Pharmaceutical products, and consequently pharmaceutical trademarks, are highly regulated in France. Both national and EU laws and regulations govern various aspects of the development and commercialisation of pharmaceuticals, including the intellectual property deriving therefrom. As far as trademarks are concerned, the main regulations are as follows: • the EU Community Trademark Regulation (40/94) (now EU Regulation 207/2009); • the EU First Trademarks Directive (89/104/ EEC) (now the EU Trademarks Directive (2008/95/EC)); and • Articles L711-1 and following and R711-1 and following of the French IP Code. In addition to the EU and national provisions relating to trademarks, the following regulations have an impact on the registration and use of pharmaceutical trademarks: • EU Regulation 726/2004 on procedures for the authorisation and supervision
of medicinal products for human and veterinary use; • EU Directive 2001/83/EC on medicinal products for human use, modified by EU Directive 2004/27/EC (implemented in France by Law 2007-248); and • Articles L5111-1 and following and R5111-1 and following of the French Code of Public Health. In addition to trademark law, the general rules prohibiting unfair competition set out in Article 1382 of the Civil Code are also applicable to pharmaceuticals, notably where presentation and packaging of products are concerned. National and EU antitrust regulations have an important effect on the organisation of the market for these products. Selection, clearance and registration Trademarks for pharmaceuticals must obey the general rules for validity that apply to all trademarks. Absolute grounds for refusal The sign for which registration is sought must be capable of graphical representation and used
to distinguish the products concerned. Most often, signs in the pharmaceuticals field are complex signs including both graphical and denominative elements. Colours, sounds and shapes can be registered as trademarks, as long as they can be represented graphically. Smells are currently not registrable as trademarks. A sign’s capacity to identify the origin of the goods to which it applies may be challenged in some cases. So far, the French courts have not ruled on whether shapes can identify the origin of a pharmaceutical, but in Sandoz v Biogaran (October 12 2006) the Versailles Court of Appeal assessed the capacity for pictograms to identify the goods to which they apply. In that case, the pictograms were used to inform patients of the dosage and manner of administration of the pharmaceutical. The court found that the signs were not used to identify the origin of the goods concerned. Consequently, it held that the marks were invalid. Another absolute requirement for trademark registration is that the sign be distinctive: it must not be descriptive, usual, generic, misleading, excluded by law or contrary to public order. If the mark consists of the shape of a product, the shape must not be determined solely by the nature or function of the product. This may cause difficulties when filing a trademark that consists of the shape of the drug itself (galenic shape). However, in Laboratoires Irex v Roche (September 27 2005) the Versailles Court of Appeal held such a shape to be nonfunctional and thus protectable as a trademark. However, a law issued on December 29 2011 provides that the holders of IP rights for galenic shapes cannot prohibit the use of a shape and texture for generics that is the same as the original pharmaceutical (Article L5121-10-3 of the Code of Public Health). International non-proprietary names (INNs) used to designate pharmaceutical substances belong to the public domain and cannot be registered as trademarks. Further, Article R5121-2 of the Code of Public Health provides that the name of a pharmaceutical (which is usually filed as a trademark) must not be confusingly similar to an INN. As part of its examination process, the Trademark Office will check whether a proposed trademark registration is likely to cause confusion with existing INNs; if this is the case, it will reject the application. Moreover, Article R5121-3 specifically provides that the invented name chosen to designate a pharmaceutical must avoid any confusion with other pharmaceuticals and may not mislead as to the quality or properties of the product. The Trademark Office will check that a trademark application is not misleading during the examination of a pharmaceutical mark. Relative grounds for refusal The Trademark Office undertakes no examination of prior rights. It is the applicant’s responsibility to check that the mark does not infringe prior rights. Pharmaceutical companies must obtain a marketing authorisation before commercialising their products. Drug producers often seek this authorisation concurrently with the prosecution of their trademark application. An application for an EU marketing authorisation involves clearing the mark and checking its validity in all EU member states, which is a lengthy and difficult process. In addition, the administrative authority granting the marketing authorisation sometimes reaches a different conclusion from the other relevant bodies. The general rules applicable to trademarks provide that a trademark must not cause prejudice to the prior rights listed in Article L711- 4 of the IP Code. These prior rights are mainly: • trademarks; • company names; • trade names and signboards (when they are known in the entire French territory); • appellations of origin; • copyrights; • designs; • personality rights; • image rights; and • the image or repute of a local authority. According to case law, domain names can now also constitute prior rights opposable to a trademark under certain conditions (the domain name must relate to a website launched and active before the trademark application for identical or similar activity, and
the trademark must be confusingly similar to the domain name). French case law provides that the assessment of the risk of confusion between pharmaceutical trademarks follows the same rules as for trademarks in other fields. In Pierre Fabre Médicament v Institut National de la Propriété Industrielle (February 28 2007) the Paris Court of Appeal noted that nothing can justify a different approach to the assessment of the risk of confusion with regard to pharmaceutical trademarks. The fact that the trademarks are to be used for different therapeutic preparations is irrelevant (see Boehringer v Fournier, Paris Court of First Instance, January 19 2010). Further, case law provides that the risk of confusion must be evaluated from the point of view of the average consumer, not from a specialist’s point of view (see Organon v Sanofi Synthélabo (Paris Court of Appeal, September 19 2001)). However, pharmaceutical trademarks are usually made up of elements that refer to the active components of the product. This means that the weak distinctive character of such elements will be taken into consideration in the global appreciation of the similarity between signs when assessing the risk of confusion (eg, see the Paris Court of Appeal’s October 2 2009 decision, in which the court ruled that ARTHRALGIC was different from ARTICALGIC). The criteria applied by the Office for Harmonisation in the Internal Market in the case of Community trademarks may appear to be slightly different. However, it is now established Community trademark law that the pertinent public for pharmaceuticals comprises not only health specialists, but also end users. Use of pharmaceutical trademarks A prerequisite for the market launch of a pharmaceutical is that the product have been approved for sale. The marketing authorisation is delivered after a lengthy examination process by the European Medicines Agency for an EU-wide authorisation and the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) for an authorisation valid only in France. In order to remain valid, a trademark must be used within five years of registration, except where there is a legitimate excuse not to have done so. A legitimate excuse can be that the marketing authorisation procedure was not completed during this five-year timeframe (eg, Farmaceutisk Laboratorium Ferring v EDRA (Paris Court of First Instance, September 14 1999)). Distribution In France, pharmaceutical products are sold in pharmacies only (Article L4211-1 of the Code of Public Health). This monopoly is protected and breach thereof is a criminal offence. Parallel imports and repackaging Once a product bearing a trademark has been launched on the EU market by the rights holder or with its consent, the product shall circulate freely within that market. Where pharmaceuticals are concerned, local rules on distribution may necessitate that the product be relabelled or repackaged – for instance, when a specific translation not provided on the original packaging is needed. Consumer resistance towards the relabelling of goods may also force the importer to repackage them. Courts at national and EU levels have issued many decisions concerning the parallel import of pharmaceuticals. The courts have imposed several conditions on the repackaging or relabelling of pharmaceuticals. A rights holder can oppose relabelling or repackaging, except when the following conditions are cumulatively fulfilled: • The relabelling or repackaging is necessary to gain access to the market and its prohibition would contribute to the artificial partitioning of markets between member states; • The relabelling or repackaging will not affect the original condition of the product inside the packaging; • The name of the party that repackaged the product and the name of the manufacturer are clearly mentioned on the new packaging; • The presentation of the product will not prejudice the reputation of the trademark or that of the rights holder; and • The importer has given notice to the rights holder before commercialising the relabelled or repackaged product.
These conditions were set out by the European Court of Justice (ECJ) in Boehringer Ingelheim (C-348/04, April 6 2007) and Bristol Myers Squibb v Paranova (C-427/93, C-429/93 and C-436/93, July 11 1996). The burden of proving these five conditions rests with the importer; but if the importer provides evidence that the original condition of the product is not affected, or that the presentation of the product does not prejudice the reputation of the trademark or of the rights holder, it is up to the rights holder to prove the contrary. Following these decisions, a new question was raised in Orifarm v Merck: does a parallel importer which has not repackaged the pharmaceuticals itself, but has requested a third party to do so, and which has nonetheless mentioned its own name on the new packaging, infringe the rights holder’s rights (C-400/09, October 19 2009)? The ECJ answered that the trademark holder could not oppose the commercialisation of the repackaged product simply because of the presence on the packaging of the name of the parallel importer instead of the name of the company which actually repackaged the goods (C400/09 and C207/10) There may be discrepancies between the situation deriving from ECJ case law and the regulations of the French Code of Public Health (eg, see Articles R5121-108 to 136 of the code). Anti-counterfeiting and enforcement Infringement can lead to civil or criminal penalties, depending on the circumstances and the procedure used. The EU IP Rights Enforcement Directive (2004/48/EC) was implemented in France on October 29 2007. This has reinforced the means for fighting infringement. Rights holders can file requests with Customs to stop infringing goods from entering the French or European market. Customs can also act ex officio to stop the import of infringing goods into France or Europe. Advertising The advertising of pharmaceuticals is strictly regulated. However, a distinction is made between prescription-only products and over-the-counter drugs. Advertising for prescription products can be directed at health professionals, doctors and pharmacists only. In all cases (including over-the-counter drugs), pharmaceutical advertisements are controlled by the AFSSAPS and must be authorised before broadcast or publication. With the development of generics, issues have arisen with regard to the reproduction of the trademark of the original in comparative advertising. Comparative advertising must adhere to specific conditions and should relate to a comparison of characteristics that are essential, pertinent, representative of the products and verifiable. Legitimate comparative advertisement can make reference to a trademark without the authorisation of the rights holder. Otherwise, such reference is considered to be an infringement (Article L121-8 of the Consumer Code). Another issue is whether the manufacturer of a generic product can refer to the trademark of the original or should refer solely to the INN. Currently, reference to a trademark belonging to a third party, without authorisation, is allowed only when this reference is necessary to indicate the destination of the product, on condition that there is no confusion as to the origin of that product (Article L713-6 of the IP Code). In Beecham v GlaxoSmithKline (March 26 2008) the Supreme Court reversed a Paris Court of Appeal May 3 2006 decision and found that the presentation of a product as the generic of an original product was legitimate comparative advertising, without any comparison of other elements of the pharmaceutical product being necessary. This position was confirmed again by the Supreme Court in Sandoz v Beecham Group PLC (May 24 2011). Generic substitution Under Article L5125-33 of the Code of Public Health, pharmacists are allowed to substitute a trademarked product prescribed by a medical practitioner with a generic product, whereas substitution of a trademarked product with another is prohibited by Article L716-10 of the IP Code. The court condemned a company which had presented its product as a generic of a pharmaceutical in order to have the product substituted to this pharmaceutical: when a pharmaceutical is prescribed by a doctor, the
pharmacist cannot deliver another product without the consent of the doctor, except in case of emergency and the interests of the patient, or when a generic is available. In the present case, the two pharmaceuticals were both originals. Substitution therefore is not possible (Mylan v Ipsen Pharma, Supreme Court, October 9 2012). Online issues Online advertising Online advertising is covered by the general rules of advertising. Domain names and websites must respect the rules governing pharmaceutical advertising. Consequently, according to an agreement concluded in December 2001 between Les Entreprises du Médicaments (an organisation representing pharmaceutical companies) and the AFSSAPS, a trademark may be registered as a domain name only if it designates an over-the-counter product or vaccine. Distribution through the Internet The development of the Internet has radically changed the distribution environment. France has now incorporated into French law EU Directive 2011/62/EC (Ordinance of December 19 2012 and Decree of December 31 2012). Thus, from January 2 2013, owners of a pharmacy can sell certain medicinal drugs online. Prescription drugs, veterinary drugs and medication not freely accessible to the consumer are excluded. Such activity is strictly regulated and the creation of a website is conditional on the physical existence of a pharmacy (Articles L5125-34 to L5125-41 of the Public Health Code). The pharmacist must obtain permission from the Regional Health Agency and inform the Order of Pharmacists of the intent to sell online. The site itself must include certain minimum information on each page. A breach of these rules may result in penalties ranging from temporary closure of the site to an administrative fine, which may be accompanied by a maximum penalty of €1,000 a day. However, the entry into force of the new regulation was suspended due to a February 14 2013 decision of the Conseil d’Etat on a request claiming that the decree was illegal because the prohibition to sell drugs on the Internet was not limited to prescription drugs (Decision 365459). In addition, on May 15 2013 the Competition Authority made public an opinion considering that the French regulation restricted competition for French drug sales websites, compared to other websites from other EU member states (Opinion 13-A-12, April 10 2013). In parallel, the authority has launched a major sector inquiry in order to analyse how competition works in the pharmaceutical distribution field (Decision of February 25 2013). In the meantime, at present only nonprescription drugs can be sold on the Internet in France.