CJEU restricts SPCs for new therapeutic applications

What’s happened?

The CJEU, in a reversal of an earlier seminal decision in 2012, has restricted the availability of SPCs in relation to products that are developed for multiple therapeutic applications. Sitting as a Grand Chamber, the CJEU agreed with the primary recommendation of the Advocate General to reverse its earlier caselaw and, by doing so, has delivered a contrasting seminal decision addressing a hotly debated aspect of SPC law.

Background

The case in question is Santen (C-673/18), a referral from the Paris Court of Appeal made in 2018, following the original rejection of Santen’s SPC application by the French Patent Office (INPI). The opinion of the Advocate General (AG Pitruzzella) was given in January 2020 (see our article here), with whom the CJEU has now agreed.

The CJEU’s decision

The case concerns Article 3(d) of the SPC Regulation, which sets the requirement that the marketing authorisation being used in the SPC application must be the first for the product in question.

The CJEU set this field alight in 2012 via its decision in Neurim (C‑130/11), when the SPC applicant was allowed to rely on the authorisation for its product (in humans) as the first, despite the same product having been authorised for an earlier, different therapeutic application (in animals).

When you compare that outcome to the answer the CJEU has now given in Santen, the contrast is stark:

“… a marketing authorisation cannot be considered to be the first marketing authorisation … where it covers a new therapeutic application of [a product] and [that product] has already been the subject of a marketing authorisation for a different therapeutic application.”

In giving that answer, the CJEU decision emphasises that the SPC regime is not intended to protect all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but only the research leading to the first placing on the market of the product in question as a medicinal product.

The CJEU’s reasoning is heavily based on the limits of the definition of product and the scope of protection offered by SPCs as demonstrating that the intended use of the product is not a decisive factor for the grant of an SPC. Those reasons refer to caselaw, which had been pointed out as being impossible to square versus the outcome in Neurim. Indeed, the same was highlighted when the UK Patents Court originally rejected Neurim’s SPC, only for the Court of Appeal to make the CJEU referral and the rest, as they say, is history.

Comment

The significance of reversing Neurim and the ramifications for the pharmaceutical industry are illustrated by the, again stark, contrast to the conclusion of Jacob LJ when the UK Court of Appeal originally referred the case to the CJEU: “In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose.” However, what purpose that is, has continued to divide opinion.

Given these sentiments, it is tempting to speculate how UK courts will react if they are faced with Neurim-type SPC applications in the future. However, by arriving during the UK’s Brexit transition period, the Santen decision applies to the UK and would become part of the retained EU law. Whether the UK diverges in the future will remain to be seen, which is currently an interesting proposition due to the UK Government’s ongoing consultation on whether lower courts should be given the power to diverge from retained EU law.

Overall, the reversal of Neurim adds to a line of recent CJEU decisions that have already restricted SPCs for medical devices and new formulations of active ingredients (again despite earlier contrary outcomes). In his opinion, AG Pitruzzella’s considered that Neurim had swung the balance too far in favour of pharmaceutical companies and that it should be the job of the legislators and not the courts, to decide whether its principle is permissible. There are accordingly a growing number of areas that appear to require new legislation, rather than CJEU caselaw, if broader incentives are to be afforded via the SPC system.