Supplementary protection certificates (SPCs) provide patent term extension of at least five years for a medicinal product if that product has received marketing authorisation. SPCs aim to negate the loss of time of patent protection whilst the product is undergoing the necessary requirements for achieving marketing authorisation, often a lengthy process. An SPC must be applied for in each relevant member state through the national patent office; they do not cover multiple member states. Usually, the SPC is of narrower scope than the patent it is based on as it aims to protect the active formulation which has received marketing authorisation, rather than all products potentially covered by the claims of the patent.
Regulation 469/2009 of the European Parliament and of the Council (EC) concerns the guidelines for the issuance of SPCs for medicinal products. When read in light of Article 1, Article 3d states that the marketing authorisation for a new formulation of an old active ingredient cannot be considered as being the first marketing authorisation for that product when the active ingredient has already received marketing authorisation.
The European Court of Justice (CJEU) recently issued a decision (C-443/17) concerning the rejection by the Comptroller General of Patents of an SPC application filed by Abraxis Bioscience LLC. Referral to the CJEU was from the UK High Court, where Abraxis appealed against the Comptroller’s decision to reject the application. The application referred to a number of formulations containing paclitaxel in nanoparticle form bound to albumin, known as nab-paclitaxel, or Abraxane. Paclitaxel previously received marketing authorisation for use in eradicating cancer, and subsequently nab-paclitaxel also received marketing authorisation for use in cancer treatment.
The CJEU was requested to consider if the marketing authorisation for nab-paclitaxel was the first marketing authorisation for anti-cancer treatment, considering that it was in nanoparticle form bound to albumin and therefore it could be considered a new product. The facts of this case were somewhat similar to an earlier judgement, Neurim (C-130/11) and the UK High Court specifically requested the CJEU clarify the scope of Neurim in order to determine the outcome of the present case. In Neurim, the existence of an earlier marketing authorisation for a veterinary medicinal product did not prevent the grant of an SPC for human therapeutic use, if the specific therapeutic use is within the scope of the base patent. The issue of new formulations of a product was also raised in this case – in short, it was handed down that new formulations of products should also be entitled to additional SPC protection, provided they are within the scope of the base patent.
In the present case, the CJEU took a narrower view compared to Neurim. Firstly, the CJEU stated that any carrier molecules which do not themselves render a therapeutic effect cannot be considered active ingredients. The albumin conjugates in the nab-paclitaxel particles was considered by the CJEU to be a product distinct from paclitaxel, and which has no therapeutic effect by itself. The decision further stated that even if a new formulation of an old active ingredient increases the efficacy of said active ingredient, as in the present case, it still cannot be the subject of a successful new SPC application.
In summary, it is important to note that the decision does not preclude the grant of an SPC for an old active ingredient for a new therapeutic use, i.e. the use of nab-paclitaxel for a non-anti-cancer use. What is clear from this decision is that all uses covered by a successful SPC application must be covered in the base patent, and that new formulations containing old active ingredients for an SPC protected use which solely include non-therapeutic carriers will likely not be granted. However, there is much discussion regarding the distinction between the grant of SPCs for the same therapeutic veterinary and human use – it is likely that the Neurim judgement may hold sway over future decisions in this area, but is unlikely to affect future decisions where SPC applications concern the same human therapeutic use with a different formulation of an old active ingredient.