On 9th July 2020, the Court of Justice of the European Union (CJEU) handed down their emphatic judgement concerning Supplementary Protection Certificates (SPCs) in Santen v INPI (C‑673/18). For those interested in the details and history of the case they can be found in my earlier blog, published in January, where I discussed the Advocate General’s preliminary and non-binding opinion. As far as this judgement is concerned the conclusion is clear: “a marketing authorisation (MA) cannot be considered to be the first MA … where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application” – emphasis added Put another way, the CJEU has decided that the literal wording of Articles 1(a), (b) and 3(d) of the SPC Regulation mean what they say. The previous CJEU decision in Neurim is consigned to the scrapheap.
Insights: marketing authorisation
Supplementary Protection Certificates (SPCs) are European sui generis rights which provide a form of patent term extension available in Europe for medicinal products or plant protection products. The period of effective patent protection for medicinal products and plant protection products can be significantly less than in other sectors because of the need to obtain a marketing authorisation (MA). Obtaining an MA can take a significant amount of time (typically around 12 years), which can be a large portion of the lifetime of a patent (20 years from its filing date). SPCs are national rights available in individual EU countries (and European Economic Area (EEA) countries: Switzerland and Norway) which are governed by EU regulations. They will also continue to be available in the UK following its exit from the EU. The SPC sphere is a fascinating and extremely active area of intellectual property law. There is a steady stream of decisions from the Court of Justice of the European Union (CJEU) attempting to clarify the SPC Regulations, and there are a number of issues outstanding. This brief guide attempts to give a sense of the current state of play.
When it comes to exclusivity in the pharmaceutical and biopharmaceutical fields, patents and supplementary protection certificates (SPCs) are not the only games in town. In Europe, it is important to consider another layer of exclusivity, associated with regulatory data.