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Colors, shapes, smells, configurations and packaging are all examples of non-traditional trademarks. As with traditional word trademarks and logos, owners of non-traditional marks can register them with the US Patent and Trademark Office and establish an exclusive right to use the marks. One familiar example is the “Purple Pill,” Nexium.

Non-traditional marks can be protectable forever, as long as they are used and cultivated. However, particularly in the pharmaceutical field, these difficult to develop and maintain. Some would-be marks are simply not protectable. Companies planning to adopt and develop a non-traditional mark should carefully assess its potential for success under the law of nontraditional trademarks.

Marks must be non-functional

Functional aspects of products or packaging are never protectable as marks. A feature is functional as a matter of law if it is “essential to the use or purpose of the device or when it affects the cost or quality of the device.” TrafFix Devices, Inc. v. Mktg. Displays, Inc., 532 U.S. 23, 33 (2001). The color pink was deemed functional for surgical wound dressings because pink blends with some skin tones and falls within the scope of being “flesh colored.” In re Ferris Corp., 59 U.S.P.Q.2d 1587 (TTAB 2000). Exclusive use of pink by one party would put competitors at a non-reputation-based disadvantage. That is, there is a competitive need to use the color pink for wound dressings.

Functionality is the most significant hurdle to overcome in establishing a protectable pharmaceutical mark: consumer safety and policy considerations not present in other fields often play a role. For example, a drug feature increasing patient safety and compliance may very well be functional.

The Trademark Trial and Appeal Board held that orange flavor was functional for an antidepressant because it improves taste, which in turn increases patient compliance. In re N.V. Organon, 79 U.S.P.Q.2d 1639 (TTAB 2006). In Shire US Inc. v. Barr Laboratories Inc., 329 F.3d 348 (3d Cir. 2003), the Third Circuit found blue and orange color-coded round and oval Adderal pills used to treat ADHD were functional and, therefore, not protectable. Evidence showed ADHD patients tend to select proper pill dosage using clear visual cues, such as shapes and colors – features that increased patient safety and compliance.

Other public policy considerations come into play when a company offering a branded drug claims that a similarly styled generic infringes on the branded drug. In fact, this was the context of the Adderal case. That court found the record to show that general patient safety and compliance are positively impacted when generic drugs look like branded drugs. Further, federal policies favoring therapeutic generic drug equivalents generally weigh against a company’s interest in pursuing an exclusive right to its unique or creative product configuration or feature.

“Acquired distinctiveness” is sometimes required

The unanimous United States Supreme Court decision in Wal-Mart Stores, Inc. v. Samara Bros., 529 U.S. 205 (2000) held that product designs must always acquire “secondary meaning” to be protectable as exclusive marks. Consumers must come to associate the design with a particular product from a single source. The success of a secondary meaning or “acquired distinctiveness” claim depends on how long the claimant has exclusively used the claimed features and the strength of promotional expenditures as well as the nature of the advertising. Five years of exclusive use increases the chance a product feature will be found distinctive. With extraordinary sales and promotions, a mark could acquire distinctiveness sooner.

Distinctiveness is the second hurdle product configuration marks must overcome to establish protectable status. Non-functional product design marks are not automatically protectable and must ultimately be substantiated. Because a claim will generally fail without strong sales figures and advertising expenditures, it may take many years after a drug is introduced in clinical trials for it to acquire distinctiveness. It is not unusual for an acquired distinctiveness claim to fail primarily because product advertisements do not include “look for” elements highlighting the claimed mark. For example, widespread commercials suggesting “ask for the square green tablets” can shore up a distinctiveness case. The existence – and absence – of such advertising weigh heavily in assessing acquired distinctiveness. Thus, including high-profile “look for” advertising in an advertising plan is a sound strategy in developing a protectable mark.

Planning is key

Non-traditional marks can be strong product differentiators, but they may not come easily. The pharmaceutical field faces heightened functionality and policy considerations; also, the time from product development to market can be long. Because the implementation and development of non-traditional marks also can be a long, costly process, it is important to first ask whether the prospective mark has potential for success as a source identifier for the product. To move forward intelligently with a non-traditional pharmaceutical mark, one must look to the state of the law and then implement a branding strategy custom tailored for the desired mark. A well selected, non-traditional mark has potential to foster strong consumer recognition and loyalty. Proceeding with forethought and a careful plan will be key to establishing such a mark in the pharmaceutical field.

For more information, please contact Heather Dunn.