Naming the Product: The Intersection of FDA and Trademark Law
January/February 2009By: Frances M. Jagla and Boris Umansky
IP Litigator
This paper is somewhat euphemistically titled “The Intersection of FDA and Trademark Law”. Many in industry and in the FDA would be more likely to refer to it as “The Collision of FDA and Trademark Law”. It is important to understand at the very beginning that when we are considering trademarks for pharmaceutical products, we need to consider not only the traditional trademark clearance, filing and prosecution of potential trademarks before the United States Patent and Trademark Office, but also must consider the practices of the Food and Drug Administration. In the pharmaceutical trademark practice, we deal with two separate governmental agencies that are not required to accept or agree to the other’s practices and findings. In this paper, we will attempt to identify the steps that a practitioner will need to take in order to successfully navigate through this intersection. Unless otherwise indicated, we shall deal with United States practice, but the unwary should be warned that other jurisdictions, such as the European Union, have similar issues and practices.
Trademarks provide a means for consumers to identify and distinguish the goods and services of one manufacturer or seller from those of another, thereby allowing the consumers to purchase those goods and services they desire. A strong system of trademark protection, therefore, helps not only trademark owners, but benefits the consuming public. The overriding concern is to prevent buyer confusion as to the source of the goods and services, and this allows for trademarks to develop goodwill in the marketplace, which in turn provides an incentive for manufacturers or sellers to produce quality goods and provide quality services.
As important as trademarks are to our brand-driven world, they play an especially vital role in the pharmaceutical industry. If a consumer accidentally purchases an article of clothing from the wrong manufacturer due to a confusingly similar product name, this may upset the consumer and may provide grounds for an infringement lawsuit. However, most likely this will not cause any physical harm. Misleading or confusing pharmaceutical trademarks, on the other hand, might present a life or death situation to the unsuspecting consumer. Public policy, therefore, calls for a lesser burden of proof of likelihood of confusion where the products at issue are drugs. See McCarthy on Trademarks and Unfair Competition, § 23:32 (4th ed.).
One might argue that physicians and pharmacists are so sophisticated that marketplace confusion of similar prescription medications would be unlikely. However, where even a remote chance of danger exists relating to use, sale or distribution of such products, greater care should be taken with respect to trademarks to insure that confusion is prevented. See American Home Products Corp. v. USV Pharmaceutical Corp., 190 USPQ 357 (TTAB 1976). Medical expertise alone is not enough to avert a likelihood of confusion in prescription drug cases. See KOS Pharmaceuticals, Inc. v. Andrx Corp., 70 USPQ2d 1874 (3d Cir. 2004) (where consumers include both professionals and the general public, standard of care to be exercised is equal to that of the least sophisticated consumer in the class). “There is no reason to believe that medical expertise as to products will obviate confusion as to source or affiliation or other factors affecting goodwill.” Id. at 1888.
In fact, both the Trademark Trial and Appeal Board (“TTAB”) and the federal courts have found that since confusion amongst pharmaceutical products can lead to catastrophic consequences, it is essential that confusion be avoided at all costs. Public policy, thus, requires that if there is any possibility of confusion in such a situation, use of the confusingly similar trademark must be enjoined. See Schering Corporation v. Alza Corporation, 207 USPQ 504 (TTAB 1980) (great care exercised to prevent any possibility of confusion in use of pharmaceutical trademarks); Alfacell Corp. v. Anticancer Inc., 71 USPQ2d 1301 (TTAB 2004) (avoiding confusion extremely important when dealing with marks used in connection with medicines); Glenwood Laboratories Inc. v. American Home Products Corp., 173 USPQ 19 (CCPA 1972) (view that higher standard be applied to medicinal products is supported by case law); Blansett Pharmacal Co. Inc. v. Carmrick Laboratories Inc., 25 USPQ2d 1473 (TTAB 1992) (avoiding confusion even more important when marks used on pharmaceuticals); and Morgenstern Chemical Co., Inc. v. G. D. Searle & Co., 116 USPQ 480 (3d Cir. 1958) (“In the field of medical products, it is particularly important that great care be taken to prevent any possibility of confusion in the use of trademarks.”).
The examination of trademarks before the USPTO takes into consideration this higher standard of care when examining pharmaceutical trademarks. The Examining Attorneys at the USPTO review the marks to determine whether the pending trademark is likely to cause confusion with prior pending or registered trademarks and must consider similarities in sound, appearance, connotation and commercial impression, similarities in the goods, the trade channels and the conditions under which sales are made. In re E.I. du Pont de Nemours & Co, 177 U.S.P.Q. 563(CCPA 1973). They will also make determinations as to whether the proposed trademark is merely descriptive of the goods based upon a search of various on-line and print reference guides or is a generic name for the goods that is incapable of functioning as a trademark. The establishment of a priority date, whether the date of first use of the trademark or the date of filing of an intent to use trademark application, is of key importance.
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