THE NAME GAME
The USPTO and FDA Approval
Process: Selection and
Protection of New Proprietary
Drug Names
Lisa M. Tittemore, Esq.
Sunstein Kann Murphy & Timbers LLP
June 2017
Presentation Overview
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U.S. Patent & Trademark Office (USPTO)
procedures and issues relevant to prosecution of
drug name trademarks
U.S. Food & Drug Administration (FDA)’s drug
name review process and criteria
Strategies for trademark prosecution as a part of
drug name selection and approval process
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Trademarks
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What is a trademark?
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An identifier of source
Rights May be Based on Use or Registration
– Word(s)
– Symbol
– Device (design)
– Sound
– Any combination thereof
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Likelihood of Confusion
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U.S. Courts and USPTO apply likelihood of
confusion analysis
– Similarity of sight, sound and meaning of marks, goods,
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channels of trade, sophistication of purchasers, etc.
USPTO doesn’t investigate actual use in the marketplace
USPTO analysis is conducted by attorneys based on the
likelihood of confusion factors
Consideration of heightened review for
pharmaceutical trademarks
– Doctrine of “Greater Care” applies to pharmaceutical
trademarks
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Examination and Opposition
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USPTO examination
– Applications filed based on use or “intent to use”
– Descriptiveness, generalness, and other grounds for
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rejection, likelihood of confusion
Allowed marks published in Official Gazette
Must prove use before registration will issue
Opposition proceedings
– Interested third parties can oppose based on registered or
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common-law trademarks
Oppositions conducted before the Trademark Trial and
Appeal Board, with a right of appeal to the Federal Courts
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Common Trademark Issues for Drug Names
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Paradox of the pharmaceutical industry
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Bona fide intent in the drug name context
– Glut of “strong” fanciful marks contributes to confusion
– ITU applications require a bona fide intent to use the
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mark
Contingent intent to use; common practice of filing for
multiple marks for a single product
Limited shelf life of ITU applications
– Generally must commence use in approximately 4 years
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from application date
Must consider uncertainties involved in the drug
development time frame
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USPTO v. FDA: Differing Approaches
USPTO
FDA
— Review practices designed
for trademarks across all
industries
— Review procedures built
with pharmaceutical
industry in mind
— Focuses on likelihood of
confusion
— Focuses on health and
safety
— Priority based on first to file
or use (regardless of
registration date)
— Priority based on first
allowed (regardless of filing
date)
— Review conducted by
“Examining Attorneys” who
only review registered
trademarks and pending
applications
— Review conducted by
medical specialists, who
gather empirical evidence
about the marketplace
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FDA and USPTO
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Success with USPTO does not guarantee success
with FDA
– Likelihood of confusion v. health and safety
– FDA considers names in the order presented to them;
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trademark priority dates not considered by FDA
FDA approval may influence USPTO
– But USPTO likelihood of confusion may consider marks
and factors not considered by FDA
Courts may have their own view
– FDA approved ALTOCOR (prescription cholesterol reducing
drug) and 3d Cir. found confusion with ADVICOR
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FDA Proprietary Name Review
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2007 PDUFA IV Act broadened FDA drug safety
program
– FDA committed to goal of minimizing medication errors
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which are “any preventable event that may cause or lead
to inappropriate medication use or patient harm . . .”
Sharing Information with Industry
– September 2008: PDUFA Pilot Project for Proprietary
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Name Review (voluntary)
February 2010: Guidance for Industry: Contents of a
Complete Submission for the Evaluation of a Proprietary
Name
May 2014 Draft Guidance for Industry: Best Practices in
Developing Proprietary Names for Drugs
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May 2014 Draft FDA Guidance for Screening
Names Prior to FDA Submission
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Comment period closed at the end of 2014,
but FDA has yet to issue final
recommendations
Non-binding guidance on three major topics:
– Recommendations for prescreening
candidates
– Naming attributes that may be considered
misleading or error prone
– Misbranding and safety reviews
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Draft Guidance: Recommendations for prescreening candidates
Avoid the following:
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Obvious similarity in pronunciation or spelling to other
proprietary names
Medical/coined abbreviations or dose designations
Misleading references to inert/inactive ingredients
Suggestions of combination of some but not all active
ingredients
Same name for products with different active
ingredients
Reuse of proprietary names of discontinued products
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Draft Guidance: Naming attributes that may be
misleading or error prone
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Inclusion of product-specific attributes, such as dosage
interval (e.g. MARKBID), dosage form, route of
administration (e.g. MARKCAPS, MARKORAL),
manufacturing characteristics, or symbols in the name
Use of non-standardized or inconsistent modifiers –
standard modifiers include “ODT” for orally
disintegrating tablets or “XR” for extended release
Use of brand name extensions for multiple products
without adequately distinguishing between the products
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Draft Guidance: Naming attributes that may be
misleading or error prone (continued)
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Use of a drug name that is marketed outside the US for a
completely different product with a different active
ingredient
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Continued use of name when prescription drug is only
partially switched to over-the-counter (OTC) (i.e.,
prescription-only status still applies to some indications,
dosages or strengths)
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Use of sponsor name in the proprietary name (e.g.,
“ABCName1,” “ABCName2,” “ABCName3”)
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Draft Guidance: Naming attributes that may be
misleading or error prone (continued)
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Misuse of common medical and product name
abbreviations
Names that suggest fewer than all active ingredients,
or suggests ingredient not included
Use of United States Adopted Names (USAN) and
International Nonproprietary Name (INN) stems (stems
are for generic names, not proprietary names)
Labeling/packaging based issues
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Draft Guidance: Misbranding Review
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Misbranding review:
– Avoid any suggestions that a drug is safer or more effective
than has been demonstrated by appropriate scientific
evidence
– Avoid fanciful names suggesting it has some unique
effectiveness or composition when it does not
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Draft Guidance: LASA Safety Review
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Look-alike Sound-alike (LASA) Safety Review
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Search for similar names using the FDA’s Phonetic and Orthographic
Computer Analysis (POCA) system
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Determine similar scores with other marketed names and categorize:
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High similarity: Combined POCA score is ≥ 70%
Moderate similarity: Combined POCA score is ≥50% to ≤69%
Low similarity :Combined POCA score is ≤49%
Use similarity checklists to determine if it is safe and acceptable from
a LASA perspective
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FDA provides checklists for use prior to FDA submission
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Draft Guidance: Highly and Moderately Similar Name Pairs
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Orthographic factors that may render a pair less likely to cause confusion:
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Names begin with different first letters
Length of the names are dissimilar when scripted
Variations of scripting of some letters
Different number or placement of cross-stroked or dotted letters
Differences in infixes of the name when scripted
Differences in suffices of the name when scripted
Phonetic factors that may render a pair less likely to cause confusion:
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Names have different numbers of syllables
Names have different syllabic stresses
Different phonologic processes, such as vowel reduction, assimilation, or deletion
Names consistently pronounced differently across range of dialects
For moderately similar pairs, the FDA also suggests comparing dosage and
administration, and storage and handing sections of prescribing
information
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Office of Drug Safety: Name Approval Players
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CDER and CBER
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Center for Drug Evaluation and Research and Center for Biological
Evaluation and Research
OSE
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Office of Surveillance and Epidemiology (formerly Office of Drug
Safety)
OPDP
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Office of Prescription Drug Promotion (formerly DDMAC); performs
first-line consultation on potential names
DMEPA
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Division of Medication Error Prevention and Analysis, part of
CDER; reviews medication error reports and prospectively reviews
proprietary names, labeling, packaging and product design prior
to drug approval
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Proprietary Name (PN) Review Process
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Overview of FDA Approval Process
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Company may seek “initial evaluation” of
proposed name while product under IND, but FDA
will not evaluate until product completes phase 2
trials
– 180-day timeline for review for names submitted during
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IND phase
May submit up to two names at a time
Preliminary name approval evaluated when is filed
(90 day timeline), and re-evaluated 90 days
before product approval
– Need back up alternatives right up to time of final
approval
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OPDP Review
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OSE has lead responsibility within CDER for
communications to industry re new drug names
OPDP reviews for false or misleading promotional
claims
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Names that overstate efficacy, minimize risk, broaden indication,
claim unsubstantiated superiority, or overly “fanciful” by
misleadingly implying unique effectiveness or composition, etc.
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(e.g., SUPERCORTIZONE)
OPDP consults with DMEPA
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OPDP performs first-line consultation; if no issues, followed by
review by DMEPA for safety and prevention of medication errors
If rejection letter received from OSE, opportunity for sponsor to
reply to rejection
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DMEPA’s Process
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Step 1: Screening for common causes of medical
errors and USAN Stem Names
– Includes labeling and packaging analysis (if submitted
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with application)
Step 2: Generation of list of potentially similar
names
– Database searching
– POCA Computer algorithm
– Active ingredient medication errors
Step 3: Assessment of Risk
– Failure Mode and Effects Analysis (FMEA)
– Expert panel analysis
– Expert panel analysis
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DMEPA’s Process: Developing list of
similar drug names
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Database searching
– Review numerous pharmaceutical, medical, and
trademark data bases for similar names
Computer Analysis
– FDA developed tool to identify look-alike, sound-alike
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names
Phonetic Orthographic Computer Analysis (POCA)
Released to public February 2009
Active ingredient medication error data
– If any active ingredients are marketed, DMEPA reviews
incidents and causes of reported medication errors
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Assessment of risk
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Handwriting and verbal analysis
– Prescription analysis studies
– Simulate prescription ordering process
– Conducted within FDA to determine degree of confusion in
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visual appearance or pronunciation between proposed
name and existing names
Nurses, pharmacists and physicians interpret written
prescriptions and verbal orders
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Assessment of risk (continued)
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Internal expert panel analysis
– Physicians, nurses, and pharmacists
– Use expertise to evaluate and expand list of problematic
names
Failure mode and effects analysis
– Analyzing how errors may occur and likely effects
– Considers findings of review steps, and additional factors,
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including storage, dosage, indications etc.
More rigorous than prior “all things considered” analysis
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Assessment of risk (continued)
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Factors to weigh in determining risk:
– Similarity with established (generic) names
– Strength of the dose
– Recommended dose and unit of measure
– Similar storage conditions
– Similar patient populations
– Similar prescriber populations
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Sample Problem Names
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Amaryl (Ruminal)
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Avandia (Coumadin)
– Amaryl (diabetes)
– Ruminal (Alzheimer’s); name changed to Raza dyne
– Avandia (oral diabetes)
– Coumadin (anticoagulant)
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Avandia or Coumadin?
The results of FDA’s handwriting analysis are often
hard to predict
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Role of Electronic Prescribing
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Roles of Labeling and Side-by-Side
Storage
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Look-Alike Trade Dress
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What To Do if Proposed Name is Rejected
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FDA rejection rate continues upward
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Upwards of 30% new drug names were refused in 2011, and the
FDA also invites some applicants to withdraw their submissions
Discuss possibility of reconsideration?
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Work with the FDA to identify and alleviate concerns
May be able to use regulatory screening investigation results to
support reconsideration
Be prepared to submit second name (may submit 2
names)
Need back up alternatives right up to time of final
approval
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Foreign Drug Approval Process
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Each jurisdiction has its own rules and
procedures
European Medicines Agency (EMA)
– Reviewed drug names since 1995 (formerly European
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Agency for the Evaluation of Medicinal Products or EMEA)
Published guidelines
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Guideline on the Acceptability of Names for Human Medicinal Products
Processed Through the Centralized Procedure
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– Does not consider third party trademark rights
In 2011, “(Invented) Name Review Group”
(NRG) ~48% rejection rate
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Putting It All Together . . .
Overview of the Drug Name Selection Process
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Ultimate goal is to have a name that:
– Satisfies branding and marketing goals
– Minimizes the risk of medication errors
– Is approved by the USPTO and foreign trademark offices
– Is acceptable to the FDA, EMA, and other regulatory
bodies
Timing is important
– Need to have a name ready and approved on launch day
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Step 1: Initial List of Candidates
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Start with a list of about 10-12 marks
– Too few, and risk of none being acceptable to USPTO and
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FDA
Too many, prohibitive costs and potential issues with
trademark filings
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Selection considerations
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Secrecy considerations
– Brand identity, consumer reaction
– Domain name availability
– Connotations in foreign markets (remember NOVA)
– FDA and trademark prescreening
– No rights in name candidates until applications are filed
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Step 2: Research Trademark Availability
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Trademark search (U.S. and International)
Advisable at earliest stage of process
Indispensable step in selection process
– Identify pre-existing use by others and evaluate chances
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of successful registration with the USPTO
Limits of trademark prescreening
Helpful to generate potentially similar names to do risk
analysis on as part of the Safety Investigation
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Step 3: Apply with USPTO
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U.S. Patent and Trademark Office
– File early, but remember application starts clock ticking
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Must commence use in approximately 4 years from application date
– Describe goods broadly, but accurately
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• “Pharmaceutical preparations” – Class 5 only?
• Usually required to narrow during examination process
• Cannot expand description once on file (file separate application)
Domain name registrations
– timing important –domain name registration can reveal
intentions)
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Step 4: Safety Investigation
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Some companies opt to simulate look-alike,
sound-alike investigations conducted by the FDA
– Recommended but not required under the current FDA
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rules
2014 FDA Guidance provides sample simulation study
procedures
Helpful to evaluate chances of FDA name approval
Can serve as ammunition for an appeal of rejection
Timing
– Best to conduct the Safety Investigation early in the
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process to eliminate problem marks
But, may be desirable to wait until trademark applications
are on file before the costs associated with such an
investigation are incurred
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Step 5: Foreign Trademark Filing
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Trademark rights are territorial
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Paris Convention filing deadline – 6 months
from U.S. application date
– Each jurisdiction has its own rules and procedures
– U.S. priority date becomes foreign priority date
– If possible, trim list of candidates to reduce cost prior to
filing
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Step 6: Apply with the FDA
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The earlier the better
– FDA recommends applying as early as the end of Phase
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II, beginning of Phase III
May submit up to 2 marks at once to expedite process
Approval is only preliminary until 90 days before NDA
approval
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Summary of the Name Selection Process
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Step
Step
Step
Step
Step
Step
1:
2:
3:
4:
5:
6:
Initial List of Candidates
Research Availability
Apply with USPTO
Safety Investigation
Foreign Trademark Filing
Apply with the FDA
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Closing Thoughts
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Drug name selection process must be started
early, well before (sometimes years) target launch
date
Trademark counsel plays important role in
establishing and protecting rights in name
Communication between trademark counsel and
those involved in the FDA regulatory process is
critical
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Useful Web Sites
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USPTO
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European Trademark Authority
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FDA Guidance for Industry
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– www.uspto.gov
– oami.europa.eu
– http://www.regulations.gov/#!documentDetail;D=FDA2014-D-0622-0002
European Agency for the Evaluation of Medicinal
Products
– www.ema.europa.eu
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Thank You
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Lisa M. Tittemore, Esq.
[email protected]
www.sunsteinlaw.com
©Lisa M. Tittemore & Sunstein Kann Murphy & Timbers LLP