




























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to shape purchase intentions and purchase decisions [751. These factors

are illustrated in the model in Figure II.

In this study, the manipulated independent variable and attribute of

interest is the color appearance of a generic drug product substitute.

The dependent variable is the patients' purchase choice of either the

brand name drug which they are familiar with or a less expensive

look-alike or nonlook-alike generic drug substitute. The controlled

experiment involves exposing patients to different appearing samples of

fictitous generic drug products to test whether the looks of the generic

product affect patients' purchase intention. Because the generic drug

samples are fictitious, patients can have no prior brand beliefs or

attitudes toward these products. Thus, the Fishbein model as applied to

this research involves only belief and attitude formation, not change.

In designing the study, the investigator attempted to control for

salient product attributes of generic drugs which were identified from

the literature. These attributes included generic drug equivalency,

effectiveness, and economic savings. All subjects were given verbal

information indicating that the generic drug was the same medication in

the same strength and potency as their brand name drug. Patients were

also told that the dispensing of the generic product would likely result

in approximately a one-third savings on their prescriptions.

The most important social (normative) influences identified from the

literature came from the physician and the pharmacist. Information

received from these sources were also controlled. Patients were told to

assume that their physician had given his consent on the prescription for

a generic drug substitute and that the pharmacist was willing to dispense

a less expensive generic drug with confidence if they chose to purchase

it.










In addition to the factors above, a number of salient predisposi-

tional variables identified from the literature which were thought to be

associated with the willingness of patients to accept generic drugs were

evaluated for equal distribution among the look-alike and nonlook-alike

experimental groups. Specifically, the demographic variables of sex,

age, annual income, and highest education level were examined.

Additionally, other factors thought to impact on generic drug acceptance,

such as total prescription drug use, the pharmacologic class of the brand

name drug, the length of time the patient had been taking the brand name

drug, who pays the cost of the prescription, past discussions of generic

drugs with health practitioners, and past experiences in taking generic

drugs were evaluated for equal distribution among the experimental

groups.

The above text concludes the review of the literature. The next

chapter, Chapter IV, presents the methodology used to conduct the study.















CHAPTER IV

METHODOLOGY

Overview

A survey of 240 patients was conducted in six community pharmacies

in Gainesville, Florida. Patients in the study were identified as taking

at least one single-source, brand name prescription drug over the

extended period of time which was chosen for the investigation. The

survey was accomplished utilizing a structured interview/questionnaire

instrument designed and pretested by the investigator. It was divided

into three separate parts (Part I, Part II, and Part III) for

administration. The first patient survey was taken on November 9, 1981,

and the last survey was taken on May 20, 1982.

In Part I, patients were shown a sample of their single-source,

brand name drug product with its trademark side not visible. A fixed

form interview was conducted to uncover the manner in which patients

initially identified their drug product and to ascertain whether they

were knowledgeable of the drug product's trademark name, source, and

function. In addition, patients were asked what they thought the

trademark name of their drug product meant. This part of the study was

primarily designed to evaluate secondary meaning in prescription drug

product trade dress appearance.

In Part II, a controlled experiment was conducted to investigate

whether the trade dress colors of prescription drugs have significant









impact on patients' purchase choice between their brand name drugs and

less expensive generic drug equivalents. This part of the study was

designed to discover whether the trade dress colors of brand name drugs

are functional in respect to patients' acceptance of generic drug

products.

Patients were randomly divided among two experimental conditions.

In the control group, patients were shown mock samples of "look-alike"

generic drugs which had the same size, shape, and color as their brand

name drug. In the treatment group, patients were shown mock samples of

"nonlook-alike" generic drugs which had the same size and shape as their

brand name drugs, but which differed in color. Patients in both groups

were initially informed that a less expensive generic version of their

brand name drug would soon be available on the market. In addition, the

patients received a brief explanation about generic drug substitution as

required under Florida's generic drug substitution law. The patients

were shown the mock samples and asked if they would want their pharmacist

to continue dispensing the brand name drug or if they would want to

switch to the less expensive generic drug equivalent. In addition,

several open-ended questions were asked in order to gain insight into the

patients' decision-making rationale.

In Part III, patients were asked to respond to questions posed in a

self-administered questionnaire. The data obtained from the question-

naire were used to describe the demographic characteristics of the

resulting patient sample, to evaluate certain predispositional factors

associated with patients' acceptance of generic drugs, and to compare the

distribution of these characteristics and factors between the two experi-

mental groups.









The Survey Population

The survey population consisted of community pharmacy patients, at

least 18 years of age, who were currently taking on a long-term (refill)

basis one of twenty-five single-source, brand name prescription drugs

selected for the investigation. Only those patients who paid out-of-

pocket in whole or in part for their medications were pertinent to this

investigation. Patients who did not pay for their medications (e.g.,

Medicaid recipients) were purposely excluded from the study because they

would have no motivating monetary incentive to switch to a less expensive

generic drug. In addition, these patients commonly have no real choice

among equivalent prescription drugs because regulations under government

insurance programs (e.g., MAC regulations) dictate that the pharmacist

dispense the lower cost product.

The drug products selected for investigation were identified in

respect to four pharmacologic drug categories for which long-term

medication therapy is usually indicated [76]. These categories are (1)

cardiovascular drugs; (2) nonsteroidal anti-inflammatory drugs; (3) mild

tranquilizing drugs; and (4) gastrointestinal drugs.

The investigator identified all single-source, brand name drugs in

tablet or capsule dosage form which fell into one of the selected

pharmacologic categories and which was reported in the list of the "Top

200 Drug Products" for 1980 [77]. Twenty-five single-source, brand name

drug entities were identified for potential investigation. A number of

the drug entities came in more than one dosage strength. Thus, the 25

drug entities represented a total of 54 different drug products.

Appendix A illustrates the 54 drug products identified for the study.









The single source status of each brand name drug was validated

through information obtained from the Food and Drug Administration's

"Approved Prescription Drug Products" publication [78]. The study was

limited to single-source drugs in order to assure that patients had not

previously been offered a less expensive generic substitute for that

particular drug entity.



Selection of the Sample

In the initial phase of the study it was determined that a minimum

sample size of 238 patients (119 patients per experimental group) would

be necessary in order to find significance in the results. It was

decided that a total of 240 patients would be included in the study.

A judgmental sampling procedure was utilized to select patients for

the survey. Six community pharmacies in Gainesville were selected on the

basis of ownership classification and location in order to obtain a

reasonable cross-section of patients. Accordingly, three chain-owned



The sample size was determined in respect to the number of patients
required in each of the two groups in the research experiment. The
underlying assumptions of the sample size determination were (a) that
at least 80 percent of the patients would accept the generic drug; (b)
that a difference of ten or more percentage points between the two
experimental groups would be significant; and (c) that the level of
significance of the statistical test would be 0.05. See Fleiss, J.L.,
Statistical Methods for Rates and Proportions (New York: John Wiley &
Sons, 1973), p.194.









pharmacies and three independently owned pharmacies were identified as

desirable practice settings in which to conduct the survey. These

pharmacies were contacted and they agreed to participate in the study.

The pharmacies and their locations appear in Appendix B.

The sampling plan called for a quota sample of 40 patients per

pharmacy. To generate the sample population, the investigator spent

between eight and twelve consecutive work days at each pharmacy

identifying and interviewing patients as they appeared to have their

prescription drugs refilled. The pharmacist on duty informed the

investigator each time a patient was eligible for inclusion in the study.

This was accomplished by verbal signal or by the pharmacist's notation on

the patients' prescription bags. In some instances the investigator was

able to identify potential subjects by their prescription vials which

were brought into the pharmacy for refills. The specific criteria for

inclusion were

(1) the patient had to be at least 18 years old;

(2) the patient had to be taking at least one of the investigative

prescription drugs included in the study on a refill basis;2

(3) the patient had to have at least one month's experience in

taking the drug; and

(4) the patient had to pay for the drug, in whole or in part, out-

of-pocket.


2
In those cases in which a patient was refilling more than one drug
product selected for the study, the first product which was identified
by the investigator or the pharmacist on duty was utilized in the
investigation.









Patients who presented themselves in the pharmacies during the

investigation and who met the above criteria were approached and asked to

participate in the study. Patients were told that the investigator was a

pharmacist pursuing a graduate degree who would like to ask them some

questions about their medication therapy. Patients who agreed to

participate were asked for their signed consent in compliance with

University of Florida regulations which clearly stated the purpose of the

study. The consent form appears in Appendix C.



Laboratory Procedures

Prior to the start of the study, the investigator obtained three

samples of each drug product selected for the investigation. The various

tablets and capsules were affixed to cards of white cardboard (1 inches

square) and organized in an indexed expanding folder.

The first sample of each drug product was attached with the

trademark clearly visible. In Part II (the controlled experiment), these

products were to be shown to the patient alongside its mock generic

counterpart for visual comparison.

The second sample was attached with the trademark side down so as

not to be visible, therefore allowing only the drug product's size,

shape, and color appearance to be apparent. These products had a dual

purpose. In Part I, they were to be shown to patients for identifi-

cation; in Part II, they were to be utilized as the sample "look-alike"

generic drugs.

The third sample was also attached with the trademark not visible.

However, these drug products were purposely altered to appear different,

solely in color, than the first and second sample drug products. They









were to be utilized as the sample "nonlook-alike" generic drugs in

Part II of the study.

The trade dress colors of the brand name drugs and the "nonlook-

alike" mock generic products utilized in the study appear in Appendix A.

To establish uniformity and control, the investigator recoated most of

the brand name products with a navy blue color. This shade of color is
3
frequently found in various drug products. In several instances, the

"nonlook-alike" mock generic products were created from existing

blue-colored drug products that had the same basic size and shape as the

brand name product. In those cases where the investigative brand name

products were already coated blue, the colors tan or yellow were utilized

to create the "nonlook-alike" generic product appearance.



Instrumentation and Pilot Study

During the initial phase of the study, a fixed form

interview/questionnaire instrument comprised of three parts was designed

to collect the data necessary to address the research objectives. The

instrument was developed so that each of its parts could be administered

separately. Part I incorporated the personal interview, Part II the

controlled experiment, and Part III the self-administered questionnaire.

The instrument was pretested in a two-day pilot study which began on

November 2, 1981. It was conducted at the Shands Teaching Hospital out-

patient pharmacy in Gainesville, Florida. A total of 12 patients who



3
For example, see the product identification section of a Physicians'
Desk Reference (PDR) for common drug product color coatings.
Physicians' Desk Reference (Oradell, New Jersey: Medical Economics
Company, 1981).









met the study criteria were surveyed. Each survey took between five and

ten minutes of the patient's time.

Following the pilot study, the interview/questionnaire instrument

was evaluated for question content and appropriateness of the response

categories. In addition, the instrument was corrected for potential bias

introduced by specific wording of the questions. Instructions to the

interviewer appearing in the instrument were rewritten for clarity to

assure consistent administration of the survey.

The pilot study was useful in that it familiarized the investigator

with the data collection process and provided him with experience in

conducting the survey with objectivity and consistency. The final form

of the interview/questionnaire instrument appears in Appendix D.



Variables of Interest and Data Collection Procedures

Part I-The Personal Interview

The specific variables to be investigated in this part of the study

were adopted from studies found in the marketing literature measuring

consumer awareness and knowledge of branded goods [38-45]. The variables

were

1. the patient's fundamental recognition of his drug product;

2. the patient's initial responses as to the identification of his

drug product;

3. the patient's knowledge of the drug product's source after

verbal probing;

4. the patient's knowledge of the drug product's source after

visual prompting;

5. the patient's knowledge of the drug product's name after verbal

probing;









6. the patient's knowledge of the drug product's name after visual

prompting; and

7. the patient's knowledge of the function of his drug.



The investigator began each interview by showing the patient a

sample of his drug product which was attached to the sample card with its

trademark not visible. Next, the patient was handed the sample drug

product for close inspection. The investigator then asked the patient to

simply respond "yes" or "no" to the question of whether he recognized or

had seen the drug product before. The patient's answer was recorded by

checking the appropriate response category on the data collection

instrument. The drug product was then withdrawn from the patient's view.

A patient who responded positively to the first question was asked if he

could identify the drug product he was shown. One or more check marks

were entered in accordance with the patient's response and the categories

incorporated in the data collection instrument. If a patient had

initially given a negative response to the first question, he was told

the brand name of his medication. No further questions in Part I of the

survey were asked to that group; they were led to Part II of the study.

A patient who did not initially identify his drug product with the

manufacturer's name was asked by verbal probe if he knew what company

made the drug. If his response was negative or indefinite (e.g.,

incomprehensible), he was shown a prepared list of 22 drug manufacturers

which appeared in alphabetical order and asked if he could identify the

drug manufacturer. Appendix E illustrates the list of 22 drug

manufacturers incorporated in the visual prompt.









A patient who did not initially identify his drug product by its

trademark name was verbally probed as to whether he knew the name of his

drug product. If his response was negative or indefinite (e.g.,

incomprehensible), he was shown a prepared list of 48 trademark names of

drug products which appeared in alphabetical order and asked if he could

identify the name of his drug product. Appendix F illustrates the list

of 48 trademark names used as a visual prompt.

In addition to collecting information on the variables listed above,

a decision was made following the initiation of the research project to

examine a variable related to the patient's understanding as to the

meaning of the trademark name of the drug product. A patient who

identified the trademark name of his drug product either initially, under

verbal probing, or under visual prompting was asked if the name of his

drug, "XYZ," was a trademark name identifying a specific company's drug

product, or if it was the name of the drug itself. Since this question

was added after 120 patients had already been interviewed, it could only

be posed to a potential sample of 120 patients remaining to be surveyed.

This question was added to page one of the data collection instrument as

question (2a).

The final question included in Part I of the study was whether the

patient knew the functional reasons) he was taking the drug. Following

the patient's response, the investigator continued to Part II of the

investigation, the controlled experiment.









Part II--The Controlled Experiment

The single dependent variable to be investigated in this phase of

the study was the patient's purchase choice between his brand name drug

and a less expensive generically equivalent drug. The specific product

attribute of interest and independent variable to be investigated was the

color appearance ("look-alike" or "nonlook-alike") of the less expensive

generically equivalent drug product. In addition to ascertaining the

patient's choice, two open-ended exploratory questions were posed to all

patients in order to gain some insight into (1) their decision-making

rationale; and (2) their attitude towards generic drug color appearance.

These questions were

1. Why did you choose the generic (or brand name) drug?

2. Would it matter to you if the color of the generic drug was the

same as (or different) than the brand name?

The responses to these questions were recorded and subsequently

categorized upon completion of the survey.

Prior to the start of the study, the investigator randomly assigned

240 patients to one of two experimental condition groups of 120 each. A

random numbers table was utilized for patient group assignment [79]. The

appropriate assignment group for each patient was marked on the data

collection instrument.

In the control group, 120 patients were shown a mock "look-alike"

generic drug product (sample card #2) alongside the brand name drug they

were taking (sample card #1). In the treatment group, 120 patients were

shown a mock "nonlook-alike" generic drug product (sample card #3)

alongside the brand name drug they were taking. Patients in both groups

were initially told that there was a generic drug that would soon be









available on the market. In addition, the patients were also told that

the generic drug would be the same medication in the same strength and

potency as their brand name drug, but that it would be less expensive.

The patients were then shown the mock generic drug samples alongside

their brand name drugs. The investigator explained that the Florida

generic drug substitution law required the pharmacist to offer the

patient a less expensive generic version of their brand name drug if the

physician would allow a substitution and if the pharmacist stocked the

equivalent generic drug for substitution purposes [80]. In addition it

was explained that the dispensing of the generic drug would likely result

in approximately a one-third savings to the patient on his prescription.5

This savings was also translated into approximate dollar amounts. After

this explanation, each patient was asked if he would want the pharmacist

to continue to dispense the brand name drug, or if he would want the



A number of patients questioned why the generic drug was less expensive
if it was the same as the brand they were taking. They were told that
the company which made the generic product did not have the promotional
and advertising expenses of the company which made their brand name
drug, nor the research expenses, and thus could sell their products at a
lower price.

The savings attributed to a generic drug substitution were based on
actual market data collected by the University of Florida. See Vuturo,
G.J., Krischer, J.P. and McCormick, W.C., "Drug Product Selection: The
Florida Experience," American Journal of Public Health, 70:479, May,
1980.









pharmacist to dispense the less expensive generic drug.6-7 The patient's

response was recorded by checking the appropriate indicator space

(look-alike choice or nonlook-alike choice) on the data collection

instrument. Next, the investigator asked the two open-ended questions

referred to above. The patient's responses were recorded as given on the

data collection instrument.

At this point in the interview, the investigator fully explained the

reason for the experiment:

"The generic drug product samples you have just been shown are

not available on the market. They are fictitious samples of

patented drugs which we have designed to see if their appearance

would affect your response to whether you would switch to the

generic drug product. However, sometime in the future a real lower

cost generic equivalent drug should be available. But for now, it

is impossible for us to know whether the real generic will be made

to look like or not look like the brand name drug you are taking.

Your response may help us gain input in resolving this question."



In a small number of cases the patient asked why the "nonlook-alike"
generic drug was different in color appearance. These patients were
told that the drug product was made by a different company who used
their own color coatings.

About one-fourth of the patients stated that they would accept whatever
their pharmacist recommended. They were told to assume that their
pharmacist was confident about the generic substitution and had
indicated it was their choice.









Part Ill--The Self-administered Questionnaire

After the explanation above was given, the patients were asked to

complete the short questionnaire (Part III) by checking the one

appropriate response for each question. The investigator helped motivate

the patients to complete the questionnaire by explaining that their

8
responses would aid in evaluating the results of the survey.

The initial data collected in the questionnaire were utilized to

describe the demographic characteristics of the patient sample and to

determine whether these characteristics were equally distributed among

the two experimental groups. The salient demographic variables of

interest were identified from previously conducted studies regarding

generic drug acceptance [53-613. These variables were

1. sex category;

2. age category;

3. annual family income category; and

4. education category.

The specific demographic brackets incorporated in the instrument were

formulated from standardized categories used in studies examining

utilization and expenditures for prescribed medications [81-82].


8
8In a small number of the interviews the patients indicated they could
not respond to the self-administered questionnaire because they could
not read it. Most often the patients stated they did not have reading
glasses on hand. In these cases, the investigator read the
questionnaire out loud to the patients.









In addition to the above information, a number of predispositional

variables identified in the literature which were thought to be

associated with patients' acceptance of generic drug products were

collected in order to determine whether they were equally distributed

between the experimental groups. These variables were

1. the total number of prescription drugs taken by the patient on

a regular basis;

2. the length of time the patient had been taking the brand name

drug being investigated;

3. the patient's source of payment for the prescription drug;

4. the patient's recollection of any conversations with his

physician or pharmacist concerning generic drugs; and

5. the patient's recollection as to having taken a generic drug in

the past.

Two exploratory questions were asked in the questionnaire in order

to gain information regarding where patients obtained knowledge of the

drug product's brand name identity, identification marks, or source of

manufacture. The two variables of interest were

1. the patient's knowledge of whether the brand name of the drug

was recorded on the prescription label; and

2. the patient's knowledge of any identifying names, numbers,

marks or symbols appearing on the drug product itself.

The interview was terminated when the patient completed the

questionnaire. Patients were reminded that their responses and comments

would remain anonymous and they were thanked for their participation in

the study.









Data Processing and Preparation

The data collected on the interview/questionnaire instrument were

coded by the investigator, entered in blocks provided on the instrument,

key punched on a computer terminal, and transferred to computer disk

space. Responses to the open-ended questions on the instrument were

categorized and coded. The data coding sheets appear in Appendix G. The

investigator visually validated the coding, editing, and key punching

procedures. The data were electronically tabulated and analyzed in part

by utilizing the SAS package for data analysis [83].



Major Limitations of the Study

An extremely small number of patients who take brand name

prescription drugs were sampled. These patients were strictly defined by

the specific criteria required for inclusion in the investigation.

Patients who obtain refills for brand name prescription drugs in

Gainesville, Florida, may not be representative of all patients taking

various kinds of medications or representative of patients taking the

same medications in other cities and states. Consequently, caution must

be exercised in extending the findings beyond the sample patient

population examined in this study.

Given both the time constraints and the economic considerations,

every effort was made to design the study so that an unbiased,

representative number of appropriate patients could be surveyed.

However, the judgmental sampling procedures utilized to select patients

for the study do not guarantee a random or representative sample.

Therefore, the problems associated with selecting a nonrandom or biased

sample from the population of interest must be considered (e.g., the use

of statistics based on random samples).









The data collection instrument incorporated in this investigation

was original. While the instrument was pretested and evaluated for

content validity, it has no established norms or established reliability.

The controlled experiment part of the study was carried out in

hypothetical form. Since the knowledge levels, attitudes, intentions,

and behavior of people change over time, there is no guarantee that

patients would respond in the same way in an actual situation.

The personal interview is an interactive process in which the

background characteristics, perceptions, and reactions of both the

interviewer and interviewee are important determinants affecting the

subject's response. Every interview in this study was conducted by the

sole investigator in order to eliminate bias resulting from the use of

multiple interviewers. However, bias could still have been introduced by

the questions themselves, by the manner in which the questions were

asked, by probing the respondents, by motivating the respondents, or by

improperly recording the responses. Any bias which was unknowingly

introduced by the investigator should have remained consistent over the

patient sample.















CHAPTER V

RESULTS AND ANALYSES

The Findings of the Study

This chapter presents the results and the statistical analyses for

Part I, Part II, and Part III of the study in respect to the research

objectives and the specific research hypotheses outlined in Chapter I.

A total of 263 patients who met the study criteria were contacted by

the investigator. Twenty-three patients declined to be interviewed. The

interview/contact response rate was equal to 0.91 (91 percent). Most of

the patients who refused to be interviewed stated that they were rushed

or short of time. Only a few patients indicated that they did not want

to talk about their medications or their medication therapy. No hard

data, however, were collected in regard to patient refusals.



Part I--The Personal Interview

In regard to the first question, Table I shows that 232 (96.7

percent) of the 240 patient-respondents indicated that they recognized or

had previously seen the drug product which was shown to them. Eight

patients (3.3 percent) responded negatively to the recognition question

even though they were currently taking the drug. Although patients were

asked to respond simply "yes" or "no," approximately one-third of the

patients responded by saying "I believe so," or "it looks familiar," etc.


Hypothesis 1: More than 50 percent of the patients initially identify
their drug product by its trademark name or source of manufacture in a
trademark sense.
















TABLE I


Patients' Initial Recognition
of Their Prescription Drug Products
(yes or no)
(n=240)


Response


Yes

Noa


Total


Number

232


8


240


"Do you recognize this drug? Have you seen it before?"


aThese patients were informed of the correct identification and
directed to Part II of the study.


Percent

96.7%

3.3%


100.0%









In response to the second question, Table II indicates the manner in

which the patients initially identified their drug product. The "Z" test

statistic was utilized to test the first hypothesis for acceptance at a

confidence level of 95 percent. For a one-tailed test, this means that

a computed "Z" value greater than 1.65 would indicate that the research

hypothesis is accepted with 95 percent confidence.

Data from Table II show that 154 patients (64.2 percent) identified

their drug by giving only the trademark name. Accordingly, the computed

"Z" value was calculated to be 4.39. This means that Hypothesis 1 above

is accepted with 95 percent confidence. An important finding is that all

patients in the sample who identified their drug product in a trademark

sense did so by giving the trademark name of the medication. A total of

168 patients (70.0 percent) initially identified their drug by its

trademark name alone or in combination with function. No patients

initially identified their drug by giving the source of manufacture.

Twenty-eight patients (11.7 percent) were initially uncertain in their

response to the identification question. One patient (0.4 percent)

incorrectly identified the drug product.


Hypothesis 2: Less than 50 percent of the patients initially identify
their drug product by its colors, functions, or effects without regard to
trademark.



The "Z" statistic is the appropriate statistical test assuming the
normal approximation to the binomial distribution. This assumption is
valid when n(p) and n(l-p) are greater than 10. For all hypothesis
testing in this study, the significance level associated with the
statistical test will be specified at 0.05. That is, the probability of
accepting the research hypothesis when it is false will be specified at
alpha equal to 5 percent. Accordingly, the confidence level of the test
(1-alpha), the probability of not accepting the research hypothesis when
it is false, is specified at a level of 0.95 or 95 percent. See
Churchill, G.A., Marketing Research Methodological Foundations, 2nd ed.
(Hinsdale, Illinois: The Dryden Press, 1979), pp.435-443.













TABLE II


Patients' Initial Manner of Identifying Their
Branded Prescription Drug Products
(n=240)


Manner of Initial
Identification

No fundamental
recognition

Uncertain or
unsure

Trademarka

Function

Both Trademark
and Function

Incorrect

Total


Number


"Can you identify for me
just shown?"


Percent


3.3%


11.7%

64.2%

14.6%


5.8%

0.4%


Confidence Intervals
(95 percent)


1.0 5.6%


7.6 15.8%

58.1 70.3%

10.1 19.1%


2.9 8.7%

0 1.2%


100.0%


the drug product you were


aTrademark identification was equated with patient's responses)
in terms of the trade name or name of manufacturer.

identification by function was equated with patients' responses)
in terms of color or function/effect, e.g., "my red heart pill."

cOne patient incorrectly identified NAPROSYN as PERCODAN. The
patient was informed of the correct identification and led to
Part II of the study.









The data show that of the 240 respondents, 35 (14.6 percent)

patients initially identified their drug product solely by function. A

computed "Z" value of 10.96 indicates that Hypothesis 2 is acceptable

with 95 percent confidence. An examination of Table II reveals that 14

(5.8 percent) patients initially identified their drug product both in a

trademark and functional sense. If these patients are added to the

number of patients who initially identify their drug product solely by

function, a total of 49 (20.4 percent) patients were found to initially

identify their drug in some functional manner. However, a calculated "Z"

value of 9.16 still indicates that Hypothesis 2 can be accepted with 95

percent confidence.


Hypothesis 3: There is a significant difference between the percentage
of patients who initially identify their drug product in a trademark
sense and the percentage of patients who initially identify their drug
product by its colors, functions, or effects without regard to trademark.


Table II also contains 95 percent confidence intervals constructed

for each of the percentage estimates of patient responses to the second

interview question. Statistically, a 95 percent confidence interval

indicates that in a repeated process of drawing samples from a population

and computing percentage estimates and confidence intervals for a

particular parameter, 95 percent of the intervals so formed contain the
2
"true" percentage in the total population. Information from Table II

reveals that the true percentage of patients who initially identify their

drug product in a trademark sense would lie in the interval 58.1 to 70.3

percent, and the true percentage of patients who initially identify their

2
For a complete discussion of calculating and using confidence intervals,
see Ott, L., An Introduction to Statistical Methods and Data Analysis
(Belmont, California: Duxbury Press, 1977) pp.74-79, 278-80.









drug product soley in a functional sense would lie in the interval 10.1

to 19.1 percent. The percentage estimate measuring the difference

between the number of patients who identify solely by function and the

number of patients who identify solely by trademark is 49.6 percent. A

95 percent confidence interval indicates that the true percentage

difference in the population would lie in the interval 40.3 to 58.9

percent. Since this interval does not contain "zero" percent, Hypo-

thesis 3 can be accepted with 95 percent confidence.

As mentioned above, a total of 49 (20.4 percent) patients are found

to make identification of their medication solely by function or by

function and trademark. Therefore, a 95 percent confidence interval

constructed to measure the true percentage difference between the number

of patients who identify in some functional manner and the number of

patients who identify solely by trademark is equal to 36.6 54.0 per-

cent. Since this interval does not contain "zero" percent, Hypothesis 3

can still be accepted with 95 percent confidence.


Hypothesis 4: More than 50 percent of the patients who do not initially
identify their drug product by its trademark name are knowledgeable of
its trademark name after verbal probing and visual prompting.


Table III shows the patients' knowledge of their drug product's name

initially, after verbal probing, and after assistance under visual promp-

ting. Table IV shows the patients' knowledge of their drug product's

name only after probing and prompting. Of the 232 patients who recog-

nized their drug product, 168 (72.4 percent) initially identified the

drug by its trademark name. One patient (0.4 percent) misidentified the

product. The remaining 63 (27.2 percent) patients were either verbally

probed or visually prompted to give the name of their drug product.














TABLE III


Patients' Knowledge of Their Drug Product's Name
Initially, After Verbal Probing, and After Visual Prompting

(n = 232)a


Response

Initially gave correct name

Gave correct name under verbal probing

Gave correct name under visual prompting

Could not identify name

Initially incorrectly identified named


Total


Respondents
Number Percent

168 72.4%

24 10.4%

22 9.5%

17 7.3%

1 0.4%


100.0%


aEight patients out of 240 total did not initially recognize their
drug product and were led to Part II of the study.

b"Can you tell me what is the name of the drug product?"

cThe visual prompt was a listing of 48 drug products in alphabetical
order grouped in a series of 4 trademark names (see Appendix F).

dThis patient was given the correct name of the drug product and
led to Part II of the study.
















TABLE IV



Patients' Knowledge of Their Drug Product's Name
After Verbal Probing and Visual Prompting

(n = 63)a


Respondents
Response Number Percent


Gave correct name under verbal probing

Gave correct name under visual prompting


Could not identify name


38.1%

34.9%

27.0%


100.0%


Total


aThis number represents those patients who recognized their drug
product but who did not initially identify the drug by its trademark
name.









The data in Table IV indicate that 46 (73.0 percent) of the patients

who were verbally probed and visually prompted gave the correct name of

their drug product. A total of 17 (27.0 percent) patients could not

identify their drug product's name. A computed "Z" value of 3.65

indicates that Hypothesis 4 is acceptable with 95 percent confidence. In

this study, a total of 214 (92.9 percent) patients who initially

recognized their drug product were knowledgeable of their drug product's

trademark name.


Hypothesis 5: More than 50 percent of the patients who do not initially
identify their drug product by its source of manufacture are
knowledgeable of its source of manufacture after verbal probing and
visual prompting.


Table V shows the patients' knowledge of their drug product's source

after verbal probing and after assistance under visual prompting. No

patient who initially recognized his drug product identified it by the

source of manufacture. Thus, all of these patients were given verbal

probing or visual prompting as to source.

The results indicate that only 17 (7.4 percent) patients were

knowledgeable of their drug product's source after verbal probing and/or

visual prompting. Moreover, 198 (85.7 percent) patients indicated that

they could not identify the drug product's source. Hypothesis 5 was not

accepted at a 95 percent confidence level. The hypothesis was tested for

rejection at the 95 percent confidence level, and a calculated "Z" value

of 12.94 indicates that the hypothesis is rejectable with 95 percent

confidence. A total of 16 (6.9 percent) patients incorrectly identified

their drug product's source.
















TABLE V



Patients' Knowledge of Their Drug Product's Source
After Verbal Probing and Visual Prompting

(n = 231)a


Respondents
Number Percent


Knew the source of manufacture after
verbal probe

Knew the source of manufacture after
visual prompt

Could not identify source

Incorrectly identified source


Total


Responses


2.2%


5.2%

85.7%

6.9%


100.0%


aEight patients out of 240 total did not initially recognize their
drug product and one patient initially incorrectly identified their
drug. These patients were led to Part II of the study.

b"Can you tell me what company makes the drug?"

cThe visual prompt was a listing of 22 drug manufacturers in alpha-
betical order (see Appendix E).









Hypothesis 6: Less than 50 percent of the patients who are knowledgeable
of their drug product's trademark name associate that name with the
trademark of a specific company's product.

Hypothesis 7: More than 50 percent of the patients who are knowledgeable
of their drug product's trademark name associate that name with the drug
entity itself without regard to the trademark of a specific company's
product.


Since the interview question relative to Hypotheses 6 and 7 was

incorporated into the study after half the patient sample had been

surveyed, the maximum number of subjects that could be questioned was

120. Thus, all patients in the second half of the patient sample who

were knowledgeable of their drug product's trademark name initially,

after verbal probing, or after visual prompting were asked the interview

question.

Table VI indicates that only 25 (22.9 percent) of the patients who

were knowledgeable of their drug product's name thought the name

identified a trademark of a specific company's product. A computed "Z"

value of 5.66 indicates that Hypothesis 6 is acceptable with 95 percent

confidence.

Table VI also shows that 62 (56.9 percent) patients thought the

trademark name identified the name of the drug itself. Twenty-two (20.2

percent) patients responded that they "did not know." A computed "Z"

value of 1.44 indicates that there is insufficient evidence on which to

accept Hypothesis 7 at a confidence level of 95 percent. However, the

data indicate that a significant majority or 77.1 percent of patients

(69.2 85.0 percent with 95 percent confidence) did not know or think

that the name of their medication was a trademark name of a specific

company's drug product.







68






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Hypothesis 8: There is a significant difference between the percentage
of patients who associate the trademark name with the trademark of a
specific company's product and the percentage of patients who associate
the trademark name with the name of the drug entity itself.


Table VI gives the 95 percent confidence intervals constructed for

the corresponding percentage estimates of the patient responses. The

estimated percentage difference between patients who associate the

trademark name with the drug entity and patients who associate the

trademark name with a specific company's drug product is 34.0 percent. A

95 percent confidence interval indicates that the true difference in the

population lies in the interval 18.6 to 49.4 percent. Since this

interval does not contain "zero" percent, Hypothesis 8 is acceptable with

95 percent confidence.

Table VII shows the responses to the question of whether patients

were knowledgeable of the reason why they were taking the drug. This

question was incorporated in order to gain information about patient's

knowledge of the function of their drugs. Although a specific hypothesis

was not formulated, the results indicate that 223 or 96.5 percent of the

patients (94.2--98.8 percent with 95 percent confidence) did know the

functional reason why they were taking their drug.



PART II--The Controlled Experiment

Table VIII depicts the choices made by patients between their brand

name drugs and the samples of less expensive generically equivalent

look-alike and nonlook-alike drug substitutes. Information from the

table was utilized to test Hypothesis 9.

















TABLE VII



Patients' Knowledge of the Reason(s)
Why They Take Their Drugs

(n = 231)




Response Nu

Patient knows 2

Patient does not know


Total 2


Respondents
mber Percent


8


96.5%

3.5%


100.0%


"Can you tell me the reason why you take this drug?

















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Hypothesis 9: There is a significant difference between the percentage
of patients who choose "look-alike" generically equivalent drug products
and the percentage of patients who choose "nonlook-alike" generically
equivalent drug products when patients are offered a less expensive
generic drug substitute in place of their brand name drug.


Data from Table VIII reveals that 103 (85.8 percent) patients of a

total of 120 patients assigned to the "look-alike" group accepted the

generic drug substitute, while 101 (84.2 percent) patients of a total of

120 patients assigned to the "nonlook-alike" group accepted the generic

drug substitute. The data indicate that 1.6 percent more patients chose

the look-alike generic drug substitute. The "Z" statistic was utilized

to test for a significant difference between the percentages of patients

3
in each experimental condition who chose the generic drug product. For

a two-tailed test, a calculated "Z" value greater than 1.96 indicates

acceptability of Hypothesis 9 with 95 percent confidence. The "Z" value

was calculated to be 0.35. Thus, the statistical test indicates there is

insufficient evidence upon which to accept the research hypothesis that

the difference between the percentage of patients who chose look-alike

generic drugs and the percentage of patients who chose nonlook-alike

generic drugs is statistically significant.

Tables IX and X show the reasons given by the patients for choosing

the generic drug substitute or for remaining with their brand name drug.

In regard to the 204 (85.0 percent) patients who chose the generic drug,

200 (98.0 percent) patients indicated the reason they chose the generic



3
The "Z" statistic is the appropriate test under the assumption of
(a) the normal approximation to the binomial distribution and
(b) independent, random samples. The Z- test incorporates a pooled
sample variance. See McClave, J.T. and Dietrich, F.H., STATISTICS
(San Francisco: Dellen Publishing Company, 1979), pp.310-14.

















TABLE IX



Patients' Reasons for Choosing the Generic Drug

(n = 204)


Respondents
Number Percent

200 98.0%


Reason

Cheaper or because of savings

Previous (good) experiences with
generic drugs


4


Total


2.0%


100.0%


"Why did you choose the generic drug?"
















TABLE X



Patients' Reasons for Choosing the Brand Name Drug

(n = 36)


Respondents
Reason Number Percent

Want only what their physician
ordered 21 58.3%

Prefer the brand name drug 12 33.3%

Previous (bad) experiences with
generic drugs 3 8.4%


Total 36 100.0%


"Why did you choose the brand name drug?"









drug was because of the savings involved in the substitution. The

remaining four (2.0 percent) patients indicated they chose the generic

drug because of previous good experiences with generic drug substitutes.

In regard to the 36 (15.0 percent) patients who chose to stay with their

brand name drug, 21 (58.3 percent) patients indicated that they wanted

only what their physicians had originally ordered. Twelve (33.3 percent)

patients indicated that they preferred the brand name drug, and 3 (8.4

percent) patients indicated they previously had bad experiences with

generic drug products. No patients who chose to stay with their brand

name drug indicated that the color or "looks" of the generic drug

affected their choice.

Table XI shows the responses pertaining to the open-ended question

of whether the trade dress colors of generic drugs mattered to the

patients. Examination of the table reveals that 136 (56.7 percent)

patients indicated that the colors of the generic drug did not matter, 20

(8.3 percent) patients indicated that the colors did matter or were of

concern, and 84 (35.0 percent) patients indicated that the colors did not

matter as long as they were informed, in some manner, that the generic

product being dispensed was the same drug as their brand name product.

Of the 20 patients who indicated that color was of concern, 11 patients

chose the brand name drug. Six of the 11 patients were shown a

look-alike generic drug and five were shown a nonlook-alike generic drug.

In regard to the remaining nine patients who chose the generic drug and

indicated their concern about color, six patients were shown a look-alike

generic product and three patients were shown a nonlook-alike generic

product. The additional data appears to support the finding that trade

dress colors of generic drug products do not significantly impact on














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patients' choice among their brand name drugs and less expensive

generically equivalent drug substitutes.



PART Ill--The Self-administered Questionnaire

The self-administered questionnaire was utilized to collect descrip-

tive information concerning the patient population. Data collected in

the instrument were used to compare the equivalence of the experimental

groups in respect to demographic characteristics and other specific

variables related to patients' knowledge of their prescription drugs.

Table XII shows the demographic categories of sex, age, income, and

educational levels of patients in the sample population. Of 240 patients

interviewed, 92 (38.3 percent) were male and 148 (61.7 percent) were

female. Eighty-two (34.2 percent) patients indicated they were 64 years

of age or older, and a total of 191 (79.6 percent) patients in the sample

indicated they were at least 45 years of age.

Fifty-three (22.6 percent) patients indicated that annual family

income was less than $10,000. Slightly less than half of the patients

(110 or 46.8 percent) indicated their family income fell into the

$10,000-$24,999 per year range. Thus, approximately 70 percent of the

patients indicated that their family income was less than $25,000 per

year. Nineteen (8.0 percent) patients indicated their annual family

income was $50,000 or higher. Five patients did not respond to the

income question.

In regard to the patients' highest level of education, 118 (49.2

percent) patients responded that they had received a high school diploma.

However, 41 (17.7 percent) patients indicated that their highest level of

















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education was grade school. A total of 81 (33.7 percent) patients

indicated they were college graduates, and 27 (11.2 percent) of these

patients indicated they had received graduate degrees.

In summary, it appears that the sample patient population was skewed

towards middle aged and elderly females, with low to middle family

incomes, and low levels of education. However, previous studies

conducted on prescription drug utilization indicate that the subjects

were not atypical of patients who take prescription medication [81-82].

Table XII also presents a breakdown of the respondents' demographic

characteristics in each of the look-alike and nonlook-alike experimental

groups. The chi square test was utilized to determine whether any

particular patient characteristic was dependent on the experimental

groups. In this investigation, a chi square value with a corresponding

"P" value of 0.05 or less is considered statistically significant and

would indicate with 95 percent confidence that the two experimental

groups are not equal in respect to that particular patient character-
.4
istic. An examination of Table XII reveals that the calculated chi

square values were not sufficiently significant to conclude dependence

existed among the patients' demographic characteristics and the

experimental groups.



The "p" value associated with the chi square test indicates the
probability of exceeding the magnitude of the chi square statistic for a
given number of degrees of freedom. If this probability is small, the
likelihood that the disparities between the observed frequencies and the
actual frequencies are due to chance is small. In this study, a
particular cross-classification will be deemed dependent if the
probability of exceeding the chi square statistic is less than or equal
to 0.05. See Akrin, R. and Caltow, R.R., STATISTICAL METHODS (New
York: Harper and Row, 1970), pp.131-35.









Table XIII presents the patients' drug products which were

investigated and their distribution within the experimental groups. An

examination of the table reveals that the most frequently investigated

drug product was INDERAL (35 or 14.6 percent), followed by DYAZIDE (25 or

10.4 percent), VALIUM (22 or 9.2 percent), and TAGAMET (20 or 8.3

percent). The drugs investigated the least number of times were NALFON,

NORPACE, and TOLECTIN (each having only two observations). Two drugs

originally selected for the survey, ATROMID-S and ZAROXOLYN, were not

investigated during the study period since no patients requested refills

for them.

Table XIV shows the distribution of drug products within

pharmacologic class and by experimental groups. A total of 134 (55.8

percent) drug products were in the cardiovascular category. Mild

tranquilizers and nonsteroidal anti-inflammatory drugs constituted 18.8

and 17.1 percent, respectively. Gastrointestinal drugs accounted for

only 8.3 percent. A chi square value of 2.322 (p = 0.5064) indicates

that the pharmacologic class of the drug products investigated are not

dependent on the experimental groups.

Data from Table XV show the total number of prescription drugs which

the patients indicated they were taking on a regular basis. A chi square

value of 2.846 (p = 0.4159) reveals that the number of prescription drugs

the patients took on a regular basis is not dependent on the experimental

groups. A total of 103 patients, or approximately 43 percent, indicated

they were taking three or more prescription drugs on a regular basis.

Seventy-two patients (30.0 percent) indicated they were regularly taking

only one drug.














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Table XVI shows the length of time patients had been taking their

prescription drug. Two-thirds of the patients (160 or 66.7 percent)

indicated they had been taking the drug for more than one year. Of the

remaining 80 patients, 45 (18.7 percent) indicated they had been taking

the drug less than six months, and 35 (14.6 percent) indicated they had

been taking the drug between six months and one year. A calculated chi

square value of 1.822 (p = 0.4021) indicates no dependence on the length

of time the patients had been taking their drug and the experimental

groups.

Data from Table XVII show the manner in which patients in the study

normally paid for their prescription drugs. Approximately 79 percent of

the patients (189 or 78.8 percent) indicated they paid for their drug

products entirely out of pocket. The remaining patients indicated that

insurance paid a portion of their prescription expenses. A chi square

value of 0.025 (p = 0.8746) indicates there is no dependence regarding

the manner in which patients pay for their prescriptions and the

experimental groups.

Table XVIII is a summary of answers to the question investigating

whether patients had previously talked with their pharmacist or physician

about taking a generic drug. Less than half of the patients (112 or 46.7

percent) indicated they had discussed generic drugs with their pharmacist

or physician at any time. A chi square value of 1.674 (p = 0.1957)

reveals no dependence on whether patients had previous conversations with

their pharmacists or physicians about generic drugs and the experimental

groups.

Patients were also asked if they had knowledge of taking a generic

drug in the past. The results are depicted in Table XIX. Slightly more
















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than 50 percent of the patients (121 or 50.4 percent) indicated they had

taken a generic drug in the past. Ninety (37.5 percent) patients

indicated they had not taken a generic drug, and 29 (12.1 percent)

patients reported "Don't know." A chi square value of 1.069 (p = 0.5861)

indicates that there is no dependence on whether patients had taken a

generic drug and the experimental groups.

Data from Table XX show the responses to the first exploratory

question pertaining to whether the patients had knowledge of any identi-

fying names, numbers, symbols, or marks imprinted on the drug product

itself. Forty-seven (19.6 percent) patients indicated on the

questionnaire the presence, in part or in whole, of some identification

imprinted on their drug product. Eighty-four (35.0 percent) patients

indicated that they were aware of some identification on the product, but

could not recall the specific imprint. Even though all of the drug

products included in the study had some kind of identifying imprint, 38

(15.8 percent) patients indicated "no" to the question. A total of 109

(45.5 percent) patients responded "no" or "don't know." A chi square

value of 3.725 (p = 0.2927) indicated there is no dependence regarding

patients' knowledge of any identification imprinted on their drug product

and the experimental groups.

Table XXI illustrates the results to the second exploratory question

investigating whether the patients knew if the brand name of their drug

product appeared on the prescription container label. In all of the 240

refill prescriptions studied, the pharmacist had typed the brand name of

the patient's drug product on the prescription label. The table shows

that 197 (82.4 percent) patients answered "yes" and 30 (12.6 percent)

patients answered "don't know" to the interview question. Twelve (5.0

























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percent) patients responded "no" even though their drug product

containers were labeled with the brand name. A chi square value of 3.942

(p = 0.1392) indicates there is no dependence regarding the patients'

knowledge of whether the brand name appeared on the prescription label

and the experimental groups. The patient responses to this question,

however, must be evaluated with caution. First, patients were told

earlier in the interview that the name of their medication was, in fact,

a trademark (brand) name. Second, several patients who had answered "no"

to this question later explained to the investigator that they thought

the wording "brand name" referred to the manufacturer's name and not the

trademark name of their drug. Consequently, the validity of this

question as worded in the questionnaire is in doubt.

These findings complete the results chapter. The next chapter,

Chapter VI, presents a summary and a discussion of the results of the

investigation.




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