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

2. 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

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

4. 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 trademarks

5. 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

6. Common Trademark 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
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

7. USPTO v. FDA: Differing Approaches
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

8. FDA and USPTO
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

9. 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 Name

10. Office of Drug Safety: Name Approval Players
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

11. 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 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

12. OPDP Review
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

13. DMEPA’s Process
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

14. 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., 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

15. 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 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

16. 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

17. 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” analysis

18. 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

19. Sample Problem Names Amaryl (Reminyl) Avandia (Coumadin)
Amaryl (diabetes)
Reminyl (Alzheimer’s); name changed to Razadyne
Avandia (Coumadin)
Avandia (oral diabetes)
Coumadin (anticoagulant)

20. Avandia or Coumadin?
The results of FDA’s handwriting analysis are often hard to predict

21. What To Do if Proposed Name is Rejected
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

22. FDA PDUFA Proprietary Name Review Pilot Project
PDUFA Initiative, Sept
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 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

23. Foreign Drug Approval Process
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

24. Putting It All Together . . . Overview of the Drug Name Selection Process
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

25. Step 1: Initial List of Candidates
Start with a list of about 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

26. 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

27. 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 intentions)!

28. 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
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

29. 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

30. 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

31. 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

32. Closing Thoughts
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

33. Useful Web Sites USPTO European Trademark Authority
European Trademark Authority
oami.europa.eu
FDA Pilot Program to Evaluate Proposed Name
European Agency for the Evaluation of Medicinal Products

34. Thank You Lisa M. Tittemore, Esq. (617) 443-9292 x. 274