14 July 2020 - Authored by:Charles Tuffreau
In a landmark decision dated 9 July 2020 concerning the Santen case (C‑673/18), the Grand Chamber of the CJEU clearly reverses the Neurim decision (C‑130/11) and ruled that a MA cannot be considered to be the first MA, for the purpose of Article 3(d), where it covers a new therapeutic application of an active ingredient (or of a combination of active ingredients) and when that active ingredient (or combination) has already been the subject of a MA for a different therapeutic application.
In other words, the CJEU abolishes the possibility to obtain an SPC based on an MA covering new therapeutic indications of a medicinal product which has already been the subject of a MA.
According to the CJEU, granting such an SPC would undermined the objectives of the EU legislature that intends “to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product”.
The CJEU considers that the proposed solution would enable “a fair balance to be struck between, on the one hand, the objective of the SPC regime, as it is made apparent from recitals 3 to 5 and 9 of Regulation No 469/2009, of compensating for the inadequacy of protection conferred by a patent for the purpose of covering the investment put into research concerning new active ingredients or combinations of active ingredients and, therefore, of encouraging such research and, on the other hand, the EU legislature’s intention, as set out in recital 10 of that Regulation, to achieve that objective in a manner that takes into account all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector”.
The decision is available here.