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What are the trademark requirements for obtaining an authorization to market medicinal products in the EU?
The European Medicines Evaluation Agency (EMEA) was set up following EC Regulation No. 2309/93 and became operational from January 1, 1995. The Regulation introduces two new instruments to obtain a marketing authorization for medicinal products in the EU:
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a centralized procedure to obtain authorization to market medicinal products which is particularly relevant for those pharmaceutical products which fall under Annex A of Regulation No. 2309/93 (certain biotechnology-derived medicinal products, e.g. products which are produced by recombinant biotechnology); and
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a decentralized procedure to obtain authorization to market medicinal products in the EU which fall under Annex B of Regulation No. 2309/93 (certain medicinal products with novel characteristics or containing a new active substance). The decentralised route is set out in Council Directive 93/39/EEC and is based on the multistate procedure in existence when this directive was adopted. Starting January 1, 1998 this procedure will apply when another member state has already granted a marketing authorization for a product and authorization in further countries is applied for.
National regulatory arrangements will continue to apply for products marketed in one member state only.
Under the centralized procedure the EMEA will be unwilling to grant market authorization if an applicant does not put forward a single pan-European tradename. It will readily be appreciated that obtaining a pan-European trademark in the pharmaceutical area is extremely difficult. The Community Trademark system (CTM) was implemented to overcome these difficulties but the fact that a successful opposition in one CTM jurisdiction will automatically trigger the application to collapse in all other countries will make it extremely difficult for the pharmaceutical industry to take advantage of the system.
Conflicts are likely to arise between trademark professionals, and marketing and regulatory departments, particularly over the selection and adoption of trademarks and the ability to obtain a single trademark. However, we recommend that companies making regulatory applications under the centralized procedure to obtain authorization to market medicinal products before the EMEA should consider attempting to register trademarks via the CTM system early in the development of the product. Because of the difficulties involved therewith the preferred trademark should be filed together with a number of back up marks.
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