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 : l’essentiel

Under European Union law, the marketing authorisation of a generic cannot be refused or delayed on the ground that a patent is in force. In other words, there is no patent linkage. The patent holder must therefore act itself, through an infringement action or an application for a preliminary injunction, before or after the launch of the generic. However, launching at risk exposes the generic manufacturer to damages if the patent is subsequently held valid and infringed. See our page on pharmaceutical patents, our entry on marketing authorisation and the texts of the European Medicines Agency.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. Where the question arises in a real case, the useful moment is almost always before proceedings are issued.

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