CURRENT PRACTICES FOR
Robert E. Lee, Jr.
Chair, PhRMA Trademark Subcommittee
• Jim Dettore, President, Brand Institute
• Clement Galluccio, Interbrand Wood
• Susan Proulx, President, Med-ERRS
• Jerry Phillips, Director, FDA DMETS
• Toni Stifano, FDA CBER
• Overview of trademark legal clearance process.
• Overview of trademark error potential evaluation
• Questions/comments on data collection issues.
• Questions/comments on decision process.
• Panelists’ remarks.
• Moderator’s closing comments.
Legal Analysis Surviving
Promising Subset of
and Opinion by Candidates with
Promising Trade- Expert Analysis Surviving
mark Candidates and Opinions by Candidates with
that Survived Independent Acceptable
Legal Search Consider Pharmacists Similarity
• 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+).
• 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
Computer searches, data bases, clinical
• Do you use an individual expert or an expert
• 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
• BRAND INSTITUTE
• INTERBRAND WOOD
• Need for error potential evaluation of trademarks
• 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
• Looking forward to expert assessment of current
• Is this a scientific vs subjective process?