This is based on a talk given by Beatriz San Martin at the CIPA Life Science Conference on 14 November 2013. Her talk had the title ‘SPC’s – Are they Fit for Purpose?’
1. The SPC Regulation have been around for 20 years, but a lot of uncertainties remain. Given that there is a strong commercial incentive for innovators and competitors to challenge the Regulation, purposive construction has been exploited to interpret it in different ways. The Regulation is drafted vaguely to allow for new technologies which emerge subsequently, but that has led to a lot of uncertainty and a lot of referrals to the CJEU. Unfortunately the CJEU is guilty of not providing clear decisions and national judges are now reluctant to make decisions based on the Regulation if any degree of interpretation is required.
The SPC Regulation works well for traditional medicines, i.e. those with single active ingredients, where it is the first marketing authorisation (MA) and it is covered by basic patent. However, uncertainty quickly arises for situations beyond this, e.g. combination products or where the product is being used for another therapeutic indication.
2. Most people assume that the objective of SPC’s is to compensate for patent protection which is lost due to regulatory delay. However the explanatory memorandums and recitals for the SPC regulations for pharmaceutical and plant products do not refer to this. Instead the objectives are stated to be protection for high levels of investment, to maintain high levels of research in these areas and to maintain competitiveness.
3. What is the product? Article 3 of the Regulation refers to a product which is protected by a basic patent and which is the subject of an MA and SPC. The assumption would be that it is the same product in these three cases. Article 1 defines the product as an active ingredient or a combination of active ingredients. The explanatory memorandums and recitals provide guidance and suggest a strict definition, so that different salts or use of different excipients could not lead to a subsequent new SPC.
4. The question of what the product can be was the subject of GSK C-210/13 concerning whether an SPC was possible to an adjuvant on its own and or in combination with a flu vaccine. Judge Arnold from the UK referred this to the CJEU because the law was not clear and because there were diverging decisions across the EU. The essential question was ‘can an adjuvant be an active ingredient?’. The Neurim decision had previously caused a lot of uncertainty as to defining a product. Before Neurim, MIT C-431/04 had established a strict approach where an excipient was not considered an active ingredient. However Neurim used a purposive construction of the Regulation [Subsequent to this talk the CJEU now said decided in GSK C-201/13 that an adjuvant is not an active ingredient because it does not give a therapeutic effect when used on its own]
5. There is a similar situation in Bayer Cropscience C-11/13 for a plant protection product. The decision concerns lsoxadifen which is a safener used to prevent the harmful action of herbicides. The question is whether a safener can be an active substance. [Subsequent to the talk the Advocate General has given the opinion that a safener can be an active substance for the purpose of the SPC Regulation, but the CJEU has yet to decide]
6. Another issue concerns the relationship between the product and the basic patent. In Medeva C-322/10 it was held that the SPC product had to be specified/identified in the wording of the claims of the basic patent. In that case the patent claim referred to a product with 2 active ingredients, but the product in the MA and SPC had in addition to those 2 ingredients other active ingredients. Thus the SPC could not rely on that patent. The UK Court of Appeal criticised the CJEU’s decision as not providing proper guidance and being unclear. The Medeva decision led to uncertainty in national courts and notably in the case of the Irbesarten and HCTZ combination litigation it led to different decisions across the EU.
7. In Actavis v Sanofi C-443/12 the patent claims refer to Irbesarten and a diuretic, but not specifically to HCTZ, which is specified as the diuretic in the SPC. [Subsequent to the talk the CJEU decided that since there is already an SPC for the main product a subsequent SPC is not possible for the combination]
In Eli Lilly v HGS C-493/12 the question was whether an antibody can be sufficiently identified by simply referring to what it binds, or whether the structure is needed. [Subsequent to the talk the CJEU has now said that a structure does not need to be given for an antibody, and it can be defined just by reference to what it binds]
8. In a pending referral Actavis v Boehringer C-577/13 the question is whether a patent can be amended post-grant to solve the issue of mentioning a specification combination product in the claims.
9. Georgetown C-422/10 concerns how many SPC’s are possible per patent. [Subsequent to the talk the CJEU has decided that it is possible to have more than one SPC per patent where the patent protects more than one product]. A previous decision on this point, Biogen C-181/95, could be interpreted both ways.
In Neurim C-130/11 the CJEU surprisingly said that a subsequent SPC was possible because the earlier MA did not fall within the scope of protection of the later patent.
10. Is it time for reform of the SPC system given new technologies such as biologics and gene therapy, and given the increased cost of developing medicines? The European Commission has indicated to the CJEU that reform of the SPC system is on the political agenda.