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CJEU restricts SPCs for new uses of previously authorised products

The Court of Justice of the European Union (CJEU), the EU’s highest court, has issued its decision in case C-673/18 (Santen). The ruling relates to the interpretation of Article 3(d) of the SPC regulation and it represents a significant divergence from the court’s previous case law. The CJEU’s judgment has negative implications for many SPC applications based on new authorisations for older products (e.g. new medical indications) and is likely to come as a body-blow to pharmaceutical innovator companies. Applicants will need to review their existing SPC portfolios, and revisit their filing strategies for new SPCs. 

Santen’s SPC application related to the product, ciclosporin, and was based on a marketing authorisation (‘MA’) that authorised the product for the treatment of keratitis. The application was rejected by the French Patent Office (INPI) because a previous MA had been granted for ciclosporin in 1983, albeit for a different therapeutic indication. The INPI held that the SPC application contravened Article 3(d) of the SPC regulation, because the SPC for ciclosporin was not based on “the first authorisation to place the product on the market as a medicinal product”. Santen appealed this decision, arguing that the SPC should be granted, based on the CJEU’s judgment from 2012 in the Neurim case (C-130/11).  

In the Neurim judgment, the question arose as to what is the first MA for SPC purposes under Article 3(d). Neurim had applied for an SPC for the product melatonin based on a patent claiming a certain medical use of melatonin and an MA for melatonin corresponding to the claimed medical use. The SPC application was initially rejected because Neurim had failed to identify an earlier, veterinary MA for melatonin as the first MA in the jurisdiction, notwithstanding the fact that the earlier veterinary use was directed to a different use and was not covered by Neurim’s claims. The CJEU viewed things differently, however, holding that the earlier veterinary MA was no obstacle to an SPC based on a later MA, because the first MA for SPC purposes was one which fell within the limits of protection of the basic patent. 

The CJEU ruled in Neurim that, when correctly interpreted, the legislation ‘refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate’. As the veterinary MA for melatonin did not fall within the scope of the patent, it could not be the first MA. Based on this ruling, many patent offices across Europe have granted SPCs for new uses of previously authorised products, even if the earlier authorisation was also for use in humans (unlike the factual situation underlying Neurim).

The Paris Court of Appeal in Santen referred various questions to the CJEU seeking to clarify the scope of the Neurim judgment, to determine the extent to which it could be applied to the Santen application. The CJEU has now answered these questions as follows:

‘Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, 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 a marketing authorisation for a different therapeutic application.

In arriving at this conclusion, the CJEU noted that Article 3(d) makes no reference to the limits of protection of the basic patent and stated that ‘contrary to what the Court held in paragraph 27 of the judgment in Neurim, to define the concept of ‘first [MA for the product] as a medicinal product’ for the purpose of Article 3(d) of Regulation No 469/2009, there is no need to take into account the limits of the protection of the basic patent’.

This is consistent with a direction of travel towards a stricter interpretation of the SPC Regulation which was hinted at in last year’s Abraxis decision (C-443/17), in which the CJEU ruled that SPCs could not be granted on the basis of a new MA for a new formulation of a previously-authorised active ingredient. The Court now appears to have gone one step further by contradicting the Neurim judgment itself. Careful consideration of SPC filing strategies will be necessary to mitigate the negative implications of the Santen judgment for SPCs which relied on Neurim.

The trend towards an increasingly strict interpretation of the SPC Regulation will renew debate about whether the protection available under the Regulation, which is now almost 30 years old, is suitable for the needs of the modern pharmaceutical industry. The European Commission is currently reviewing the Regulation with a view to possible revision. Meanwhile, with the CJEU’s jurisdiction in the UK due to lapse at the end of this year, a post-Brexit UK could potentially consider whether a more liberal domestic SPC regime is called for.

For further information on SPCs, visit our specialist page, or contact one of the authors of this article, Peter Arch, Alexander Robinson, David Miller or Stephen Garner.

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Peter Arch
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Alexander Robinson
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David Miller
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Stephen Garner
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