CJEU rules on status of emergency MAs in SPC applications

Case C‑210/12, Sumitomo Chemical Co. Ltd v Deutsches Patent- und Markenamt, is a decision of the Court of Justice of the European Union on a reference for a preliminary ruling from the German Bundespatentgericht. What was this case about?

Sumitomo was the proprietor of European patent EP 0 376 279, DE 689 06 668, which covered Germany among other countries. The patent was for the active substance clothianidin, used for insecticide products. Back in February 2003 the United Kingdom authorities issued a marketing authorisation (‘MA’) to a company in the Bayer group, in accordance with Article 8(1) of Directive 91/414, for a product containing clothianidin. That ‘provisional’ MA was the first issued in the European Union for a product containing that active substance. In December of the same year the German authorities, on the basis of the national provisions transposing Article 8(4) of Directive 91/414, issued an emergency MA to a company in the Bayer group for a plant protection product containing the active substance clothianidin. That emergency MA was valid for 120 days, from 15 January to 13 May 2004.

On 14 May 2004, Sumitomo applied to the German patent office for a supplementary protection certificate for plant protection products. In its application Sumitomo referred to (i) the provisional MA granted in the UK in February 2003, this being the first MA granted in the European Union, and (ii) to the emergency MA issued in Germany in December 2003. In September 2004 the German authorities granted, on the basis of the national provisions transposing Article 8(1) of Directive 91/414, a provisional MA to a company in the Bayer group for a product based on clothianidin. The period of validity of that provisional MA was from 8 September 2004 until 7 September 2007. In November 2004 Sumitomo informed the German patent office of the existence of the provisional MA of 8 September 2004.

The German patent office eventually, in January 2006, dismissed Sumitomo's SPC application. Although the application had been lodged within the period set out in Article 7(1) of Regulation 1610/96, the German patent office considered that no SPC could be granted since the MA -- being an emergency MA which had expired -- was no longer valid within the meaning of Article 3(1)(b) of Regulation 1610/96. Sumitomo appealed to the Bundespatentgericht, which decided to refer to the CJEU the following questions for a preliminary ruling:

‘1. Is Article 3(1)(b) of [Regulation No 1610/96] 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]?

2. If Question 1 is answered in the affirmative:

Is it necessary under Article 3(1)(b) of [Regulation 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 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?’

Earlier this month the CJEU ruled as follows:

1. Article 3(1)(b) of Regulation ... 1610/96 ... concerning the creation of a supplementary protection certificate for plant protection products must be interpreted as precluding the issue of a supplementary protection certificate for a plant protection product in respect of which an emergency marketing authorisation has been issued under Article 8(4) of Directive 91/414 ... concerning the placing of plant protection products on the market, as amended....

2. Articles 3(1)(b) and 7(1) of Regulation No 1610/96 must be interpreted as precluding an application for a supplementary protection certificate being lodged before the date on which the plant protection product has obtained the marketing authorisation referred to in Article 3(1)(b) of that regulation.

Thanks go to Tony Breen (Syngenta) for drawing our attention to this decision.

SPCs in Cyprus: can you help?

A reader has emailed us to ask if anyone can advise as to good sources of information concerning the theory and practice relating to SPCs in Cyprus.  The question did not specify any specific part of Cyprus.
As usual, readers' suggestions and recommendations are most welcome.

New journal seeks contributions on bio-patents, SPCs

The Journal of Law and the Biosciences (JLB) has just been launched by Oxford University Press. According to the notice on the JLB's website, it is

"... is the first peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard University Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. The Journal contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.

The biosciences are booming. Stem cell technologies are developing rapidly, reproductive technologies are being used in new ways and with new frequency, life science patents are hotly contested, and neuroscience and genetics are being used to make new predictions about behavior and health. And that’s just a taste of the current scientific revolutions in the biosciences".

This blogger has been appointed to the JLB's editorial board, in which capacity he should like to encourage the submission of learned contributions on patents in the biosciences, and of course articles on the legal and commercial dimensions to pharmaceutical patent term extension, whether in the European Union or beyond it.

Paediatric extensions: a recent article

"Better Medicines for children? What have been the benefits and lessons learned after 5 years of the Paediatric Regulation?", by Grant Strachan (an Associate, Bristows LLP, London), has recently been published in the Bio-Science Law Review, published six times a year by Lawtext. According to the abstract:

"Maintaining the pace of innovation in the life sciences sector is a complex and challenging process for all pharmaceutical companies engaged in research and development. Prior to 2006, there was a lack of suitably authorised medicinal products for paediatric use. To combat this problem the Paediatric Regulation was implemented in order to facilitate the development and accessibility of age-appropriate paediatric medicines. The European Commission has recently published a progress report which provides an in-depth appraisal of the successes and failures of the Paediatric Regulation. The recommendations outlined in this report will shape the development of this important piece of legislation, which is of crucial significance for innovator companies operating in the life sciences sector and to the paediatric population as the ultimate beneficiary of an effective regulatory platform that supports innovation".

Actavis v Boehringer: more questions for the CJEU

There's a double blog-post on the IPKat (here and here) on Actavis v Boehringer [2013] EWHC 2927, a Patents Court, England and Wales, decision from the recently-promoted Mr Justice Birss which was handed down last month but which is still not available in the BAILII databank. The first post gives a brief background and deals with the four further questions that have been referred to the Court of Justice of the European Union for preliminary rulings, while the second deals with an important practical issue: the scope of a cross-undertaking where the alleged infringer has agreed to keep a product covered by the disputed SPC off market pending the full trial.

The IPKat is hosting the full text of this decision for your convenience: you can read it here.

Irbesartan + HCTZ: news from France

From our friend Denis Schertenleib, Avocat, of Cabinet Schertenlieb, Paris, comes a timely update on the Coapprovel (irbesartan + HCTZ) litigation in France, following the revocation of the SPC in this dispute on the merits (said the court, claim 20 of the basic patent was invalid).

I attach the decision in French and in English. By way of a disclaimer, Denis tells us that he represented Mylan in these proceedings and has advised us that this decision is naturally subject to an appeal.

Further news is that the Cour d'appel, ruling on the injunction that was issued against Teva, lifted it on the grounds that the basic patent could be challenged on validity and also confirmed the decision not to grant an injunction against Sandoz and Arrow -- also on the basis that the SPC could be challenged on validity.

Thanks so much, Denis, for this update.

RPC reports four SPC decisions

In case you missed it, the recently-published August 2013 issue of the Reports of Patent, Design and Trade Mark Cases (RPC), produced on behalf of the UK's Intellectual Property Office by Oxford University Press, was entirely dedicated to reports of cases involving SPCs.  The cases are:

* Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (Court of Justice of the European Union)

* Actavis Group PTC EHF v Sanofi (Patents Court, England and Wales)

* AstraZeneca AB v Comptroller-General of Patents (Patents Court, England and Wales)

* GlaxoSmithKline Biologicals SA v Comptroller-General of Patents (Patents Court, England and Wales).

The RPC is an official law report, published since 1884 and suitable for citation in UK litigation.