In May 2014, the U.S. Food & Drug Administration (FDA) released its long-awaited draft guidance document, Best Practices in Developing Proprietary Names for Drugs, for both nonprescription and biological drug products. The draft guidance is designed to help the industry adopt trademarks that minimize health risks and potential confusion with other existing marks.
FDA approval of a pharmaceutical trademark can be quite challenging, and approximately one-third of marks submitted are rejected. The draft guidance document helps to verify the FDA’s position and solidify numerous industry practices. Adhering to the draft guidance can also maximize the chances that any particular name will win FDA approval.
Recommendations for “Prescreening” Pharmaceutical Trademark Candidates
The FDA recommends that manufacturers consider the following issues when considering potential name candidates:
- Avoid obvious similarities in spelling and pronunciation compared to existing trademarks, generic names, or ingredient names
- Avoid incorporating medical abbreviations, dose designations, or symbols that might contribute to medical errors
- Avoid incorporating reference to inert or inactive ingredients in a way that creates an impression that the ingredient has greater value than it really does
- Avoid incorporating generic stems in the stem position
- Avoid “recycling” the trademark of a discontinued product
- For fixed combination drug products, avoid trademarks that include or suggest the name of one or more, but not all, of the active ingredients
Naming Attributes That Might Be Misleading or Contribute to Errors
After narrowing the list of candidates based on the initial “prescreening,” the FDA recommends manufacturers consider the following characteristics:
- Avoid incorporating product-specific attributes such as manufacturing characteristics (“NameLyophilized”), dosage form (“NameTabs”), or route of administration (“NameOral”).
- Avoid modifiers of trademarks (“Name XR”) that do not have an established meaning or that otherwise might cause confusion
- Avoid modifiers that consist of numerals
- For combination drug-device products, avoid incorporating a device‑related modifier into the trademark that implies the device component operates in a way inconsistent with the modifier
- Avoid modifiers that are inconsistent with the proposed labeling or otherwise hard for the end user to understand
- Avoid incorporating the sponsor’s name in multiple trademarks
- Avoid terms that may suggest the product as some unique effectiveness or composition it does not actually have (such as “best”)
The comment period on the draft guidance closed in July, 2014. While FDA draft guidances sometimes seem to live on forever in draft form, the FDA is expected to release a final guidance in the not-too-distant future.
Published in thePharmaceutical Trade Marks Group “Law Lore & Practice” newsletter, September 2014.