More references, more gaps?

... unless it has been
caused by the CJEU

"Two gaps instead of one: the CJEU's effect on Supplementary Protection Certificate jurisprudence" is the title of the June 2014 Guest Editorial in the Journal of Intellectual Property Law & Practice (JIPLP), written by editorial board member and patent attorney Darren Smyth (EIP, London). In keeping with normal JIPLP practice, the full text of this editorial is posted on the journal's informal jiplp weblog, here.

Darren concludes:

"You have all the guidance from the CJEU you are going to get. Every referral you make will result in more “gaps”, not fewer, in the legislative framework. Decide some cases; aim for consistency; but if there happen to be some anomalies, well, it is better than spending the time, effort, and money on a referral that will simply make the issues more complex than they were to begin with".

New home for SPCs on UK government portal

The UK Government's GOV.UK portal now has an SPC page, "Apply or extend a supplementary protection certificate", which you can check out here.  This page houses the 32-page guide for applicants which was last revised in November 2013.

The UK Intellectual Property Office still has its own website, but this too will soon be drawn into GOV.UK.

Swiss paediatric extensions: a swift answer from the "crowd"

Following this morning's blogpost calling for a crowd-sourced response to a plea for information as to where Switzerland currently stands with regard to paediatric extensions, we have received the following response from a two-man crowd consisting of Simon Holzer & Kilian Schärli (meyerlustenberger | lachenal Rechtsanwälte) who write:

Crowds of Swiss Rechtsanwälte gather round to answer
readers' questions -- but Simon and Kilian were first!

On 7 May 2014, the Swiss National Council adopted the revision of the Swiss Therapeutic Products Act (see excerpt of the Official Bulletin of the National Council of 7 May 2014 [in German and French only]). The legislative proposal now goes to the Council of States. The Federal Office of Public Health, which is leading the revision of the Therapeutic Products Act, expects that the revised version will come into force on 1 January 2016. 

With regard to transitional provisions the new Art. 140o of the Swiss Patent Act stipulates that the application for the paediatric extension can be filed no earlier as with the application for the grant of an SPC and no later then two years before the expiry of the SPC, but no later than six months after the first authorization to place the product on the market as a medicinal product in the European Economic Area with the exception of the Principality of Liechtenstein, and only if the associated medicinal product information reflects the results of all studies that have been carried out in compliance with the paediatric investigation plan considered during the marketing authorization. Further, the new Art. 140s para. 2 sets forth that for the procedure (as well as for the register and for the publications) the rules of the European Union shall be taken into account. 

More information can be found on the following websites:

• Federal Office of Public Health, here

• Swiss Agency for Therapeutic Products, here

• Swiss Federal Institute of Intellectual Property, here

Thanks so much, Simon and Kilian -- this is really helpful!

Swiss paedriatric extensions: where are we now?

One of our readers has asked if he might use the good services of this weblog in order to crowd-source the following question:

What is the legislative status of the Swiss law that is intended to introduce paediatric extensions, similar to the existing EU law?

He tells us that the most recent information he has been able to find on the internet about it is from July 2013. So, he wonders, when is the law going to be introduced, and are any transitional provisions intended?

If you have any current information and don't mind sharing it, we'd be delighted to know -- and so would our reader.

The trio of Article 3 CJEU decisions from December 2013: a new article

News comes from our good friend and occasional contributor Mike Snodin (Avidity IP) that an article of his has recently been published in the Journal of Intellectual Property Law & Practice (JIPLP).  The article reviews, analyses and comments upon the decisions in Cases C-443/12 (Actavis v Sanofi), C-484/12 (Georgetown University) and C-493/12 (Eli Lilly v HGS). While noting areas that have been clarified and speculating upon strategies that may now represent "best practice" in the light of the decisions, the article also points out the many areas of uncertainty that still remain -- or that have been generated by the decisions.

This useful six-pager can be accessed by clicking this link.

JIPLP has proved to be a rich source of articles and current intelligence notes on SPCs since it was launched at the end of 2005. Could it be anything to do with the fact that this blogger is its editor?  At any rate, you can get an idea of the range items addressing SPCs by clicking here.  Mike has previously published in JIPLP, as have many other readers of or contributors to this weblog.