The USPTO and FDA Approval Process
Selection and Protection of
New Drug Names
Lisa M. Tittemore, Esq.

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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’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

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What is a trademark?
 Word(s)
 Symbol
 Device (design)
 Sound
 Any combination thereof
An identifier of source

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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 trademarks

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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

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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
 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

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USPTO
 Review practices designed for trademarks across all industries
 Focuses on likelihood of confusion
 Priority based on first to file or use (regardless of registration date)
 Review conducted by attorneys who only review registered trademarks and pending applications
FDA
 Review procedures built with pharmaceutical industry in mind
 Focuses on health and safety
 Priority based on first allowed (regardless of filing date)
 Review conducted by medical specialists, who gather empirical evidence about the marketplace

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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

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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
Name

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CDER and CBER
 Center for Drug Evaluation and Research and Center for
Biological Evaluation
OSE
 Office of Surveillance and Epidemiology (formerly Office of
Drug Safety)
OPDP
 Office of Prescription Drug Promotion (formerly DDMAC); performs first-line consultation on potential names
DMEPA
 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

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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 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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OSE has lead responsibility within CDER for communications to industry re new drug names
OPDP reviews for false or misleading promotional claims
 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

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Step 1: Screening for common causes of medical errors and USAN Stem Names
 Includes labeling and packaging analysis (if submitted 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
 Handwriting and verbal confusion experimentation

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 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
(stems are for generic names, not proprietary names)
 Labeling/packaging based issues

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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 names
 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

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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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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” analysis

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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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Amaryl (Reminyl)
 Amaryl (diabetes)
 Reminyl (Alzheimer’s); name changed to Razadyne
Avandia (Coumadin)
 Avandia (oral diabetes)
 Coumadin (anticoagulant)

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The results of FDA’s handwriting analysis are often hard to predict

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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

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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

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Each jurisdiction has its own rules and procedures
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

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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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Start with 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 important at this stage
 No rights in name candidates until applications are filed

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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 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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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 intentions)!

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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
Timing
 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

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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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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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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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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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USPTO
 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/E9-
23620.htm
European Agency for the Evaluation of Medicinal
Products
 www.ema.europa.eu

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Lisa M. Tittemore, Esq.
 (617) 443-9292 x. 274
 ltittemore@sunsteinlaw.com