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...
Industrial property,Uncategorized

Opinion of Advocate General Nicholas Emiliou delivered on June 6, 2024 (1) Joined Cases C-119/22 and C-149/22

In an opinion of 6 June 2024, the Advocate General Emiliou suggests a straightforward and literal construction of Article 3 (c) of the SPC Regulation 469/2009, while providing clarifications on Teva I (C-121-17) on the interpretation of paragraph (a) of the same Article. Background AG Emiliou opine in the context of the closely followed cases opposing Merck Sharp & Dome Corp. (hereinafter Merck) to: Teva BV and Teva Finland Oy (hereinafter Teva), challenging the validity of Merck’s SPC covering a combination of sitagliptin (hereinafter substance A, as the opinion puts it) and metformin (substance B) to treat type 2 diabetes, in front...