|Illustration not based on detailed analysis. Not even based on real data|
Well, Arnold J has made another referral, in AstraZeneca AB v Comptroller-General  EWHC 2840 (Pat). To be fair to the legislators, this referral arises from a situation which was not easily foreseen, but on the other hand, it arises because of an alleged inconsistency between a number of earlier CJEU rulings on SPCs.
|Iressa a.k.a. gefitinib|
The questions referred
Which was the first MA?
|Three questions: word them very carefully|
“If, however, the Court of Justice decides to overrule or qualify Novartis, I would request that it says so in clear and unambiguous terms, in order to avoid the need for yet another reference on this issue.”
Is the drug now disqualified entirely from SPC protection?
The implication, the Comptroller argued, was that the compound in Iressa could now never be granted a valid SPC, having been marketed in the EEA without having first received an EU-compliant MA.
Given the demonstrated inadequacy of many of the SPC Regulation’s provisions, and the fact that so many of the answers coming back from the CJEU simply beget more referrals, this Kat suggests a more radical approach is needed.