A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Monday, 30 August 2010
Wednesday, 18 August 2010
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?".
Friday, 13 August 2010
"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.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.
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 translation can be read here and will soon be posted on the Resources site too.