The Name Game : How the USPTO and Changing FDA Approval Processes Affect Protection of New Drug Names

1. 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

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 • FDA pilot program • Strategies for trademark prosecution as a part of drug name selection and approval process

3. 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

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 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

5. 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

6. 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

7. 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 USPTO v. FDA: Differing Approaches

8. 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

9. 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%

10. Office of Drug Safety: Name Approval Players • Center for Drug Evaluation and Research (CDER), orCenter 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

11. 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

12. 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

13. 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)

14. 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

15. 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

16. 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

17. 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

18. 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

19. Sample Problem Names • Duagen (Dynapen) • Sound alike/look alike • Zygara (Zyprexa) • Sound alike • Avandia (Coumadin) • Handwriting errors

20. Avandia or Coumadin?

21. 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

22. 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

23. 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

24. 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

25. 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)

26. 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)

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” • Usually required to narrow during examination process • Cannot expand description once on file (file separate application)

28. 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

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, 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

33. 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

34. Thank You • Lisa M. Tittemore, Esq. • (617) 443-9292 x. 274 • ltittemore@bromsun.com • Keith E. Toms, Esq. • (617) 443-9292 x. 321 • ktoms@bromsun.com