No SPCs for new formulations of existing authorised medicines, says Advocate General

No SPCs for new formulations of existing authorised medicines, says Advocate General

In a recent opinion concerning the cancer drug Abraxane, the Advocate General (AG) of the Court of Justice of the EU (CJEU) advises the Court to rule that supplementary protection certificates (SPCs) are not available for new formulations of existing authorised medicines.  If the Court follows the AG’s lead no SPC will be available for nab-paclitaxel (Abraxane).

The case

The issue arises in the context of an application by Abraxis Bioscience LLC (Abraxis) to the UK Intellectual Property Office (IPO) for an SPC for ‘nab-paclitaxel’ (Abraxane), an injectable formulation of paclitaxel used to treat breast cancer among other things. SPCs extend patent protection for authorised medicines for up to five years. The UKIPO refused the application and Abraxis appealed to the High Court, which referred to the CJEU a preliminary question about the scope of SPCs. It is hoped that the CJEU’s answer will put an end to current uncertainty about the extent to which SPC protection is available for ‘secondary’ or ‘follow on’ patents.

How far should SPCs go?

SPCs are available to extend patent protection for authorised medicines containing new active ingredients and new combinations of active ingredients. They can also extend patent protection for new licensed therapeutic uses (arguably including new formulations and dosages), where there is no prior marketing authorisation for the active ingredients in question. Current case law and practice is, however, not clear about the extent to which SPCs can be granted for such uses if there has been a prior authorisation for the active ingredients. Whereas earlier CJEU case law suggests that a prior authorisation for the active ingredient would rule out SPC protection for the new use or formulation, a 2012 case (C-130/11 Neurim Pharmaceuticals (2012)) suggests a broader approach allowing such SPCs at least in some circumstances. Practice on this point varies across the different EU member states as illustrated in this case where so far an SPC appears to have been granted for nab-paclitaxel in nine Member States (Denmark, Greece, Spain, France, Italy, Luxembourg, Austria, Portugal and Finland) and rejected in two (Sweden and the UK).

The AG takes a narrow view

The AG makes it clear that he prefers the narrow view that, in all cases, a prior authorisation for the active ingredients should rule out SPC protection for new uses and formulations. At the other extreme is Abraxis’ approach, which implies that SPCs should be available for new authorised uses and formulations generally. A more moderate view, supported by the UK Government, is that in cases where there is a prior authorisation, SPCs should be available for new therapeutic uses only, not for formulations. A further possible view, supported by some other Member States, is that SPCs should only be available if the prior authorised use was not in human medicine. We must now await the CJEU’s ruling to find out what approach will ultimately be adopted.

The effect of Brexit

In the event of a no-deal Brexit the UK Government has committed to retain 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.  In the aftermath of Brexit, CJEU case law will be incorporated into UK law as binding Supreme Court precedent, so that the CJEU’s eventual ruling in this case will apply in the UK provided it is handed down before Brexit. After that, the UK courts would in principle be free to diverge from the CJEU ruling, but the expectation is that they are likely to be cautious in this respect.

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