pharmaceutical trademark impact study

Pharmaceutical Trademark Impact Study Building a case for naming sooner.

December 20, 2015

Brand Acumen. “The Global Leader in Pharmaceutical Name Development and Submissions”

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In March, 2015, and again in November, 2015 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 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 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 FDA Review Programs, Oncology, Orphan Drug, Cell and Gene Therapy Submissions.




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 Survey Overview


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)

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

The Research Results: Pharmaceutical Naming Impact Study

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










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?



10 of 12

13 of 17

6 of 9 9 of 14

4 of 7

17 of 20


The New Factors Impacting Naming Brand Acumen “The Global Leader in Pharmaceutical Name Development and Submissions”



bioarbitrageIn 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

Emerging New Business Models are Driving Early Stage Name Development

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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


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Lentiglobin® Lenti-D® Starbeam Study North Star Study

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




Emerging New Business Models are Driving Early Stage Proprietary Name Development

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.

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•  CAR-T •  Gene Therapy •  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

Sleeping Beauty

RheoSwitch®

ZIO

PHA

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AttSite®

UltraVector®

LEAP®

In the case of ZIOPHARM, brand recognition can also be key to securing pivotal strategic and financial partnerships.

investment

new platform

early stage brands

Emerging New Business Models are Driving Early Stage Proprietary Name Development

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Earlier Naming Behavior

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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’s Expedited Review Programs

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

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@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 2015 assumed to allow sufficient time for name pre-clearance.

FDA + USPTO: Parallel Process Adoption



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

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Emerging New Business Models are Driving Early Stage Non- Proprietary Name Development As Well




CAR-T a new lexicon 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.

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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.

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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)

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24

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Lentiglobin® Lenti-D® Starbeam Study North Star Study

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


Brand Acumen 19 Leonard St. NY, NY 10013 Bill Smith, CEO (Call Bill. 704.906.3402) [email protected]

pharmaceutical trademark impact study

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