After years of promise, in May 2014 the U.S. Food & Drug Administration (FDA) finally released its long-awaited draft guidance document on “best practices” for developing trade marks for pharmaceuticals, including nonprescription and biological drug products. The draft guidance is designed to help industry adopt trade marks that minimize health risks and potential confusion with other existing marks.
FDA approval of a mark for a pharmaceutical product can be notoriously challenging. Approximately one-third of marks are rejected. The draft guidance document helps to verify the FDA’s position and solidify numerous practices of what many in industry have been following for years. Adhering to the draft guidance can maximize the chances that any particular name will win FDA approval.
Recommendations for “Pre-screening” Pharma Trade mark 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 trade marks, 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 trade mark of a discontinued product;
For fixed combination drug products, avoid trade marks 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 “pre-screening,” 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 trade marks (“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 trade mark 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 trade marks;
Avoid terms that may suggest the product has some unique effectiveness or composition it does not actually have (such as “best”).
The use of brand name “extensions”, also known as family marks or umbrella names, are evaluated by the FDA on a case-by-case basis, considering whether the products share at least one common active ingredient, are differentiated by labeling, and have appropriate modifiers. The FDA will also evaluate on a case-by-case basis the use of different trade marks by the same manufacturer for products that contain the same active ingredient but for different indications.
When a product goes from prescription to over-the-counter (OTC), use of the same trade mark may be acceptable if there is no change in indications, dosing, or strength. However, if the OTC and Rx versions are not identical, the FDA believes it “might be appropriate” to market the OTC product under a different or modified trade mark.
The FDA will review a proposed trade mark for an OTC drug that will be marketed pursuant to a New Drug Application or Abbreviated New Drug Application. However, many OTC drugs are marketed under an FDA monograph and are not individually scrutinized by the FDA. For these, the FDA still recommends that the trade marks be evaluated by the sponsor for safety considerations.
Finally, the draft guidance contains detailed descriptions of how the FDA conducts and how sponsors should conduct name simulation studies to try to gauge how likely any given name will cause end-user error based on phonetic, spelling, and orthographic similarities. Although sponsors are not required to submit their own studies, the FDA “believes more comprehensive simulation studies would be useful.
This article first appeared in the Pharmaceutical Trade Marks Group Law, Lore & Practice (September 2014) and can be read in its entirety here.
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.