Seattle "Relevant date" reference: UKIPO seeks comments

Back in October The SPC Blog posted a this item from Daniel J. Wise (Carpmaels & Ransford), "Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?". The UK Intellectual Property Office is now seeking comments on this reference, with a view to advising the UK government as to whether it wishes to make representations in this reference. According to the UKIPO's media release:

CJ case: C-471/14: SEATTLE GENETICS

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?

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?

This case and the questions referred to the Court can also be viewed on our website at:

https://www.gov.uk/government/publications/references-to-the-european-court-of-justice/references-to-the-european-court-of-justice-2014

If you would like to comment on this case please e-mail policy@ipo.gov.uk by 01 December 2014.

The UKIPO provides further information about its solicitation of comments:

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. 

Patent term extensions: a new book, hot off the press

Let no-one accuse The SPC Blog of being slow to being you the news. Only a few minutes ago a new publication was launched, which may be of great interest and relevance to most of this blog's readers. It's titled Ergänzende Schutzzertifikate - Patent Term Extensions: USA, Japan, EU, Germany, Korea, Taiwan, Switzerland, Australia, Israel, Russia and Singapore and it's a bilingual text put together for our benefit by Dr Arne Markgraf. It's published for the very modest sum -- for a specialist law book -- of 134 euro. Oh, yes, and you can order it from the website of publishers Nomos here.

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.

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.

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

• 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

The SPC Blog looks forward to reviewing this book in due course.

SPC Blog Seminar presentations: now available online

Here, in record time thanks to the efficiency of our friends at Olswang LLP, are the video links to the seven speaker presentations from ""SPC Law and Practice: All You Need to Know", this year's SPC Blog Seminar:

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

• Dr Martijn de Lange, Dutch Patent Office here

SPCs involving medical devices (Charlotte Teall, Forresters) here 

SPCs for biologics (Mike Snodin, ParkGrove IP) here 

The 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

Israel's Commissioner acts on "wrongfully given bureaucratic decision" on Bazedoxifene

Michael Factor (of the IP Factor weblog) has drawn our attention to a recent blogpost of his own, here, on in Ruling Concerning Patent term extension to IL 120701 to Wyeth, 3 November 2014.  This is a somewhat strange tale involving Israel's recently amended patent law. In short, Wyeth filed a request to correct an error in the patent extension order for Bazedoxifene. The Commissioner for Patents did not allow the amendment but cancelled the patent term extension altogether as a "wrongfully given bureaucratic decision". Having established that it was null and void, he ordered that the patent term extension application be subjected to accelerated re-examination under the amended law.

Michael's post contains all the details.

SPC Blog PowerPoints and biographies now available

The PowerPoints and speakers' biographical details for yesterday's seminar, "SPC Law and Practice 2014: All you need to know" are now available for your delectation. You can read them online by clicking here or download them by clicking here.

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.

The SPC Bog seminar 2014

SPCs for fish vaccines? Or is this
the dawning of the Age of Aquarium ...?

This is just a quick note to let readers know that

• 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!

Specific Mechanism applies to paediatric extensions, says Danish Court

From Martin Dræbye Gantzhorn (Partner, Head of Life Science & Healthcare, Horten Advokatpartnerselskab, Copenhagen) comes this swift, short note to inform readers of The SPC Blog that in October the Danish Maritime and Commercial Court rendered a very rare decision on the scope of the "Specific Mechanism". The proceedings concerned the question whether a paediatric extension to a SPC will also prolong the patentee's protection under the "Specific Mechanism". In short:

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".

As its primary line of defence, the defendant held that the paediatric extension did not prolong the protection conferred by the "Specific Mechanism". As its second line of defence, the defendant held that, even if such protection could be conferred by a paediatric extension, such extension would only be applicable to those of the plaintiff's products which -- by their strength -- were indicated for children.

The Bailiff's Court (the court of first instance) held that the patent, the SPC and the paediatric extension thereof were to be considered as a single coherent right that covers all products and not just the ones authorized for the treatment of children. Accordingly, the Bailiff's Court found for the plaintiff.

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.

The judgement (in Danish) can be found here.

Thanks, Martin, for this really helpful summary.