Generic and hybrid marketing authorisation

A generic marketing authorisation is themarketing authorisation granted to a generic medicinal product under an abridged procedure: the applicant does not have to provide the results of pre-clinical and clinical trials, it refers to the dossier of the reference medicinal product and demonstrates bioequivalence. This regime is provided by the Directive on the Community code relating to medicinal products for human use and transposed in France in the Public Health Code. The generic marketing authorisation is the act that most often triggers pharmaceutical patent litigation.

The conditions of the generic marketing authorisation

First, the generic medicinal product must have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and its bioequivalence must be demonstrated by appropriate studies. Next, the application may only be filed after expiry of a period of protection of the reference product’s data , and the generic may only be marketed after expiry of an additional period of market protection. Finally, the generic may exclude from its leaflet the indications still covered by a patent, a practice known as the skinny label, which raises questions of indirect infringement.

The hybrid marketing authorisation

Where the medicinal product does not strictly meet the definition of a generic, for instance because of a different pharmaceutical form, strength or route of administration, or where bioequivalence cannot be demonstrated, the applicant follows the hybrid procedure: it relies on the reference dossier and provides additional pre-clinical or clinical data. The hybrid marketing authorisation is subject to the same data protection periods. The texts can be consulted on EUR-Lex and on the website of theEuropean Medicines Agency.

The relationship with patents

The health authority grants the marketing authorisation without examining patents, subject to patent linkagemechanisms, which do not exist in EU law. The trials needed for the application are covered by theBolar exemption. But marketing before expiry of the patent or the supplementary protection certificate constitutes infringement, and the holder monitors marketing authorisation applications, entries in the generics register and pricing applications in order to seek interim relief. In practice, the firm acts in these disputes in launch at risk, as presented on the page pharmaceutical patents and regulation.