A new article modifying the Public Health Code and impacting the Design Law has recently been introduced[1].
It allows an Intellectual Property Right offense as it leads to the substitutability of generic medicines under the European Guideline[2] with regards to their aspect and substitutability link with the original medicine.
The French Intellectual Property Right Code already contains a provision for trademarks allowing for substitutability between original and generic medicines. But this substitutability takes place only after the legal period of protection of the original product has expired.
The medicine’s external aspect (shape of tablet or capsule; color; texture) likely to be protected by Design Law, is from now on framed by this provision.
Patients will have now an offer that recalls the organoleptics characters of the original medicine with the generic medicine’s price.
The scope of the article is limited to original oral medicines with a recognizable and identifiable external aspect. These medicines are likely to cause confusion in taking medication and so to jeopardize the patient safety. Indeed, patients often identify their medication by their external aspect.
It refers as well to generics medicines with regard to their substitutability link under the article L. 5125-23 of Public Health Code.
This new provision facilitates the commercial distribution of generics medicines to the extend that strong differences in aspect are likely to get patient confused which is an impediment to the development of generics medicines despite the substitutability principle.
However, this new article is an exception to the Design Law. Registered Design confers on its owner the exclusive right to use it and to prevent any third party from using it without consent.
This provision jeopardizes the Design Law granted for original medicines to the benefit of generics.
But why is this article introduced into the Public Health Code only and not into the Intellectual Property Right Code as well, since it significantly modifies the Intellectual Property Right in general and Design Right in particular?
Even if this new provision meets a need in terms of public health it contravenes the European Guidelines about Design Law which allows for no exception.
[1] The Law N° 2011-2012, of December 29, 2011 on improvement of medicines and health product’s safety has introduced a new article L. 5121-10-3 in Public Health Code stipulating that : « the owner of an Intellectual Property
Right which protects the external aspect and the texture of the original pharmaceutical’s oral forms under article L. 5121-1 cannot prohibit pharmaceutical’s oral forms of a generic product likely to be substitutes for the original form pursuant to l’article L. 5125-23 from having identical or similar aspects and textures ».
[2] A generic medicine is, under European Guideline D2004/27/EC, article 10: “a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form
as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies”.