Branding Of Clinical Trials

PTMG Spring Meeting London 2014

Tapio Blanc

Outlook

1. Introduction by a true story and definition

3. Creation and checks of Clinical Trial Names

4. Registration of Clinical Trials

5. Database of names

6. Closing words

7. Discussion

Positioning of Clinical Trial Names in the

Lifecycle of Pharmaceutical Branding 2.

How it all began in 2006 ...

Cease & Desist

It’s mine! AVANT Clinical Trial

Name for Roche!

Cease & Desist Letter

• Previous Trademark Registration • Goodwill and Reputation • Confusion with Roche AVANT • Success/Failure of the Trial refers

to Avant Immunotherapeutics, Inc. • Misleads Scientists and Investors • Claim: Cease and desist using AVANT for clinical trials

Defence

Coexistence Agreement

“For the purposes of registration, a clinical trial is any research

study that prospectively assigns human participants or groups

of humans to one or more health-related interventions to evaluate

the effects on health outcomes. Clinical

trials may also be referred to as

interventional trials. Interventions

include but are not restricted to drugs, cells and other biological

products, surgical procedures, radiologic procedures, devices,

behavioural treatments, process-of-care changes, preventive

care, etc. This definition includes Phase I to Phase IV trials.”

Definitio

n

Looking at the scene ...

Pfizer Ireland Pharmaceuticals

CTM 4756631, Cl. 42 and 44

Novartis AG

Reg. No. 550909, Class 42

Novartis AG

Reg. No. 544674, Class 42

GlaxoSmithKline IP Ltd.

CTM 8806366, Class 42

Pfizer Inc.

Reg. No. 3321911, Class 42

Daiichi Sankyo Co., Ltd.

IR 1092172, Cl. 42 and 44 Almirall S.A.

IR 907728, Class 42

Biofarma

IR 904054, Class 42

Boehringer Ingelheim Int. GmbH

IR 1043578, Class 42

Nomenclature

Clinical Trial

«Athena»

Working Title/

Buzz Name

«Peg»

INN

peginterferon alfa-2a

Lifecycle of Pharmaceutical Branding

Trademark

PEGASYS®

Branding Opportunity?

Stakeholders

Scientists

In-House colleagues

Journalists

Patients

Investors

Doctors (GPs)

Hospitals, HCPs

Clinical

Trial

Names

Regulatory Bodies

RO460522

GO25632

GX4984

MO28230

WA29049

Acronym

Soprano

Egyptian Mythology

CLEOPATRA*

Breast Cancer = PERJETA®

+

HERCEPTIN®

pertuzumab + trastuzumab

Mountains

Matterhorn

Fuji

Mont-Blanc

Breast Cancer = KADCYLA®

trastuzumab emtansine

Female Names

EMILIA*

ROSALIND

CORDELIA

Breast Cancer = HERCEPTIN®

trastuzumab

Roman Numbers

DAUPHINE I

DAUPHINE II

for connected

studies

TH3RESA

KRI5TINA

«third line treatment»

«the five arm study»

Creation: Categories and

Examples

Compliance (Dont’s)

Clinical Trial Name Rationale

RAMBO, AMUSING, BYE-BYE, frivolous

VAMP

ASTON MARTIN famous trademark

EFFICIENT, MASTERPIECE, VICTORY too promotional

TRIUMPH, OPTIMAL, FANTASTIC

AWESOME (Angina With Extremely

Serious Operative Mortality Evaluation)

SURVIVE, CURE, MIRACLE too promising

ANIMALS misleading (veterinary preparation?!)

BATMAN comix

DEMON, DEVIL, DIOS religion and “ordre publique”

SMART diluted («me too!») more than 25 studies

Searches

Territories

• Basel

Tokyo

Performance of Clinical Trial?

Communication and Interaction of the Clinical Trial Name

X

√

San Francisco

•

•

Registration - Trademark Use?

A trademark/servicemark must designate

goods and/or services. If a pharmaceutical

company conducts clinical trials for its

very own purposes in R & D and brands

them with names and devices, it simply

does not qualify as proper trademark use.

Trademark Use?

Services X Services √

NO YES

No Trademark Registration

required

Trademark Registration

for exclusivity

No Watch required Initiate Watch

No Costs Attorney Fees

PTO Fees

Use of Clinical Trial Name

Classification of Clinical Trial

Names Class Wording Result

05 Pharmaceutical preparations

42 Conducting clinical trials for

pharmaceutical preparations

44 Medical services

Providing information about the results

of clinical trials for pharmaceutical

preparations

Conducting of scientific studies

X

√

X

X

X

The US PTO changed its previous practice, and will now only grant registrations

for the service of «conducting clinical trials for others». In fact, the wording «for

others» was added to the PTO’s ID manual (= US Acceptable Identification of

Goods and Services Manual) with a note explaining that conducting your own

clinical trial was not considered selling services in commerce (January 2012).

Comparison

Clinical Trial Name Registration No Registration

Use of brand allowed

Notification effect of PTO

Blows up your portfolio

Defensive effect of PTO

Psychological effect

of PTO registration

X

√

X

X

X

Clutters up PTO

Watch Service

Registration mandatory

for Regulatory Authorities

Pressure on health cost

Costs for 15 names a month

√

√ √

150’000 = month √1’800’000 = year (Swiss Francs)

√

√

√

√

√

X

X

X

X

X

X

Saves Headcount √ X

Clinical Trial Names Create your own Database

Overview

Control

Order

Reserve Brands

Function

Name

Project No.

Client

Trademark

INN

Indication

Territories

Date In

Date Out

Use (Yes/No)

File location

Availability

Parameters

Simple

Cheap (free)

Easy to transmit

Covers your needs

Software

Be careful, smart and wise in the creation of names. It avoids confusion

and makes your pipeline distinctive in communications

Closing Words

√

√

√

√

√

Branding of clinical trials is a good thing to do and a branding

opportunity in the modern world

Process legal, compliance and linguistic checks

Trademark registration is not mandatory or necessary, but might

be recommendable under special circumstances

In a conflict situation stipulate a coexistance agreement or

switch the name

Create and maintain a simple clinical trial names database

√

Determine a tailormade strategy and process how your company can

manage its own clinical trial names

The study that your company runs for itself does not qualify as

trademark use

√

√

The proper management of clinical trial names has become

«best practice» in our industry

√

© Tapio Blanc 2014

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