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18-01-2012 » Generic drugs: a bitter medicine to swallow for IP Rights Owners!

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 – French Public Health Code). It includes two articles which affect the extent of the exclusive rights of intellectual property right owners.

The law brings in a new article L 5121-10-3 of the CSP, stating that “The holder of an intellectual property 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 may be recalled that, twice, there had been votes in favour of a similar statement but these had quickly been censured, both times, by the Conseil Constitutionnel (decisions of December 22, 2009, and August 4, 2011, Dec. No. 2009-596 DC and Dec. No. 2011-640 DC). On the present occasion this limit on intellectual property rights has duly been adopted.

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 the protection granted to pharmaceutical laboratories over the shape of their medicines via intellectual property 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 intellectual property 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 from EU Community Regulations, which French Law should, in principle, not be able to affect.

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 intellectual property right”. Therefore, although that statement constitutes, in itself, an assault on the rights of intellectual property rights holders, its application will nevertheless certainly lead to future litigation regarding what is to be understood by texture and whether the appearance and the texture have to be cumulated in one right in order for the Text to be applicable.

The second relevant provision in the Law refers to patents and the legal exceptions to the exclusive rights of the patent’s owner that are prescribed in Article L613-5 of the Intellectual Property Code. A new exception is added, specifying that the rights conferred by patents do not extend “d) bis To acts necessary to obtain the visa authorizing advertising mentioned in Article L. 5122-9 of the Public Health Code”. This provision also aims at facilitating the commercialization of generic medicines, by allowing generic producers to start the procedures necessary to obtain the mandatory visa authorizing 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.

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