Law 2011-2012 of December 29, 2011, relating to the reinforcement of the safety of drugs and medicinal products, has modified the French public health code.
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.
The law brings in a new article to the CSP, stating that: “The 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.
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Generic drugs, CSP