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, 19 November 2014

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, Attorney at law, 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.

Monday, 17 November 2014

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

Thursday, 13 November 2014

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.

Friday, 7 November 2014

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.

Thursday, 6 November 2014

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!

Tuesday, 4 November 2014

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.

Thursday, 30 October 2014

The Court of Justice: who needs it? A new article

New has reached The SPC Blog of the latest publication by Mike Snodin of Park Grove IP (a copy of which can be viewed here). On this occasion, Mike’s article (“The CJEU – for supplementary protection certificates, who needs it?”) discusses the arguments for and against the use of Notification Date for “centralised” marketing authorisations (MAs) and explains why the arguments against, as typified by a decision of the Danish Patent Office, are fatally flawed.

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

Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?

From our friend Daniel J. Wise (Partner, Carpmaels & Ransford LLP ) comes the following information about a development from Austria:
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.

Friday, 24 October 2014

Merck and the Specific Mechanism: the Advocate General offers some guidance

Just over a year ago, the Court of Appeal for England and Wales made a reference for a preliminary ruling to the Court of Justice of the European Union (CJEU) in Case C-539/13, Merck Canada Inc., Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals PLC (as noted by The SPC Blog, here). The questions referred are somewhat wordy and relate to the Specific Mechanism -- a derogation from the principle of free movement of goods which was appended to the Act of Accession when a whole batch of new members -- the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and the Slovak Republic -- joined the European Union. 

This Special Mechanism allowed the owner of a pharma patent or an SPC to prevent the parallel importation of the patented product from one of the accession states if, at the time of filing, such protection was unavailable in that accession state; anyone who intended to import such a product was required to demonstrate to the relevant national authority that he had given notice of that intention to the holder or beneficiary of the protection.

The questions read as follows:

1 May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so? 
2 If the answer to Question 1 is yes:
(a) How must that intention be demonstrated?
(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights? 
3 Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:
(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product?
(b) Where. as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?;  and
(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?
(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product? 
4 To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:
(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?
(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC, or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?
If the answer to Question 4(b) is yes, 
(c) is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?
Yesterday the CJEU's Advocate General offered the following Opinion as to how these questions should be answered:

Questions 1 and 2
A holder of a patent or a supplementary protection certificate, or his beneficiary, duly notified of an intention to import and market pharmaceutical products covered by the Specific Mechanism ... is required to respond to the notification, so as to demonstrate an intention to oppose the proposed importation and placing on the market, within the period prescribed in the second paragraph of the Specific Mechanism, in order to be entitled to enforce any restriction on the import and marketing of the products concerned. A holder of a patent or a supplementary protection certificate, or his beneficiary, is precluded from relying upon his rights with respect to any import and marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights.
Question 3
The notification required under the second paragraph of the aforementioned Specific Mechanism may be carried out by someone other than the potential importer and marketer provided that the identity of the latter is clearly identified by the notifying entity.
Question 4
Prior notification under the second paragraph of the aforementioned Specific Mechanism must be given to a person who has a legal right under national law to bring proceedings to enforce the patent or supplementary protection certificate.
It is now for the CJEU to decide whether to adopt this Opinion, on which it is expected to give a ruling in the next few months.

Sunday, 19 October 2014

Ezetimibe in Israel: a recent ruling on retroactive effect

There's a recent blogpost on Michael Factor's IP Factor weblog, "Israel Patent Office Shortens Patent term Extension for Ezetimibe", which provides a detailed analysis of Re 110956 Association of Israel Industrialists v Schering and Mercke, decided by Asa Kling on 18 September 2014. This ruling deals with, among other things, the retroactive effect of Israeli legislation on patent term.