SPCs: eligibility of a protein-bound drug
16 December 2016
Supplementary protection certificates (SPCs) are available in Europe to extend the effective protection available to eligible products. To qualify, a product must be covered by a basic patent; must not be the subject of an earlier SPC; and must have been granted the first authorisation to place it on the market as a medicinal product (Article 3 of the SPC Regulation).
An SPC application was filed for albumin-bound paclitaxel nanoparticles (nab-paclitaxel). The SPC Regulation defines a product as "the active ingredient or combination of active ingredients of a medicinal product" (Article 1(b) of the SPC Regulation). However, the examiner objected that the only active ingredient in nab-paclitaxel is paclitaxel, an established anti-cancer drug with earlier marketing authorisations (eg, for Taxol®). Therefore, the marketing authorisation for nab-paclitaxel was not considered the first authorisation for the product. Consequently, it was held that the application did not comply with the SPC Regulation.
The applicant objected that nab-paclitaxel is a single active ingredient, and therefore eligible for SPC protection. In response, the examiner offered a hearing, and set out two questions:
- Does nab-paclitaxel constitute a new active ingredient?
- If not, should an SPC nonetheless be granted in light of Neurim Pharmaceuticals v Comptroller General of Patents C-130/11  (Neurim)?
Purpose of the SPC Regulation
Pharmaceutical research is often the subject of regulatory delays and significant financial costs. On account of this, the SPC Regulation intends to provide further protection to compensate the time and money invested in drug development.
The applicant argued that an SPC for nab-paclitaxel met the purpose of the SPC Regulation, and that the case was analogous to Generics UK Ltd v Daiichi Pharmaceutical Co Ltd EWCA Civ 646  (Daiichi). In Daiichi, an SPC was granted for a single enantiomer of a racemic antibiotic with earlier marketing authorisations, because it was considered inventive over the racemate.
Despite similar circumstances, the hearing officer found that the facts of the cases were not comparable. Daiichi concerned two different forms of a single molecule, whereas nab-paclitaxel comprised two different molecules. Nevertheless, the hearing officer agreed that obtaining an SPC for nab-paclitaxel case may not be inconsistent with the purpose of the SPC Regulation, and proceeded to consider the examiner's questions.
A new active ingredient?
To answer the examiner's first question, the hearing officer initially considered the activity of nab-paclitaxel at the cellular level.
Based on evidence supplied by the applicant, the hearing officer accepted that nab-paclitaxel is more effective than paclitaxel for the treatment of some tumours. The hearing officer also accepted that nab-paclitaxel is more effective at crossing cell membranes, and that it is transported as a single unit.
However, the hearing officer required a closer inspection of nab-paclitaxel's activity. At the molecular level, the hearing officer held that nab-paclitaxel is not a single "active ingredient". Instead, nab-paclitaxel is made up of two distinct components - paclitaxel and albumin.
Accordingly, the hearing officer considered whether nab-paclitaxel might be eligible as a "combination of active ingredients". The hearing officer held that, although nab-paclitaxel had improved efficacy over paclitaxel, the albumin component merely behaves as a carrier, and does not have its own therapeutic effect.
In Massachusetts Institute of Technology C-431/04  (MIT), the CJEU decided that a "combination of active ingredients" does not include combinations of substances where only one has its own therapeutic effects.
The applicant argued that the facts in the cases were different, because the MIT excipient breaks down and does not enhance the active ingredient's efficacy in vitro, whereas nab-paclitaxel enters the cell as a single unit.
However, in MIT, the CJEU had acknowledged that excipients may influence the efficacy of an active substance. The hearing officer understood from this that carriers that enhance an active ingredient's efficacy cannot themselves be considered "active ingredients" unless they have therapeutic activity alone. With this in mind, the hearing officer determined that MIT was applicable, and that nab-paclitaxel is not a "combination of active ingredients".
Should an SPC be granted in light of Neurim?
The applicant submitted that nab-paclitaxel is a new application of paclitaxel, and is consequently entitled to SPC protection following Neurim (reviewed in our July 2012 newsletter). However, the hearing officer held that the new application must be a new therapeutic application for Neurim to apply. Nab-paclitaxel did not have a different therapeutic application to paclitaxel. As such, the hearing officer did not consider Neurim to affect the SPC eligibility of nab-paclitaxel. As a result, nab-paclitaxel was not considered to be a new product under the SPC Regulation. Therefore, the marketing authorisation for nab-paclitaxel was not considered the first authorisation for the product.
Consequently, the SPC application was refused.
The applicant lodged an appeal on 13 September 2016. We will keep you informed of developments in this matter.
Case details at a glance
- Decision level: UKIPO
- Applicant: Abraxis BioScience LLC
- Citation: BL O/410/16
- Date: 26 August 2016
- Full decision: http://dycip.com/bl041016
'Sheep don't follow authorization – CJEU decides on Neurim SPC application, Garreth Duncan, 24 July 2012: www.dyoung.com/article-neurimspc0712
Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents, C-130/11: http://dycip.com/c-13011
Generics UK Ltd v Daiichi Pharmaceutical Co Ltd and Daiichi Sankyo Co Ltd, EWCA Civ 646 : http://dycip.com/ewcavic6462009
Massachusetts Institute of Technology C-431/04 : http://dycip.com/c-43104