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The Name Game:
How the USPTO and Changing FDA Approval
Processes Affect Protection of
New Drug Names
Lisa M. Tittemore, Esq.
Keith E. Toms, Esq.
Bromberg & Sunstein LLP
November 5, 2008
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
• FDA pilot program
• Strategies for trademark prosecution as a part of
drug name selection and approval process
2
Trademarks
What is a trademark?
• Word(s)
• Symbol
• Device (design)
• Sound
• Any combination thereof
Serves as an identifier of source
Rights may be based on use or registration in
the United States
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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 have resources or expertise to investigate the
marketplace
– Likelihood of confusion analysis is conducted by attorneys
based on the likelihood of confusion factors
• USPTO does apply some heightened review for
pharmaceutical trademarks
– Doctrine of “Greater Care” applies to pharmaceutical trademarks
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Examination and Opposition
USPTO examination
• Descriptiveness, genericness, and other grounds for rejection
• Likelihood of confusion
Publication and opposition
• Allowed marks published in Official Gazette
• Interested third parties can oppose based on registered or
common-law trademarks
• Case before the Trademark Trial and Appeal Board, with a
right of appeal to the Federal Courts
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Common Trademark Application Issues for
Drug Names
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 mark
• Open issue regarding acceptable bounds 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
• Can be problematic given the 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
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
Success with USPTO does not guarantee success
with the FDA
• Likelihood of confusion v. health and safety
FDA is unlikely to be influenced by USPTO
• FDA considers names in the order presented to them
• Trademark priority dates not considered by FDA
FDA approval may influence USPTO
• Strong evidence of no likelihood of confusion in some
circumstances
• USPTO likelihood of confusion may consider marks and factors
not considered by FDA
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FDA Proprietary Name Review
FDA authorized to prevent “misbranding” of drugs
• FDA sees role as preventing medication errors which are “any
preventable event that may cause or lead to inappropriate medication
use or patient harm . . .”
No published official guidelines, but the winds of
change are blowing
• September 2008: PDUFA Pilot Project for Proprietary Name Review
FDA name approval more rigorous than USPTO
trademark examination process
In 2004, FDA reviewed 338 applications,
rejecting 36%
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Office of Drug Safety: Name Approval Players
Center for Drug Evaluation and Research (CDER), or
Center for Biological Evaluation and Research (CBER)
Division of Drug Marketing, Advertising, and Communications
(DDMAC)
• Reviews for false or misleading promotional claims
Division of Medication Error Prevention
• Performs pre-marketing review of all proprietary names and labeling
• Formerly Division of Medication Errors and Technical Support (DMETS)
• Acronym problem – “DMEP” is already taken
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Overview of FDA Name Approval Process
Can begin as early as the end of Phase 2 or
beginning of Phase 3 testing
• May submit up to two names at a time
Names submitted to project manager in CDER
or CBER, who consults with DDMAC and
DMEP
• Appears that DMEP is taking a greater role in final
approval
Preliminary name approval re-evaluated when
NDA is filed and 90 days before NDA approval
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DDMAC Review
DDMAC reviews for false or misleading
promotional claims
• Names that imply efficacy, risk, indication, superiority, or that
are overly “fanciful” (e.g., SUPERCORTIZONE)
DDMAC consults with CDER or CBER
• If proposed name is rejected, it is not sent to DMEP for safety
testing
• Opportunity for sponsor to reply to rejection
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DMEP’s Process
Step 1: Prescreening for common causes of medical
errors
Step 2: Hypothesis generation
• Database searching
• Expert panel analysis
• Handwriting and verbal confusion experimentation
• Labeling and packaging analysis
• Active ingredient medication errors
Step 3: Risk assessment
• Failure Mode and Effects Analysis (FMEA)
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Drug Name Prescreening
Common causes of medication errors
• Dosing interval terminology (e.g., MARKBID)
• Dosage form and routes of administration (e.g., MARKCAPS,
MARKORAL)
• 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
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Hypothesis Generation
Database searching
• Review numerous pharmaceutical, medical, and
trademark data bases for similar names
• FDA developed tool to identify look-alike, sound-alike
names
– Phonetic Orthographic Computer Analysis (POCA)
– POCA scheduled for public release this year
Internal expert panel analysis
• Panel generally consists of physicians, nurses, and
pharmacists
• Use expertise to evaluate and expand list of problematic
names
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Hypothesis Generation, cont.
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
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Hypothesis Generation, cont.
Labeling and packaging analysis
• Safety assessment of container labels, carton and packaging
insert labeling and proposed packaging
Active ingredient medication error data
• If any active ingredients are marketed, DMEP reviews incidents
and causes of reported medication errors
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Risk Assessment
Failure mode and effects analysis
• Analyzing how errors may occur and their likely effects
• Considers finding of review steps, and additional factors,
including storage, dosage, indications etc.
• More rigorous than prior “all things considered” analysis
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Sample Problem Names
Duagen (Dynapen)
• Sound alike/look alike
Zygara (Zyprexa)
• Sound alike
Avandia (Coumadin)
• Handwriting errors
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Avandia or Coumadin?
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What To Do if Proposed Name is Rejected
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
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FDA Proprietary Name Review Pilot Project
Brand new initiative
• June 2008 public comment, September 2008 final concept
paper
Procedure inspired by NDA/BLA procedure
• Company conducts name review under FDA guidelines and
best practices
• FDA reviews results and methodology
Pilot program 2009-2011
• Sponsors enrolled in program will conduct testing parallel to
FDA’s review
• FDA will compare results at program’s end
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Foreign Drug Approval Process
Each jurisdiction has its own rules and
procedures
European Agency for the Evaluation of Medicinal
Products (EMEA)
• Reviewed drug names since 1995
• 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 2006, NRG rejected 152 of 305 candidates –
50% rejection rate
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Putting It All Together . . .
Overview of the Drug Name Selection Process
Ultimate goal for a drug name trademark is to have
a mark 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, EMEA, 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
Develop a list of about 10-12 marks
• Too few, and risk of none being acceptable to USPTO and FDA
• 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 paramount at this stage
• No rights in name candidates until applications are filed (assuming
no prior use)
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Step 2: Research 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 for the “hypothesis generation” phase for the Safety
Investigation (Step 4)
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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”
– Usually required to narrow during examination process
– Cannot expand description once on file (file separate
application)
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Step 4: Safety Investigation
Many 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
Timing
• Best to conduct the Safety Investigation early in the process
to eliminate problem marks
• But, may be desirable to wait until applications are on file
before the costs associate with such an investigation are
incurred
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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
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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
approval
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Summary of the Name Selection Process
Step 1: Initial List of Candidates
Step 2: Research Availability
Step 3: Apply with USPTO
Step 4: Safety Investigation
Step 5: Foreign Trademark Filing
Step 6: Apply with the FDA
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Closing Thoughts
Drug name selection process must be started early,
years before 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 important
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Useful Web Sites
USPTO
• www.uspto.gov
European Trademark Authority
• oami.europa.eu
FDA Pilot Program to Evaluate Proposed Name
• www.fda.gov/CDER/drug/MedErros/Meeting_2008.htm
European Agency for the Evaluation of Medicinal
Products
• www.emea.europa.eu
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Thank You
Lisa M. Tittemore, Esq.
• (617) 443-9292 x. 274
• [email protected]
Keith E. Toms, Esq.
• (617) 443-9292 x. 321
• [email protected]
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