Les obstacles juridiques à l'essor des génériques
Institution:
Montpellier 1Disciplines:
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Abstract EN:
The development of generic medicines encounters numerous obstacles. First of all, the direct obstacle constituted by patent law. The multiplicity of patents which exist for the same active ingredient: patents on products, processes, formulations, therapeutic applications or even a combination thereof, the coverage of these various patents being spread over time, greatly complicates the task of the manufacturers of generics and delays the availability of the copied products on the market. Furthermore, some of these inventions, and most particularly the later therapeutic applications have attained patentability thanks to an atypical application of the conditions for patentability. Moreover, the validity of patents for drugs/medicines can be prolonged by means of a supplementary protection certificate which further delays the availability of copies on the market. Some of these titles, based on their very filing procedure, may give rise to controversies as regards their validity. Thereafter, once the validity of these patents and/or supplementary protection certificate expires, or even regardless of their previous existence, there exist other obstacles which delay the development of copies on the market. Thus, starting from the reservation of know-how and raw materials by the laboratory of the "leader" product, which sometimes makes it utterly impossible for a third party to be competitive, getting through the administrative protection of data required for the marketing authorization, the prohibition of substitution and the derisory authorization for comparative advertising, the generics will have a hard time to work their way up to the market, which can thus still be reserved for the leader product for a long time. These are indirect obstacles which nevertheless prove to be very crippling ones and slow down the expansion of the generics.
Abstract FR:
L'essor des medicaments generiques se heurte a de nombreux obstacles. Il convient d'evoquer tout d'abord l'obstacle direct constitue par le droit des brevets. La multiplicite des brevets existants sur une meme molecule active: brevet de produit, de procede, de formulation, d'utilisation therapeutique ou encore d'association, ces differents brevets etant echelonnes dans le temps, complique grandement la tache des generiqueurs et retarde l'arrivee des copies sur le marche. En outre, certaines de ces inventions, et plus particulierement les applications therapeutiques ulterieures, ont accede a la brevetabilite grace a une application atypique des conditions de brevetabilite. De plus, les brevets de medicaments peuvent etre prolonges par un certificat complementaire de protection (ccp), ce qui differe encore l'arrivee des copies sur le marche. Certains de ces titres, de par la facon dont ils ont ete deposes, pourraient preter a discussion en ce qui concerne leur validite. Ensuite, une fois les brevets et/ou ccp arrives a expiration, ou meme independamment de l'existence prealable de ceux-ci, il existe d'autres obstacles qui freinent l'essor des copies sur le marche. Ainsi, de la reservation du savoir-faire et des matieres premieres par le laboratoire du produit "leader", rendant parfois impossible toute concurrence par les tiers, en passant par la protection administrative des donnees de l'autorisation de mise sur le marche, l'interdiction de la substitution et l'autorisation derisoire de la publicite comparative, les generiques auront grand peine a se frayer une place sur le marche, qui pourra ainsi etre longtemps reserve au produit leader. Il s'agit la d'obstacles indirects, mais qui se revelent etre des freins tres handicapants pour le developpement des generiques.