Abuse of regulatory and patent procedures

Abuse of regulatory and patent procedures refers to the use by a dominant undertaking of medicinal product authorisation procedures, patent offices or the courts in order to delay or prevent the entry of generic or biosimilar competitors. It is penalised under Article 102 TFEU and French competition law as a form of abuse of a dominant position. It must be distinguished from the normal exercise of rights, which competition law does not call into question.

Misleading representations and withdrawal of authorisations

The Court of Justice of the European Union has held abusive, first, the submission to patent offices of misleading representations designed to obtain supplementary protection certificates to which the undertaking was not entitled and, second, the selective withdrawal of marketing authorisations in order to prevent generic manufacturers from referring to the dossier of the reference medicinal product. Abuse is assessed objectively, in light of the capacity of the conduct to restrict competition, without any need to establish fraudulent intent. The second type of conduct has lost some of its relevance since Directive 2001/83/EC has allowed reference to a product that has been authorised, even if it no longer is.

Vexatious litigation and the use of patent procedures

Bringing legal proceedings is in principle the exercise of a fundamental right. Under the criteria applied by the European Commission and the General Court of the European Union, it becomes abusive only if it cannot reasonably be regarded as an attempt to assert the undertaking’s rights, serves only to harass the competitor and forms part of a plan to eliminate competition. The authorities also examine the multiplication of secondary patents or divisional applications aimed at sustaining legal uncertainty, as well as interventions with health authorities aimed at delaying the authorisation or reimbursement of generics, practices that the French Competition Authority and the Commission have already penalised.

Interplay with patent law and procedure

These competition sanctions coexist with the tools of patent law and civil procedure. French courts may sanction abuse of process with damages and a civil fine, and the invalidity of a wrongly obtained patent is pleaded by way of an invalidity action or a counterclaim. Evergreening strategies are not unlawful in themselves, the line being drawn by the good faith of the steps taken and the exclusionary aim pursued.

Key points

Use of regulatory and patent procedures remains free as long as it seeks to protect rights that are seriously founded. A dominant undertaking should document the justification for each step, whether a divisional application, a withdrawal of authorisation, an intervention with a health authority or an infringement action, and ensure the accuracy of the information provided to the offices. For the competitor, such conduct may ground a complaint and a claim for damages, to be coordinated with the defence on the merits.

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

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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