While recognising that the opinion that the EFTA Court has been asked to provide will not be binding (especially in respect of EU member states), Mike points out that the questions posed in Pharmaq v Intervet
* are potentially of huge importance to those seeking (or holding) supplementary protection for biological active ingredients in European Union (EU) or EFTA Member States (Iceland, Norway, Liechtenstein and Switzerland); and
* have elicited observations from parties that include the European Commission and the Government of the United Kingdom.
In connection with the questions that relate to the breadth of protection provided by an SPC to a biological product, Mike draws attention to the fact that the European Commission has proposed answers that may have profound (and, in part, undesirable) implications. For example, those proposed answers could lead to both harsh results for innovators and/or prolonged uncertainty for producers of “copycat” (biosimilar and “me too”) biological products. Mike therefore suggests that parties having a stake in either innovative or “copycat” biological products may wish to develop, and advocate to national governments and the European Commission, alternative solutions to the problem of SPC scope for biological products that lead to
* a fairer result for innovators; and
* more (and earlier) certainty on freedom to operate.
3 comments:
The Report for the hearing is simply a note of the positions taken in writing and which may or may not be followed by them at the hearing. The hearings at the EFTA Court as at the CJEU are open and it is better to attend rather than to rely on a document which may be superceded thereafter. The CJEU has done away with the Report for the hearing.
Anonymous - thank you for the tip-off. If (as I think that you are) you are suggesting that the position of the European Commission may have changed between 13 October 2014 (when the EC submitted their position in writing) and 27 January 2015 (when the parties presented their arguments at the hearing), then that would indeed be a significant development. If you have any information on that point, then I am sure that the wider SPC community would be delighted to hear about it.
The judgment's out this morning
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