Name that drug

The role of the European Medicines Agency (EMA) as a regulator is to protect and promote public and animal health by evaluating and supervising medication for both human and veterinary use. The EMA was created to harmonise the working practices of the various EU member state territories. It also reduces the costs for those requiring approval throughout the EU. It is only after authorisation has been granted that a company can market a product.

However, while regulatory approval might be granted by the EMA, there is still the legal side to consider, both in terms of registering the brand name as a trademark and checking that you are free to use that brand name. Advantages of registered protection Securing registered trademark protection for a product brand name (or the patent for the product itself) has a number of advantages, both commercial and legal. On the commercial side, a patent or trademark is a tangible asset against which you can secure backing. Additionally, a patent or trademark can secure income by licensing use of it to a third party. By registering your brand name as a trademark, you also assume a stronger legal position. Some countries only recognise registered protection, so if you do not have a registration it is not possible (or it is at least very difficult) to stop a third party from using or registering, for example, a sign that is identical or similar to your own trademark. On the flip side, when you are entering the market with a new brand name, you should be aware that a third party might own a trademark that is too close. Risks There is also the risk that if you do not file for protection then someone else will do it for you. Dealing with squatters is time consuming and expensive, but in some countries the effects are more serious. If the squatter has filed first and secured registered protection, then your use of your brand name might actually infringe the squatter’s trademark and so it could prevent you from manufacturing or exporting any products. This could lead to an unusual situation where, on the one hand, you might have regulatory approval, but on the other hand, use of the brand name for those products is prevented by the rights of someone else. For these reasons, it is important to analyse the potential legal threats in parallel with securing regulatory approval. Trademarks are negative rights, meaning they permit the owner to prevent a third party from using something that is identical or similar for an identical or similar product. That means owning a registered trademark does not necessarily mean that you are free to use it. For example, a third party might own earlier rights but didn’t spot your application when it was filed, so it did not oppose it. Search strategy A clearance search will identify whether there are any earlier marks that pose a risk to you using the brand name you have chosen for the product. The pharmaceutical sector is a crowded market with more than 120,000 European Community trademarks (that cover all 28 EU member states), so it is a good idea to have more than one product brand name in mind. Both identical and similar marks are relevant for products that are identical and/or similar. That means it is not necessarily an earlier trademark in the pharmaceutical sector that will pose a threat. For example, a trademark registered in respect of cosmetic items might cause a problem. There are several search companies that review trademark databases, company names, internet use, etc, on a country-by-country basis. For pharmaceutical products there is often an enhanced feature so that the searches will extend to include trademarks that are registered for pharmaceutical products in any additional countries of interest. That can save costs and time by conducting a worldwide trademark register search in a single report, but it is worth remembering that trademarks registered in other relevant fields may not necessarily be located. Assuming the search is clear then the next step would be to file an application to secure registered protection. Ideally, you would receive confirmation of registration at around the same time as the regulatory approval was confirmed, but at the very least the application should be filed in time for product launch. If competitors are able to access the regulatory records and view the products and their brand names that are going through the clearance process, then you might consider conducting the clearance search and filing your trademark application before commencing the regulatory approval process. In the UK, the trademark registration process is fairly quick—it takes four to six months. However, in other countries the process can take years, so it is important to bear these timescales in mind so that it is aligned with the regulatory side. Pitfalls As outlined above, owning a trademark registration does not necessarily mean you are free to use that trademark. Another pitfall is to assume that registering the company name at Companies House or owning the domain name means you are free to use that name. A company name or domain name does not give rise to any rights per se, so you should still conduct a clearance search. Finally, once registered protection has been secured those rights need to be policed. That means paying the renewal fees on time and also setting up watches to monitor what your competitors are doing and if they filing applications that are too close to your brand name. You might also set up internet alerts so that you are notified of your competitor’s activity in the marketplace. Clearing products names for use and securing registered protection can be a complicated exercise, but by seeking advice early you can align it with the regulatory procedures to make the process as smooth as possible and so that you end up with a valuable brand name with which you are free to promote your product.