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
Tuesday, 22 September 2015
Seattle is a city that is famous for its coffee, always a good way to help wake you up -- but on 6 October the SPC community will need no wake-up call. We'll all be waiting expectantly for the CJEU to make its pronouncement.
Sunday, 20 September 2015
|Anyone working with SPCs must have|
a very special sort of understanding ...
We offer our apologies for the fact that we have not been able to reply to all emails already sent to us regarding the seminar -– we have had a large number requesting a place before this formal invitation. We promise to reply as soon as possible confirming places.
Details of the programme can be accessed by clicking here. To register, please email Natalie Whiteford at firstname.lastname@example.org
We will try to accommodate all comers, but if demand for places outstrips the supply it may be necessary to limit the number of people attending per law firm in order to give as many firms as possible a chance of attending. Preference will be given to anyone from industry, since they are kind enough to provide the patents, the SPCs, the litigation and the competitive edge that makes the whole seminar possible.
Wednesday, 16 September 2015
Friday, 11 September 2015
Both the term of an SPC and the deadline for applying for an SPC may be set by the date of the first Marketing Authorisation for a product. An issue has arisen since many Marketing Authorisations have two dates associated with them: the date of the Marketing Authorisation itself and the (later) date on which the Marketing Authorisation is notified in the EU’s Official Journal. Practice across Europe has begun to diverge as to which of these dates should be used. The UK Intellectual Property Office, for instance, uses the date of notification, as do the Belgian, Slovenian and Portuguese Patent Offices. In many other EU territories, however, the earlier date of the Marketing Authorisation is used. In practical terms this has resulted in SPCs being granted in EU territories with different terms, albeit only differing by a few days in length.
This issue came before the Oberlandesgericht Wien after Seattle Genetics appealed a decision of the Austrian Patent Office to use the date of Marketing Authorisation to calculate the term of an SPC. Given the divergent practice across the EU territories, and the fact that it was not clear whether Community law or local law should apply, the Oberlandesgericht Wien referred two questions to the CJEU. The questions referred were:
Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the Member State in question? If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification? The Advocate General (AG) has now issued his preliminary Opinion, answering the first question by confirming that it is Community law which applies. The AG has answered the second question by confirming it is the date of notification which should be used. The AG’s Opinion is therefore in conformity with the approach currently adopted by the UK Intellectual Property Office, and Belgian, Slovenian and Portuguese Patent Offices.
The questions referred by the Oberlandesgericht Wien and the AG’s Opinion deal only with Article 13 of the SPC Regulation, which sets the term of an SPC. It is nonetheless slightly disappointing that the AG did not see fit also to comment upon other Articles in the SPC Regulation which are affected by the date of the first Marketing Authorisation. In particular, Articles 3(d) and 7, which concern the requirement for an SPC to be based on the earliest Marketing Authorisation in an EU member state, and the deadline for applying for an SPC, respectively. However, it seems likely that the same reasoning would apply to those Articles.
The AG’s opinion is not binding on the CJEU, but does set out the key points which will be taken into account by the CJEU when coming to their decision. The CJEU’s final decision is not expected for another 12 months or so.