SPCs: the simplest issue is in doubt

There has been a considerable amount of activity in the Court of Justice of the European Union (CJEU) recently on the subject of supplementary protection certificates (SPCs). A number of rulings have come down, and others have been referred to the court. Some of these have concerned what ought to be regarded as one of the most simple elements of the legislation: what is meant by a ‘product’, as defined, for the purpose of being capable of protection by an SPC?

But this question has proved to be anything but simple. This is unfortunate, because if something qualifies as a ‘product’ then it is potentially capable of up to five years’ additional exclusivity protection when the patent that protects it expires.

The recent rulings from the CJEU on products have concerned SPC protection for medicinal products, under Regulation (EC) No 469/2009 (the medicinal SPC regulation). These have been controversial. The reason is that under earlier authorities it had been understood that a product, as the regulation itself stipulates, is restricted to an active ingredient or combination of active ingredients. As a result, products which are, for example, new salts of previously authorised active ingredients are not capable of SPC protection.

However, this consensus was disrupted in July 2012 by the CJEU’s controversial Neurim decision. Neurim concerns an application for an SPC on the basis of a marketing authorisation (MA) and a patent for use of the active ingredient circadin-melatonin in the treatment of insomnia in humans. The same active ingredient had previously been authorised for improving the reproductive activity of sheep in the veterinary product Regulin.

The question therefore arose of whether the MA for Regulin meant that the product was the subject of an earlier MA, thereby preventing the grant of an SPC for circadin-melatonin for the new use. The CJEU ruled that it is possible to obtain SPC protection for second medical use products even when the active ingredient at issue has already been the subject of an earlier MA. The reasoning of the decision was based largely on the understanding that the SPC regulation is intended to protect the investment made in pharmaceutical research to discover new therapeutic uses of products.

Soon afterwards, and relying in part on the investment argument that was successful in Neurim, GSK Biologicals sought an SPC on an adjuvant to a vaccine (GSK Biologicals [C-210/13]). However, in this case, the CJEU ruled that an adjuvant cannot be properly regarded as an active ingredient, because it merely assists the working of a vaccine, rather than having activity itself. An adjuvant is therefore not a ‘product’ for the purpose of the medicinal SPC regulation. The court also affirms the Neurim decision, but appears to try to draw a line under it as a special case.

Similar questions

As if the law in this area had not become unsettled enough, an opinion of Advocate General (AG) Niilo Jääskinen has now been published in Bayer CropScience AG (Case C-11/12), a case decided under the related Regulation (EC) No 1610/96 concerning SPCs for plant protection products.

It is related legislation because both regulations are concerned with SPCs and are drafted similarly. Hence, as the AG remarks, rulings on the medicinal SPC regulation can be used to elaborate the interpretation of Regulation 1610/96. In this case the AG was addressing the similar question of what an ‘active substance’ is, the equivalent of an ‘active ingredient’ in the medicinal SPC regulation.

"The AG suggests that the definition of active substance should not be limited to substances which merely act directly on harmful organisms for the purpose of plant protection, and that investment protection matters."

The substance in question in Bayer CropScience AG is a safener called isoxadifen. Safeners are defined in the Plant Protection Products Regulation 1107/2009 (the PPP regulation) as “substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants”. But, under the PPP regulation, safeners are not regarded as active. Indeed, the same regulation defines ‘active substances’ differently, although the use of both must be approved in the same way under the PPP regulation.

Furthermore, as with the medicinal SPC regulation, CJEU rulings so far on ‘active substances’ have been strictly construed to mean compounds that act on harmful organisms, plants, parts of plants or plant products.

In his opinion in Bayer CropScience, the AG now casts doubt on a generally applicable, strict reading of ‘active substance’. First, in his opinion, the term ‘active substance’ in Regulation 1610/96 is to be interpreted to cover any substance which meets the conditions laid down in Regulation 1610/96, including, where appropriate, safeners. In other words the treatment and definition of an active substance in Regulation No 1107/2009 is essentially irrelevant to how it is to be understood under Regulation 1610/96—the regulation must be understood on its own terms.

However, this seems to be a somewhat circular way of dealing with the issue and leaves open the original question of what an ‘active substance’ is and whether it does include safeners.

As well as expressly drawing the comparison between the two SPC regulations, the AG also refers to the GSK Biologicals SA case (C-210/13) discussed above. The AG recognises that such earlier decisions, both under the medicinal SPC regulation and Regulation 1610/96, must be taken into account. However, at the same time, he emphasises that Regulation 1610/96 must be applied on a case-by-case basis according to the effects of the particular substance at issue.

This requires an analysis in each case to determine whether there is a special mechanism or activity of the substance at issue that should be taken into account to determine whether it is an ‘active substance’. Ultimately, this is an issue of fact for the national court to determine.

However, the reasoning of the AG then becomes more subtle and potentially significant in understanding what an active substance is and, by analogy, what an active ingredient is under the medicinal SPC regulation. The AG suggests that the definition of active substance should not be limited to substances which merely act directly on harmful organisms for the purpose of plant protection. Instead, the AG indicates that an active substance should also include substances that trigger a chemical or biological pathway within a plant which results indirectly in such protection.

What about the Neurim case? This case is not referred to by the AG, but its influence is clear: given the economic purpose of SPCs to encourage innovation by lengthening exclusivity protection, it would be somewhat artificial, the AG says, to distinguish between two or more substances that are patented, included in the same product and the subject of a single MA (as here), by granting an SPC for one of them—the herbicidal ingredient—and not the other—the safener.

It remains to be seen how the CJEU will rule on this issue. As a rule of thumb, the CJEU follows the opinion of the AG, but by no means always. With the somewhat inconsistent, some would say erratic, decision-making that has characterised rulings from the CJEU in the area of SPCs, no presumptions can be made.

However, by issuing an opinion that a safener may qualify as an active substance, in particular the reasoning (i) that a substance could qualify as an active ingredient; (ii) that investment is a factor in this; and (iii) by virtue of an indirect action—apparently at odds with the decision under the medicinal SPC regulation in GSK Biologicals—the rules on SPCs are once again thrown into doubt on the simplest issue.

Paul England is a senior associate at Taylor Wessing LLP. He can be contacted at: p.england@taylorwessing.com