Adoption of Pharmaceutical Trademarks for Approval: Navigating Differing Standards at the FDA and USPTO
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Trademark and Copyright
- event Date
Thursday, November 7, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide IP counsel on the complexities of the pharmaceutical trademark adoption process to support a successful launch of a company's new pharmaceutical product. In particular, the panel will discuss the challenges inherent in pharmaceutical brand development and approval, an overview of the pharmaceutical trademark adoption process from brainstorming to clearance as well as the FDA trademark review process, and best practices to minimize the risk of rejection.
Ms. Clarke handles all non-patent IP matters from prosecution to enforcement and everything in between. Her primary focus is providing support to the business for the hematology franchise. Prior to going in-house, Ms. Clarke started her career as an attorney at a boutique IP firm representing clients in the areas of consumer products, fashion, medical devices, education and technology. Outside of Novartis, Ms. Clarke is a member of INTA, the Pharmaceutical Trademark Group, New York City Bar Association and Intellectual Property Owners Association. She is also a member of the Board of Directors for the New York Intellectual Property Association.
Mr. Tepper’s practice encompasses all aspects of the creation, registration, maintenance and enforcement of trademarks, copyrights and domain names. He regularly assists clients with marketing, legislative and licensing issues; and in IP dispute resolution. He also provides strategic counsel to clients on IP transactions and portfolio acquisition and management. Mr. Tepper formerly served as Director and Trademark Counsel for GlaxoSmithKline, a leading research-based pharmaceutical company. He has been appointed, by four different Secretaries of Commerce, to serve on the Trademark Public Advisory Committee to the U.S. Patent & Trademark Office, where he most recently served as Chair. Mr. Tepper has served on the INTA Board of Directors and is a founding member of INTA PAC. He has also served as counsel, chaired the Legislation and Regulatory Analysis Committee, the Audit Committee of the Board, the USPTO Subcommittee and the U.S. Legislation Subcommittee. He has also served as an expert witness in pharmaceutical trademark cases. Mr. Tepper is regularly called upon to lecture on trademark developments at conferences throughout the U.S., as well as abroad.
While all potential trademarks face challenges in development and registration, adoption of brand names for new pharmaceutical drugs and biologics is one of the unique challenges faced by pharmaceutical companies. Brand names need to strike a balance between patient safety and product appropriateness. Development of a proprietary name is a creative endeavor yet often involves a formal process requiring collaboration of multiple disciplines. And, proposed proprietary names must go through a significant amount of due diligence based on regulatory, linguistic, and legal evaluations. From a marketing perspective, the brand name should be memorable, impactful, distinctive, and able to function as a global brand. But, from a legal standpoint, the proposed name must be available for trademark use, registrable with the U.S. Trademark Office and abroad, and meet the FDA's stringent regulatory requirements, as well as those of international regulators. Clearing all of these hurdles is necessary in order for a company to achieve its goal of a successful product launch.
The FDA and the USPTO, two independent government agencies, with two fundamentally different purposes and goals, oversee the approval of pharmaceutical trademarks using two very different review approaches, each independent of one another. In particular, the FDA focuses on patient health and safety concerns to avoid medication error. The USPTO focuses on likelihood of confusion as to source. FDA trademark approval is mandatory to use a brand name. USPTO trademark registration is not a prerequisite to use of a brand name but most pharmaceutical companies seek registration to protect their investment and goodwill in their brand names.
Listen as our authoritative panel examines the challenges and complexities of the pharmaceutical trademark adoption process, including the differing approaches to trademark review by the FDA and the USPTO and how to minimize the impact between the two. The panel will also walk through the pharmaceutical trademark adoption process, including selection and clearance, as well as the FDA trademark review process. Finally, the panel will discuss best practices to minimize the risk of rejection.
- Challenges to pharmaceutical trademark development and approval
- Differing approaches to trademark review by the USPTO and the FDA
- Overview of the pharmaceutical trademark adoption process
- Overview of the FDA trademark review process
- Best practices
The panel will review these and other priority issues:
- What unique challenges do pharmaceutical companies face in seeking to adopt trademarks for pharmaceuticals and biologics?
- What are the differences between the FDA trademark review process and the USPTO trademark review process, why, and what are the consequences?
- What best practices should companies employ for adopting and clearing pharmaceutical trademarks?
