Introduction

The pharmaceutical industry's understanding of the value of trademarks has matured rapidly, but the owners of drug trademarks can face significant problems created by confusingly similar trademarks. While similar trademarks in general can cause consumer confusion, similar drug trademarks can be more serious in that they can lead to fatalities. It is the role of federal agencies to screen trademarks in order to protect consumers from the sometimes serious consequences that result from the use of confusingly similar trademarks.

The United States Patent and Trademark Office ("USPTO") is responsible for reviewing trademark applications and issuing federal trademark registrations. However, companies that are in the business of developing and marketing pharmaceuticals must also consider the policies of the Food and Drug Administration ("FDA") when it comes to selecting trademarks for their FDA regulated products. Thus, pharmaceutical companies are faced with additional federal administrative hurdles in developing trademarks for FDA regulated drugs.1 It is unfortunate when a company obtains a federal registration of a trademark only to discover that the FDA will not approve the same mark for use with the company’s product; or vice versa.

In October of 1999, the FDA opened a division called the Office of Postmarketing Drug Risk Assessment. The Office was renamed in 2002 to the more manageable name – Office of Drug Safety ("ODS"). This agency is a sub-group of the Center for Drug Evaluation Research ("CDER") and was created in response to the growing problem of medication errors caused by look alike and/or sound alike drugs. The ODS is responsible for reviewing and either accepting or rejecting new drug trademarks (also know as proprietary names) before they hit the market. Guidelines and official policies for the ODS review process are being finalized by the ODS. When published, the guidelines should appear on the FDA’s web site.2

IMPORTANT NOTE: While the ODS may review the USPTO database in its evaluation process, the ODS’s review is distinct from the USPTO examination of a trademark. Because the FDA’s review criteria and concerns are different from those of the USPTO, the existence of a federal trademark application or the grant of a trademark registration by the USPTO is of no real value in the ODS’s review of the same mark and vice versa. However, the existence of a third party trademark application or registration in the USPTO for a similar mark may have a negative impact on the analysis of a sponsor’s proposed name in the ODS.

Related reviews are conducted for labels and packaging by the Division of Drug Marketing, Advertising and Communication ("DDMAC"). Proprietary names for biologic products that are regulated by the Center for Biologics Evaluation ("CBER") are not generally reviewed by the ODS, but are instead reviewed by CBER’s advertising, promotion and labeling staff ("APLS").

OUTLINE OF THE FDA/ODS REVIEW PROCESS

A request for review is submitted to the drug sponsor’s reviewing division. The request format is informal and can be a simple letter to the reviewing division requesting the review of proprietary names used in connection with the sponsor’s drug. The sponsor may submit up to two names for review in order of preference. If the first choice is approved, the second choice will not be reviewed.

The review process can begin between phase two and phase three of an investigational drug ("IND") application or new drug application ("NDA"). Proprietary names on abbreviated new drug applications ("ANDA") and supplemental new drug applications ("SNDA") are also subject to ODS review.

Review requests for NDAs are given priority over INDs, and are reviewed on a first-come, first-served basis. The target time period for initial review of an NDA name is 60 days. Review requests for IND names can take considerably longer depending upon the backlog in the ODS. If a name passes through the initial review, the sponsor is given provisional approval of the name. A second review is conducted approximately 90 days before the final NDA approval. The second review is intended to intercept any intervening approvals for newly marketed drugs that may be problematic.

The review process starts with clinical sampling by a sample group of approximately 100 health care professionals. The sample groups analyze and interpret handwritten and verbal test prescriptions. Samples are compared against existing proprietary drug names for look alike and sound alike problems.

Next, the ODS analyzes the proposed name and packaging using factors such as unsupported clinical promises, unproven indications, questionable alpha or numeric prefixes or suffixes, dosages encoded in the name, and generic names.

The indications for the proposed drug name are evaluated by an FDA safety evaluator who weighs the risks and benefits of such factors as overlapping strengths, dosage forms and recommendations, use and indications, storage, labeling, and packaging. The evaluator also runs a literature search. Recently, more staff have been added to the reviewing division resulting in more in-depth literature searching.

A database review is conducted to compare the proposed name against names on other applications undergoing FDA product review. Software for the review system for searching on spelling and phonetic similarities in proprietary drug names was scheduled to be in place by the fall of 2003. The ODS medication error staff also conducts a search of several reference texts and FDA databases.

The common name associated with the subject drug application is also checked for published reports of medication errors. The proposed name is compared against other proprietary names that are associated with reported medication errors for the same drug type.

When the initial review is complete the ODS puts the information gathered in the review into a report, called a "Consultation Response," conducts a risk assessment of the same, and prepares a summary of any safety issues. If the risk assessment is positive, the sponsor is given provisional approval of the submitted name.

In fiscal year 2002, the ODS reported that it processed 274 proprietary name consultations. Of the 274 names reviewed, 86 names were found to be unacceptable, a 31% rejection rate. If a proposed name is rejected, the sponsor may appeal the decision by presenting persuasive evidence relevant to the concerns raised in the ODS risk assessment evaluation. One commentator on the subject set the appeal success rate at 50%.

As noted, FDA approval of an FDA regulated drug trademark does not have any bearing on federal trademark registration. To avoid potential conflict with third party marks, the owner of an FDA regulated drug trademark should seek approval by both the USPTO and the FDA. It may seem daunting to have to go through two different government agencies to establish a viable FDA regulated drug trademark. However, the consequences of having to change the name of a product once it is in the marketplace or defending a trademark infringement action are much more burdensome.

Related version originally published in the July/August 2002 issue of the Food and Drug Law Institute’s Update magazine.

Footnotes

1 In the vast majority of cases, it is advisable to seek federal registration of trademarks. However, trademark rights in the United States stem from use of a mark in commerce. Unregistered trademarks that are in use in commerce do have some protection, but the cost of protecting an unregistered mark can far outweigh the cost of seeking federal registration.

2 Note that because the ODS is a new agency and guidelines have not yet been published, this document contains information that has been gathered from a variety of sources, including from within the ODS. Thus, the information contained herein is subject to change pending the approval of proposed ODS guidelines.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.