This article first appeared in IP Value 2008 - Building and Enforcing Intellectual Property Value, published by Globe White Page.
In addition to extensive research as to the chemical composition of a new pharmaceutical product, pharmaceutical companies often face another hurdle when it comes to naming their product. Pharmaceutical companies must consider not only what might be an attractive trademark for their product, but also how that mark fits with the chemical and generic names for the compounds in that product.
General considerations for all new trademarks
For all products, a trademark should:
• identify a single source;
• be capable of distinguishing one product from another; and
• be protectable under the laws of the country (or countries) in which the product will be marketed.
Marks are categorised on a sliding scale of distinctiveness, from fanciful and arbitrary marks, which are the most protectable, to suggestive marks, descriptive marks and, finally, generic terms, which are not protectable since they do not function as trademarks. Some examples along this spectrum of protection include the following:
• fanciful – KODAK;
• arbitrary – APPLE (for computers);
• suggestive – COPPERTONE, WHIRLPOOL;
• descriptive – ROLLERBLADE, WEIGHT WATCHERS; and
• generic – aspirin.
Generic terms enjoy no legal protection. Companies rarely fall into the trap of choosing a generic term as the trademark for a new product, although it does happen (eg, In re Cell Therapeutics Inc, 67 USPQ2d 1795 (TTAB 2003), in which the US Patent and Trademark Office (USPTO) held the term ‘Cell Therapeutics Inc’ to be generic for use in connection with pharmaceutical preparations, laboratory research and development services; thus, no registration was granted). Moreover, owners of once-distinctive marks can lose protection by failing to police their marks. For example, in 1897 Frederich Bayer & Co isolated acetylsalicylic acid and branded a drug product called Aspirin, which it registered as a trademark in Germany in 1899. After the First World War other manufacturers began to sell identical products under the name ‘Aspirin’, which ultimately led to the mark’s inability to identify a single source (ie, Bayer).Therefore, the name no longer functioned as a trademark and aspirin is now a generic term in the United States.
At the other end of the spectrum, fanciful and arbitrary marks enjoy the greatest legal protection. A fanciful mark is a newly coined term which had no meaning prior to its adoption. Arbitrary marks are existing words used for goods which bear no logical relationship to the goods on which the term is used (eg, APPLE for computers). Although choosing a fanciful or arbitrary mark is the safest route to legal protection, companies tend to shy away from entirely fanciful or arbitrary marks because, at least initially, the mark has no recognisable meaning to the public. Typically, companies need to engage in extensive advertising campaigns in order to introduce new arbitrary or fanciful marks.
The next strongest mark in the spectrum is a suggestive one, where a consumer has to make some mental leap to determine how the mark relates to the good or service. For example, although the COPPERTONE mark does not describe any major aspect of a sun-tan lotion, it suggests the deep skin tone achievable through using the lotion. Thus, COPPERTONE is considered a suggestive, and thus a strong, trademark. Suggestive marks are powerful because they are memorable, create positive associations with the good or service and can be registered without proof of the public’s recognition of the mark.
A descriptive mark is one which describes a major property of the product for which it is used (eg, In re Gyulay, 820 F 2d 1216 (Fed Cir 1987), in which APPLE PIE was held to be descriptive of apple pie-scented pot pourri). The USPTO refuses to register purely descriptive trademarks as registration would prevent others from using common words to describe their goods or services. However, descriptive marks can be transformed into protectable trademarks in a number of ways, the most common being through marketing and advertising. As a result of advertising, the public may associate a descriptive mark with a single source, at which point the mark could be considered to have acquired secondary meaning. The descriptive mark can then function as a trademark and be registered at the USPTO.
In choosing a new brand name for a pharmaceutical, a company should consider the distinctiveness (or lack thereof) of the proposed mark. Whereas generic marks cannot be registered or protected, fanciful, arbitrary and suggestive marks are assumed to be distinctive without proof of public recognition, which can save time in acquiring a registration. Although these concepts need to be considered each time a mark is chosen, there is a greater level of analysis involved in developing and branding a new chemical compound.
Considering chemical, generic and trademark names for new pharmaceuticals
In developing a pharmaceutical companies must first choose valid generic names to designate the new drug. Unlike consumer products, which usually have one name associated with them, a pharmaceutical product typically has three names associated with it:
• a chemical name (eg, acetylsalicylic acid);
• a generic name (eg, aspirin); and
• a trademark or brand name (eg, BAYER).
A company which discovers a new drug cannot simply coin a new generic name for it. Rather, a pharmaceutical company must first apply for a chemical name in the form of a Chemical Abstracts Service (CAS) Registry number. The CAS number is a unique identifier which differentiates a chemical compound from a database of millions of other compounds, each of which may be designated by other chemical names.
After obtaining a CAS Registry number, a pharmaceutical company must apply for a generic name for its new compound. Two organisations standardise and harmonise generic, non-proprietary drug names through an application process and a naming classification system based on pharmacological and/or chemical relationships. In the United States, the US Adopted Names Council assigns a US Adopted Name (USAN) to new therapeutic substances to be marketed in the United States. Its international counterpart, the International Non-proprietary Name Committee of the World Health Organisation, assigns an International Non-proprietary Name (INN). Both the INN and the USAN designations are deemed generic per se and can be used by competitors.
Obtaining a USAN is required before filing a new drug application with the US Food and Drug Administration, even if an INN already exists for the drug, and a company will typically apply for a USAN during the Phase I or II clinical trials of the investigative new drug application process to ensure that the USAN is ready for a new drug application. In applying for a USAN, in addition to proposing a name a company must provide necessary chemical information about the drug and explain the drug’s indications. Upon receipt of a completed USAN application, the council will examine the proposed name for conformity with certain criteria, including:
• usefulness to healthcare providers;
• patient safety (ie, whether patients will confuse thedrug with another drug based on the similarity of thenames);
• adherence to prescribed nomenclature rules;
• absence of conflicts with existing names;
• suitability for international use; and
• ease of pronunciation.
Once the assigned staff member is satisfied that the company has met the requisite criteria, the council submits the name to the INN Expert Group for further trademark clearance and linguistic evaluation. The group screens the name to avoid words harbouring unintended negative connotations in other languages and potential international trademark conflicts. If the group approves the name, the USAN is adopted and is entered into the US Pharmacopeia Dictionary of USAN and International Drug Names and the CAS database.
Selecting a USAN is not easy and the guidelines set out by the council’s Rules for Coining Names, which enumerate factors it considers when reviewing an application, should be followed. For example, whenever possible names should use existing USAN stems such as ‘-actide’ for synthetic corticotrophins and ‘-bufen’ for non-steroidal anti-inflammatory agents. Moreover, during the selection process companies should try to anticipate and avoid possible trademark issues. For instance, as a USAN is generic, a pharmaceutical company should avoid any overlap between the proposed brand name and the proposed USAN. Otherwise, it could face problems at the USPTO for choosing a generic mark which cannot be protected.
In fact, not only will the council consider existing trademarks as grounds for rejecting a proposed USAN, but once a company obtains a USAN, the USPTO can reject the proposed trademark based on that USAN. Although choosing a USAN usually involves a company’s regulatory or in-house counsel rather than its IP counsel, ideally the two should work together to streamline the process.
The final stage in the three-part process is choosing the actual trademark name. The name must be chosen with a eye towards avoiding any confusion not only with existing trademarks, but also with USANs and common chemical names. Due to the potential health risks involved, the USPTO often requires a lesser degree of likelihood of confusion in order to reject a pharmaceutical mark.
Once a name is chosen and cleared by trademark counsel, the application process for a pharmaceutical trademark is similar to that for consumer goods – it includes filing the mark application with the USPTO with a description of the goods or services for which the mark will be used (eg, “anti-cancer preparations” or “pharmaceutical preparations for use in chemotherapy” in International Class 5). The application must also state whether it is based on pre-existing use of the trademark in commerce or whether it is simply based on a future, good-faith intention to use the mark. If the application is based on an intention to use the mark, the examination may continue, but the USPTO will not grant a registration until the actual use of the trademark in commerce is proven.
The actual use requirement can be quite different for a pharmaceutical product compared to an ordinary consumer product because a pharmaceutical cannot be commercialised without regulatory approval. Therefore, whereas use in commerce for a branded training shoe means actually selling or offering to sell the shoe in commerce, typically there is no such similar use for a pharmaceutical product which has not yet been brought to market. Instead, the courts have typically looked at what kind of use is normal or customary in the industry to which the named product pertains. To that end, with regard to pharmaceuticals the US courts have indicated that shipping a drug to a clinical investigator for use in clinical trials during the Food and Drug Administration approval process can constitute use in commerce sufficient to obtain a registration before the USPTO (eg, GD Searle & Co v Nutrapharm, Inc, No 98-6890, 1999 US Dist LEXIS 16862, 1999 WL 988533 (SDNY Oct 29, 1999).
Even without use, however, companies often opt to file applications based on an intention to use the mark before they begin actual use of the mark because the filing date of an application in the United States can afford the filer priority over a subsequent user of the same or a similar mark. Therefore, companies are wise to file such applications to try to preserve their priority over names that they intend to use in the future.
After the application is filed at the USPTO, an examining attorney conducts a search of existing federal trademark registrations and applications to determine whether the mark could be considered confusingly similar to a pre-existing trademark. If the proposed trademark is similar to an existing trademark, especially where the existing trademark is used in connection with similar goods or services (eg, they are both used for pharmaceutical preparations), the USPTO may refuse registration based on a likelihood of confusion. Although the likelihood of confusion is one of the most common reasons for the USPTO’s refusal to register a new mark, the examining attorney can also refuse to register a mark for other reasons (eg, for being merely descriptive or generic).
Once a company overcomes any outstanding refusal by the examining attorney, the proposed mark is published in the Official Gazette. Any opposition to the registration must be filed within 30 days of publication by initiating a proceeding before the Trademark Trial and Appeal Board. If no opposition proceeding is initiated, the USPTO will register the mark provided that the applicant has shown proper use of the mark in commerce.
For both pharmaceutical and non-pharmaceutical trademarks, prior to filing the company’s trademark attorney should conduct a search of registered and pending trademarks to anticipate those that the USPTO may consider confusingly similar during the examination of the trademark application. If the product is to be marketed worldwide under a single brand name, the trademark owner should also consider a global search, the breadth of which largely depends on the owner’s needs and finances. These searches help to avoid potential USPTO refusals and oppositions.
For pharmaceutical trademarks, the trademark attorney handling the matter should also consider standard, common and chemical names to avoid problems that might arise before the USPTO. To that end, the trademark attorney should consider whether the proposed brand name is too close to a USAN. For example, in 2002 TopoTarget ApS sought to register TOPOTECT for “pharmaceutical preparations for the treatment of cancer” (Smithkline Beecham PLC v TopoTarget ApS Corp, Opp No 91157491, 2004 TTAB LEXIS 504 (TTAB Sept 2 2004)). Smithkline Beecham opposed the registration on the basis that TOPOTECT was a slight misspelling or abbreviation of topotecan, which was the generic USAN name of the applicant’s pharmaceutical product. Smithkline argued that the contemporaneous use of TOPOTECT as a trademark with the generic drug name topotecan “presents a significant threat to public health and safety and that both the World Health Organization and USAN strongly discourage the use of USAN and INN generic terms as trademarks”. Although the Trademark Trial and Appeal Board denied Smithkline’s request to prevent the registration on summary judgment, TopoTarget ultimately abandoned its application after a lengthy opposition proceeding.
The trademark attorney involved in naming a pharmaceutical should also consider common chemical abbreviations for a drug. Even if a pharmaceutical company secures a trademark registration for a new drug product and the USPTO does not consider the similarity of that mark to a USAN to be problematic, claiming any common chemical name may result in the preclusion of trademark rights. For example, in 1976 Canada Packers Inc sought and secured a US federal trademark registration for CHENO for use in connection with “pharmaceutical preparations, namely, bile acid”. Years later, Rowell Laboratories asked the USPTO to cancel the registration, claiming that for a long time the trademark CHENO had been used generically in the pharmaceutical industry as an abbreviated name for chenodeoxycholic acid (Rowell Laboratories, Inc v Canada Packers Inc, Cancellation No 12,375, 1982 TTAB LEXIS 68; 215 USPQ 523 (TTAB 1981)). The USAN for the drug was ‘chenodiol’. The Trademark Trial and Appeal Board held that the prior abbreviated use of ‘cheno’ to refer to chenodeoxycholic acid precluded Canada Packers from claiming trademark rights over the term and cancelled the registration.
Pharmaceutical trademarks merit special considerations. Choosing the trademark and the USAN simultaneously can help to prevent expensive collisions in the USPTO. Although it is tempting for a pharmaceutical company to draw on the USAN – especially if it invented the drug compound and came up with its name – the more distance between a new brand name and the universe of registered trademarks, USANs and common chemical names, the fewer potential problems there may be before the USPTO and thereafter.