Patent linkage

Patent linkage, or the linkage between patent rights and regulatory approval, refers to a mechanism under which the grant, maintenance or examination of a marketing authorisation for a generic or biosimilar medicinal product is made dependent on the status of the patents protecting the reference medicinal product. It may, in particular, take the form of a requirement for the regulatory authority to verify that no relevant patent remains in force, to obtain the consent of the patent holder, or to suspend the marketing authorisation procedure pending the resolution of patent infringement proceedings. The term may also be used more broadly to describe a comparable linkage at the pricing or reimbursement stage.

Under European Union law, patent linkage is prohibited at the marketing authorisation stage: the patent status of the reference medicinal product is not among the grounds on which a marketing authorisation may be refused, suspended or revoked. The competent authority is required to assess the quality, safety and efficacy of the medicinal product, rather than determine a question of patent infringement, which falls within the jurisdiction of the civil courts. A marketing authorisation may therefore be granted for a generic medicinal product before the relevant patent expires, although such authorisation does not in itself permit the product to be lawfully placed on the market in infringement of a patent that remains in force.

Patent linkage : ce qu’il faut retenir

En droit de l’Union européenne, l’autorisation de mise sur le marché d’un générique ne peut pas être refusée ou retardée au motif qu’un brevet est en vigueur. Autrement dit, il n’existe pas de patent linkage. Par conséquent, le titulaire doit agir lui-même, par une action en contrefaçon ou un référé-interdiction, avant ou après le lancement du générique. Toutefois, le lancement à risque expose le génériqueur à des dommages-intérêts si le brevet est ensuite jugé valable et contrefait. Voir notre page brevet pharmaceutique, our entry marketing authorisation et les textes de l’European Medicines Agency.