ECJ SPC decison
The IPKat is grateful to the sharp eyes of Andrea Glorioso for spotting yesterday’s ECJ decison (reported in the FT) on supplementary protection certificates for pharmaceuticals. SPCs are granted to formerly certain patent-protected pharmaceutical inventions for up to five years once the patent has expired. The extra protection reflects the fact that the patentee has been deprived of the chance to exploit his invention during the patent term because of the time taken by the regulatory approval process.
In yesterday’s decision in a case concerning MIT, the ECJ held that SPCs are only available where two active ingredients are involved and where a drug consists of one active ingredient and one that controls the release of theraputic efficacy of that active ingredient (as was the case in this case) no SPC can be granted.
The IPKat can see how this works bearing in mind the wording of the Supplementary Protection Certificate Regulation (on which the ECJ appears to rely heavily) but can’t see why, as a matter of principle, drugs with one active ingredient are less deserving of extra protection than drugs with two active ingredients.
Also in the ECJ yesterday
AG Sharpston’s Opinion in the Laserdisken case, interpreting the InfoSoc Directive but, since it’s not available in English, the IPKat will have to keep you in suspenders.
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The ECJ was not ruling on whether drugs with more then one active ingredient were deserving of less protection than those with only one, but that in this case since the separate active and inactive ingredients were already known, the SPC could not be granted, since the SPC regulation only applies to new active ingredients or new combinations of active ingredients. It appears that the decision came down (contrary to the A-G's opinion) to the inactive excipient in this case not being classed as an active ingredient for the purposes of the regulation. Is that any clearer? Probably not.
ReplyDeleteThanks Woodpecker. I think that's what I meant to say in the post anyway. My comment wasn't directed at whether the ECJ was correct as a matter of strict law - I can see from the wording of the Regulation that it was. Rather it was asking why SPCs are, as a matter of principle, only granted to pharmas with two active ingredients.
ReplyDeleteOne for IPKat's Translation Watch: AG Sharpston's Opinion not being available in English is even more outrageous than usual since she is English and presumably wrote it in English!
ReplyDeleteFurther to my earlier comment, I've now looked at AG Sharpston's Opinion and footnote 1 states "Langue originale: L'anglais"! This is absurd.
ReplyDeleteI would imagine the matter of principle is that the development of inactive ingredients is not sufficiently important (in terms of improvements to public health) to justify extending the patent term, bearing in mind that the active ingredient has probably already been extended via an earlier SPC.
ReplyDeleteMs Sharpston appears to be saying that the InfoSoc Directive is valid, and that no Member State has the right to allow for international exhaustion to apply. Quite clear really, but it would have been better to have the opinion in English. It does seem outrageous, and I am quite certain that it is part of a French conspiracy to try to prevent English becoming the official (rather than just the de facto) language of Europe. Just note the language of the words in the urls for the various languages that the opinion is provided in.
ReplyDelete