Adoption of Pharmaceutical Trademarks for Approval: Navigating Differing Standards at the FDA and USPTO

Description

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.