Bayer CropScience: case note published

The just-published current issue of the Bio-Science Law Review (six times a year from Lawtext Publishing, Oxford),vol.14, issue 1, pp 21-24, contains a case note, "The meaning of 'Active Ingredient' for SPC Protection is again uncertain: Bayer CropScience AG (Case 11/13)" by our friend Paul England (Taylor Wessing LLP's London office).

Paul incidentally furnished a note for this blog on the Advocate General's Opinion in this case which was not initially published in English. The SPC Blog's note on the ruling can be found here.

A safener can be an 'active substance', CJEU tells Bundespatentgericht

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The Court of Justice of the European Union (CJEU) today handed down its ruling in Case C‑11/13, Bayer CropScience AG, as to whether a safener can be the subject of a Supplementary Protection Certificate. In contrast with the Advocate General's Opinion (reported by the IPKat courtesy of Paul England, Taylor Wessing, here), it is available in English.

In short, a safener can indeed be the subject of an SPC. The slightly longer answer, according to the operative part of the CJEU's ruling, is this:

The term ‘product’ in Article 1.8 and Article 3(1) of Regulation ... 1610/96 ... 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 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 1107/2009, which is a later Regulation concerning authorisation of plant protection products). 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 1610/96, relates to substances which have a toxic, phytotoxic or plant protection action of their own. In this regard, since Regulation 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 states:

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.

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, which contains no great surprises, means that SPCs "safeners" in the plant protection field are not treated the same way as "excipients" in the field of medicinal products, but perhaps the two are not technically equivalent either.

The SPC Blog thanks Darren Smyth (EIP) for letting us use his IPKat post, here, as the basis for this post.

Bayer CropScience: AG's Opinion published

Yesterday the Advocate General's Opinion in Case C-11/12 Bayer CropScience AG was delivered by Niilo Jääskinen. Frustratingly for this blogger, the Opinion was published in almost every official language of the EU, except English --the only one this blogger can truly understand.

There's a short note on this Opinion on the IPKat weblog, by Paul England (Taylor Wessing). If any readers can add to it, The SPC Blog will be really grateful. Although it's "only" a plant protection product for which the SPC is sought, it's about active substances and safeners and should, at least in theory, be of interest to our pharma readers too.

Isoxadifen and SPCs for safeners: UK invites comments

Following on from The SPC Blog's earlier posts here and here, the UK Intellectual Property Office has now issued a circular inviting interested parties to comment on the Court of Justice of the European Union reference in Case C-11/13 Bayer CropScience so that the UK government can decide what, if any, position it wishes to take with regard to the question referred. To jog readers' memories, the IPO explains:

The appellant is seeking a supplementary protection certificate for ‘Isoxadifen and the salts and esters thereof’. Isoxadifen is a ‘safener’, that is, a substance added to a product to prevent the harmful action of an herbicide in plants.

The referring Court asks whether such a safener falls within the meaning of the terms ‘product’ in Article 3(1) and Article 1(8), and ‘active substance’ in Article 1(3) of the Regulation.

While the precise official English version of the reference from the German Bundespatentgericht does not appear to be available, the gist of the question is clear.

If you would like to comment on this case please email policy@ipo.gsi.gov.uk by 25 February 2013.

Isoxadifen: here's the original reference

Following our earlier post this morning, it is with great thanks to Justizhauptsekretärin Elke Höchner of the German Bundespatentgericht that The SPC Blog is delighted to be able to offer readers the full text of the decision -- in German -- in which the status of safeners was referred to the Court of Justice of the European Union for a preliminary ruling in Case C-11/13 Bayer CropScience. You can read it here.

Isoxadifen reference: can you help?

One of our readers has written in to ask:

"Would it be possible to ask the SPC community for a copy of the decision of the German Federal Patent Court (BPatG; file number: 15 W (pat) 14/07 with regard to the corn safener Isoxadifen from Bayer) with regard to the recent referral to the Court of Justice of the European Union in Case C-11/13 Bayer CropScience? The referred question seems to ask whether a "safener" can be a product and an active ingredient according to Article 3(1) and Article 1 No. 8 and No. 3 of Regulation 1610/96. Unfortunately (although the court decided the referral as long ago as July 2012) the decision has not yet been published".

While this weblog is inevitably much more focused on pharma products than on the agrochemical sector, we do have some readers on that side too. Can they, or indeed anyone, help?