The eagerly awaited CJEU decision on the two joined referrals Teva v. MSD (C-119/22) and MSD v. Clonmel (C-149/22) relating to SPCs for combination products was handed down today on December 19, 2024. The two referrals arose from national litigation involving SPCs for a combination of active ingredients, i.e., the combination of sitagliptin and metformin…

The SPC reform which is currently undergoing the legislative procedure in the European Union has taken a further decisive step forward, as the European Parliament’s Committee on Legal Affairs (JURI Committee) has approved an amended version of the draft text of the four new EU regulations on SPCs for medicinal and plant protection products as…

A sweeping reform of the European Union’s legislation on supplementary protection certificates for medicinal products and plant protection products is currently underway, which features the introduction of a new centralized SPC examination procedure at the EUIPO as well as the creation of a new unitary SPC on the basis of the unitary patent, as previously…

After years of preparation, the European Union’s draft legislation for a sweeping reform of the existing legal regime on supplementary protection certificates (SPCs), which includes the establishment of a centralized SPC filing and examination procedure as well as the introduction of a unitary SPC, has finally been published today on April 27, 2023. This draft…

There are currently two referrals on SPC law pending before the Court of Justice of the European Union (CJEU), both of which concern the interpretation of Article 3(c) of the SPC Regulation (EC) 469/2009. This provision essentially ensures that the same person cannot obtain more than one SPC for the same product (active ingredient), which…

On 18 October 2021, the Russian IP Court rendered the decision in Geropharm vs. Novo Nordisk. While dismissing the claims, the IP Court has given the green light to a new legal mechanism of challenging a Patent Term Extension (‘PTE’) and Supplementary Protection Certificate (‘SPC’). It used to be problematic for generic companies to meet…

The question whether SPCs should be available for new therapeutic applications of previously approved active ingredients has been a matter of debate ever since the SPC Regulation for Medicinal Products came into force in the European Union more than a quarter-century ago. While a literal reading of the SPC Regulation would clearly seem to exclude…