Seattle Genetics and an alternative question -- but will the CJEU answer it?

The SPC Blog has received further news from our friend Mike Snodin (Park Grove IP) that he has published another article in Scrip Regulatory Affairs. This latest article, entitled “Supplementary Protection Certificates: the Court of Justice of the EU will have its day after all” (a copy of which can be obtained here), relates to the questions referred to the Court of Justice of the European Union (CJEU) in Case C-471/14 Seattle Genetics [on which see earlier SPC Blogpost here].

As regular readers of this blog will know, the questions referred by the Oberlandesgericht Wien in Seattle Genetics relate to the issue of whether longer term should be awarded to certain SPCs by relying upon the date of notification of a “centralised” Marketing Authorisation instead of the (earlier) date of the European Commission’s decision to issue the Authorisation.

Mike’s article discusses and analyses the questions referred to the CJEU and highlights potential problems with regard to the framing of those questions. In an attempt to clear away any confusion that could be caused by the manner in which the questions referred have been framed, Mike presents an alternative question that is more precisely adapted to the facts underlying Seattle Genetics. He concludes by expressing the hope that the CJEU decides to answer such an alternative question, and by outlining reasons why, in his view, that alternative question should be answered in favour of using the date of notification for “centralised” MAs.

Portugal adjusts term to match CJEU order

From our friend João Jorge (RCF - Intellectual Property, Lisbon) comes the following information for which we gratefully thank him:

As a consequence of CJEU Decision C-555/13 (that's Merck Canada, noted on The SPC Blog here), the Portuguese PTMO has released on 17 April a Directive from the Board (2/2014), dated 10 April, informing that a verification is to be conducted to ensure that the term for all SPCs complies with the referred decision ensuring that "the 15 years exclusivity defined in that CJEU decision is not exceeded".

In practice this decision will affect about 30 SPCs currently in force, all corresponding to products in the market as SPCs normally do.

This Directive was not unexpected.

However, as PT patent attorneys we are used to seeing in this type of change, the PTMO has already corrected the term in the online database and has sent notifications informing the respective patent attorneys. The effect of the recalculation is that some of the SPCs will have a sudden death, some of them with a new end of validity date that is before the date of entry into force. The others will see a reduction in the duration but still remaining in force.

The Directive has a final note stating that a one month term shall be given to the owners of these affected SPCs that wish to file paediatric extensions but that, due to this recalculation, they would no longer be able to do it. We have to bear in mind that the duration of some of these SPCs was cut by more than two years.

Finally, publication in the Official Journal will be carried out for those SPCs that, with these changes, have already reached the end of their validity. For all the other affected SPCs, no publication is expected to occur.

Just a final note: this publication of end of validity will only happen in 21 April. So, until then what a wonderful grey area for lawyers!"

The SPC Blog also thanks its friends at the Lisbon practice of Baptista, Monteverde & Associados for sending us the link to the same information on the BMA Newsflash, here.

With all this news coming from Portugal, it almost feels as though that lovely country lies right at the heart of Europe and not at its distant Atlantic edge.