Paediatric extensions: is there an official county-by-country list?

One of our readers has asked if there exists a reliable and authentic source that lists all of the countries which support paediatric patent extensions. This blogger clicked around the World Intellectual Property Organization and World Health Organization websites a bit, but couldn't find such a list in either of them -- and he's not sure who else might compile one. Does anyone know?

Paediatric poser: an answer

Earlier today this weblog published a paediatric poser concerning plans for paediatric extensions in Switzerland and asked if any reader could assist. Kilian Schärli, (a Rechtsanwalt with meyerlustenberger lachenal) has kindly obliged with the following information:

"Switzerland is indeed planning to introduce paediatric extensions to its SPC (new Art. 140n PatG) along the same lines as the EU’s legislation with the Ordinary Revision of the Therapeutic Products Act (stage 2). 

Here's the Explanatory Report (p. 98 f.) and the Results of the Consultation concerning the Ordinary Revision of the Therapeutic Products Act (p. 72 ff.). Unfortunately, both documents are not yet available in English. 

The Federal Office of Public Health (FOPH) is in charge for the Ordinary Revision of the Therapeutic Products Act. According to FOPH’s webpage the following persons should be able to provide up-to-date information regarding the expected date for its entry into force: Matthias Enderle / Amedeo Cianci Tel: +41 31 324 50 41 / +41 31 322 63 19; email matthias.enderle@bag.admin.ch; website www.bag.admin.ch  

In this regard, it is worth to mention that the Swiss Federal Institute of Intellectual Property has changed its practice (sic! 6/2012, p. 419 f.) regarding the grant of SPC with a negative term of protection – effective as of now – based on the decision in Case C-125/10  Merck in June 2012".

The SPC Blog has tried, so far without success, to email its personal gratitude to Kilian, so for the time being all we can say is a very public "thank-you!"

Paediatrics and transitional periods: a reader writes

The SPC Blog has received this question from a concerned reader who would like to draw upon the collective brain-power of this weblog. He asks:

"According to Regulation 469/2009, Article 7(4) my understanding is that the transitional period of six months prior to the SPC expiry will rise to two years from 27 January 2012. The implication would appear to be that the six months transition will only exist for current and granted SPCs up to that date. The day after it will change to two years. So, if you are a company working on a paediatric extension using the six months transition, you will have to make sure your application is filed by 27 January 2012. Failure to comply, even by one day, could mean that the application for the paediatric extension will not be allowed. This is bound to cause some problems, a concern shared by the UK Patent Office. The wording in the Regulation has obviously not been constructed to deal with this anomaly.

Also it is not absolutely clear, when the two year transition period comes into force, how SPCs with less than two years duration will be treated. I have been informally advised by the UK Intellectual Property Office that, in such instances, applications for the SPC and any subsequent paediatric extension will have to be filed concurrently".

Hopes rise for a bright future, if the court gets it right ...

"Hopes rise for a bright future for paediatric SPC extensions in the EU" is the title of an article by Mike Snodin (Potter Clarkson) which has recently been published in Scrip Regulatory Affairs. Mike's article, which considers the effects of Advocate General Bot's Opinion in Case C-125/10 Merck,  concludes with the following thoughts.

"The innovative pharmaceutical industry will welcome Mr Bot’s opinion as representing a pragmatic interpretation of the objectives of the legislation governing SPCs and their extension. A particularly important practical aspect of the opinion is that, if followed in the CJEU’s final ruling, there will no longer be a perverse incentive in some cases to delay marketing authorisation issuance in order to obtain a longer patent / SPC monopoly period.

However, the opinion will not allay the concerns of those who obtain marketing authorisation issuance 4 years and 6 months or less after patent filing. This is because this category of patent holder could still be obliged to conduct additional clinical trials in the paediatric population, but would not have the option of using an extended monopoly period to recoup the costs associated with the additional trials.

There may therefore be some in the innovative industry who will be hoping that the CJEU does not follow Mr Bot’s opinion, but instead agrees with the patent office of Greece. If this were to happen, patent holders might be able to obtain a full 6-month period of (extended) SPC monopoly beyond patent expiry, regardless of how short the time between patent filing and marketing authorisation issuance.

As discussed in the 2007 RAJ Pharma article, a uniform reward of a full (additional) 6 months of SPC exclusivity after expiry of a patent meeting the qualifying criteria of the SPC legislation could well be viewed as being consistent with the objectives of the Paediatric Regulation.

In particular, Recital (26) of the Paediatric Regulation indicates that, for those products where the marketing authorisation holder has satisfied the obligations of the Regulation:

“a reward should be granted in the form of a 6-month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92” (emphasis added).

It will be interesting to see what the CJEU make of this point, especially with regard to what “reward” will be granted to those who are able to obtain an SPC having a term of negative 6 months or less".

You can read Mike's article in full here.

Paediatric extensions and transitional provisions: a question of timing

The SPC Blog learns from Martin Paltnoi (Managing Director, MPA Business Services Ltd) that there may be some confusion regarding the timing of forthcoming paediatric extensions. He explains as follows:

"The European Regulation governing paediatric extension on medicinal products for paediatric use was covered by Regulation 1901/2006 of 12 December 2006, which finally came into force on 27 January 2007.

I have noticed that an amendment to this covered by Regulation 469/2009 concerning the application of Paediatric Certificates may have gone through unnoticed by people who may be involved. Under the present system those conducting work allowing for an extension for paediatric use can file their application no later than six months prior to the expiry to the appropriate SPC. This newer Regulation alters that transitional period of which, we believe, those interested parties should be fully aware. Under Article 7 of the Regulation, Paragraph 4, the application for the duration of the Certificate for Paediatric Use for SPCs already granted shall not be lodged later than two years before the expiry of the SPC. Paragraph 5 of Article 7 indicates that this will come into effect five years from the entry into force of Regulation 1901/2006. So, from 27 January 2012 those companies wishing to make an application for an extension for paediatric use of an SPC will have to ensure that it is carried out not less than two years before the expiry of the SPC. In those instances where the duration of an SPC would be less than two years the application for that SPC and the extension for paediatric use would have to be carried out concurrently.

This is bound to cause some confusion but it would seem that those SPCs already granted prior to 27 January 2012 will still be bound by the six month period. It will be interesting to see the effect of this change and the significance to those interested parties".

Thanks, Martin!