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…

by Dr. Simon Klopschinski On February 13, 2020 the German Federal Constitutional Court decided that the German law ratifying the Agreement on a Unified Patent Court is void (see here). In the meantime the Constitutional Court has issued another sentence which deals with the European Central Bank’s bond-buying programme (see here). On May 13, 2020…

With the rendering of the judgment in Royalty Pharma (C-650/17) by the Court of Justice of the European Union today on 30 April 2020, a series of referrals relating to the interpretation of Article 3(a) of the SPC Regulation, which requires that the product of an SPC must be “protected” by the basic patent, finally…

In its 30 January ruling in Generics (UK) and others v CMA, the EU Court of Justice (CJEU) in effect upheld the existing approach of the European Commission and EU General Court in relation to the assessment of so-called “reverse payment” patent settlements.  The CJEU confirmed that settlements in which a generics manufacturer is paid…

Today, Advocate General (AG) Mr. Giovanni Pitruzzella handed down his opinion in the referral C-673/18 (Santen). The case concerns an SPC based on a second medical use/formulation patent and stems from a referral to the CJEU made by the Paris Court of Appeal with decision of 9 October 2018 in Santen v. INPI (see here…

The debate over standard-essential patents (SEPs) is typically distinguished as much by concerns over competition than issues of patent law per se. Erixon argues: ‘…SEP disputes are less concerned about the rights and boundaries of patents, and more about antitrust limits to market behavior.’ At the European level EU institutions acknowledge the policy concern that…

The injunction gap is a frequently discussed characteristic of those European jurisdictions, Hungary being one such country, whose  patent litigation systems are bifurcated. In a preliminary injunction proceeding in Hungary the court does not assess the validity of the patent in suit, at least not simply at the level of arguments, although decisions on invalidity…

One of the features that render the European Union’s Supplementary Protection Certificate (SPC) unique in comparison to similar legal instruments in other jurisdictions, including the United States and Japan, is that there is no legal provision expressly calling for any specific relationship or agreement between the patent proprietor (and SPC applicant) on the one hand,…

In the field of supplementary protection certificates (SPCs) in the European Union, the majority of all CJEU referrals resolved to date have dealt with the interpretation of the – presumably simple – condition that an SPC can only be granted for an active ingredient (or a combination of active ingredients) that is “protected” by the…