The SPC saga continues...
The UK Intellectual Property Office (IPO) has asked for comments on this referral, but respondents must be quick because the deadline is 29 August 2014. However, as usual, the IPO appreciates that this is a very tight deadline, so a short e-mail to firstname.lastname@example.org indicating whether the UK should intervene should suffice, which may be followed up with more detailed comments after the deadline.
The new referral concerns the validity of an SPC and the case details are: E-16/14 PHARMAQ SA v INTERVET INTERNATIONAL
The following questions have been referred to the European Court of Justice:
1. Has a product been placed on the market as a medicinal product in the EEA before it has been granted marketing authorisation in accordance with the procedure for administrative authorisation laid down in Directive 81/851/EEC or Directive 2001/82/EEC when delivery of the product has taken place in accordance with the relevant domestic legislation?
2.If the answer to this question is yes, then is such a product outside the scope of the SPC Regulation, and is an SPC granted on the basis of that product invalid?
3.Should a marketing authorisation granted for a veterinary medicinal product pursuant to Article 26(3) of Directive 2001/82 be deemed to constitute an administrative authorisation pursuant to Directive 81/851 or Directive 2001/82 within the meaning of Article 2?
This referral, details of which may be accessed here, highlights once more the failure of the SPC Regulation to provide clear guidance. It remains to be seen how many more referrals are required to untangle the confusion sourrounding this legislation.
Barbara Rigby, Associate