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, 3 December 2014
Monday, 24 November 2014
CJ case: C-471/14: SEATTLE GENETICSThe UKIPO provides further information about its solicitation of comments:
We have received notification of a new case referred to the Court of Justice of the European Union (CJEU): C-471/14: A request for a preliminary ruling concerning the supplementary protection certificate for medicinal products.
The questions referred to the Court of Justice (CJ) for a preliminary ruling are:
1. Is the date for the first authorisation to place the product on the market, 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 in the law of the Member State in question?This case and the questions referred to the Court can also be viewed on our website at:
2. If the Court determines that the answer is that the date is determined by Community law, is this the date of authorisation or the date of notification?
If you would like to comment on this case please e-mail firstname.lastname@example.org by 01 December 2014.
We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on CJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.
You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing.
If you are aware of any references to the Court of Justice that are not currently included on our website, you are also welcome to send us your views. If you choose to do this, please include clear information about the case to help us to identify it.
Further information on intellectual property CJ cases can be found on our website https://www.gov.uk/government/publications/references-to-the-european-court-of-justice.
Wednesday, 19 November 2014
According to the abstract
Patent term extensions are the most important instrument for securing rights to innovative medicines after expiry of the regular patent term. The new manual comments on all relevant provisions including the relevant case law in the U.S., Japan and Europe. In addition, it presents corresponding extension opportunities in Australia, Israel, Korea, Russia, Switzerland, Singapore, Taiwan and in the free trade agreement between the U.S. and the Central American countries. It also comments on the current state of negotiations on the Free Trade Agreement between the European Union and Canada. So the manual covers all important markets, which offer the possibility of a patent term extension. It is aimed at lawyers from pharmaceutical companies and international law firms.Many of the contributors of chapters will be known to readers of this blog. Apart from the editor himself you will encounter the efforts of
Its bilingual German/English synoptic structure is tailored to support the global development of innovative medicines. It facilitates the decision-making in international project teams through a rapid and easy access to all relevant information. It also assists to find uniform argumentation during grant or revocation proceedings across borders.
- Cheol-Gyoon Ahn, Senior Korean Patent Attorney, Seoul, Korea
- Eran Bareket, Attorney at law, Tel-Aviv, Israel
- Chen Ben Dori-Alkan, Attorney at Law, Tel-Aviv, Israel
- Ronnie Benshafrut, Patent Attorney, Tel-Aviv, Israel
- Ruth Fang, Attorney at law, Taipei, Taiwan
- Dr. Nicolai von Füner, Patent Attorney, Munich, Germany
- Dr. Siegfried Grimm, Patent Attorney, Zürich, Switzerland
- Brion P. Heaney, Patent Attorney, Arlington, USA
- In-Hwan Kim, Senior Foreign Legal Counsel, Seoul, Korea
- Peter Maddigan, Barrister, Sydney, Australia
- Dr. Arne Markgraf, Attorney at law, Berlin, Germany
- Dr. Olaf Meiselmann, Munich, Germany
- Kristian Robinson, Patent Attorney, Singapore
- Dr. Regula Rüedi, Patent Attorney, Zürich, Switzerland
- Harry B. Shubin, Patent Attorney, Arlington, USA
- Damian Slizys, Patent Attorney, Melbourne, Australia
- Yoichi Watanabe, Patent Attorney, Tokyo, Japan
- Paul Whenman, Patent Attorney, Sydney, Australia
Monday, 17 November 2014
Review and analysis of pending CJEU referrals and recent CJEU decisions (Dr Robert Stephen, Olswang LLP) here
Amending and attacking SPCs (Dr Dorothea von Renesse, König Szynka Tilmann von Renesse) here
What’s up?” from the perspective of the IPOs
- Patrick Purcell, UK IPO here
- Dr Oliver Werner, German Patent Office here
SPCs involving medical devices (Charlotte Teall, Forresters) here
- Dr Martijn de Lange, Dutch Patent Office here
SPCs for biologics (Mike Snodin, ParkGrove IP) hereThe PowerPoints for the various sessions, together with the speakers' biographical details, have already been uploaded for your delectation and can be accessed here.
The seminar's SPC Law and Practice 2014 - Q&A session can be viewed here
Thursday, 13 November 2014
Michael's post contains all the details.
Friday, 7 November 2014
WARNING! It's a big 2.56 MB file, running to some 143 pages, so think twice before printing it in full -- particularly if your ink cartridge is coming up for replacement.
Thursday, 6 November 2014
|SPCs for fish vaccines? Or is this|
the dawning of the Age of Aquarium ...?
- the speakers' PowerPoints and notes will all be made available on this weblog in the near future;
- the seminar has been recorded on video, which should be processed and published more swiftly than on previous occasions, on the basis that Olswang LLP (the host firm -- thanks!) has had more practice at video-recording seminars than it did when last an SPC seminar was held there.
This year a variety of topics were discussed, with a first-ever mention of the phenomenon of SPC for fish vaccines and the prospects of shoal immunity. But that's another matter and, if you want to know what was said about this and other issues, you shouldn't have long to wait.
Apart from Olswang (whose London office staff also provided the logistics and processed the refreshments), gratitude is also expressed to all of the speakers and participants for giving of their time and effort, and to the Court of Justice of the European Union for their possibly inadvertent contribution by providing so much content for us to analyse and discuss -- a contribution that shows no signs of abating.
Do please be patient: all items will be made available as soon as possible, so there's no need to chase!
Tuesday, 4 November 2014
The defendant (Orifarm) had imported a pharmaceutical product, MSD’s Singulair, from Poland during the term of the paediatric extension of the SPC. The plaintiff brought interlocutory injunction proceedings, claiming that such imports could be prohibited relying upon the "Specific Mechanism".The judgement (in Danish) can be found here.
The Maritime and Commercial Court agreed with the Bailiff's Court, stating that the expression "such protection" under the Specific Mechanism as stated in the Treaty of Accession is to be interpreted as the patent protection being one continuous string of protection. The Maritime and Commercial Court added that the paediatric extension is not dependent on a product being indicated for the treatment of children, but only on whether or not the drug is tested for children.
The protection would not therefore terminate until the paediatric extension had expired.
Thanks, Martin, for this really helpful summary.
Thursday, 30 October 2014
Mike concludes that it is acte clair that the SPC legislation requires the use of the date of validity of a MA to calculate the duration of an SPC. How the date of validity is calculated will depend upon the type of MA involved – but for “centralised” MAs it will involve use of the Notification Date.
In the light of his analysis of the legislation, Mike concludes that it is not necessary for patent offices to refer this matter to the CJEU in order to accept arguments in favour of the use of the Notification Date. Mike’s article was published too late to persuade the Oberlandesgericht Wien not to make a reference on this point. However, Mike hopes that his article will help the CJEU quickly grasp the key points of the matter. He also hopes that they will forgive the title that the publishers chose for his article!
Tuesday, 28 October 2014
On 15 October 2014 the Oberlandesgericht Österreich referred questions to the CJEU on a preliminary ruling regarding the calculation of the SPC term under Article 13 of the SPC regulation. The case has been assigned the reference number C-471/14 (Seattle Genetics). The referral not only asks whether under Community law the authorisation’s notification or the decision date should be used to calculate the SPC term, but crucially first asks whether Community law even applies, or whether instead the relevant date should be determined under national law. The referred questions are (translated from the original German-language decision):
1. Is the date of the first authorisation to place the product on the market in the Community under Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products determined under Community law, or does the Regulation refer to the date on which the authorisation takes effect according to the law of the respective member state?
2. If the CJEU affirms that the date under question 1 is determined under Community law: which is the relevant date – that of the authorisation or that of the notification?
The need for a referral in this area has been clear, particularly since the UKIPO’s change of practice a year ago to use the date of notification rather than the date of the decision to calculate the SPC term based on centralised authorisations (BL O/418/13 – GENZYME). This approach typically results in a few extra days of term, which can be very valuable. Belgium, Slovenia and most recently Portugal use a similar approach, but other national patent offices have resisted, arguing either that the SPC regulations make it clear that the date of the decision is the relevant date, or that in the absence of a CJEU ruling on the matter there is no need for them to change their practice.
The referral is based on Austrian SPC application no. SZ 39/2012 (“Brentuximab vedotin or pharmaceutically acceptable salts thereof”). The applicant (Seattle Genetics) applied for the SPC based on EP 1 545 613 and Takeda’s authorisation EU/1/12/794/001 for Adcetris (Brentuximab vedotin). The authorisation is dated 25th October 2012, but was notified 5 days later, on 30th October 2012. In calculating the SPC term, the Austrian patent office used the decision date of the authorisation, but Seattle Genetics argued that the notification date should be used, resulting in 5 additional days of SPC term bringing the SPC’s term to 30th October 2027. In its reasoning, Seattle Genetics referred to the practice in the UK, Belgium, Slovenia and Portugal, as well as Art. 13 and Recital 9 of the Regulation, and the authorisation itself which states that the authorisation is valid from the date of notification. The Austrian Oberlandesgericht seems to think that if Community law applies, then the relevant date should be the date of the decision, but if national law applies then in Austria it is likely that the relevant date is the notification date.
It will be interesting to see what the CJEU says. It would be short-sighted if the CJEU only answered these questions with reference to Article 13, though. Whatever the answers, SPC applicants will want to know if the same logic applies to Articles 3(d) and 7 as well ...Thanks so much, Daniel, for taking the trouble to share this with us.