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JURISDICTION REPORT: FRANCE GENERIC DRUGS:


A BITTER PILL TO SWALLOW Aurélia Marie


Cabinet Beau de Loménie


Law 2011-2012 of December 29, 2011, relating to the reinforcement of the safety of drugs and medicinal products, has modified the Code de la Santé Publique (CSP, the French public health code). It includes two articles that affect the extent of the exclusive rights of intellectual property owners.


Te law brings in a new article to the CSP, stating that: “Te holder of an IP right protecting the appearance and texture of oral dosage forms of a specialty of reference within the meaning of Article L. 5121-1 may not prohibit oral dosage forms of a generic specialty which may be substituted for that specialty in pursuance of Article L. 5125-23 from presenting an identical or similar appearance and texture.”


It means that now, in France, generic companies will not only be able to refer to the original trademark in their own products, rather than to the international non-proprietary name (INN), but they will even been allowed to reproduce the shape of the branded medicine itself, even in cases when there is no medical need for it.


Tere have been votes in favour of a similar statement twice before, but these were quickly overruled by the Conseil Constitutionnel. But on this occasion, this limit on IP rights was adopted and no action was raised before the Conseil Constitutionnel to have the corresponding articles removed from the law. It entered into force with the publication of the law on December 30, 2011.


By allowing generic specialties that are intended to be ingested to reproduce an identical or similar appearance and texture to that of the brand name medicine, the legislator greatly reduces the scope of protection granted to pharmaceutical laboratories over the shape of their medicines via IP rights, notably by trademark and design rights. It is to be noted that the new law does not differentiate based on the nature of the IP right in question, and therefore also applies to copyright or patents.


It is also to be noted that the text does not deal with the hierarchy of legal norms and trademarks and design rights originating in EU Community Regulations. French law should, in principle, not be able to affect the rights deriving from the Community regulations and therefore it would be advisable for the pharmaceutical industry to choose and favour the filing of Community figurative trademarks and Community designs over French applications.


Regarding the wording of the text itself, it appears less simple to interpret than it looks, as it refers to two notions (“appearance” and “texture”), which are two distinct and unrelated qualities, or which are at least not necessarily the object of a simultaneous protection, whereas it is stated that they are protected by “an IP right”. Terefore, although that statement constitutes,


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“ALTHOUGH THAT STATEMENT CONSTITUTES, IN ITSELF, AN ASSAULT ON THE RIGHTS OF IP HOLDERS, ITS APPLICATION WILL CERTAINLY LEAD TO FUTURE LITIGATION REGARDING WHAT IS TO BE UNDERSTOOD BY ‘TEXTURE’.”


in itself, an assault on the rights of IP holders, its application will certainly lead to future litigation regarding what is to be understood by texture, and whether the appearance and the texture have to be bound up in one right in order for the text to be applicable.


Te second relevant provision in the law refers to patents and the legal exceptions to the patent owner’s exclusive rights that are prescribed in Article L. 613-5 of the Intellectual Property Code. A new exception is added, specifying that the rights conferred by patents do not extend “to acts necessary to obtain the visa authorizing advertising mentioned in Article L. 5122-9 of the CSP”. Tis provision also aims to facilitate the commercialisation of generic medicines, by allowing generic producers to start the procedures necessary to obtain the mandatory visa authorising advertising of their products, without having to wait for the end of the monopoly conferred by the patent related to the corresponding brand name medicine.


Tese two provisions are of course political, because France wants to limit expenses in the field of health. However, the result is a new threat to IP rights holders and a clear and significant gesture for the generic industry.


Aurélia Marie is a partner at Cabinet Beau de Loménie. She can be contacted at: amarie@bdl-ip.com


World Intellectual Property Review January/February 2012 73


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