In the challenging and complex world of life sciences product development, choosing a brand name that survives numerous trademark office and regulator

Transcription

1 Ten tips for generating a life sciences brand name Christina Martini and Virginia Wolk Marino Roman Tsubin / Shutterstock.com The proliferation of brands, combined with the financial and PR consequences of a potential rebrand in the event of infringement, has made selecting a trademark trickier than ever. Christina Martini and Virginia Wolk Marino of DLA Piper report. 1/5

2 In the challenging and complex world of life sciences product development, choosing a brand name that survives numerous trademark office and regulatory clearance processes is essential. An effective pharmaceutical or medical product name can become a significant source of value to companies in this industry, and can serve to both differentiate a product and engender loyalty in a competitive market. Given the high stakes, pharma companies often retain specialists to help compile lists of names for global legal consideration and brand clearance, a process that usually entails several rounds of searching and often includes both preliminary and more in-depth analyses. Preliminary trademark searches provide a review of nearly identical trademark applications and registrations. Full trademark searches are typically generated by experienced search vendors and include a more comprehensive review of trademark filings in a particular jurisdiction. Depending on their scope, they can also include domain name registrations, common law references and corporate name registrations. In the US, full trademark searches will often cover state registrations, Orange Book references, US adopted names (USANs) and Food and Drug Administration (FDA) Phonetic and Orthographic Computer Analysis scores. Each of these sources can provide crucial information when analysing whether a potential name is likely to survive regulatory and trademark office scrutiny. The US and other jurisdictions require the submission of proposed drug names to regulatory authorities before a product may be marketed and sold. For example, the EU may require filing a marketing authorisation application with the European Medicines Agency. Regulatory clearance often includes promotional and safety reviews, taking into account various ways in which a name may trigger a medication error, as well as an analysis of name simulation studies/assessments. Experienced counsel can help anticipate potential issues associated with both regulatory and trademark office clearance processes. Brand names in this industry are generally subject to heightened scrutiny because confusingly similar names can lead to medication error and patient harm. Serious consequences may result from mistakes made in the dispensing and administration of these goods and, therefore, more concerted efforts must be made to avoid confusion. This doctrine of greater care should be carefully considered throughout the brand clearance process in this field. There is no magic formula for creating a successful life sciences trademark. However, certain names tend to fare better than others. We recommend that companies keep the following ten tips in mind when developing brands: 2/5

3 1. Start the clearance process early It often takes several rounds of searching to identify viable names. The trademark and regulatory clearance processes usually take at least a few months. Names should be generated and vetted at least two to three years before a scheduled product launch. Any logos and other design elements used in product packaging or advertising should be similarly evaluated. 2. Capture ancillary goods and services The trademark clearance process should include any ancillary offerings which may be provided in connection with the product, including medical devices/equipment or medical information services, for example. These additional goods and services should be searched early in the process, particularly if the pharma preparation will be marketed and sold with a drug delivery device, such as an autoinjector. 3. Avoid USANs/INNs and their stems USANs and international nonproprietary names (INNs) are nonproprietary, generic names that are assigned to new pharma products. USAN and INN stems are common elements that are incorporated into the USANs and INNs of members of a group of related drugs and are typically found at the end of nonproprietary names. Due consideration should be given to whether groupings of certain letters are likely to trigger pronunciation or spelling issues in English and other languages. Given that pharma manufacturers are required to use the proper stems in connection with their products, it is important that brands do not incorporate these elements since such use often violates naming convention requirements issued by the USAN Council and the World Health Organization. 4. Adopt multisyllable marks Successful brands for new life sciences products often share certain characteristics. For example, they tend to incorporate three or more syllables which can serve as points of differentiation among a large universe of brand names. Use of conventional, ubiquitous prefixes and suffixes may result in a host of potential issues, such as increasing the likelihood that a name candidate will be too close to an existing third-party brand. 5. Include unique letters and letter combinations Certain letters are more popular in words than others, such as a, m and t. Given the relative scarcity of available brand names in the life sciences sector, those marks incorporating more uncommon letters, such as q and x, often fare better during the clearance process. 3/5

4 Effective letter combinations tend to comprise more consonants than vowels. Due consideration should be given to whether groupings of certain letters are likely to trigger pronunciation or spelling issues in English and other languages. 6. Phonetic searching is important Very slight modifications in spelling can sometimes make a meaningful difference in the availability of a name (eg, substituting the letter i for y ). Domestic and foreign phonetic searches should be conducted from the outset to capture these types of substitutions. Letters that have different sounds in English may be pronounced similarly in foreign languages, such as b and v in Spanish. 7. Steer clear of product claims Brands should steer away from incorporating terms which constitute an express or implied product claim, either in English or in other languages. These names should not include elements which comment on the efficacy or safety of a product, nor should they include references to attributes of the product, such as the manner in which a product is administered, its dosage form or frequency. 8. Minimise risk of medication error Regulatory clearance processes are particularly focused on minimising the risk of medication errors. These can occur in a variety of contexts, including nurses and pharmacists misunderstanding a doctor s handwritten or oral prescriptions. Experienced trademark counsel can help anticipate potential risks by taking into account letters which may appear similar when handwritten, such as p and q or b and d, or when spoken out loud, such as m and n, or s and x. Companies also may find it instructive to consult lists such as the FDA s Drug Products Associated with Medication Errors ( and The Institute for Safe Medication Practice s List of Confused Drug Names ( for real-world examples of product names which look and sound like other brands, and therefore may require additional safety measures to avoid medication errors. 9. Consider translation and pronunciation issues International searching should be conducted in tandem with clearance searches in the US. Full foreign searches are typically handled by local counsel, who can also advise if there are 4/5

5 pronunciation or translation issues with the mark in the local language which may result in difficulty saying the names or in negative connotations. Counsel should also conduct searches in local characters in addition to Roman characters, if applicable. 10. Develop distinguishable back up names Companies should be prepared to submit several names for regulatory and trademark office consideration, in the US and other jurisdictions. Candidates should be meaningfully different from one another in appearance, sound and commercial impression. For example, marks that include the same letter string(s) or phonetics may all suffer the same fate if one is rejected. Moreover, first-choice names may not be available in each of the relevant countries, thereby requiring some pharmaceuticals to be marketed under different names in those jurisdictions. Final word Through a sound investment in strategic name generation and thorough legal analysis from the outset, life sciences companies can make the most of their branding. Proactively and consistently managing the brand clearance process on a global level can result in more successful results during trademark office and regulatory review of potential trademarks. Christina Martini is the chair of the Chicago intellectual property practice group at DLA Piper. She can be contacted at: christina.martini@dlapiper.com Virginia Wolk Marino is an intellectual property associate at DLA Piper and is based in Chicago. She can be contacted at: virginia.marino@dlapiper.com 5/5