Answering one question and raising others – the CJEU on SPCs for new formulations

The CJEU handed down its decision on Abraxis Bioscience LLC v Comptroller General of Patents (Abraxis) on 21 March 2019.

The case

In January 2017, Arnold J referred the question relating to the correct interpretation of Article 3(d) of Regulation No 469/2009 (the Regulation) whether a supplementary protection certificate (SPC) can be granted for 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).

Abraxis had applied for 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, but it allows the active ingredient to exercise its therapeutic effects with an increased efficacy.

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.

Earlier decisions

It is to be borne in mind that the CJEU had initially ruled in MIT (Massachusetts Institute of Technology – Case C-431/04, [2006] ECR I-4089) that a "product" in the sense of Article 1 (b) 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.

In the following, in Yissum (Yissum Research v Comptroller-General of Patents. Case C-202/05, [2007] ECR I-2839), the CJEU ruled that a product cannot include the therapeutic use which means that an SPC could not be obtained for the second medical use of a product which has already benefitted from an SPC.

In contrast, relating to Article 3(d) the CJEU and with regard to the purpose of the Regulation to allow amortization of investments in costly R&D activities of the pharmaceutical industry, the CJEU found in Neurim (Neurim Pharmaceuticals v Comptroller-General of Patents. Case C-130/11, [2012] ECR I-0000) that the meaning of "product" could include the therapeutic use. Hence, 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.

The Neurim decision gave rise to many discussions in the patent world and practitioners hoped that the Abraxis case would bring further clearance and legal certainty with regard to whether there could be SPCs on new formulations or a new use.

However, one is tempted to say that, as always, the decision of the CJEU raises more questions than it answers.

The Abraxis decision

The question referred to by Arnold J reads as follows:

"Is Article 3(d) of Regulation [No 469/2009] to be interpreted as permitting the grant of an SPC where the [MA] referred to in Article 3(b) [of that regulation] is the first [MA] 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 CJEU first of all took into consideration the purpose of the Regulation of encouraging research by compensating for the investment put into research concerning new medicinal products (cf. Recitals 3 – 5 and 9 of the Regulation), while at the same time underlining that all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector must be taken into account (Recital 10) (n° 36 of the decision).

This led the CJEU to a narrow interpretation of Article 3 (d), ie that the EU legislator only wanted to protect pharmaceutical research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product (n° 37 of the decision).

Consequently, the CJEU answered the question in the negative. It decided that an MA granted for a new formulation of an old active ingredient, such as nab-paclitaxel, cannot be regarded as being the first MA granted for that product as a medicinal product within the meaning of Article 3(d), when that active ingredient has already been the subject of an MA.

Consequences of the decision

Abraxis concerned the specific case of a new formulation of a known substance having higher efficacy. It does not relate to a new therapeutic use.

It does not answer to which extent the earlier case law (MIT and Yissum) can be reconciled with Neurim (ie whether an SPC can only be granted where the earlier MA was for veterinary use or only for a new therapeutic application where the earlier MA was for veterinary medicinal products).

Hence, it is currently still difficult to draw any general conclusions on the grant of SPCs for second medical use patents in general.

Upcoming next decision

Another referral with more questions on whether an SPC can be granted for second medical use patents is still pending. In Santen SAS/Directeur général de l'Institut national de la propriété industrielle (C-673/18, cf.), the French Cour d'Appel de Paris (Paris Court of Appeal) referred the question whether the concept of a "different application" within the meaning of the judgment of 19 July 2012, Neurim (C-130/11, EU:C:2012:489), be interpreted strictly, that is to say:

• as limited only to the situation where an application for human use follows a veterinary application
• or as relating to an indication within a new therapeutic scope, in the sense of a new proprietary medical product, compared with the earlier marketing authorisation, or a medicinal product in which the active ingredient acts differently from how it acts in the medicinal product to which the first marketing authorisation related
• or more generally, in the light of the objectives of Regulation (EC) No 469/2009 of establishing a balanced system taking into account all the interests at stake, including those of public health, must the concept of a "new therapeutic use" be assessed according to stricter criteria than those for assessing the patentability of the invention
• or must it on the other hand be interpreted broadly, that is to say, as including not only different therapeutic indications and diseases, but also different formulations, posologies and/or means of administration.

It is to be hoped that the decision of the CJEU will then give more guidance than it is doing now in order to give the pharmaceutical industry more legal certainty with regard to the grant of SPCs for second medical use patents in general.