Intellectual property

Entitlement to an SPC under Article 3(d) of an uncombined medicinal product (drospirenone): Laboratorios Leon Farma SA v Comptroller-General of...

By Daniel Byrne, Partner, VENNER SHIPLEY, London  Summary The historic CJEU decision in Medeva (C-322/10) states that a product “A” having an SPC precludes a later SPC for product “A + B” (except in some special cases). However, does the Medeva decision prevent a product “A” from being granted an SPC where that product has previously been authorised as part of a combination “A + B”? The court held that it does. It confirmed that the IPO had been right to refuse an SPC for drospirenone on that basis: an earlier marketing authorisation (“MA”) for drospirenone in combination with estrogen...
Intellectual property

Une nouvelle taxe contre l’« evergreening » pharmaceutique : l’article L.138-10-1 du Code de la sécurité sociale

Par Maître François Pochart et Maître Océane de La Verteville, cabinet August Debouzy Une nouvelle taxe s'est glissée dans la loi de financement de la sécurité sociale pour 2026 (Loi n° 2025-1403 du 30 décembre 2025 de financement de la sécurité sociale pour 2026), plus précisément dans son article 29 qui crée l’article L. 138-10-1 du Code de la sécurité sociale (L. 138-10-1 du Code de la sécurité sociale) reproduit ci-dessous. Ce nouvel article institue, à la charge des entreprises pharmaceutiques, une taxe de 3 % (portée à 5 % en cas de récidive) sur le chiffre d'affaires réalisé sur...
Intellectual property

A New Tax to Combat Pharmaceutical “Evergreening”: Article L.138-10-1 of the Social Security Code

By François Pochart, Partner, and Océane de La Verteville, Counsel, of the August Debouzy law firm A new tax was included in the French Social Security Financing Act for 2026 (Act No. 2025-1403 of December 30, 2025, on Social Security Funding for 2026), specifically in Article 29, which creates Article L. 138-10-1 of the French Social Security Code (Article L. 138-10-1 of the Social Security Code) as reproduced below. This new article imposes on pharmaceutical companies a 3% tax (increased to 5% in the event of a repeated offense) on the revenue generated from a pharmaceutical product when the commercial...