Plant Protection Product SPCs - an article

News comes from Velautha-Cumaran Arunasalam and Filip de Corte who report the publication of their recent article "Supplementary protection certificates for plant protection products: the story of 'The Ugly Duckling'" in the Journal of Intellectual Property Law & Practice (JIPLP).  They write:

The paper was put forward to celebrate the upcoming 20th anniversary of the PPP (plant protection product) SPC Regulation coming into effect and to confirm the continued importance of the SPC Regulation for the plant protection sector.

Importantly, the paper considers briefly the social as well as economic factors behind the SPC Regulations and puts forward reasons why not all the case law on medicinal product SPCs, especially those concerning combination products, should be directly applicable to the plant protection sector.  The Regulations can be said to be sisters but not twins.

The article can be accessed here.

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.

Bayer CropScience: AG Opinion this coming Thursday

Here's a forthcoming attraction!  Next Thursday we expect to see the Opinion of Advocate General Jääskinen in Case C-11/13 Bayer CropScience. The SPC Blog will bring you news of it as soon as it can.

Thursday 13/02/2014 09:30	Opinion C-11/13	Intellectual property Bayer CropScience Court of Justice - Third Chamber	DE	Courtroom I - Level 8
	Request for a preliminary ruling – Bundespatentgericht – Interpretation of the terms ‘product’ and ‘active substance’ contained in Article 1.3 and 1.8 and in 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 (OJ 1996 L 198, p. 30) – Whether those terms cover Isoxadifen Advocate General : Jääskinen

Sumitomo CJEU reference: some further information

The EU Law Radar weblog carries a helpful note on Case C-210/12 Sumitomo Chermical, which has recently been referred to the Court of Justice of the European Union.  An extract of this note is reproduced here, with permission.

Case C-210/12, Sumitomo Chemical – insecticide and an SPC application 

Posted on 21 June 2012 

Can a supplementary protection certificate for a plant protection product be issued to a company when the application is made after an earlier marketing authorisation has expired?

Facts
In this case involving Sumitomo Chemical, the claimant holds patents for an insecticide with Clothianidine as an active substance (European Patent EP 0 376 279 covering Guanidine derivatives, their production and insecticides; and German patent DE 689 06 668). The claimant had applied for its European Patent on 27 December 1989 so the claimant was now seeking to gain a supplementary protection certificate for the plant protection products known as ‘Poncho Pro’, which contains Clothianidine.

The dispute relates to the fact that on 14 May 2004 the claimant’s legal predecessor sought a plant protection product certificate from the German Patent and Trade Mark Office. The application was supported by reference to a decision of Germany’s Federal Office of Consumer Protection and Food Safety. The authority had issued an authorisation in December 2003 to Bayer CropScience for the latter’s product ‘Poncho Pro’, that contains Clothianidine as an active substance.

Whilst the German Patent and Trade Mark Office was reaching its decision in respect of the claimant’s application, other events were taking place. On 8 September 2004, Germany’s Federal Office of Consumer Protection and Food Safety granted Bayer a provisional authorisation valid for the active substance of Clothianidine – its decision being based on Article 8(1) of Directive 91/414. This provisional authorisation was valid for 3 years until 7 September 2007, an authorisation which later became definitive by dint of a decision taken in June 2007.

Learning of the initial provisional authorisation granted in 2004, the claimant’s legal predecessor informed the German Patent and Trade Mark Office of this development. Time passed. In January 2006, a year and a half after the claimant’s legal predecessor had applied for a plant protection product certificate, the German Patent and Trade Mark Office decided to turn down the application. The reason given for the refusal was that the authorisation which enabled Poncho Pro to be put on the German market had been rather a special one. It had been an emergency authorisation granted in accordance with Article 8(4) of Directive 91/414. The Directive’s provision allows for a limited use of a plant protection substance where this appears necessary because of an unforeseeable danger that cannot be contained by other means. As such, the authorisation had run for only 120 days covering the period from 15 January 2004 until 13 May 2004. Since the claimant’s application had been made on the 14 May 2004, the day after the expiry, a plant protection product certificate could not be granted because the phytosanitary certificate could not be considered to be ‘in force’ for the purposes of Article 3(1)(b) of EC Regulation 1610/96.

The claimant’s legal predecessor launched an appeal against the decision of the German Patent and Trade Mark Office. And it sought to revoke the Office’s decision to grant an emergency certificate to Bayer. In turn, Bayer launched two appeals against the German Patent and Trade Mark Office’s decisions which refused to grant subsequent certificates – even though the company had been granted both provisional and definitive authorisations from Germany’s Federal Office of Consumer Protection and Food Safety.

Questions Referred 

According to the UK IPO website, the German Federal Patent Court asked: 

1. Is Article 3(1)(b) 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 to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC? 

2. If Question 1 is answered in the affirmative: is it necessary under Article 3(1)(b) of Regulation (EC) No 1610/96 for the marketing authorisation to be still in force at the time of application for the Certificate? 

3. If the answer to Question 1 is in the negative: is Article 7(1) of Regulation (EC) No 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?

Sumitomo plant protection reference: it's all a question of timing

Case C-210/12 Sumitomo Chemical is a reference for a preliminary ruling from the Court of Justice of the European Union. The referring court is the German Bundespatentgericht, which wishes to obtain the guidance of the CJEU on the following questions relating to SPCs for plant protection products:

"1. Is Article 3(1)(b) of Regulation (EC) No 1610/96 ... concerning the creation of a supplementary protection certificate for plant protection products to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC?

2. If Question 1 is answered in the affirmative:

Is it necessary under Article 3(1)(b) of Regulation (EC) No 1610/96 for the marketing authorisation to be still in force at the time of application for the Certificate?

3. If the answer to Question 1 is in the negative:

Is Article 7(1) of Regulation (EC) No 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?"

If you have any comments on this reference which you would like to share with the British government, you are invited to email policy@ipo.gsi.gov.uk before 22 June 2012 -- that's this Friday.

If you have any interesting background information concerning this reference, do feel free to share it with us!

Plant protection patents and emamectin benzoate -- more news

Yesterday The SPC Blog posted this news from Hungary concerning a ruling of the Metropolitan Court of 12 January 2012 ("Plant SPC from earlier veterinary SPC? Yes, it can be done", submitted by James Horgan).

Today we are fortunate to have received some further information from our friend Alice de Pastors who writes:

To complete information on the Hungarian Plant Protection SPC for emamectin benzoate I wanted to point out three other Plant Protection SPCs for emamectin benzoate in Europe: Italy, Belgium and The Netherlands. 

In Italy and Belgium the SPCs refer to the Plant Protection first MA in The Netherlands, 13260 of December 4, 2009 (AFFIRM®) but in The Netherlands to the UK veterinary MA VM00201/453 MA (Slice®) with a date of March 9, 2010".

Thanks, Alice!

Plant SPC from earlier veterinary SPC? Yes, it can be done

"Can you get a plant SPC where there is an earlier veterinary SPC?" That's the question posed by James Horgan (Merck & Co., Inc. The answer, which he thoughtfully provides for us, is "Yes, say the Hungarians". The proof of this proposition may be found in a decision of the Metropolitan Court of 12 January 2012.

James has sent us a handy English translation from Danubia, which represented Merck Sharp & Dohme Corp. in the application. The patent, with a filing date of 2 April 1992, was for “Stable BLA/BLB salts of 4”-deoxy-4”-epi-methylamino avermectin”. To the SPC application there was attached, in addition to the basic patent on which the application was based, the first authorisation to place a composition called Slice on the market in the Community as a veterinary product (Vm00201/4153, United Kingdom, January 14, 2000); as a product the petitioner named an insecticide called Affirm (active ingredient: emamectin benzoate). To read what happened next, click here for the 8-page decision.

Benoxacor and (S)-metolachlor: French ruling now available in English too

On Thursday 16 February The SPC Blog posted this item from France on the rejection by the Cour de Cassation -- the nation's highest court -- of an appeal against the refusal of an SPC for Benoxacor and (S)-metolachlor.  Edouard Kling and his colleague François Pochart (august & debouzy avocats) provided the original news and said they'd let us have an English translation. Well, here it is. It's five sides long which, though very short by the standards of many countries, actually seems quite lengthy for a Cour de Cassation ruling.

Thanks, Edouard and François, for your help and support.

France: Cour de Cassation upholds rejection of SPC for Benoxacor and (S)-metolachlor.

From Edouard Kling and his colleague François Pochart (of the Paris-based international practice of august & debouzy avocats) comes this fascinating news of a recent decision of the French Cour de Cassation -- its Supreme Court. Edouard writes:

"Here is a link to a ruling of the French Supreme Court for your blog which may have remained unnoticed among the various Medeva and Queensland discussions. This ruling is concerned with SPC Regulation 1610/96.

The Cour de Cassation confirmed the decision of the Cour d'Appel to reject SPC application No 02C0020 directed to a mixture of Benoxacor and (S)-metolachlor. It came to the conclusion that the product was already the subject matter of a previous SPC (No 97C0048 based on a different basic patent), though the former SPC did not specify the stereochemistry of the metolachlor component. Said the Cour de Cassation

“Whereas, first, the Cour d'Appel decision found that SPC no. 02C0020 was requested for a plant protection product whose active substance is the combination of benoxacor and S-Metolachlor and that SPC no. 97C0048 granted previously on the basis of patent no. 84810599 covers the combination of benoxacor and metolachlor without reference to one or more specific spatial forms of metolachlor; it further pointed out, on specific and adopted grounds, that the metolachlor molecule has two R and S enantiomers and four possible spatial forms, and that S-Metolachlor is only one enantiomer of the metolachlor substance; finally, it pointed out, on valid grounds, that it is not demonstrated that the transition of the active substance in question, from a racemic form to an enantiomer form, implies that the product has a different activity profile; from these findings and assessments, the Court of Appeal, which carried out the study referred to in the second part of the argument, was able to infer that the combination of benoxacor and S-Metolachlor constituted the same active substance as the combination of benoxacor and metolachlor since it was composed of the same sequence of atoms and, thus, one and the same product within the meaning of Articles 1. 3, 1. 8 and 3 of EC Regulation 1610/96”

This ruling may be related to the different European Escitalopram decisions dealing with the definition of a product under the scope of medicament SPCs, i.e. the Austrian and German decisions you have posted earlier. It however remains unclear about the burden, requirements and means left to the patentee to demonstrate an improved profile".

Edouard and François look forward to providing readers of this weblog with a complete translation as soon as possible.

Court of Justice rules on Hus(s)ar SPC

Napoleonic Hussar: an early
experiment in European unity?

The Court of Justice gave its ruling earlier today in Case C‑229/09, Hogan Lovells International LLP, formerly Rechtsanwaltssozietät Lovells v Bayer CropScience AG.  This was a reference for a preliminary ruling under Article 234 EC from the Bundespatentgericht.

Bayer owned a European patent covering, inter alia, a herbicide known as iodosulfuron. The application for this patent was filed on 12 February 1992; the patent issued on 11 November 1998 with an expiry date of 13 February 2012.  On 13 December 1998, an application to have iodosulfuron included in Annex I to Directive 91/414 [concerning the placing of plant protection products on the market] was lodged with the German authorities by an undertaking the rights of which were subsequently acquired by Bayer.  On 9 March 2000 the German authority issued a marketing authorisation to Bayer for a herbicide based on that substance, sold under the name ‘Husar’.  This was a provisional MA, issued on the basis of a provision of national law designed to transpose Article 8(1) of Directive 91/414. In order to take account of Commission Decision 2003/370 [allowing Member States to extend provisional authorisations granted for the new active substances iodosulfuron-methyl-sodium, indoxacarb, S-metolachlor, Spodoptera exigua nuclear polyhedrosis virus, tepraloxydim and dimethenamid‑P], the expiry date of that provisional MA, initially fixed at 8 March 2003, was put back to 21 May 2005.

On 17 July 2003 the Bundespatentgericht granted Bayer an SPC for iodosulfuron and some of its salts and esters for the period between 13 February 2012, the expiry date of the European patent and 9 March 2015. In calculating the duration of the certificate, the Bundespatentgericht took the view that the provisional MA of 9 March 2000 was the first MA.  On 25 September 2003 the Commission included iodosulfuron in Annex I to Directive 91/414 by means of Commission Directive 2003/84.

On 13 January 2005 the German authority issued a definitive MA to Bayer for Husar on the basis of the national provisions transposing Article 4 of Directive 91/414. Its expiry date was fixed at 31 December 2015.

The word is spelled 'Husar'
but an image search reveals
use of 'Hussar' only

Lovells brought an action before the Bundespatentgericht for annulment of the SPC of 17 July 2003, arguing that it was invalid in the light of Regulation 1610/96 [concerning the creation of a supplementary protection certificate for plant protection products].  Under Article 3(1)(b) of that regulation an SPC may be issued only after a definitive MA has been issued under the conditions laid down in Article 4 of Directive 91/414. In this case, however, the MA of 9 March 2000 was a provisional MA coming under Article 8(1) of that directive.

Bayer challenged that interpretation of Article 3(1)(b), which it considered contrary to the general scheme of that regulation and to the practice of the competent national authorities. The Bundespatentgericht decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:

‘For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must account be taken exclusively of [a MA] under Article 4 of Directive 91/414 … or can a certificate also be issued pursuant to [a MA] which has been granted on the basis of Article 8(1) of Directive 91/414 …?’

Today the court ruled as follows:

"Article 3(1)(b) of Regulation ... 1610/96 ... must be interpreted as not precluding a supplementary protection certificate from being issued for a plant protection product in respect of which a valid marketing authorisation has been granted pursuant to Article 8(1) of Council Directive 91/414 ..., as amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005".

Dutch speaking readers can note this decision on the excellent Boek9.nl blog here

A.G. Opinion out on C-229/09

The Opinion of the Advocate General in Case C-229/09 was published this morning on the Curia site (here for our prior posting on the matter). It is, as usual, available in all sorts of languages including Latvian, but, of course, not in English.

Here's a short translation:

"In the light of the above considerations, I suggest that the Court answer the questions referred by the Bundespatentgerichts as follows:

1. Article 3 (1)(b) 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 is to be interpreted such that an SPC for a plant protection product cannot be granted based on a marketing authorisation according to Art. 8(1) of Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market.

2. Nobody can use this interpretation of Article 3(1)(b) of Regulation (EC) No. 1610/96 to challenge the validity of a plant protection product SPC that was filed before the present decision was handed down."

Thanks to Martijn de Lange for letting us know.

Jodosulfuron dispute: hearing this Thursday

In June last year The SPC Blog reported on a German reference for a preliminary ruling from the Bundespatengericht to the Court of Justice of the European Union on the interpretation of Art. 3(1)(b) of Council Regulation 1610/96 regarding the creation of a supplementary protection certificate for plant protection products. This reference is Case C-229/09 Rechtsanwaltssozietät Lovells v Bayer CropScience AG (jodosulfuron) and the single question referred for a ruling is this:

"For the purpose of the application of Article 3(1)(b) 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, must account be taken exclusively of a marketing authorisation under Article 4 of Directive 91/414/EEC, or can a certificate also be issued pursuant to a marketing authorisation which has been granted on the basis of Article 8(1) of Directive 91/414/EEC?".

The hearing before the Court takes place this Thursday, 22 April at 11.00am.

Plant protection products -- any interest?

Browsing over the 120 or so posts that this weblog has posted over the past year, I was struck by the fact that the entire focal point of interests has been the extension of patents in the pharma sector. In contrast, while SPCs are available for agrochemical patents too, that sector appears to generate little controversy, news or even interest.

Accordingly I thought it would be a good idea to test out the readership and ask: "is there anyone out there who is actively involved in the extension of patents for herbicides, pesticides and the like?". If so, please don't feel shy about making yourselves known: just email me here and let me know. If there's sufficient interest, we'll see if we can provide more content.