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.
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).
ReplyDeleteA 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.
ReplyDeleteThe (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.
ReplyDeleteThus, 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.
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.
ReplyDeleteThis 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 ...