In brief

In a judgment delivered on 9 July 2020, the CJEU held that a new therapeutic application for an authorised medicinal product cannot be the subject of a supplementary protection certificate (SPC).  This clarifies the position on an issue that has been unclear for nearly a decade, but will be unwelcome to companies in the healthcare and life sciences sector who have invested, and continue to invest, in the development of new therapeutic applications for authorised products. It will have a significant impact on pending SPC applications relating to second medical uses.


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In more detail

The availability of patent term extensions for second medical uses in the EU had been unclear since the CJEU’s judgment in Neurim in 2012 (C 130/11). The SPC Regulation (Regulation No 469/2009, Article 3(d)) provides that an SPC is only available if the marketing authorisation (MA) on which it is based is the “first authorisation to place the product on the market as a medicinal product”. In Neurim the CJEU held that the existence of an earlier MA for a veterinary medicinal product did not preclude the grant of an SPC for a different application of the same product in humans, provided that the new therapeutic application was “within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.” It was unclear from subsequent case law whether Neurim established a general principle that SPC protection may be available for second medical uses in certain circumstances, was confined to its specific facts, or should be disregarded entirely. In the Advocate General’s opinion in Santen, discussed in more detail here, the AG criticised the CJEU’s failure to take a clear stance on its own previous decision in Neurim.

In its recent judgment in Santen (C-673/18) the CJEU held that its own previous judgment in Neurim was wrong (or at least, the wrong conclusion had been drawn from it by the referring court): there are no circumstances in which it is possible to obtain an SPC for a new therapeutic application of an active ingredient which has already been the subject of an MA. The limits of protection of the basic patent are not relevant to defining which is the “first authorisation”, and “product” for the purposes of the SPC Regulation means the active ingredient or combination of active ingredients of a medicinal product, and is not limited to the therapeutic application(s) for which that product is used.

The CJEU held that “a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of [Article 3(d) of the SPC Regulation], 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.”

The CJEU’s judgment in Santen provides a firm answer on the interpretation of Article 3(d)) and the requirement that the MA on which an SPC application is based must be the “first authorisation to place the product on the market as a medicinal product”. For a more in depth discussion of the decision, its broader implications for the interpretation of the SPC legislation, and its impact on your SPC portfolios, contact our European patent litigation team.

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