The CJEU has today handed down judgment in the case C-443/17 (Abraxis Bioscience), link here (English version). Thank you to Andrew Hutchinson and Nicholas Fischer of Simmons & Simmons for providing some commentary on the decision.
The CJEU’s full answer is as follows:
Overall, the decision avoids giving full and definitive guidance on the scope of the Neurim exception. In particular, a considerable portion of the judgment is spent emphasising that Abraxane is paclitaxel and not a new “product” under Article 1(b) (which was not in issue having been decided by the UKIPO and affirmed by Arnold J, and so not referred). However, what seems clearer is that “new formulations” will not succeed and the reasoning emphasises that the CJEU will adopt a narrow approach under Article 3(d). This raises question marks for strategies that have been deployed seeking SPCs in reliance on Neurim, in particular those that do not have the veterinary-to-human facts. We may know more on this issue soon given the pending referral from the French courts in Santen (C-673/18).
The CJEU’s full answer is 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, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient.”The decision follows the AG Opinion in December 2018 (covered on the SPC blog here and also by Andrew and Nicholas here). The decision is quite short, and the main points are that:
- MAs for “new formulations” of ‘old’ active ingredients do not qualify for “first MAs” under Article 3(d) (or 3(b));
- Unlike the AG Opinion, the CJEU did not go so far as to overrule Neurim; and
- The CJEU does not state that Neurim is limited to its facts (i.e. veterinary-to-human), but the reasoning indicates that the direction of travel is a very narrow approach.
Overall, the decision avoids giving full and definitive guidance on the scope of the Neurim exception. In particular, a considerable portion of the judgment is spent emphasising that Abraxane is paclitaxel and not a new “product” under Article 1(b) (which was not in issue having been decided by the UKIPO and affirmed by Arnold J, and so not referred). However, what seems clearer is that “new formulations” will not succeed and the reasoning emphasises that the CJEU will adopt a narrow approach under Article 3(d). This raises question marks for strategies that have been deployed seeking SPCs in reliance on Neurim, in particular those that do not have the veterinary-to-human facts. We may know more on this issue soon given the pending referral from the French courts in Santen (C-673/18).
