Defining the Product
An SPC is granted based on both the award of a market authorization for a medicinal product and the existence of patents that protect that product. The product in this sense means solely the active ingredient(s) of the authorized drug.
However, it is this question of when a patent can be deemed to “protect” the active ingredients that has given rise to some of the greatest uncertainty. The national courts of some EU Member States have taken the view that if the unauthorized use of the active ingredient(s) would infringe the patent, then the patent protects those ingredients (“the infringement test”).
Most Member States, however, have rejected this test in favor of a stricter requirement that requires the patent, or indeed the claims of the patent, specifically cite the active ingredient(s). This can be problematic where, for example, the product is a combination product with multiple active ingredients, as it may well be the case that a patent covers only one of the active ingredients in the combination. In these circumstances, the product (e.g. a multidisease vaccine) will infringe the patent but not the SPC (i.e., not the patent once extended) if the stricter test is adopted.
This issue has been referred to the highest court in the EU, the Court of Justice of the European Union (CJEU). Although the court has yet to rule on this, the Advocate General (AG) has now issued her opinion; the CJEU tends to follow the AG’s opinion in about 80% of cases, and so this is a good guide as to what the court may decide.
In the AG’s opinion, the infringement test should not be used. For a patent to be eligible for patent term extension, the active ingredient(s) should form the subject matter of the patent, according to the rules governing the basic patents (i.e., the national laws of the Member States). Consequently, if the product comprises multiple active ingredients, those multiple actives should “form the subject matter of the basic patents.” What this will mean may, and probably will, vary between Member States but will mean that the combination of actives must have been envisaged in some way in the patent.
The AG also ruled, though, that where a marketing authorization has been granted for a particular combination of active ingredients, it is legitimate when applying for an SPC for a patent covering only one of those actives to then define the product for the purposes of the SPC as only that active which the patent covers.
Consequently, the AG has sought to provide a way for patentees to obtain patent term extensions for multiactive products when the patentees only have a patent relating to one of those actives. Assuming this decision is followed by the CJEU, it will provide a means for new applicants for SPCs to apply their patents for single or a subset of active ingredients to products comprising multiple active ingredients.
This will not help existing applicants, however, whose SPC applications did not define the product in a way that the AG has approved of but which was previously thought to have been potentially unacceptable. It may be possible for these existing applications to be amended, but this will depend upon national laws, again giving the potential for disharmony between the EU Member States. Further, the uncertainty and disharmony will remain, at least for the time being, when trying to decide whether a product forms the subject matter of the patent. It is possible that a number of pending cases may yet add more clarity to this though.