I believe a distinction must be made between the treatment of novel and inventive products (for example two distinct antibodies or active ingredients) and a combination product where the invention solely resides in one active ingredient, e.g., irbesartan, which is combined with HCT or a diuretic in general. In the first case. In the first case it should be possible to secure SPCs for each active ingredient. It is a pity that the question before the CJEU lumps the two types of "products" together. In case of a non-inventive combination, it could be said that you are only dealing with one product (for example, irbesartan), whether it is irbesartan alone or in combination with a diuretic.Do readers agree with this sentiment? It presumably isn't too late to amend the questions which are being referred to the Court of Justice for a preliminary ruling but which, so far as one can tell from the Curia website, have not yet been received by the Court.
Saturday, 29 September 2012
Combination products: one lump or two?
Following on from last Sunday's post on Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC, "Combination SPCs: more hypertension for the Court of Justice?" (here) our distinguished reader Herwig von Morze provides the following comment:
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2 comments:
Perhaps the best thing to do would be to assess the Claim as a independently valid claim, and then ascertain the SPC
I feel in this particular case, the claim itself is a dependent claim, and the SPC regulation doesnt look at the inventiveness of the claim. Therefore if the ECJ concludes that in order for a SPC to be granted to a combination, its inventiveness as a independently valid claim be assessed first before granting an SPC
I agree, but I doubt we are going to get anything particularly useful out of the CJEU on this.
In my view the irbesartan + HCTZ SPC is clearly a turkey, and on a straight reading of Medeva it should be invalid. However, on a teleological reading of Medeva, with an eye of what the consequences of a strict reading of Medeva actually means for other SPCs (such as antibodies, Markrush claims, etc) then the whole thing perhaps starts to unravel.
However, I think Arnold is right when he says that the irbesartan + HCTZ SPC should still be invalid EVEN IF the claim had actually specified HCTZ. That seems fair when you look at the inventive contribution of the patent in question (it's a pure compound patent, nothing more). Thus, Arnold was therefore, effectively rejecting Medeva. I feel that problem is, however, that his alternative test ("encapsulating inventive concept...") is going to be too tricky for the CJEU to deal with, as it essentially involves an assessment of validity of each and every claim. The CJEU has an easy way out by simply saying that, until things change (such as, er, the Unified Patent ...?) then validity is for the national courts.
My bet is that they will simply re-state Medeva.
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