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Thursday, 19 June 2014

Is it Safe? Judgment from the CJEU in Bayer CropScience SPC

Isoxadifen
The CJEU today handed down its decision in Case C‑11/13, Bayer CropScience AG, concerning whether a safener can be the subject of a Supplementary Protection Certificate. This moggy was delighted that, unlike the Advocate General's decision (reported by the IPKat courtesy of Paul England of Taylor Wessing here), it is available in English, allowing this Kat to digest it at much greater speed.

The short answer is "yes", a safener can be the subject of an SPC. The slightly longer answer is:
The term ‘product’ in Article 1.8 and Article 3(1) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, and the term ‘active substances’ in Article 1.3 of that regulation, must be interpreted as meaning that those terms may cover a substance intended to be used as a safener, where that substance has a toxic, phytotoxic or plant protection action of its own.
This was the formal answer given to the referring Court (the Bundespatentgericht), which had referred to the CJEU the question:
Are the terms “product” in Article 3(1) and Article 1.8 and “active substances” in Article 1.3 of [Regulation No 1610/96] to be interpreted as covering a safener?
In a little more detail, Regulation (EC) No 1610/96 deals with the granting of supplementary protection certificates for plant protection products, that is:
active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
(b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
(c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;
(d) destroy undesirable plants; or
(e) destroy parts of plants, check or prevent undesirable growth of plants;
In that Regulation, "active substances" are defined as:
substances or micro-organisms including viruses, having general or specific action:
(a) against harmful organisms; or
(b) on plants, parts of plants or plant products;
A safener, on the other hand, is a compound added to a herbicide product "intended to prevent the harmful effects of a herbicidal active substance, in order to increase its effectiveness" (according to the referring decision quoted by the CJEU) or ‘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’ (according to Article 2 of Regulation no 1107/2009, which is a later Regulation concerning authorisation of plant protection products).

Foramsulfuron
So the issue was whether, based on a patent directed towards the safener, and a marketing authorisation for a herbicide comprising herbicidal compounds (in the particular case at issue, two herbicidal compounds Foramsulfuron and Iodosulfuron) and a safener falling within the scope of the patent, an SPC could be granted.

The CJEU considered that "no express provision of that regulation [1610/96] either specifically authorises or excludes such a possibility."  It then considered that, "It follows from the above that the term ‘active substances’ [definition quoted above], for the purposes of the application of Regulation No 1610/96, relates to substances which have a toxic, phytotoxic or plant protection action of their own. In this regard, since Regulation No 1610/96 makes no distinction according to whether that action is direct or indirect, there is no need to restrict the term ‘active substances’ to those whose action may be characterised as direct."

Accordingly, the judgment stated:

The answer to the question whether a safener is an active substance, within the meaning of Article 1.3 of Regulation No 1610/96, therefore depends on whether that substance has a toxic, phytotoxic or plant protection action of its own. If that is the case, it falls within the concept of a ‘product’, within the meaning of Article 1.8 of that regulation and may therefore, provided the conditions set out in Article 3 of Regulation No 1610/96 are observed, give rise to the issue of a supplementary protection certificate.

While misleadingly stating:

It is for the national court before which the case in the main proceedings has been brought to ascertain, in the light of all the relevant factual and scientific evidence, whether the substance at issue in the main proceedings can, on account of its action as a safener, be classified as an ‘active substance’ within the meaning of Article 1.3 of Regulation No 1610/96.

Iodosulfuron
thus giving the impression that it was not going to answer the question at issue, the Court went on, using factual information about the action of the safener at issue (Isoxadifen) given by the referring Court ("Isoxadifen was examined in connection with a procedure for a provisional MA for a product containing two other active substances and that the duration of that procedure reduced the effective duration of protection provided by the patent"), to conclude:

It follows from all the foregoing considerations that the answer to the question referred is that the term ‘product’ in Article 1.8 and Article 3(1) of Regulation No 1610/96, and the term ‘active substances’ in Article 1.3 of that regulation, must be interpreted as meaning that those terms may cover a substance intended to be used as a safener, where that substance has a toxic, phytotoxic or plant protection action of its own.

It then gave the answer presented at the beginning of this post.

This decision appears consistent with the position adopted by Advocate General Niilo Jääskinen, and therefore this Kat does not think that it will come as a huge surprise to practitioners.  It does mean that for SPCs "safeners" in the plant protection field are not treated the same way as "excipients" and "adjuvants" in the field of medicinal products, but perhaps these are not technically equivalent either.

As usual, over to you dear readers for your comments and views on the decision. 

2 comments:

Anonymous said...

I think this does not contradict the GSK adjuvant decision because the protective effect of the softner will happen even in the absence of the herbicide, whereas an adjuvant on its own would do nothing. It would need the presence of the antigen for it to perform its function.

Anonymous said...

If I were GSK I'd be feeling incredibly hard done by.

If an indirect plant protection effect is sufficient to enable one to get an SPC why should an effect on human immunity resulting indirectly from the use of a particular vaccine adjuvant be denied one?

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