Yesterday (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.
It is interesting how little this judgement refers to Neurim; there is no great fanfare or exclamation denouncing the earlier decision. The judgement simply works methodically through the language of the SPC Regulation and its objectives and concludes that an extension to the usual 20-year patent term via an SPC should only be available based the first authorization to place an active ingredient or combination of active ingredients on the market as a medicinal product.
Based on this judgement, new indications for a previously approved active ingredient cannot act as basis for an SPC. This follows on from last year’s CJEU Abraxis judgement which found that new formulations of a previously approved active ingredient cannot acts as basis for an SPC.
As discussed in my previous blog, this decision will not come as a great surprise to most in the pharma & biotech sectors. To the vast majority of companies who have obtained “new indication” SPCs it will be an annoyance but is unlikely to have any significant bearing on their top line.
The biggest impact will be felt by companies whose business is built around “re-purposing” old medicines. Developers of personalised medicines and orphan drugs who identify new, unmet, therapeutic uses for known active ingredients are likely to rely more heavily on this type of SPC so for them, this decision could have serious commercial consequences.
However, as a final point, is it worth taking a few moments to consider whether time, as much as logic, has rendered Neurim obsolete?
This decision coincides with a step change in how medicinal products are developed. The use of big data, AI and bioinformatics is dramatically speeding up the processes for identifying new therapeutic uses and in turn reducing the time to approval, so is an extension to the 20-year patent term even justified for these products?
Almost a decade on from Neurim, maybe even the teleological argument that won the day has been blunted by the advances of technology in the pharma and biotech sectors.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.