Patents

Why Europe Needs the Biotech Act’s SPC Extension?

By Brigitte Carion Taravella, French and European patent attorney The EU Biotech Act, proposed by the European Commission in December 2025, introduces a targeted Supplementary Protection Certificate (SPC) extension mechanism for qualifying biotech medicines — 12 additional months of exclusivity, conditioned on demonstrable investment in European clinical development and manufacturing. The proposal sits within a broader five-pillar regulatory package designed to address structural competitiveness deficits in the EU life sciences sector. Competitive Position of the EU Life Sciences Sector The EU's share of global industry-sponsored clinical trials fell from 22% in 2013 to 12% in 2023, a contraction of nearly...
Uncategorized

SPC Manufacturing Waiver CJEU Referral on the Export Exemption: Case C-371/26

By European Federation of Pharmaceutical Industries and Association  Supplementary Protection Certificates and the Manufacturing Waiver Intellectual property (IP) rights, and their effective enforcement, are fundamental to ensure continued investment in pharmaceutical innovation and the development of innovative medicines. Supplementary protection certificates (SPCs) are a key component of this incentive structure by providing a limited period of additional patent term to innovative medicinal products in order to compensate for the time lost during the long development and regulatory approval processes required for innovative medicines. As such, SPCs are a critical form of IP protection for pharmaceutical investment in Europe, supporting continued...
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...