An early Christmas present for combination products

As always, the CJEU continue to refine the rules regarding obtaining SPCs in Europe. The latest judgment on combination products leaves both gifts and a lump of coal in the stocking of patent holders (forgive me if the Christmas metaphor is becoming strained!)

In combined cases C-119/22 and C-149/22, the Court was asked to rule on whether it is possible to obtain an SPC on a combination product (here, metformin and sitagliptin; and ezetimibe and simvastatin) when an SPC had already been granted on a product containing the first of those actives alone. Further, if the “inventive advance” of the basic patent is only in connection with one of the actives (and the second was already known at the relevant priority date), does this make a difference?

The first of those points is answered with a clear “yes”. A “product” is clearly defined in Regulation EU 469/2009 as “the active ingredient or combination of active ingredients of a medicinal product”. A combination of (A+B) is therefore a distinct product from A or B alone.

However, the second point then comes into play. Here the Court held that it is not sufficient for the combination to be specifically mentioned in the patent claims; but rather the inventive advance should also be considered. “It is also necessary … that that product necessarily fall, from the point of view of a person skilled in the art, and in the light of the description and drawings of that patent, under the invention covered by that patent at the filing date or priority date.” In essence, the combination of (A+B) must itself solve the problem addressed by the patent, rather than A alone solving the problem, and the patent drafter simply reciting lists of additional potential combinations with no data behind them.

On balance, this seems positive for patentees holding IP directed to synergistic combinations, but less so for those who have merely adopted drafting tricks.

The impact of this ruling will take some time to become apparent in the national courts and patent offices; but for now it is clear that SPC law continues to evolve and take unexpected turns.