CURRENT PRACTICES FOR DATA COLLECTION & DECISION ANALYSIS

1. CURRENT PRACTICES FORDATA COLLECTION &DECISION ANALYSIS Session Moderator: Robert E. Lee, Jr. Chair, PhRMA Trademark Subcommittee

2. SESSION PARTICIPANTS • Jim Dettore, President, Brand Institute • Clement Galluccio, Interbrand Wood • Susan Proulx, President, Med-ERRS • Jerry Phillips, Director, FDA DMETS • Toni Stifano, FDA CBER

3. SESSION AGENDA • Overview of trademark legal clearance process. • Overview of trademark error potential evaluation process. • Questions/comments on data collection issues. • Questions/comments on decision process. • Panelists’ remarks. • Moderator’s closing comments.

4. USPTO Trademark Database Common Law References Subset of Possible Blocks Legal Analysis and Opinion by Trademark Attorney Surviving Candidates with Acceptable Similarity Promising Trademark Candidates Domain Names Other Sources, e.g. Internet Searches

5. Look-Alike, Sound-Alike Prescription Testing Responses to Questionnaire Subset of Names with Error Potential Expert Analysis and Opinions by Independent Pharmacists Surviving Candidates with Acceptable Similarity Promising Trade- mark Candidates that Survived Legal Search Consider Medical Terms and Abbreviations Other Dispensing Issues, e.g. Clinical Setting, Dosage, etc.

6. DATA COLLECTION:SAMPLING ISSUES • How do you select your respondent sample? Random, selected from a panel, other. • Who do you include in your sample? Physicians, pharmacists, nurses, others. • What is your sample size? Smaller sample size (e.g. ~ 30). Larger sample size (e.g. 100+).

7. DATA COLLECTION:QUESTIONNAIRE ISSUES • Are questionnaires self-administered? Internet, mail, other. • Do you use personal interviews? One on one, phone, other. • Are your questions multiple choice or open ended? • Do you supplement respondent input with other data? Computer searches, data bases, clinical information, etc.

8. DECISION PROCESS • Do you use an individual expert or an expert committee? • Do you have objective measures or thresholds for establishing problematic name similarity? • What scoring methods do you use? Numbers, letter grades, words, other. • Do you have weighting techniques for clinical variables?

9. PANELISTS’ REMARKS • BRAND INSTITUTE • INTERBRAND WOOD • MED-ERRS • DMETS

10. CLOSING COMMENTS • Need for error potential evaluation of trademarks appears warranted. • Reasonable methods would be welcome. • Goal is to obtain relevant and reliable information to the question at hand while improving timing and predictability for adoption of trademarks. • Looking forward to expert assessment of current methods. • Is this a scientific vs subjective process?