Pharmaceutical Trademark Impact Study December, 2018

Pharmaceutical Trademark Impact Study
Building a case for naming sooner.
December 1, 2018
Brand Acumen. “The Global Leader in Pharmaceutical Name Development and Submissions”

chimeric antigen receptor therapy
In September, 2018 a study of 79
pharmaceutical naming and trademark
professionals was conducted by Brand
Acumen.
The purpose of the study was to define
challenges and trends in the drug naming
process.
The key findings …
The Research:
Pharmaceutical Naming Impact Study

U.S.External TM Counsel (12)
U.S. Internal (Company) TM Counsel (17)
Chief Medical Officer (9)
Regulatory (Internal) (14)
Regulatory (Government) International (7)
Commercialization/Launch Directors (20)
Sample Profile Of Survey Respondents
Total Respondents
79

Drug companies are developing trademarks for
new products at an earlier stage of development
in an effort to entrench a brand in the minds of
HCPs, BioJournalists, Potential Patients,Affinity
Proponents,Academia and the Financial
Community.
The Research:

The overwhelming majority of the
professionals surveyed in the study stated
that they develop generic and trademark
names, 90% and 86% respectively, before
or during Phase II of clinical trials.
The Research:

The outcome of the study recommends
seeking a trademark early — even during
Phase I — as trademark searches have a
low success rate.
This fast movement is even more important
for compounds with Expedited FDAReview
Programs, Oncology, Orphan Drug, Cell and
Gene Therapy Submissions.
The Research:

Moreover, the study suggests drug companies
identify empty vessel names along with
suggestive names, arguing that empty-vessel
names can be easy to identify, protect and
re-use.
In addition, they pose less of a risk for rejection
under medical error recognition evaluation or
for conflicting with clinical trials results.
The Research:

The Survey Overview

Question:
Compared to this time last year, do you
feel compelled to begin the naming
process earlier in the drug development
cycle due to increased obstacles in
clearing a name?
10 of 12
13 of 17
6 of 9
9 of 14
4 of 7
17 of 20
TheResearchResults:
PharmaceuticalNamingImpactStudy
The ‘Yes’ Responses

Question:
Do you believe that general costs
associated with naming have
escalated from two (2) years ago?
9 of 12
14 of 17
5 of 9
13 of 20
4 of 7
7 of 14
TheResearchResults:

Question:
Do you believe that the growing
number of FDA naming
submissions has caused a
slowdown in the review process
over the past two (2) years?
TheResearchResults:
10 of 12
13 of 17
6 of 9
9 of 14
4 of 7
17 of 20

The New Factors Impacting Naming

bioarbitrage
In the BioArbitrage Fund, the
business model acquires early stage
assets (compounds), then quickly
repackages and embellishes the
asset for divestiture.
By creating a brand name at Pre-
Clinical/ Phase I development, the
fund amplifies the ROI prior to
‘flipping the asset’ (divesting) to an
acquirer.
Identification of Asset (Pre-Clinical or Phase I)
Negotiate Terms of Option Agreement with Seller
Brand the Asset. Name, Design, Positioning, etc.
.
Create Offering Memorandum for Divestiture
Market Asset to Potential Acquirers
Close Transaction Triggering The Option
Resulting in net ‘delta’ gain (arbitrage)
BioArbitrage Process
Early Stage Naming
• Pre-Clinical
• Phase I
EmergingNewBusinessModelsareDrivingEarlyStage
NameDevelopment
thearbitrageimpact

An orphan drug accelerator focused on
developing and delivering life-transforming
therapies for patients with severe and life-
threatening rare diseases.
Orphanetics is privately funded by public and
private investors from the pharmaceutical, life
sciences and global healthcare community.
orphanetics
Orphanetics engages in:
• Early Stage Naming of Clinical Programs
• Non-Proprietary Name Development
• Proprietary Name Development
• EPC Naming
• New Disease Branding • MultiModal Orphan Drug Class
• Infinitive Phenoptics
• Vektür Micro Orphan Designation
•  Harlequin Gan Syndrome
• Terracon SoSai Disorder
NameDevelopment
therarediseasebio-accelerator

@earlybranding=enhancedvaluation
Lentiglobin®
Lenti-D®
StarbeamStudy
NorthStarStudy
branded clinical studies
pipeline
product brands
Newly minted
public
companies are
branding early ;
not just the
product pipeline,
but also their
clinical studies.
Branding
enhances
valuation, leading
to access to
financial
resources for
acquisitions
…and
partnerships
NameDevelopment

ProprietaryNameDevelopment
The dawn of ‘Name Repositories’ which own a
broad portfolio of pharmaceutical and life
science trademarks, service marks, platform
identifiers, disease state nomenclature and
domain names is the next wave indicator of the
value of names as an intellectual property asset.
These repositories operate as IP estates with a
focus on capturing value in nomenclature as an
asset.
Emergence of Private Pharmaceutical
Name Repositiories
Structured around the concept of
Microsoft Co-Founder Nathan Myhrvold’s
Intellectual Ventures, this new breed of
‘name bank’ is creating a greater need to
capture naming assets early.
thenewbankers

• CAR-T
• GeneTherapy
• CRISPR
Companies benefit from early stage naming as
first to market leaders in their respective fields.
Additionally, as these companies seek strategic
partners and funding, brands become assets,
which in turn enhance valuations.
New Drug Technology Platforms
SleepingBeauty
RheoSwitch®
ZIOPHARM
platformbrands
AttSite®
UltraVector®
LEAP®
In the case of ZIOPHARM, brand recognition can also
be key to securing pivotal strategic and financial
partnerships.
investment
newplatform
earlystagebrands
ProprietaryNameDevelopment
earlierstagenaming

EarlierNamingBehavior
18

As a result of a greater
number of sponsors
participating in the FDA’s
Expedited Review Programs,
the proliferation of name
candidate submissions has
created a strain on FDA
resources for naming reviews.
FDA’sExpeditedReviewPrograms
Breakthrough
Designation
Accelerated
Approval
Fast Track
Designation
Priority
Review
The byproduct is that
companies are
beginning the naming
process earlier to
ensure approvals
through the parallel
channels of the FDA
and PTO
moreandmorenamesubmissions

@
Brand Acumen is recommending that drug companies adopt a parallel process for assessing trade
names that allows for contingencies as well as for pre-clearance by the FDA.
Prelim.
Reg /
Promo
screen
IP screen
USPTO
file:
Field FMEA research
(~10 weeks)
FMEA
report
Internal alignment
(assumed ~8 weeks)
PTO examiner assigned
(can be ~2 months)
1st exam report from USPTO
(can be 2-4 months)
Opposition
period
Initiate FDA, PMDA
pre-clearance
Marks
granted
WW
filings
Paperwork for
FMEA research
3/23
3/30
4/6
4/13
4/20
4/27
5/4
5/11
5/18
5/25
6/1
6/8
6/15
6/22
6/29
7/6
7/13
7/20
7/27
8/3
8/10
817
8/24
8/31
9/7
9/14
9/21
9/28
10/5

10/

12

10/

19

10/

26

11/

2

11/

9

11/

16

Sample flowchart utilizing a dual
timeline to facilitate an expedited
trademark screening process
NOTES:
1.  USPTO filing of no more than 10 names.
2.  FMEA research not contingent on Regulatory-
Promo or IP screens.
3.  Internal alignment assumed to require no more
than 8 weeks for landing on top 2 trade names.
4.  Initiating FDA pre-clearance of lead names in Nov
2019 assumed to allow sufficient time for name
pre-clearance.
FDA+USPTO:ParallelProcessAdoption

In the case of emerging drug discovery platforms, securing the first non-proprietary
designation can also prove beneficial as competitors may be compelled to adopt variants
of the nomenclature in their USAN filings.
tisagenlecleucel-T
tisa – gen – lec – leu – cel - T
generic name
non-proprietary name
thenon-proprietaryadvantage EmergingNewBusinessModelsareDrivingEarlyStage
Non-ProprietaryNameDevelopment AsWell

TheResearchResults:
CAR-T
anewlexicon
Next generation
technology platforms
birth entire new lexicons
overnight.
With this, one must also
consider the
implications of the entire
framework of the
healthcare ecosystem
when selecting name
candidates.
newlexicons:moreconfusion

Factors Driving Early Stage Proprietary Naming
• In the case of rare diseases and high profile unmet needs (liver ,
pancreatic cancers, etc.), drug companies are recognizing the
benefits of branding early to secure top of mind recognition sooner
than later.
• Compliance with FDA and PTO protocols is becoming more difficult
resulting in extended timelines.
• Aligning a “brand moniker” to a compound can protect the
corporate brand from adverse effects during clinical trials.
• FDA Naming Guidance will become more complex, not less in the
future.
keyinsights

Factors Driving Early Stage Proprietary Naming
• Drug companies are taking a page from the “high technology
playbook” when it comes to branding. The ‘First Mover Advantage’
is becoming more relevant as niche platforms define the importance
of being first to market. (i.e. CAR-T therapies)
• “High Science” in the case of many emerging drug platforms is
becoming relevant as a communication messaging model. (Juno,
Bluebird Bio, Spark Therapeutics)
• Trademarks are more difficult to secure. There will be less name
options available the longer one waits to secure the mark.
• Many trademark professionals are mapping out a clear parallel filing
strategy for the PTO and FDA. (see slide)
keyinsights

Brand Acumen 6
St. John's Lane
5th Floor
NY, NY 10013
Bill Smith, CEO
917.745.3620
william.smith@brandacumenstudios.com

Pharmaceutical Trademark Impact Study December, 2018

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