Earlier today, the CJEU delivered its judgment in joined cases C–119/22 and C–149/22 Merck Sharp & Dohme (MSD). This decision is the latest in a long line of judgments seeking to clarify the meaning of Articles 3(a) and 3(c) of the SPC Regulation.

Although the CJEU has aimed to explain how Articles 3(a) and 3(c) are to be applied to combination products in the specific context which led to the referral, questions remain on whether and how to apply the judgment to other products. 

In brief, MSD derives from referrals made by the Finnish and Irish courts on similar facts, which were joined by the CJEU, as discussed in our previous articles here and here. Both referrals related to combination products. In each, a patent was granted for a substance A, which was authorised as monotherapy. SPCs were granted for A. The patents contained later claims reciting the combination of A with a further substance B, where B was known from the prior art. A + B was authorised as a combination therapy. Further SPCs were sought for A + B. Questions were referred on whether Articles 3(a) and/or 3(c) precluded the grant of the further SPCs to the combination. The key issues where the referring courts asked for clarification were:

1. whether Article 3(c) means that the earlier grant of an SPC for A prevents the grant of a later SPC for A + B; and
2. whether Articles 3(a) and/or 3(c) should be assessed using a “core inventive advance” test, a concept which may be narrower than the scope of the claims.

The CJEU has ruled as follows (full judgment available here): 

1.  Article 3(c) (…) must be interpreted as not precluding the grant of a supplementary protection certificate (SPC) for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPC and it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent.
2.  Article 3(a) (…) must be interpreted as meaning that it does not suffice that a product is expressly mentioned in the claims of the basic patent in order for that product to be regarded as being protected by that patent, within the meaning of that provision. It is also necessary, in order to satisfy the condition laid down in that provision, 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. 
3.  Article 3(a) (…) must be interpreted as meaning that a product consisting of two active ingredients (A+B) is protected by a basic patent, within the meaning of that provision, where A and B are expressly mentioned in the claims of that patent and the specification of that patent teaches that A may be used as a medicinal product for human use alone or in combination with B, which is an active ingredient in the public domain at the filing date or priority date of that patent, provided that the combination of those two active ingredients necessarily falls under the invention covered by the same patent.

Our initial thoughts are that the decision may simplify the assessment of Article 3(c) for other combination SPCs. The rulings on Article 3(a) are potentially more complex, given that previously the CJEU rejected a “core inventive advance” test in earlier cases such as C-650/17 Royalty Pharma. We look forward to seeing how the referring courts assess the CJEU’s references to the invention in the context of assessing Article 3(a).

We are still digesting the judgment, which is likely to have far-reaching consequences on SPC practice in Europe. Questions may remain unanswered, such as how to interpret the “invention covered by that patent”, both in the context of combination products and potentially more widely.