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

Wednesday, 24 September 2014

Calculation of dates in Portugal: notification of MA

João Jorge (Raul-Cesar Ferreira) has kindly sent us some hot news from the Portuguese Intellectual Property Court in Case 457/12.7YHLSB, which is being published today although it was reflected even yesterday on the court's online database. This decision concerns the date used to calculate the term of SPC 474.
Takeda Pharmaceutical Company Ltd. filed the application for the SPC on 26/03/2012, having EP 1718641 as the base patent and based on the MA for azilsartan medoxomil -- Edarbi.  The marketing authorization (MA) for Edarbi was granted by Decision C(2011)9280 of 07/12/2011, with publication in the Official Journal of European Union dated 24/02/2012, where the date of notification to the owner is identified has being 09/12/2011, two days after the date of the Decision.

During prosecution, Takeda filed a note with the PTMO with their arguments in favour of using the Notification date (09/12/2011) instead of the Decision date (07/12/2011) for the calculation of the SPC expiry dates. This SPC was granted on 25/09/2012 with the duration being calculated using the Decision date. The Patent Office argument was the following: 
“The purpose of the present Official Communication is to inform that after analyzing the arguments filed on 06/06/2012 related to Supplementary Protection Certificate (SPC) 474, the date of the Marketing Authorization (MA) that is used to calculate the expiry date is, according to Article 13(1) of Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009, the date written in the MA, in this particular case 07/12/2011.”
With this, the expected validity end was 07/12/2026 instead of 09/12/2026.

After publication of the Decision from the PTMO, Takeda appealed from said Decision to the Portuguese Intellectual Property Court requiring that the date to be used in the calculation should be the date of the Notification.

The Court decision was based on the following most relevant reasons: 
“…the relevant date to determine the validity period of the certificate consists of the starting date of the marketing authorisation associated therewith. It is from that date that the medicament can start to be commercialized. This does not occur with the pronunciation of the marketing authorisation decision but with the effective validity of that authorisation”.
It further clarifies:
“It is provided in Article 297 of the Treaty on the Functioning of the European Union, which replaces the Treaty Establishing the European Community, that decisions that are not a legislative act and mentioning a addressee are notified to him/her and producing effects upon that notification.

From this it results that the decision to grant a marketing authorisation only has effect from the notification date, for which reason the common practice is to make reference to it by publication in the Official Journal of the mention of the date of the decision and of the date of notification to its addressee.

It would not be understandable how an administrative act granting the authorisation for the practice of a fact could produce effects before its notification to the addressee and how the addressee could know that he/she may legitimately practise that fact without being aware of that decision”
Thus, this decision confirmed that the date to be considered in the calculation of the duration of a SPC is the date of notification of the decision. Briefly, the Court decided that:
* the decision of grant of a Marketing Authorisation has effect as from its date of Notification, not from the Decision date;
* the administrative act which grants an authorisation could not have effect before its applicant had been notified.
This decision is in agreement with the previous decision BL O/418/13 of the UKIPO [on which see Mike Snodin's earlier contribution on this blog here].

It is still to be seen what will be the understanding of the PTMO of this decision and if it will apply it (to future cases or, even, to previous cases) or if the PTMO will maintain its practice waiting for a referral to the CJEU on this matter.
Earlier news from was posted by João on The SPC Blog here this April.

Friday, 19 September 2014

Bayer CropScience: case note published

The just-published current issue of the Bio-Science Law Review (six times a year from Lawtext Publishing, Oxford),vol.14, issue 1, pp 21-24, contains a case note, "The meaning of 'Active Ingredient' for SPC Protection is again uncertain: Bayer CropScience AG (Case 11/13)" by our friend Paul England (Taylor Wessing LLP's London office).

Paul incidentally furnished a note for this blog on the Advocate General's Opinion in this case which was not initially published in English. The SPC Blog's note on the ruling can be found here.

Wednesday, 10 September 2014

SPC Blog Seminar 2014: at last, the invitation!

With a lot of effort from blog team member Rob Stephen and the kind support once again of host firm Olswang LLP, The SPC Blog is delighted -- and not a little relieved -- to announce that the programme for this year's annual seminar is now published. For full details and registration, just click here.

The seminar, held on Thursday 6 November 2014, runs from 1.30 pm until 6 pm. It will address the following topics:
• Review and analysis of pending CJEU referrals and recent CJEU decisions - Robert Stephen, Olswang LLP
• “What’s up?” from the perspective of the IPOs - Various international IPO representatives
• SPCs involving medical devices - Charlotte Teale, Forresters
• SPCs for biologics - Mike Snodin, ParkGrove IP
• Amending and attacking SPCs – Dorothea von Renesse, König Szynka Tilmann von Renesse
• ‘Quick updates’ - notification dates and more…
There will be plenty of time for questions and a drink afterwards.

Do join us once again! You are very welcome.

Tuesday, 9 September 2014

The Pastors Report 2014: now published

The SPC Blog is once again delighted to inform readers that our good friend Alice de Pastors has produced yet another of her excellent reports: SPC News 28 – September 2014 is now available to read here or to download here.  As usual, it's full of information which includes statistics on SPC applications in Europe between 1991 and December 2013.  A sample table is shown above.

Alice adds that it also notes discrepancies in SPC protection in European countries which are due to differences in interpretation of the EC Regulation and/or in policy as between national patent offices.

Thanks, Alice! Your efforts are much appreciated.

Monday, 8 September 2014

Merck-y ruling has a silver lining ...

The SPC Blog has received a note from our friend and occasional correspondent Mike Snodin which informs us that the firm that he founded in July 2014, Park Grove IP, now has a fully functional website. Blog readers may wish to know that this website contains, among other things, a copy of the most recent of Mike’s publications (an article entitled “Every cloud has a silver lining: Portugal's loss may be the UK's gain”, which was published by Scrip Regulatory Affairs in June 2014). A copy of that article can be viewed by clicking here.

In this article, Mike discusses the decision of the CJEU in Case C-555/13 Merck Canada. While acknowledging the effect that the ruling has in curtailing the term of Portuguese SPCs based upon certain "old law" patents, he argues that the ruling ought to also provide some beneficial side-effects, in the form of:
(a) increased harmonisation of SPC expiry dates across the EU and
(b) an additional day's term for some SPCs in certain countries (such as the UK).
The SPCs that may be affected are those for which less than 10 years have elapsed between the filing date of patent upon which the SPC is based and the date of the first authorisation in the European Economic Area for the “product” defined in respect of the SPC.

In the Genzyme case that Mike argued before the UK IPO in 2013 (BL O/418/13), the Hearing Officer declined a request (based upon the provisions of the Euratom treaty) to award an additional day’s term to just such an SPC. However, Mike is of the view that the ruling in C-555/13 would appear to undermine the Hearing Officer’s reasons for refusing that request. Therefore, Mike’s Euratom argument may yet rise again!