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January 2019

In January 2017, Arnold J referred another question to the CJEU relating to Supplementary Protection Certificates (SPCs) in Abraxis Bioscience LLC v Comptroller General of Patents¹ (Abraxis). This referral concerned the correct approach to the interpretation of Article 3(d) of Regulation No 469/2009 (the 'Regulation') when presented with a novel formulation of an old active pharmaceutical ingredient (API), specifically where the old API has been the subject of a prior Marketing Authorisation ('MA'). Ahead of the judgment by the CJEU that is expected soon, Advocate General Saugmandsgaard Øe (the 'AG') has published an opinion on the case.

Abraxis Bioscience LLC v Comptroller General of Patents

The case at hand concerned an application for nab-paclitaxel, sold as Abraxane®, the API of which is paclitaxel which has been the subject of a prior MA used in the treatment of certain cancers. Nab-paclitaxel, a novel formulation of paclitaxel in the form of nano-particles bound to albumin, is protected by a basic patent for the same use which was relied upon by Abraxis Bioscience in support of its application for an SPC. Despite having been granted in nine EU member states, the application was refused in the UK on the basis that paclitaxel is the subject of an earlier MA for the same use. The tight association of paclitaxel to albumin was not seen as sufficient to render nab-paclitaxel a novel API, merely a new formulation of an existing API with the same therapeutic effect, since albumin does not produce a therapeutic effect of its own. The UKIPO therefore did not view Abraxane® as a new product under Article 1(b), and rejected the application on the grounds of Article 3(d), that paclitaxel was already the subject of a prior MA.

Literal or teleological interpretation?

This case followed a string of earlier cases that have focused on the interpretation of Articles 1(b) and 3(d) of the Regulation. There have been two main strands of interpretation, both of which feature heavily in the AG's Opinion. Firstly, there is the 'strict approach' that was employed in MIT². This is a reading of Article 1(b) wherein a 'Product' (as defined in that section) is an API, per se, but a combination of the same API and another substance that does not have a therapeutic effect in itself, is not a novel Product. Furthermore, in Yissum³, the CJEU ruled that a Product cannot include the therapeutic use, thereby ruling out the possibility of obtaining an SPC for the second medical use of a product which has already benefitted from an SPC.

Neurim Pharmaceuticals v Comptroller-General of Patents

However, the waters were muddied by the decision of the CJEU in Neurim⁴, which focused on the correct interpretation of Article 3(d) (and by extension, 1(b)), and introduced the teleological interpretation of the Regulation. This replaced the strict, literal interpretation, and focused instead on giving effect to the purpose of the Regulation, which was to incentivise costly R&D activities by providing the extra protection of an SPC. The CJEU in this case appeared to go against Yissum, and ruled that the meaning of Product could include the therapeutic use, meaning that a Product that had already benefitted from an SPC could benefit from another, provided it would be protecting a new therapeutic use of that Product. Since Neurim, the full implications of this ruling have remained unclear. However, with a view to providing some much needed clarity in light of the cases mentioned above, Arnold J's referral in the Abraxis case asked the CJEU the following question:

"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 Opinion

The AG's opinion delivered on 13 December 2018, includes a discussion of the merits of both the literal and teleological interpretations of the Regulation, and recognises that the Neurim decision is 'difficult to reconcile' with prior established case law such as MIT and Yissum. As a result, the AG explicitly recommends either:

• returning to the literal interpretation of the Regulation;
• or at least narrowing the scope of the Neurim judgment to only apply to situations in which the MA concerned is 'the first to cover a therapeutic indication of the product in human medicine'.

The AG, in reaching his conclusion, undertook an analysis of the opposing interpretations of the Regulation. In assessing the teleological approach, the AG examined the recitals of the Regulation and the Explanatory Memorandum which formed the basis for its adoption. In so doing, he recognises the importance of fostering an environment which balances the many interests involved in the pharmaceutical industry. This includes the encouragement of innovation in the EU by using SPCs to compensate for the occasional inadequacy of a patent's protection. However, the regime was only ever intended as a 'general compromise between those various interests'. An important undercurrent of his argument is that while teleology certainly has a place in the interpretation of the Regulation, it 'does not justify the creation by judicial decision of a test departing from the wording of Article 3(d)'.

The AG's conclusion and recommendation to the CJEU is therefore as follows:

Article 3(d) of the SPC Regulation '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' (emphasis added).

The Opinion is not binding, and the CJEU may decide to adopt a different interpretation to the one put forward by the AG. However, if the CJEU does decide to adopt either of his recommendations, the result would be that the applicability of Neurim would be strictly limited, and SPCs would not be permissible for a new formulation of an API for a human product which is already the subject of an MA. The CJEU's final judgment in the Abraxis case is expected in the new year.

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