No extension of patent term for novel combination products

The CJEU has given its decision in the Abraxis Bioscience Supplementary Protection Certificate case. We commented on this case after the UK court ruling, when a question was referred to the CJEU.

Abraxis asked the courts to reconsider a UK Intellectual Property Office refusal of an SPC for a formulation of a known drug (paclitaxel) as albumin-bound nanoparticles. The formulation had its own patent protection as it offered improved therapeutic efficacy. The difficulty with Abraxis’s request is that SPCs are only granted to protect a “product” that has not already been granted an SPC. And in the legislation “product” means an active ingredient or combination of active ingredients.

Abraxis argued that the nanoparticle formulation within its Abraxane product should be regarded as a new active ingredient, and so able to qualify for an SPC. That argument had found favour elsewhere - certificates had been issued by other offices around Europe.

The UK judge felt that it would be better not to grant SPCs in situations like this in the interests of clarity, but he asked the CJEU to rule.

The European judges agreed. Although paclitaxel was present in combination in Abraxane, the second component, albumin, did not itself have any therapeutic effect. Earlier case law and guidance did not allow sufficient flexibility to treat the combination as a “combination of active ingredients”. Albumin’s role in promoting the therapeutic efficacy of the paclitaxel was not enough.

Granting SPCs for novel combination products like this could lead to uncertainty about the legal limits of this form of protection, and could upset the delicate policy balance between promoting research and allowing use of products in the interests of public health.

Although this ruling goes against the interests of those carrying out innovative research on existing active ingredients, it does provide some certainty as to the position. The courts would appear to be of the view that bringing in novel formulation features when assessing SPC applications could cause confusion and uncertainty in an already complex area of law.