One of our readers has a problem for which no information or case law could be found. The SPC Blog wonders whether any of our other readers might be able to offer some information -- or at least their opinions -- for which our reader would be most grateful. The problem runs like this:
"The basic patent concerned covers in claim 1 an oral formulation which releases the active ingredient in a specific amount, which may exist in specific embodiments (a) to (g). (a) is a matrix tablet not specifying the excipients, while (b) to (g) are other forms such as a coated tablet, a pulsatile dosage form etc.
The SPC is based on a matrix tablet. The title reads: "Pharmaceutical formulations comprising (the active ingredient) X"
As far as reported in textbooks and commentaries, the scope of protection of an SPC is that of the basic patent, but restricted to the specific authorized product. This means that, if the basic patent claims a generally defined formula, the SPC is restricted to the specific active ingredient which is present in the authorized product. If the patent claims a use, then the scope of the SPC is restricted to this use of the authorized product. If the patent claims a process for obtaining the active ingredient, the SPC is restricted to the process for obtaining the active ingredient present in the authorized product.
My questions now are:
1: Is the scope of protection of the SPC restricted to the embodiment (a), that is, to a matrix tablet, and are the other embodiments (b) to (g) not covered by the SPC any more?
Or, even more narrowly:
2. Is the scope of protection SPC even restricted to the specific excipients used in the authorized products, and can other excipients be used without infringing the SPC literally? (Equivalency would have to be considered separately)".
If you have any bright ideas or comments, do let us know!
