Abraxis Bioscience Llc v The Comptroller-General of Patents

The concept of “product” in Article 1(b) of the Regulation 469/2009/EC concerning the supplementary protection certificate for medicinal products is interpreted narrowly. An active ingredient must produce a pharmacological, immunological or metabolic effect of its own. A carrier or formulation component does not become an active ingredient merely because it is tightly associated with, or enhances the delivery or efficacy of, the active ingredient. The medicinal product’s SmPC and EPAR may be considered when identifying the active ingredient. The court considered it unclear whether Article 3(d) permits an SPC for a new formulation of an old active ingredient and referred that question to the CJEU.

Abraxis appealed against the decision of the Deputy Director acting for the Comptroller-General, O/410/16, refusing an SPC application for nab-paclitaxel. The application relied on a patent protecting a formulation of paclitaxel with albumin-bound nanoparticles and on the marketing authorisation for Abraxane.

The hearing officer held that paclitaxel, rather than nab-paclitaxel, was the active ingredient, and that albumin was a carrier. Since paclitaxel had previously been authorised, the Abraxane authorisation was not the first authorisation for the purposes of Article 3(d). The issues were whether nab-paclitaxel was a distinct product under Article 1(b), and whether Article 3(d) allowed an SPC for a new formulation of an old active ingredient.

1. Article 1(b). The appeal on the identity of the product was rejected. The CJEU authorities established that Article 1(b) must be interpreted narrowly. An active ingredient is a substance producing a pharmacological, immunological or metabolic effect of its own. A substance without such an effect is not an active ingredient, even if it is necessary for a particular pharmaceutical form or enhances therapeutic efficacy.
2. Applying that approach, the hearing officer’s findings established that paclitaxel was the active ingredient in nab-paclitaxel and that albumin functioned as a carrier. Abraxis did not challenge those factual findings. The non-covalent association between paclitaxel and albumin did not make nab-paclitaxel a separate active ingredient. The SmPC and EPAR for Abraxane also identified paclitaxel as the active ingredient and nab-paclitaxel as a formulation of paclitaxel.
3. The court considered that no further reference was required on Article 1(b), because the relevant interpretation was acte éclairé. It did not decide whether the Comptroller’s submission that the marketing authorisation alone should be considered was correct.
4. Article 3(d). The effect of Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents [EU:C:2012:489] was unclear beyond new therapeutic uses of old active ingredients. The existing authorities did not squarely resolve whether its reasoning extended to new formulations. The court therefore referred to the CJEU the question whether Article 3(d) permits an SPC where the relevant authorisation is the first authorisation within the scope of the basic patent, but the product is a new formulation of an old active ingredient.
5. As an indicative provisional view, the judge considered that a strict interpretation of Article 1(b), the need for a simple and predictable system, and the balance between competing interests pointed against SPCs for new formulations. The judge would answer the referred question “no”, but the operative order was to refer the question and hear counsel on its precise wording.

1. High Court (Patents Court). The court heard Abraxis’ appeal from the Deputy Director’s decision dated 26 August 2016, O/410/16. The Article 1(b) challenge failed. A question concerning Article 3(d) was referred to the CJEU.