|Will our correspondent be applying|
for a Supplementary Holiday
"Dear SPC Blog
Sorry for harking back to the Medeva AG opinion (but its holiday season and some of us have been away!)
As regards the first question in this reference - what is meant by "the product is protected by a basic patent in force", it seems to me (unless I have missed something) that the AG has -- in rather an off-hand manner -- answered this in passing somewhere around the late 60s (paras).
- In para 67 she makes reference to the "subject matter" of a patent when she states that the subject matter of each of the three categories of patent referred to in Art 1(c) (i.e. product, process and use) is always the "active" [not sure if this is correct -- but anyway].
- In para 68, she then appears simply to proclaim that "the subject matter" of a patent equates to the "extent of protection" of that patent. [So there we have her answer: "protected by a basic patent" = "the subject matter of a basic patent"]. Somewhat bizarrely, she then differentiates this concept of "extent of protection" from "the protective effect" of the basic patent (despite the obvious link in the word "protect" in both phrases). Whilst there may indeed be a distinction between these two concepts, there appears to me to be no reasoning behind her proclamation that "extent of protection" equates to "the subject matter". [and anyway -- what does that mean?]
Looking at this from a wider perspective of the legislation - what does Art. 4 now mean?
- In para 69 she fortifies her position by stating "The decisive consideration in that context is the fact that the definition of the basic patent in Art 1(c) of [the Regulation] takes as its basis the subject matter of the patent, and not its protective effect." (emphasis in original). Again, there seems to be no basis for this statement, despite the fact that Art. 1(c) uses the word "protects" and not "subject matter". Nevertheless, the entire remainder of the Opinion is built on this "rock" of principle - that "protects" in Article 1(c) actually means "is the subject matter of", and "protected by" in Art. 3(a) actually means "the subject matter of".
- That article is entitled "Subject matter of protection". Should this be construed (in the context of this Regulation) as "Subject matter of subject matter"?
- The substance of Art. 4 states: "Within the limits of protection conferred by the basic patent …". Does this therefore mean "Within the subject matter of the basic patent"?
As ever, readers' thoughts and comments are invited.
Finally, does this mean we now have to refer to this Regulation as the 'Supplementary Subject Matter Certificate Regulation'?
- Art. 4 goes on: "the protection conferred by a certificate shall extend only to the product …". Does this mean "the subject matter of the certificate shall extend only to the product …"? If that is the case, how does her inference that SPCs for active(s) forming only part of multi-active medicinal products will protect those multi-active medicinal products stack up?
Back from Holiday and Confused".