UK: A Bumper Crop Of SPC Rulings From The CJEU - Part 1: When Is An Ingredient "Active"?

1. Introduction

For those having an interest in Supplementary Protection Certificates (SPCs), the months spanning November 2013 to February 2014 have been an important period. Thus is because the CJEU has produced no fewer than six judgments and one Advocate-General's opinion during that period.

All of the six rulings, as well as the opinion, are significant in terms of their impact upon either the availability of SPC protection or the duration of that protection.

This article, which focuses upon Article 1 of the SPC legislation, is the first in a series of three that aims to explain the various developments, as well as their likely practical significance.

2. Background

2.1 General

SPCs are a unique form of intellectual property that are intended to serve a similar purpose to patent term extensions (PTEs) in other territories, such as the US and Japan.

SPCs provide a period of exclusivity that extends beyond normal patent expiry. The exclusivity is awarded to the holders of patents that protect certain types of regulated products that have been officially approved for sale (i.e. that have received a Marketing Authorisation (MA)). The regulated products that can benefit from SPC protection are the active ingredients present in medicinal products (either human or veterinary) or in so-called "plant protection products" (i.e. agrochemicals and the like).

In common with PTEs, one of the stated objectives behind the creation of SPCs was the encouragement of innovation through the provision of a sufficient duration of post-marketing exclusivity. However, SPCs achieve this objective in a very different way to PTEs. Thus, although each SPC must be based upon a particular patent, the exclusivity provided by SPCs does not extend the term of that patent. Instead, an SPC only protects (to the extent that the patent protected) the authorised uses of the active ingredient(s) that are defined as the "product".

2.2 "Active" ingredients

As indicated above, SPCs are awarded in respect of a "product", which is an active ingredient or a combination of active ingredients. However, not all (combinations of) active ingredients are eligible for SPC protection.

The first hurdle that must be overcome for the "product" to be eligible for SPC protection is that it must be defined only by reference to ingredients that are "active" in the manner demanded by the provisions of Article 1 of the relevant (medicinal or plant protection product) SPC legislation.

3. The questions

Of course, in order to establish whether an ingredient is "active", it is necessary to determine what is meant by "active" in the context that it is used in Article 1 of the SPC legislation./ page 2

This was an issue that was central to two of the cases recently handled by the CJEU, namely:

• C-11/13, Bayer Crop Science, where Advocate-General Jääskinen has provided his (non-binding) opinion; and
• C-210/13, GSK Biologics, where the CJEU has issued a judgement (by reasoned order).

The questions referred in the GSK Biologics case related to the issue of whether a vaccine adjuvant per se or in combination with an antigen, can qualify as an "active ingredient" or "combination of active ingredients", respectively, in the sense of Article 1 of Regulation 469/2009 (the legislation governing SPCs for medicinal products).

On the other hand, the Bayer Crop Science case involved questions relating to whether a safener qualified as an "active substance" in the sense of Article 1 of Regulation 1610/96 (the legislation governing SPCs for plant protection products).

Although perhaps unfamiliar to those used to dealing with medicinal products, a safener is a compound that is used to protect a crop plant from the harmful effects of a herbicide that is applied to the crop.

4. The CJEU's Response

4.1 GSK Biologics

The CJEU felt that an answer to the questions posed in GSK Biologics could be gleaned from the Court's prior case law. For this reason, the Court dispensed with the step of seeking the opinion of an Advocate-General and instead issued a judgement by reasoned order.

The prior case law relied upon by the CJEU was MIT (C-431/04). In that case, it had been decided that:

Having concluded that an adjuvant has no therapeutic effects on its own, the Court then ruled that an adjuvant is not an "active ingredient" within the meaning of Article 1(b) (whether on its own or in combination with an antigen)

The Court felt that its conclusion on this point was further supported by the rules that govern the submission of dossiers in connection with the authorisation of vaccines, in which the Court considered that distinctions were drawn between "active ingredients" on the one hand and "adjuvants" on the other.

4.2 Bayer Crop Science

Compared to the reasoning for the decision reached in GSK Biologics, Advocate-General Jääskinen adopted a much more inclusive approach when concluding that, in his opinion, a safener can be an "active substance"./ page 3

Instead of asking whether the substance in question has any "therapeutic" effect of its own, Advocate-General Jääskinen adopted an approach that merely asks whether that substance satisfies the provisions of Article 1(3) of Regulation 1610/96 (the provision that defines "active substances" in connection with plant protection products).

The principal reasons for the Advocate-General adopting such a different approach are outlined in detail in the commentary below.

5. Commentary

5.1 The differences

Although there are quite marked differences between the ruling in GSK Biologics and the Advocate-General's opinion in Bayer Crop Science, these are easily explained by the differences in facts and the differences in the underlying law.

With regard to the facts, it is true to say that adjuvants and safeners differ not only in their roles, but also in the effects that are elicited by way of their administration. With respect to the underlying law, however, there are even clearer differences between the two cases.

In common with the predecessor legislation governing SPCs for medicinal products (Regulation 1768/92), Regulation 469/2009 does not define what is meant by "active ingredient". Thus, the CJEU has been required to look elsewhere in order to interpret that term. The interpretation that the CJEU settled upon was the "usual meaning in everyday language", which they believed excluded "substances forming part of a medicinal product which do not have an effect of their own on the human or animal body" (see paragraphs 17 and 18 of MIT).

In stark contrast, Regulation 1610/96 does possess a specific definition of "active substances" that the CJEU must take into account. That definition encompasses substances that have a specific or a general action, either on (parts of) plants or against harmful organisms.

Moreover, although the current regulatory legislation for plant protection products (Regulation 1107/2009) distinguishes between safeners and other (active) substances, this was not the case for the regulatory legislation (Directive 91/414) that was in place at the time that Article 1 of Regulation 1610/96 came into force (or even at the time that Bayer Crop Science obtained their MA).

This again contrasts to the situation in GSK Biologics, where the relevant regulatory legislation (Directive 2001/83, which was in place at the time that Regulation 469/2009 came into force and when GSK Biologics obtained their MA) does appear to draw distinctions between adjuvants on the one hand and "active ingredients" on the other.

Thus, although the Advocate-General's opinion in Bayer Crop Science is non-binding, the legal and factual differences from the GSK Biologics case make it perfectly possible (and perhaps even likely) that the CJEU will reach the same conclusion as the Advocate-General. If this happens, the SPC regime for plant protection products will effectively be confirmed as being much more inclusive (in terms of the range of substances that qualify for SPC protection) than the regime for medicinal product SPCs.

5.2 Application to other cases

Although the innovative pharmaceutical industry will be disappointed with the ruling in GSK Biologics, it may well not mean the end of the road for those seeking SPC protection for substances that arguably have no therapeutic activity of their own./ page 4

One simple reason for this is that Article 1 of Regulation 469/2009 specifically mentions medicinal products (and the "active ingredients" that those products contain) that have a diagnostic purpose. There are many agents that are used for diagnostic purposes and that have no therapeutic effect of their own. Nevertheless, those agents are commonly treated under regulatory legislation as "active" ingredients, and SPCs are routinely granted to such agents.

Therefore, even with respect to SPCs for medicinal products, it may still be possible to argue for the adoption of a more inclusive approach to determining whether a particular substance is "active" or not. However, such arguments will likely need to focus upon proving that the ingredient in question is "active" according to the common, everyday understanding of the term "active ingredient".

Indeed, support for this more inclusive kind of approach may be found in the Advocate-General's opinion in Bayer Crop Science. For example, by pointing to case law of the CJEU relating to whether an antiseptic could be regarded as exerting a "pharmacological action" (C 308/11, Chemische Fabrik Kreussler), the Advocate-General appears to imply that substances exerting only an indirect pharmacological, immunological or metabolic effect on a subject ought not to be excluded from the definition of "active ingredients".

When the CJEU answers questions in the pending case C-631/13, it may be that we will learn more about precisely where the dividing line lies between the substances that qualify as "active ingredients" and the substances that do not. This is because, in that case, the CJEU has been asked questions that relate to a substance (described as a carrier and an adjuvant) that is covalently attached to an active ingredient, wherein the substance in question has a therapeutic effect that is not described in the relevant MA.

6. Practice Points

• Substances that arguably do not have (direct) therapeutic effects of their own may still be eligible for SPC protection, depending upon the specific technical facts of each case.
• For substances employed in plant protection products, there may be more room for manoeuvre when arguing that the substance in question is "active".
• However, this is yet to be formally confirmed by the CJEU.

In any event, please contact us for advice if you have any queries about the eligibility for SPC protection in respect of a substance that is protected by a patent in which you have an interest.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.