Is this the end of SPC protection for second medical indications in Europe?
IP practice around Europe is at its most inconsistent when it comes to Supplementary Protection Certificate (SPC) protection for second and further medical indication inventions. A recent Opinion of the Advocate General at the CJEU may point to a pending harmonisation of practice in this area but in a direction that will dismay applicants with inventions in this area.
Supplementary Protection Certificates are “patent term extension” rights which are granted to patent owners with products that require regulatory approval before they can be marketed. Human medicines are the most obvious example, although the system also applies to veterinary medicines and certain agrochemicals. Because patents have a fixed, 20-year, duration, SPC rights are granted as a compensation for the patent term which can effectively be wasted waiting for marketing approval of a product.
In Europe, SPCs are governed by the SPC Regulation (EC 469/2009) which aims to stimulate pharmaceutical research by encouraging pharmaceutical inventions while avoiding giving patent owners limitless periods of exclusivity for old products (so-called “evergreening”). Part of this balance is set out in Art 3 of that Regulation, with Art 3(d) stating:
d) The authorisation referred to in point b) (that covering the product) is the first authorisation to place the product on the market as a medicinal product.
For this purpose, the “Product” is interpreted as being an active agent such as a drug compound. A strict interpretation of Art 3(d) would permit an SPC to be granted only the first time a specific active chemical was marketed, whether that was used for human medicine or in animals. This would reward the development of new active chemicals but not new uses of known materials.
A relatively strict interpretation of the SPC regulation was the norm until 2012 when the “Neurim” referral to the CJEU (C-130/11) changed the landscape significantly. Neurim had developed a product for treating insomnia in humans using the hormone melatonin. However, melatonin had previously been authorised for use in sheep which meant that the UK IPO disallowed Neurim’s SPC application on the basis of Art 3(d) above (the human marketing authorisation was not the first). Neurim appealed and ultimately the CJEU judged that they should be allowed an SPC to compensate for the time spent achieving regulatory approval for their product. In the judgement, the CJEU indicated that an earlier marketing authorisation could be ignored if it did not cover anything protected by the patent that was relied on for the new drug. This was a major departure from previous practice and resulted in several patent offices around Europe (including Germany and France) beginning to grant SPCs for new medical uses of old drug compounds (so-called second medical indication inventions). Thus, if a headache medicine was found to protect against heart disease then not only could that discovery be patented but an SPC granted to extend that patent if the need to obtain regulatory approval delayed it reaching the market.
The Neurim decision resulted in many but not all European countries changing their practice on second medical use SPCs with some granting them routinely and others, including the UK, remaining unconvinced. Now, however, a new referral is before the CJEU and looks set to reverse the liberalisation of SPCs seen in Neurim.
This case is another referral to the CJEU (C-443/17) from the English courts, since the UK IPO maintains its practice of interpreting Art 3(d) strictly, and relates to a SPC application by Abraxis for their new formulation of the anti-cancer drug paclitaxel. Paclitaxel is a known drug agent so Abraxis’ invention and patent are limited to the new protein-bound nanoparticle formulation that they have developed. They argue that because of this, their patent does not cover any medicine previously authorised and so they should be entitled to an SPC on the basis of the Neurim Judgement.
We only have the opinion of the Advocate General (AG) so far, which is advisory to the court but does not bind it in any way. However, the AG is absolutely savage about the decision in Neurim, setting out why he considers that the court should not have the power to decide as they did in Neurim, why that judgement was based on policy rather than on law and why even that policy may not be a good one. This opinion may not be binding but if the court accepts any of the lines of reasoning set out by the AG then practice on SPCs for second medical indications is likely to be tightening sharply.
The AG sets out four possible outcomes to the Abraxis case:
- The court agrees with Abraxis, the SPC is allowed and earlier marketing authorisations are ignored if they only cover materials that are not protected by the new patent;
- The court allows for second medical use SPCs in general but not for new formulations as Abraxis have;
- The court allows SPCs only where the earlier authorisation was for vetinary medicine and the new authorisation relates to humans (or vice versa); or
- The court overturns Neurim and reverts to the position that any prior marketing authorisation will negate all possibility of an SPC on a new invention.
The AG is clearly in favour of option 4) and makes a strong case for that. It’s possible that the court might go for option 3), however, since that would allow them to paint Neurim as a special case without having to actually overturn the earlier judgement. Option 1) would only be possible if the court were to completely reject the AG’s Opinion and all of the reasoning within it. That’s possible but highly unlikely. In any case, if the court can decide clearly on any one of the options above then we will have much more certainty on the interpretation of this article and practice around Europe may begin to unify again. Watch out for the judgement in the next few weeks.