The SPC blog

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!

Wednesday, 20 August 2014

Pharmaq AS v Intervet International BV

Of immediate relevance to the blogpost that appeared earlier this afternoon is this announcement from the EFTA Court (reproduced in full below):

Request for an Advisory Opinion from the EFTA Court by Oslo tingrett dated 16 June 2014 in the case of Pharmaq AS v Intervet International BV (Case E-16/14)

A request has been made to the EFTA Court by a letter dated 17 July 2014 from Oslo tingrett (Oslo District Court), which was received at the Court Registry on 23 July 2014, for an Advisory Opinion in the case of Pharmaq AS v Intervet International BV, on the following questions:

1. Concerning Article 2 of the SPC Regulation, has a product been placed on the market as a medicinal product in the EEA before it has been granted marketing authorisation in accordance with the procedure for administrative authorisation laid down in Directive 81/851/EEC (or Directive 2001/82 EEC) when delivery of the product has taken place in accordance with
(i) “special approval exemptions” granted by the State Medicines Agency to veterinarians and fish health biologists pursuant to Section 3-6 or 3-7 of the Norwegian Regulation of 22 December 1999, alternatively Sections 2-6 or 2-7 of the Norwegian Regulation of 18 December 2009, or

(ii) what are known as “AR 16 licences” granted by the Irish Department of Agriculture, Food and the Marine pursuant to the Irish Statutory Instrument No 144/2007 European Communities (Animal Remedies) Regulations 2007 part III “Exceptional authorisation”, point 16?
2. If question 1 is answered in the affirmative, is such a product outside the scope of the SPC Regulation and is an SPC granted on the basis of such a product therefore invalid?

3. Concerning the interpretation of Article 2 of the SPC Regulation, should a marketing authorisation granted for a veterinary medicinal product pursuant to Article 26(3) of Directive 2001/82 be deemed to constitute an administrative authorisation pursuant to Directive 81/851 (or Directive 2001/82) within the meaning of Article 2?

4. (a) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b)?

(b) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute a first authorisation to place the product on the market as a medicinal product in Norway within the meaning of Article 3(d)?

5. When the medicinal product is a virus vaccine, can the scope of protection under the SPC cover not only the specific strain of the virus that is included in the medicinal product and covered by the basic patent, but also other strains of the virus that are covered by the basic patent?

In answering this question, is it of significance whether
a) such other strains have an equivalent therapeutic effect to the virus strain included in the medicinal product or whether the therapeutic effect is not immediately equivalent?

b) a medicinal product based on such other strain will have to be the subject of a separate marketing authorisation with requirements for documentation of safety and effect?
6. If an SPC has been granted with a product definition that is not strictly limited to the specific strain of the virus authorised to be placed on the market as a medicinal product,
a) will such an SPC be valid, or

b) will the SPC be valid; such, however, that the scope of protection pursuant to Article 4 does not extend beyond the specific virus strain authorised to be placed on the market as a medicinal product?
This request was received from the Oslo District Court on 23 July.  The deadline for written observations from Governments and relevant institutions is Monday, 13 October 2014.

Special approval exemptions in a nutshell: a request for help

This blog has recently received a request for assistance from an enthusiastic young student who writes:
"I am doing research concerning SPCs and, in particular, on the implications of special approval exemptions for medicine (to be sold on the market, at the request of a doctor/vet, prior to marketing authorisation) for SPC applications. In a nutshell, I am looking for case law and articles that may have touched on this issue: does a special approval exemption under Directive 2001/82 [on the Community Code Relating to Veterinary Medicinal Products] or Directive 2001/83 [on the Community Code Relating to Medicinal Products for Human Use], granted for many consecutive years, constitute a de facto marketing authorisation, thereby disqualifying the product in question from applying for a SPC? 
If you happen to have information on this topic, I would greatly appreciate it if you could share it with me".
Well, readers -- this is your chance! Do please post any useful reading suggestions below and let's see what we can come up with.

Monday, 18 August 2014

Patent term extension in Israel: a recent ruling

It's always good to keep an eye on other weblogs, since they do feature patent term extension news from time to time. One such blog is Michael Factor's IP Factor blog, which has just posted a piece, "Israel Patent Number 94634, Extending and Shortening Patent Term Extensions", here, on The Association of Israeli Pharmacists v Sir Roy Calne and Wyeth, Ruling Asa Kling 13, July 2014.

The post is quite long and a bit complex, so we thank Michael for getting this case online while packing for his holiday.  That's enthusiasm for you!

Friday, 8 August 2014

Medical Devices Directive authorisation no good for SPC

In Leibniz-Institut für Neue Materialien Gemeinnützige GmbH, BL O/328/14, a UK Intellectual Property Office decision of 29 July, hearing officer Lawrence Cullen held that a medical device, the marketing authorisation for which was governed by Directive 93/42 -- the Medical Devices Directive -- was not a basis for granting an application for an SPC under Regulation 469/2009 in respect of the “aqueous dispersion of iron oxide nanoparticles” . According to the Institute the authorisation procedure under the Medical Devices Directive was the equivalent of an authorisation to place the product on the market as a medicinal product, granted under the administrative procedure laid down in Directive 2001/83 (the Medicinal Products Directive). Following a careful examination of all the relevant legislation and case law, the hearing officer held that a product which had not been subject to the administrative procedure in the Medicinal Products Directive is actually excluded by Article 2 of the SPC Regulation from being granted an SPC.

The 45 page ruling can be read in its entirety here.

Thursday, 7 August 2014

A Bulgarian milestone as Supreme Court rules on Atripla application

From our friend Dimitar Batakliev (IP Attorney, Bulgaria) comes the following news:
"I would like to report a recent case before the Supreme Administrative Court of Bulgaria regarding an SPC application for Atripla, a drug for treatment of HIV infection.

In a decision of 8 June 2014 the Court held that the claimed product, consisting of efavirenz, emtricitabine and tenofovir disoproxil fumarate, was not protected by the basic patent BG 62612 and therefore did not meet the requirements of Article 3 of the SPC Regulation. According to the court, this combination was outside the scope of claim 8 which protected 
“a combination of a compound of Formula I or Formula II according to claim 2 with a nucleoside analog having biological activity against HIV reverse transcriptase”. 
Although efavirenz was found to be a compound of Formula I and emtizitabine -- a nucleoside analogue -- the court held that the claim envisaged only combinations of two active ingredients, while the applied product consisted of three. Further, the court confirmed that the third ingredient, tenofovir disoproxil fumarate, was also outside the scope of the claim as it was a nucleotide rather than a nucleoside analogue. Although after its intake it was transformed in the human body into a nucleoside, at the time of composing the claimed product it lacked such characteristics. As a result the Supreme Court reversed the decision of the court of first instance and instead upheld the decision of the Patent Office to reject the application of Merck Sharp & Dohme Inc.

In its detailed analysis the Supreme Court touched on a number of important topics of the SPC domain. It provided guidance on the methods of interpretation of patent claims, on the applicability of the infringement test and the significance of the Medeva and Eli Lilly decisions. It also commented on decisions of other jurisdictions which had been put forward by the parties in support of their arguments. Therefore, in my opinion the Atripla case resulted in a milestone decision of the Bulgarian case law with respect to the application of the SPC Regulation.
If you can cope with the original Bulgarian text of the judgment, Dimitar has kindly provided a link to it here.