Trademark Evaluation Process: An Industry Perspective

1
Trademark Evaluation Process An Industry
Perspective

• Sharon Olmstead
• Executive Director, US Regulatory Liaison
• Worldwide Regulatory Affairs
• Pfizer

2
Product Development Process
Trademark Development Model
3
Trademark DevelopmentMarketing Activities

• Brand attributes
• Competitive marketplace

Strategy

• Focus groups
• Develop candidates

Creative
4
Trademark DevelopmentLegal Activities

• Search for similar marks
• Risk assessment

Legal Clearance

• Review / filing
• Notification / publication
• TM issuance (2 years)

TM Office Filing
Competitive Monitoring

• TM filings
• New drug approvals

5
Trademark DevelopmentRegulatory Activities
Trademark Safety Assessment

• Dispensing testing
• Recommendations

• Regulatory submission
• Preliminary approval

Regulatory Filing

• NDA submission
• Additional testing
• RM plan or alternate name selection

Final FDA Approval
6
Current Regulatory Challenges in Trademark
Evaluation Process

• Predictability of medication error model
• Validation of methods
• Level of evidence to FDA clearance
• Error threshold
• Zero-tolerance vs. risk/benefit
• Risk management toolbox
• Train wreck scenario
• Timing of submission
• Alternatives to last-minute name change