Thompson Drug Name Presentation


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Presentation regarding interplay of FDA and USPTO procedures relating to selection and protection of new drug names

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Thompson Drug Name Presentation

  1. 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. 2. Presentation Overview <ul><ul><li>U.S. Patent & Trademark Office (USPTO) procedures and issues relevant to prosecution of drug name trademarks </li></ul></ul><ul><ul><li>U.S. Food & Drug Administration’s drug name review process and criteria </li></ul></ul><ul><ul><li>FDA pilot program </li></ul></ul><ul><ul><li>Strategies for trademark prosecution as a part of drug name selection and approval process </li></ul></ul>
  3. 3. Trademarks <ul><li>What is a trademark? </li></ul><ul><ul><li>Word(s) </li></ul></ul><ul><ul><li>Symbol </li></ul></ul><ul><ul><li>Device (design) </li></ul></ul><ul><ul><li>Sound </li></ul></ul><ul><ul><li>Any combination thereof </li></ul></ul><ul><li>Serves as an identifier of source </li></ul><ul><li>Rights may be based on use or registration in the United States </li></ul>
  4. 4. Likelihood of Confusion <ul><li>U.S. Courts and USPTO apply likelihood of confusion analysis </li></ul><ul><ul><li>Similarity of sight, sound and meaning of marks, goods, channels of trade, sophistication of purchasers, etc. </li></ul></ul><ul><ul><li>USPTO doesn’t have resources or expertise to investigate the marketplace </li></ul></ul><ul><ul><ul><li>Likelihood of confusion analysis is conducted by attorneys based on the likelihood of confusion factors </li></ul></ul></ul><ul><ul><li>USPTO does apply some heightened review for pharmaceutical trademarks </li></ul></ul><ul><ul><ul><li>Doctrine of “Greater Care” applies to pharmaceutical trademarks </li></ul></ul></ul>
  5. 5. Examination and Opposition <ul><li>USPTO examination </li></ul><ul><ul><li>Descriptiveness, genericness, and other grounds for rejection </li></ul></ul><ul><ul><li>Likelihood of confusion </li></ul></ul><ul><li>Publication and opposition </li></ul><ul><ul><li>Allowed marks published in Official Gazette </li></ul></ul><ul><ul><li>Interested third parties can oppose based on registered or common-law trademarks </li></ul></ul><ul><ul><li>Case before the Trademark Trial and Appeal Board, with a right of appeal to the Federal Courts </li></ul></ul>
  6. 6. Common Trademark Application Issues for Drug Names <ul><ul><li>Paradox of the pharmaceutical industry </li></ul></ul><ul><ul><li>Glut of “strong” fanciful marks contributes to confusion </li></ul></ul><ul><ul><li>Bona fide intent in the drug name context </li></ul></ul><ul><ul><li>ITU applications require a bona fide intent to use the mark </li></ul></ul><ul><ul><li>Open issue regarding acceptable bounds of filing for multiple marks for a single product </li></ul></ul><ul><ul><li>Limited shelf life of ITU applications </li></ul></ul><ul><ul><li>Generally must commence use in approximately 4 years from application date </li></ul></ul><ul><ul><li>Can be problematic given the uncertainties involved in the drug development time frame </li></ul></ul>
  7. 7. USPTO v. FDA: Differing Approaches <ul><li>USPTO </li></ul><ul><ul><li>Review practices designed for trademarks across all industries </li></ul></ul><ul><ul><li>Focuses on likelihood of confusion </li></ul></ul><ul><ul><li>Priority based on first to file or use (regardless of registration date) </li></ul></ul><ul><ul><li>Review conducted by attorneys who only review registered trademarks and pending applications </li></ul></ul><ul><li>FDA </li></ul><ul><ul><li>Review procedures built with pharmaceutical industry in mind </li></ul></ul><ul><ul><li>Focuses on health and safety </li></ul></ul><ul><ul><li>Priority based on first allowed (regardless of filing date) </li></ul></ul><ul><ul><li>Review conducted by medical specialists, who gather empirical evidence about the marketplace </li></ul></ul>
  8. 8. FDA and USPTO <ul><li>Success with USPTO does not guarantee success with the FDA </li></ul><ul><ul><li>Likelihood of confusion v. health and safety </li></ul></ul><ul><li>FDA is unlikely to be influenced by USPTO </li></ul><ul><ul><li>FDA considers names in the order presented to them </li></ul></ul><ul><ul><li>Trademark priority dates not considered by FDA </li></ul></ul><ul><li>FDA approval may influence USPTO </li></ul><ul><ul><li>Strong evidence of no likelihood of confusion in some circumstances </li></ul></ul><ul><ul><li>USPTO likelihood of confusion may consider marks and factors not considered by FDA </li></ul></ul>
  9. 9. FDA Proprietary Name Review <ul><li>FDA authorized to prevent “misbranding” of drugs </li></ul><ul><ul><li>FDA sees role as preventing medication errors which are “any preventable event that may cause or lead to inappropriate medication use or patient harm . . .” </li></ul></ul><ul><li>No published official guidelines, but the winds of change are blowing </li></ul><ul><ul><li>September 2008: PDUFA Pilot Project for Proprietary Name Review </li></ul></ul><ul><ul><li>FDA name approval more rigorous than USPTO trademark examination process </li></ul></ul><ul><ul><li>In 2004, FDA reviewed 338 applications, rejecting 36% </li></ul></ul>
  10. 10. Office of Drug Safety: Name Approval Players <ul><li>Center for Drug Evaluation and Research (CDER), or Center for Biological Evaluation and Research (CBER) </li></ul><ul><li>Division of Drug Marketing, Advertising, and Communications (DDMAC) </li></ul><ul><ul><li>Reviews for false or misleading promotional claims </li></ul></ul><ul><ul><li>Division of Medication Error Prevention </li></ul></ul><ul><ul><li>Performs pre-marketing review of all proprietary names and labeling </li></ul></ul><ul><ul><li>Formerly Division of Medication Errors and Technical Support (DMETS) </li></ul></ul><ul><ul><li>Acronym problem – “DMEP” is already taken </li></ul></ul>
  11. 11. Overview of FDA Name Approval Process <ul><li>Can begin as early as the end of Phase 2 or beginning of Phase 3 testing </li></ul><ul><ul><li>May submit up to two names at a time </li></ul></ul><ul><li>Names submitted to project manager in CDER or CBER, who consults with DDMAC and DMEP </li></ul><ul><ul><li>Appears that DMEP is taking a greater role in final approval </li></ul></ul><ul><li>Preliminary name approval re-evaluated when NDA is filed and 90 days before NDA approval </li></ul>
  12. 12. DDMAC Review <ul><li>DDMAC reviews for false or misleading promotional claims </li></ul><ul><ul><li>Names that imply efficacy, risk, indication, superiority, or that are overly “fanciful” (e.g., SUPERCORTIZONE) </li></ul></ul><ul><li>DDMAC consults with CDER or CBER </li></ul><ul><ul><li>If proposed name is rejected, it is not sent to DMEP for safety testing </li></ul></ul><ul><ul><li>Opportunity for sponsor to reply to rejection </li></ul></ul>
  13. 13. DMEP’s Process <ul><li>Step 1: Prescreening for common causes of medical errors </li></ul><ul><li>Step 2: Hypothesis generation </li></ul><ul><ul><li>Database searching </li></ul></ul><ul><ul><li>Expert panel analysis </li></ul></ul><ul><ul><li>Handwriting and verbal confusion experimentation </li></ul></ul><ul><ul><li>Labeling and packaging analysis </li></ul></ul><ul><ul><li>Active ingredient medication errors </li></ul></ul><ul><li>Step 3: Risk assessment </li></ul><ul><ul><li>Failure Mode and Effects Analysis (FMEA) </li></ul></ul>
  14. 14. Drug Name Prescreening <ul><li>Common causes of medication errors </li></ul><ul><ul><li>Dosing interval terminology (e.g., MARKBID) </li></ul></ul><ul><ul><li>Dosage form and routes of administration (e.g., MARKCAPS, MARKORAL) </li></ul></ul><ul><ul><li>Common medical and product name abbreviations </li></ul></ul><ul><ul><li>Names that suggest fewer than all active ingredients, or suggests ingredient not included </li></ul></ul><ul><ul><li>Use of United States Adopted Names (USAN) and International Nonproprietary Name (INN) stems </li></ul></ul>
  15. 15. Hypothesis Generation <ul><li>Database searching </li></ul><ul><ul><li>Review numerous pharmaceutical, medical, and trademark data bases for similar names </li></ul></ul><ul><ul><li>FDA developed tool to identify look-alike, sound-alike names </li></ul></ul><ul><ul><ul><li>Phonetic Orthographic Computer Analysis (POCA) </li></ul></ul></ul><ul><ul><ul><li>POCA scheduled for public release this year </li></ul></ul></ul><ul><li>Internal expert panel analysis </li></ul><ul><ul><li>Panel generally consists of physicians, nurses, and pharmacists </li></ul></ul><ul><ul><li>Use expertise to evaluate and expand list of problematic names </li></ul></ul>
  16. 16. Hypothesis Generation, cont. <ul><li>Handwriting and verbal analysis </li></ul><ul><ul><li>Prescription analysis studies </li></ul></ul><ul><ul><ul><li>Simulate prescription ordering process </li></ul></ul></ul><ul><ul><ul><li>Conducted within FDA to determine degree of confusion in visual appearance or pronunciation between proposed name and existing names </li></ul></ul></ul><ul><ul><ul><li>Nurses, pharmacists and physicians interpret written prescriptions and verbal orders </li></ul></ul></ul>
  17. 17. Hypothesis Generation, cont. <ul><li>Labeling and packaging analysis </li></ul><ul><ul><li>Safety assessment of container labels, carton and packaging insert labeling and proposed packaging </li></ul></ul><ul><li>Active ingredient medication error data </li></ul><ul><ul><li>If any active ingredients are marketed, DMEP reviews incidents and causes of reported medication errors </li></ul></ul>
  18. 18. Risk Assessment <ul><li>Failure mode and effects analysis </li></ul><ul><ul><li>Analyzing how errors may occur and their likely effects </li></ul></ul><ul><ul><li>Considers finding of review steps, and additional factors, including storage, dosage, indications etc. </li></ul></ul><ul><ul><li>More rigorous than prior “all things considered” analysis </li></ul></ul>
  19. 19. Sample Problem Names <ul><li>Duagen (Dynapen) </li></ul><ul><ul><li>Sound alike/look alike </li></ul></ul><ul><li>Zygara (Zyprexa) </li></ul><ul><ul><li>Sound alike </li></ul></ul><ul><li>Avandia (Coumadin) </li></ul><ul><ul><li>Handwriting errors </li></ul></ul>
  20. 20. Avandia or Coumadin?
  21. 21. What To Do if Proposed Name is Rejected <ul><li>Seek reconsideration </li></ul><ul><ul><li>Work with the FDA to identify and alleviate concerns </li></ul></ul><ul><ul><li>May be able to use regulatory screening investigation results to support reconsideration </li></ul></ul><ul><li>Submit two new names </li></ul>
  22. 22. FDA Proprietary Name Review Pilot Project <ul><li>Brand new initiative </li></ul><ul><ul><li>June 2008 public comment, September 2008 final concept paper </li></ul></ul><ul><li>Procedure inspired by NDA/BLA procedure </li></ul><ul><ul><li>Company conducts name review under FDA guidelines and best practices </li></ul></ul><ul><ul><li>FDA reviews results and methodology </li></ul></ul><ul><li>Pilot program 2009-2011 </li></ul><ul><ul><li>Sponsors enrolled in program will conduct testing parallel to FDA’s review </li></ul></ul><ul><ul><li>FDA will compare results at program’s end </li></ul></ul>
  23. 23. Foreign Drug Approval Process <ul><li>Each jurisdiction has its own rules and procedures </li></ul><ul><li>European Agency for the Evaluation of Medicinal Products (EMEA) </li></ul><ul><ul><li>Reviewed drug names since 1995 </li></ul></ul><ul><ul><li>Published guidelines </li></ul></ul><ul><ul><ul><li>Guideline on the Acceptability of Names for Human Medicinal Products Processed Through the Centralized Procedure </li></ul></ul></ul><ul><ul><li>Does not consider third party trademark rights </li></ul></ul><ul><ul><li>In 2006, NRG rejected 152 of 305 candidates – 50% rejection rate </li></ul></ul>
  24. 24. Putting It All Together . . . Overview of the Drug Name Selection Process <ul><li>Ultimate goal for a drug name trademark is to have a mark that: </li></ul><ul><ul><li>Satisfies branding and marketing goals </li></ul></ul><ul><ul><li>Minimizes the risk of medication errors </li></ul></ul><ul><ul><li>Is approved by the USPTO and foreign trademark offices </li></ul></ul><ul><ul><li>Is acceptable to the FDA, EMEA, and other regulatory bodies </li></ul></ul><ul><li>Timing is important </li></ul><ul><ul><li>Need to have a name ready and approved on launch day </li></ul></ul>
  25. 25. Step 1: Initial List of Candidates <ul><li>Develop a list of about 10-12 marks </li></ul><ul><ul><li>Too few, and risk of none being acceptable to USPTO and FDA </li></ul></ul><ul><ul><li>Too many, prohibitive costs and potential issues with trademark filings </li></ul></ul><ul><ul><li>Selection considerations </li></ul></ul><ul><ul><ul><li>Brand identity, consumer reaction </li></ul></ul></ul><ul><ul><ul><li>Domain name availability </li></ul></ul></ul><ul><ul><ul><li>Connotations in foreign markets (remember NOVA) </li></ul></ul></ul><ul><ul><ul><li>FDA and trademark prescreening </li></ul></ul></ul><ul><ul><li>Secrecy paramount at this stage </li></ul></ul><ul><ul><li>No rights in name candidates until applications are filed (assuming no prior use) </li></ul></ul>
  26. 26. Step 2: Research Availability <ul><li>Trademark search (U.S. and international) </li></ul><ul><ul><li>Advisable at earliest stage of process </li></ul></ul><ul><ul><li>Indispensable step in selection process </li></ul></ul><ul><ul><ul><li>Identify pre-existing use by others and evaluate chances of successful registration with the USPTO </li></ul></ul></ul><ul><ul><ul><li>Limits of trademark prescreening </li></ul></ul></ul><ul><ul><ul><li>Helpful for the “hypothesis generation” phase for the Safety Investigation (Step 4) </li></ul></ul></ul>
  27. 27. Step 3: Apply with USPTO <ul><li>U.S. Patent and Trademark Office </li></ul><ul><ul><li>File early, but remember application starts clock ticking </li></ul></ul><ul><ul><ul><li>Must commence use in approximately 4 years from application date </li></ul></ul></ul><ul><ul><li>Describe goods broadly, but accurately </li></ul></ul><ul><ul><ul><li>“ Pharmaceutical preparations ” </li></ul></ul></ul><ul><ul><ul><li>Usually required to narrow during examination process </li></ul></ul></ul><ul><ul><ul><li>Cannot expand description once on file (file separate application) </li></ul></ul></ul>
  28. 28. Step 4: Safety Investigation <ul><li>Many companies opt to simulate look-alike, sound-alike investigations conducted by the FDA </li></ul><ul><ul><li>Not required under the current FDA rules </li></ul></ul><ul><ul><li>Helpful to evaluate chances of FDA name approval </li></ul></ul><ul><ul><li>Can serve as ammunition for an appeal of rejection </li></ul></ul><ul><li>Timing </li></ul><ul><ul><li>Best to conduct the Safety Investigation early in the process to eliminate problem marks </li></ul></ul><ul><ul><li>But , may be desirable to wait until applications are on file before the costs associate with such an investigation are incurred </li></ul></ul>
  29. 29. Step 5: Foreign Trademark Filing <ul><li>Trademark rights are territorial </li></ul><ul><ul><li>Each jurisdiction has its own rules and procedures </li></ul></ul><ul><li>Paris Convention filing deadline – 6 months from U.S. application date </li></ul><ul><ul><li>U.S. priority date becomes foreign priority date </li></ul></ul><ul><ul><li>If possible, trim list of candidates to reduce cost prior to filing </li></ul></ul>
  30. 30. Step 6: Apply with the FDA <ul><li>The earlier the better </li></ul><ul><ul><li>FDA recommends applying as early as the end of Phase II, beginning of Phase III </li></ul></ul><ul><ul><li>May submit up to 2 marks at once to expedite process </li></ul></ul><ul><ul><li>Approval is only preliminary until 90 days before NDA approval </li></ul></ul>
  31. 31. Summary of the Name Selection Process <ul><li>Step 1: Initial List of Candidates </li></ul><ul><li>Step 2: Research Availability </li></ul><ul><li>Step 3: Apply with USPTO </li></ul><ul><li>Step 4: Safety Investigation </li></ul><ul><li>Step 5: Foreign Trademark Filing </li></ul><ul><li>Step 6: Apply with the FDA </li></ul>
  32. 32. Closing Thoughts <ul><li>Drug name selection process must be started early, years before target launch date </li></ul><ul><li>Trademark counsel plays important role in establishing and protecting rights in name </li></ul><ul><li>Communication between trademark counsel and those involved in the FDA regulatory process is important </li></ul>
  33. 33. Useful Web Sites <ul><li>USPTO </li></ul><ul><ul><li> </li></ul></ul><ul><li>European Trademark Authority </li></ul><ul><ul><li> </li></ul></ul><ul><li>FDA Pilot Program to Evaluate Proposed Name </li></ul><ul><ul><li> </li></ul></ul><ul><li>European Agency for the Evaluation of Medicinal Products </li></ul><ul><ul><li> </li></ul></ul>
  34. 34. Thank You <ul><li>Lisa M. Tittemore, Esq. </li></ul><ul><ul><li>(617) 443-9292 x. 274 </li></ul></ul><ul><ul><li>[email_address] </li></ul></ul><ul><li>Keith E. Toms, Esq. </li></ul><ul><ul><li>(617) 443-9292 x. 321 </li></ul></ul><ul><ul><li>[email_address] </li></ul></ul>