It may only be the opinion of the Advocate General but after almost a decade of fog surrounding Article 3(d) of the SPC Regulation this latest offering in Santen v INPI suggests that clarity may be about to prevail.
In the past the decisions and opinions of the CJEU & Advocate General have often been criticised for their lack of clarity and applicability but this is not a criticism that can be levelled at Giovanni Pitruzzella. If the CJEU choose to follow his guidance then Neurim will be scrubbed from the record books and Article 3(d) will, once again, mean what is says.
As a quick reminder, Article 3(d) of the SPC regulation states that a certificate shall be issued if:
“the authorization [for the product] is the first authorization to place the product on the market as a medicinal product”
The “medicinal product” and “product” are defined in Article 1 of the regulation and essentially relate to “any substance or composition presented as having curative or preventive properties with regard to human or animal diseases” and “the active ingredient or the composition of active ingredients in a drug” respectively.
This was all pretty clear until Neurim came along in 2012. Without going into the weeds of the Neurim decision (and the resulting aftermath) it essentially redefined the previously crystal clear definition of “product” in Article 3(d) to the slightly less clear definition of:
“a previously authorised product reformulated into a later authorised medicinal product wherein the basic patent does not protect the previously authorised product”
I may have paraphrased here but you get the point; this did not help clarify anything.
The Advocate General goes to great lengths to explain why Neurim is at odds with both existing CJEU case law relating to Article 1 and the recent Abraxis judgement regarding Article 3(d) which acknowledged that the Neurim interpretation should not relate to new formulations of previously authorised products.
Following this in-depth analysis, the Advocate General gives the CJEU two options:
– either acknowledge that the teleological approach adopted by the Court in Neurim was wrong and should be abandoned; or
– accept the Neurim judgement applies only in cases where the marketing authorization, which serves as basis to the request for a SPC, covers a new therapeutic indication of a previously authorised active ingredient or relates to a use in which the active ingredient exerts a new pharmacological, immunological or metabolic action of its own.
There is no doubt which option the Advocate General prefers. In paragraph 17 he concludes that the interpretation adopted by the Court in Neurim should be abandoned and then dedicates the next 46 paragraphs to explaining how he reached this conclusion. In contrast, he provides a mere 10 paragraphs to reluctantly support the alternative interpretation.
So, if the CJEU do follow the recommendation of the Advocate General, what would that mean for the pharmaceutical industry?
It is probably fair to say that nobody has been enormously confident in the strength of SPCs based on new indications of old products but following Neurim these were still getting granted and a granted SPC, with the backing of a CJEU judgement, counts for a lot in preliminary infringement proceedings. Irrespective of their strength they were keeping generics off the market and/or forcing indications to be carved-out.
If the CJEU chooses to abandon Neurim there will be clear guidance that these SPCs should not be granted or are not valid and this could put a significant dent in the enforcement strategies of pharma and biotech companies for the next few years.
That said, for companies only viewing these SPCs as “upside” in their quest to maintain exclusivity the impact will probably be manageable.
But what about companies whose business model is built around “re-purposing” old medicines? Developers of personalised medicines; orphan drug developers and companies using big data and AI to identify new, unmet, therapeutic uses are all likely to rely more heavily on this type of SPC to give them valuable additional years of exclusivity. For them, a decision to abandon Neurim could have serious commercial consequences.
At the end of the day, although the Advocate General’s recommendation would undoubtedly bring clarity to Article 3(d) there will still be many who would prefer things to stay firmly in the fog of Neurim.
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.