Abraxis Bioscience v Comptroller General of Patents (CJEU, C-443/17, 2019)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the High Court (Patents Court), the Court held that Article 3(d), read with Article 1(b), of Regulation 469/2009 precludes a marketing authorisation for a new formulation of an old active ingredient from being regarded as the first authorisation of the product as a medicinal product, where that active ingredient has already been authorised (para 44 and operative part). The Court declined to extend the Neurim approach to new formulations, confining it to different applications of the same product (para 43). The judgment closes the SPC route for reformulations of an already authorised active ingredient, even where the new formulation is the first to fall within the basic patent and improves the product’s efficacy.

Facts and procedure

Abraxis Bioscience holds European patent EP 0 961 612 and markets Abraxane, indicated for certain cancers. Its active substance, nab-paclitaxel, consists of paclitaxel nanoparticles coated with albumin, which acts as a carrier and improves the efficacy of the paclitaxel. Abraxane was authorised in 2008; paclitaxel had previously been marketed in other forms by other undertakings under earlier authorisations. On 26 August 2016 the Comptroller General of Patents rejected the SPC application based on that patent and the Abraxane authorisation under Article 3(d): he accepted that the provision may cover a new and inventive therapeutic use of an old active ingredient, but not a new formulation. Abraxis appealed to the High Court relying on Neurim; finding the scope of that judgment unclear, the court referred a question by decision of 16 March 2017. The Court rejected a request to reopen the oral procedure made after the Advocate General’s Opinion.

The applicable law

Article 1(b) of Regulation 469/2009 defines the product as the active ingredient or combination of active ingredients of a medicinal product, and Article 3(d) requires the authorisation relied on to be the first authorisation of the product as a medicinal product. In the absence of a definition of active ingredient, the Court relied on its usual meaning, which excludes substances having no effect of their own on the body (para 25), and on the 1990 Explanatory Memorandum, according to which a new dose, salt, ester or pharmaceutical form does not give rise to a new certificate (para 26). It referred to recitals 3 to 5, 9 and 10 of the Regulation (para 36).

Question

Can the authorisation for a new formulation of an old active ingredient, being the first authorisation within the scope of the basic patent, be the first authorisation of the product as a medicinal product under Article 3(d) where that active ingredient has already been authorised?

Decision

The Court first addressed the concept of product: a substance with no therapeutic effect of its own, used to obtain a pharmaceutical form, is not an active ingredient and does not form a combination of active ingredients with the active substance (paras 27 to 29). The same applies to albumin used as a carrier, even if it makes the active ingredient more effective, subject to verification that it has no therapeutic effect of its own (para 30). The new formulation is therefore not a product distinct from the active ingredient (para 31). Secondly, only the authorisation of the first medicinal product placed on the market containing the product can be the first authorisation under Article 3(d) (paras 34 and 35). The legislature intended to protect research leading to the first placing on the market of an active ingredient as a medicinal product, not all pharmaceutical research (para 37); taking in isolation the first authorisation within the patent for a new formulation would defeat that aim and create legal uncertainty (paras 38 and 39). Neurim does not call that reading into question: it concerned a different application of the product, not a new formulation (paras 41 to 43).

Key points for practice

• A carrier with no therapeutic effect of its own is not an active ingredient, even if it improves the product’s efficacy (para 30).
• A new formulation of an already authorised active ingredient is not a distinct product (para 31).
• The Neurim exception is confined to different applications and does not extend to formulations (para 43); Santen of 9 July 2020 (C-673/18) has since abandoned that exception.
• Practical point: a patent for a new formulation, however inventive and effective, cannot support an SPC where the active ingredient has already been authorised as a medicinal product (paras 40 and 44).

Provisions applied

Regulation (EC) No 469/2009

Arts 1(b) and 3(d)

Case law cited

Neurim Pharmaceuticals (1991) (C-130/11); Medeva (C-322/10); GlaxoSmithKline Biologicals (C-210/13, order); F. Hoffmann-La Roche and Others (C-179/16)

Related decisions

• Neurim, CJEU, 19 July 2012, relied on by the applicant and confined by the Court to different applications (paras 41 to 43).
• Medeva, CJEU, 24 November 2011, cited on the concept of first authorisation (para 35).

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.