Paclitaxel - CJEU

On Dec 13, 2018, Advocate General of Court of Justice of European Union (CJEU) opined on the issue of interpretation of Article 3(d) of SPC regulation concerning the applicability of SPC for new formulation of old product.

Background:

This request was made in the context of a dispute between the company Abraxis Bioscience LLC (‘Abraxis’) and the Comptroller General of Patents, Designs and Trademarks (‘the Comptroller’). Abraxis is seeking from the national court the annulment of the Comptroller’s decision to reject the SPC application made by Abraxis for a combination of substances containing the active ingredient paclitaxel in the form of nanoparticles bound to albumin (‘nab-paclitaxel’). Nab-paclitaxel is protected by European patent (UK) No EP 0961612, which claims composition containing albumin bound paclitaxel having certain particle size. In the present case, the active ingredient in Abraxane, paclitaxel, had already been marketed under other brand names for use in eliminating cancer cells pursuant to earlier marketing authorisations. Nab-paclitaxel is a new formulation of that active ingredient and has the same use.

By decision of 26 August 2016, the Comptroller rejected that application on the grounds that, as that marketing authorisation was not the first marketing authorisation for paclitaxel, the condition set out in Article 3(d) of Regulation No 469/2009 was not fulfilled. Abraxis appealed the decision of Comptroller to High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom. The national court has doubts as to the scope of Neurim and, accordingly, as to the interpretation of Article 3(d) of Regulation No 469/2009. In those circumstances, that court decided to stay the proceedings and referred the following question to the CJEU for a preliminary ruling:

‘Is Article 3(d) of Regulation No 469/2009 to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) [of that regulation] 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?’

CJEU Analysis:

CJEU said that for the purposes of a coherent interpretation of the provisions of Regulation No 469/2009, the terms used in Article 3(d) of that regulation must be read by reference to the definitions in Article 1 thereof. In particular, the concept of ‘product’ means, in accordance with Article 1(b) of that regulation, ‘the active ingredient or combination of active ingredients of a medicinal product’. According to settled case-law beginning with Massachusetts Institute of Technology, the concept of ‘active ingredient’, within the meaning of that provision, excludes those constituents of a medicinal product which do not have any therapeutic effects of their own on the body, such as excipients. In the light of that definition of ‘product’, as set out in Article 1(b) of Regulation No 469/2009, a literal interpretation of Article 3(d) of that regulation presupposes, as the Court expressly found in Medeva, that the ‘first authorisation to place the product on the market as a medicinal product’, within the meaning of that provision, means the first marketing authorisation for a medicinal product incorporating the active ingredient or combination of active ingredients at issue. According to that reading, an SPC can therefore be obtained only on the basis of the first marketing authorisation covering an active ingredient or a combination of specific active ingredients. In Neurim however, the Court held that an SPC could be granted on the basis of that patent and the marketing authorisation for Circadin since, although it was not the first marketing authorisation relating to melatonin, it was the first marketing authorisation covering that active ingredient for a therapeutic use in human falling within the scope of the protection conferred by the basic patent.

CJEU however, rejected the “scope of protection of the basic patent” test & adopted literal meaning of Article 3(d) of that regulation. CJEU thus held that an SPC application must be rejected where the marketing authorisation at issue is not the first marketing authorisation for the product as a medicinal product, irrespective of whether or not that marketing authorisation is the first to fall within the scope of the protection conferred by the basic patent. Also the approach adopted by the legislature inevitably denies the protection of an SPC to certain inventions, such as the formulation of nab-paclitaxel, which, although they concern a previously authorised product, constitute genuine therapeutic advances and are subject to a considerable erosion of the effective duration of the patent by reason of the procedures to be carried out before commercial exploitation is possible. However, that finding does not justify the creation by judicial decision of a test departing from the wording of Article 3(d) of Regulation No 469/2009 and from the intention of the legislature.

Thus, court gave the following answer to the question referred by the High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom:

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.