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, 20 August 2014

Special approval exemptions in a nutshell: a request for help

This blog has recently received a request for assistance from an enthusiastic young student who writes:
"I am doing research concerning SPCs and, in particular, on the implications of special approval exemptions for medicine (to be sold on the market, at the request of a doctor/vet, prior to marketing authorisation) for SPC applications. In a nutshell, I am looking for case law and articles that may have touched on this issue: does a special approval exemption under Directive 2001/82 [on the Community Code Relating to Veterinary Medicinal Products] or Directive 2001/83 [on the Community Code Relating to Medicinal Products for Human Use], granted for many consecutive years, constitute a de facto marketing authorisation, thereby disqualifying the product in question from applying for a SPC? 
If you happen to have information on this topic, I would greatly appreciate it if you could share it with me".
Well, readers -- this is your chance! Do please post any useful reading suggestions below and let's see what we can come up with.

5 comments:

Anonymous said...

It may be worthwile to consider applying for a traineeship at the EFTA Court (Case E-16/14 - http://www.eftacourt.int/uploads/tx_nvcases/16_14_Req_Adv_Op_OJ.pdf).

Anonymous said...

This is a pretty political topic at the moment and should make for a good research project – the UK Government has been making some considerable effort to increase access to innovative medicines with its Early Access to Medicines Scheme. But as this reference highlights, all the implications with regard to SPC legislation may not have yet been fully explored. http://www.mhra.gov.uk/Howweregulate/Innovation/EarlyaccesstomedicinesschemeEAMS/index.htm

Anonymous said...

A good follow-up question is whether "named patient" programmes (which I believe is a synonym for special approval exemption) also trigger the start of the 8+2+1 data exclusivity period.

Mike Snodin said...

The (8 year) data exclusivity provisions in Directive 2001/83 include the requirement for the product to be "authorised under Article 6". Article 6 then refers to MAs under Dir. 2001/83 and Reg. 726/2004.

Thus, the answer to the question above would seem to be "no" - as access under a "named patient" programme is very unlikely to count as an authorisation under Dir. 2001/83 or Reg. 726/2004.

Ulrich M. Gassner said...

I guess the question is primarily related to Article 3(1), 5(1) of Dir. 2001/83 and Article 3(2) Dir. 2001/82. From this regulatory point of view I'd like to stress that there is no such thing as a de facto marketing authorisation. So the answer to the question would be in the negative.
This holds also true with respect to the wording of Article 3(d)of the SPC Regulation. However, a purely restrictive approach seems to be hardly consistent with Neurim (judgment of 19 July 2012, Case C-130/11 where the European Court, by interpreting Article 3(d) of the SPC Regulation,
came to the conclusion that the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product, provided that the application is within thelimits of the protection conferred by the basic patent. So, there might be some ambiguity if a teleological approach to interpretation of the SPC Regulation is to be employed ...