The Name Game
The USPTO and FDA Approval Process
Selection and Protection of
New Drug Names
Lisa M. Tittemore, Esq.
Presentation Overview
 U.S. Patent & Trademark Office (USPTO)
procedures and issues relevant to prosecution of
drug name trademarks
 U.S. Food & Drug Administration’s drug name
review process and criteria, and FDA’s pilot project
 Strategies for trademark prosecution as a part of
drug name selection and approval process
What is a trademark?
Device (design)
Any combination thereof
An identifier of source
Likelihood of Confusion
U.S. Courts and USPTO apply likelihood of
confusion analysis
 Similarity of sight, sound and meaning of marks, goods,
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
Examination and Opposition
USPTO examination
 Applications filed based on use or “intent to use”
 Descriptiveness, genericness, and other grounds for
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 common-law trademarks
 Oppositions conducted before the Trademark Trial and
Appeal Board, with a right of appeal to the Federal Courts
Common Trademark Issues for Drug
Paradox of the pharmaceutical industry
 Glut of “strong” fanciful marks contributes to confusion
Bona fide intent in the drug name context
 ITU applications require a bona fide intent to use the
 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
from application date
 Must consider uncertainties involved in the drug
development time frame
USPTO v. FDA: Differing Approaches
 Review practices
designed for
trademarks across all
 Focuses on likelihood of
 Priority based on first to
file or use (regardless
of registration date)
 Review conducted by
attorneys who only
review registered
trademarks and
pending applications
 Review procedures built
with pharmaceutical
industry in mind
 Focuses on health and
 Priority based on first
allowed (regardless of
filing date)
 Review conducted by
medical specialists, who
gather empirical
evidence about the
Success with USPTO does not guarantee
success with the FDA
 Likelihood of confusion v. health and safety
 FDA considers names in the order presented to them;
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
FDA Proprietary Name Review
2007 PDUFA IV Act broadened FDA drug
safety program
 FDA committed to goal of minimizing medication errors
which are “any preventable event that may cause or lead
to inappropriate medication use or patient harm . . .”
 In 2004, FDA reviewed 338 applications,
rejecting 36%
Sharing Information with Industry
 September 2008: PDUFA Pilot Project for Proprietary
Name Review (voluntary)
 February 2010: Guidance for Industry: Contents of a
Complete Submission for the Evaluation of a Proprietary
Office of Drug Safety: Name Approval
 Center for Drug Evaluation and Research and Center for
Biological Evaluation
 Office of Surveillance and Epidemiology (formerly Office of
Drug Safety)
 Office of Prescription Drug Promotion (formerly DDMAC);
performs first-line consultation on potential names
 Division of Medication Error Prevention and Analysis, part
of OSE; reviews medication error reports and prospectively
reviews proprietary names, labeling, packaging and
product design prior to drug approval
Overview of FDA Approval Process
Company may seek “initial evaluation” of
proposed name while product under IND, but FDA
will not evaluate until product completes phase 2
 180-day timeline for review for names submitted
during 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
OPDP Review
OSE has lead responsibility within CDER for
communications to industry re new drug names
OPDP reviews for false or misleading promotional
 Names that overstate efficacy, minimize risk, broaden
indication, claim unsubstantiated superiority, or overly
“fanciful” by misleadingly implying unique effectiveness
or composition, etc. (e.g., SUPERCORTIZONE)
OPDP consults with DMEPA
 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
DMEPA’s Process
Step 1: Screening for common causes of
medical errors and USAN Stem Names
 Includes labeling and packaging analysis (if submitted with
Step 2: Generation of list of potentially similar
 Database searching
 POCA Computer algorithm
 Active ingredient medication errors
Step 3: Assessment of Risk
 Failure Mode and Effects Analysis (FMEA)
 Expert panel analysis
 Handwriting and verbal confusion experimentation
Common causes of medication errors
Words or phrases used in the name
 Dosing interval terminology (e.g., MARKBID)
 Dosage form and routes of administration (e.g.,
 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
 Labeling/packaging based issues
Developing list of similar drug names
Database searching
 Review numerous pharmaceutical, medical, and trademark
data bases for similar names
Computer Analysis
 FDA developed tool to identify look-alike, sound-alike
 Phonetic Orthographic Computer Analysis (POCA)
― Released to public February 2009
Active ingredient medication error data
 If any active ingredients are marketed, DMEP reviews
incidents and causes of reported medication errors
Assessment of risk
Handwriting and verbal analysis
 Prescription analysis studies
 Simulate prescription ordering process
 Conducted within FDA to determine degree of
confusion in visual appearance or pronunciation
between proposed name and existing names
 Nurses, pharmacists and physicians interpret
written prescriptions and verbal orders
Assessment of risk, cont.
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, including storage, dosage, indications etc.
 More rigorous than prior “all things considered”
Assessment of risk, cont.
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
Sample Problem Names
Amaryl (Reminyl)
 Amaryl (diabetes)
 Reminyl (Alzheimer’s); name
changed to Razadyne
Avandia (Coumadin)
 Avandia (oral diabetes)
 Coumadin (anticoagulant)
Avandia or Coumadin?
The results of FDA’s handwriting analysis
are often hard to predict
What To Do if Proposed Name is
FDA rejection rate continues upward
 ~ 42% new drug names refused in 2011
Seek reconsideration
 Work with the FDA to identify and alleviate concerns
 May be able to use regulatory screening investigation
results to support reconsideration
Submit two new names
Need back up alternatives right up to time of
final approval
FDA PDUFA Proprietary Name Review
Pilot Project
PDUFA Initiative, Sept. 2008-2011
Procedure inspired by NDA/BLA procedure
 Company conducts name review under FDA guidelines
and best practices; FDA reviews results and methodology
Insufficient Data; Guidance Coming?
 FDA hoped to have 20-25 participants, only 3 registered
and FDA received only one complete submission, which
was not sufficient to assess feasibility of industry
conducting reviews of proposed proprietary names
 FDA announced public meeting would not be held due to
insufficient data; unclear whether FDA will publish draft
guidance describing best test methods for proprietary
name evaluation in future
Foreign Drug Approval Process
Each jurisdiction has its own rules and
European Medicines Agency (EMA)
 Reviewed drug names since 1995 (formerly European
Agency for the Evaluation of Medicinal Products or EMEA)
 Published guidelines
― Guideline on the Acceptability of Names for Human Medicinal
Products Processed Through the Centralized Procedure
 Does not consider third party trademark rights
In 2011, “(Invented) Name Review Group”
(NRG) ~48% rejection rate
Putting It All Together . . .
Overview of the Drug Name Selection
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
Timing is important
 Need to have a name ready and approved on launch day
Step 1: Initial List of Candidates
Start with a list of about 10-12 marks
 Too few, and risk of none being acceptable to USPTO and
 Too many, prohibitive costs and potential issues with
trademark filings
Selection considerations
Brand identity, consumer reaction
Domain name availability
Connotations in foreign markets (remember NOVA)
FDA and trademark prescreening
Secrecy important at this stage
 No rights in name candidates until applications are filed
Step 2: Research Trademark Availability
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 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
Step 3: Apply with USPTO
U.S. Patent and Trademark Office
 File early, but remember application starts clock ticking
―Must commence use in approximately 4 years from
application date
 Describe goods broadly, but accurately
―“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
Step 4: Safety Investigation
Some companies opt to simulate look-alike,
sound-alike investigations conducted by the FDA
 Not required under the current FDA rules
 Helpful to evaluate chances of FDA name approval
 Can serve as ammunition for an appeal of rejection
 Best to conduct the Safety Investigation early in the
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
Step 5: Foreign Trademark Filing
Trademark rights are territorial
 Each jurisdiction has its own rules and procedures
Paris Convention filing deadline – 6
months from U.S. application date
 U.S. priority date becomes foreign priority date
 If possible, trim list of candidates to reduce cost prior
to filing
Step 6: Apply with the FDA
The earlier the better
 FDA recommends applying as early as the end of Phase
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
Summary of the Name Selection
Initial List of Candidates
Research Availability
Apply with USPTO
Safety Investigation
Foreign Trademark Filing
Apply with the FDA
Closing Thoughts
Drug name selection process must be started
early, well before (sometimes years) target launch
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
Useful Web Sites
 www.uspto.gov
European Trademark Authority
 oami.europa.eu
FDA Pilot Program to Evaluate Proposed Name
 http://www.gpo.gov/fdsys/pkg/FR-2009-10-01/html/E923620.htm
European Agency for the Evaluation of Medicinal
 www.ema.europa.eu
Thank You
Lisa M. Tittemore, Esq.
 (617) 443-9292 x. 274
 [email protected]

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