Source: https://www.bioindustry.org/news-listing/bia-blog-cjeu-decision-denies-spcs-for-new-formulations.html
Timestamp: 2019-05-24 11:38:32
Document Index: 357587010

Matched Legal Cases: ['CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ']

BIA | BIA blog | CJEU decision denies SPCs for new formulations
This decision comes after the Advocate General’s opinion at the end of 2018, which the CJEU only partially follows but with a similar outcome in applying a narrow approach to interpreting the SPC Regulation (EC/469/2009). The key headlines are:
Marketing authorisations for “new formulations” of ‘old’ active ingredients cannot qualify as “first marketing authorisations” under the SPC Regulation (under Articles 3(b) or (d));
Unlike the Advocate General, the CJEU did not go so far as to overrule its judgment in a previous case - Neurim (C-130/11); and
The CJEU does not state that Neurim was limited to its facts (i.e. veterinary-to-human species switch in re-developing an existing drug (in that case melatonin)), but the reasoning indicates that the direction of travel is a narrow approach.
Overall, the key take-home is that the CJEU have adopted a narrow approach to Article 3(d) of the SPC Regulation, which curtails the scope of the SPC incentive in relation to the significant field of research concerning new formulations. In the 7 years since the CJEU’s decision in Neurim, SPC applicants will have considered its scope and may have relied on its principles to invest in R&D and develop strategies to bring “different applications” of existing drugs to market – including, for example, based on new formulations (like Abraxis) and further therapeutic indications (e.g. via Type II variations). This decision means that a number of those strategies may need to be reconsidered. We will hopefully know more soon, including in in particular relating to how narrowly the principles in Neurim apply to the scenario where the same drug is developed for a new indication in the same species (humans) as there is another pending referral before the CJEU in Santen (C-673/18). So, as ever with SPCs, this remains an ongoing area to watch.