ECJ rules on Aranesp reference this Thursday

This coming Thursday, 2 September, sees the handing down by the Court of Justice of the European Union of its ruling in Case C-66/09 Kirin Amgen. This is a reference for a preliminary ruling from Lithuania, noted by The SPC Blog when the Advocate General's Opinion was published here. The underlying dispute relates to the effective date of the Lithuanian marketing authorisation for Aranesp.

English, Portuguese and Slovak are the only languages in which the Advocate General's Opinion is not so far available (it's good to know that the Opinion was translated into Maltese, though one wonders whether -- given the notorious shortage of Maltese translators -- the Court of Justice has nothing more pressing to translate into that language.

Medeva: still time to comment

On 25 June The SPC Blog reported on the questions that the Court of Appeal (England & Wales) has referred to the Court of Justice of the European Union for a preliminary ruling in Case C-322/10 Medeva v Comptroller General of Patents. For the record, this case deals with SPCs for multi-component vaccines against multiple diseases and seeks a determination as to whether the product is protected by the basic patent and therefore is subject of a valid marketing authorization

The UK's Intellectual Property Office is currently seeking comments from interested persons which will presumably help shape the UK government's approach towards this action, in which it is a party. If you'd like to offer the IPO the benefit of your thoughts on the questions, please email the office here by 27 August 2010. Meanwhile, the Court's deadline for receipt of comments is 25 October 2010.

If you've forgotten the questions, here they are again:

"On Article 3(a)

1. Regulation 469/2009 (the Regulation) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by "the product is protected by a basic patent in force" and what are the criteria for deciding this?

2. In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not "the product is protected by a basic patent" according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?

3. In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not "the product is protected by a basic patent" according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?

4. For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens "protected by a basic patent" if one antigen of the vaccine is "protected by the basic patent in force"?

5.For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens "protected by a basic patent" if all antigens directed against one disease are "protected by the basic patent in force"?

On Article 3(b)

6. Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient or combination of active ingredients where:

(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and

(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market?".

AB Hässle combination product case: informal translation available

Niklas Mattsson (European Patent Attorney and Swedish Authorized IP Attorney, Awapatent AB) has kindly written to The SPC Blog as follows:

"Listed on your Resources website is a pretty interesting Swedish case, AB Hässle, which is cited in the UK Takeda case and provides the same reasoning with regard to the question of whether a combination product is covered by a basic patent relating to only one of the components. The question of course is highly interesting in light of the Medeva ECJ referral.

In connection with some casework relating to the same issue some years ago, I had occasion to prepare an informal, translation of the Swedish decision into English. If you would like to post it to the Resources web site, you’re more than welcome to use it, in the interest of “promoting the dissemination of legal information".

The SPC Blog thanks Niklas very much for his thoughtfulness and hopes that other readers, when the opportunity arises, will be able to promote knowledge and understanding in our field of interest in the same way.

The translation can be read here and will soon be posted on the Resources site too.