C-443/17 - Abraxis CJEU Judgement

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:

“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).

C-443/17 - Abraxis - AG's opinion out

The Advocate General of the CJEU has provided his opinion in C-443/17 (Abraxis Bioscience) today (here).

As a refresher, the questions referred to the CJEU by Mr Justice Arnold were:

"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?"

The Advocate General has advised the Court to rule 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 precludes the grant of such a certificate where the marketing authorisation relied upon in support of the application for a supplementary protection certificate under Article 3(b) of that regulation is not the first marketing authorisation for the active ingredient or combination of active ingredients at issue as a medicinal product. This is so even in a situation, such as that at issue in the main proceedings, where the marketing authorisation relied upon is the first to cover the formulation protected by the basic patent relied upon in support of the application for a supplementary protection certificate under Article 3(a) of that regulation.

Call for comments for C-443/17 (Abraxis Bioscience)

The UK IPO is seeking comments on CJEU case C-443/17 (Abraxis Bioscience) with a view to advising the UK government as to whether it wishes to make representations in this reference.  Comments should be sent by email to policy@ipo.gov.uk by 6 September 2017.

As a refresher, the question referred to the CJEU in this case is as follows:

Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?