On 21 March 2019 the Court of Justice (CJEU) confirmed that no Supplementary Protection Certificate (SPC) is available for new formulations of old active ingredients which have been the subject of previous marketing authorisations. The Court emphasised that although the purpose of the SPC regime is to encourage research into new medicinal products, this does not mean that all pharmaceutical research leading to new medicinal products can benefit. All interests at stake are to be taken into account, including those of public health.
Nab-paclitaxel (marketed as Abraxis) is an injectable formulation of paclitaxel used to treat breast cancer. It consists of a combination of nanoparticles of paclitaxel coated with albumin which passes through the cell membrane as a single entity and achieves greater efficacy than earlier formulations of paclitaxel for treating certain tumours. It achieved marketing authorisation (MA) in 2008, but (as now confirmed by the CJEU) has been denied an SPC because the basic active ingredient, paclitaxel, has previously been marketed in another form by other companies under previous MAs.
A narrow approach
The CJEU’s ruling confirms that SPC protection does not extend to new formulations of previously authorised active ingredients. Though not unexpected, this narrow approach is a setback for originators, which often carry out considerable research in developing such new formulations. The Court’s narrow, literal approach would arguably also lead to the conclusion that SPCs should not be available for second therapeutic uses (repurposed drugs) either if there has been a prior MA for the active ingredient in question. However, the Court declined to comment specifically on this point with the result that we can expect a further reference on this point at some time in the future.
How will Brexit affect the position?
In the event of a no-deal Brexit the UK Government has committed to retaining EU legislation on SPCs in UK law, and this will form the basis for a new UK SPC regime, which will mirror the EU scheme. At Brexit, CJEU case law will be incorporated into UK law as binding Supreme Court precedent, so that the CJEU’s ruling in this case will apply in the UK. After that, the UK courts would in principle be free to diverge. In the event of a deal and a transition period it is likely that the position will be the same, but starting after the transition period. During the transition period EU law would continue to apply. It is difficult to predict how much weight will in practice be given to CJEU case law in the UK courts after the UK has left the EU/or after the transition period. The EU SPC framework has been subject to much criticism in the UK courts and this legislation has also been interpreted variously by patent offices in the different Member States: in the case of nab-paclitaxel, SPCs have been granted in nine countries but denied in two (including the UK). This might suggest that the UK courts will be keen to step in. However, it also seems likely that they will be cautious in moving away from the EU position in such a highly regulated area.
So what will happen to my SPC after Brexit?
The SPC system was set up under EU law and applies across all Member States. After Brexit, the UK will continue with its own SPC regime, which will mirror that of the EU. UK SPCs already granted will remain in effect with those not yet in force coming into effect at the end of the patent term as usual. Applications before the UK Intellectual Property Office (IPO) will not need to be refiled. If a European Medicines Agency (EMA) MA is relied on, information about the equivalent, converted UK authorisation may need to be provided. However, the conditions for obtaining a UK SPC will not change, and these will continue to be applied for through the IPO. For the time being the fees will be the same. As at present, an MA which is valid in the UK will be required: this may be an MA granted by the Medicines and Healthcare products Regulatory Agency (MHRA) or by the EMA and converted into a UK authorisation. Information about the earliest MA for the product in the EEA will need to be provided if it predates the UK MA. Paediatric extensions will still be available and will be applied for in the same way. However, an important exception will be that, for new paediatric extension applications only, evidence of authorisations covering the product across the EEA will no longer be required.
For more detail about the position after Brexit, please see the UK Government’s guidance.
The case about nab-paclitaxel described above is: Abraxis Bioscience LLC v Comptroller General of Patents, Court of Justice case C-443/17 21 March 2019