The Irish Supreme Court has produced draft questions for the CJEU, Europe’s highest court, regarding how to determine whether a combination product is protected by a patent and whether that product has already been the subject of a certificate. These questions under Articles 3(a) and (c) of the SPC Regulation, which are reproduced below, could provide clarity for a number of situations where a product is approved both on its own as a mono-product and also separately as a combination product. While these situations are common in practice, the national patent offices currently take different approaches to awarding SPCs in such situations, even when presented with the same facts.

Combination product SPCs are highly valuable additional rights, as they may expire many years after the corresponding mono-product SPCs (e.g. because of the regulatory timelines involved), so the answers to the referred questions could have a considerable impact on filing and enforcement strategy for many patentees.

The case that led the Irish Supreme Court to prepare these draft questions was between Merck Sharp & Dohme Limited (MSD) and Clonmel Healthcare Limited. It concerned the Irish Court of Appeal’s decision that found MSD’s combination product SPC to ezetimibe and simvastatin based on EP0720599 invalid under Article 3(a). MSD also had a mono-product SPC to ezetimibe on the same basic patent that supported the combination product SPC.

This referral is the second in the area of combination products in recent months, following a referral by a Finnish Court in November 2021 (as discussed in our previous article). These referrals are the result of a tension between how “the product” should be interpreted when assessing whether a combination product SPC meets the requirements of Articles 3(a) and 3(c) in view of the CJEU’s earlier decisions. So these two new references will, we hope, provide some much-needed clarity.

The draft questions from the Irish Supreme Court are as follows:

1.(a) For the purpose of the grant of a supplementary protection certificate, and for the validity of that SPC in law, under Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products [2009] OJ L152/1, does it suffice that the product for which the SPC is granted is expressly identified in the patent claims, and covered by it; or is it necessary for the grant of an SPC that the patent holder, who has been granted a marketing authorisation, also demonstrate novelty or inventiveness or that the product falls within a narrower concept described as the invention covered by the patent?

1.(b) If the latter, the invention covered by the patent, what must be established by the patent holder and marketing authorisation holder to obtain a valid SPC ?

2. Where, as in this case, the patent is for a particular drug, ezetimibe, and the claims in the patent teach that the application in human medicine may be for the use of that drug alone or in combination with another drug, here, simvastatin, a drug in the public domain, can an SPC be granted under Article 3(a) of the Regulation only for a product comprising ezetimibe, a monotherapy, or can an SPC also be granted for any or all of the combination products identified in the claims in the patent?

3. Where a monotherapy, drug A, in this case ezetimibe, is granted an SPC, or any combination therapy is first granted an SPC for drugs A and B as a combination therapy, which are part of the claims in the patent, though only drug A is itself novel and thus patented, with other drugs being already known or in the public domain; is the grant of an SPC limited to the first marketing of either that monotherapy of drug A or that first combination therapy granted an SPC, A+B, so that, following that first grant, there cannot be a second or third grant of an SPC for the monotherapy or any combination therapy apart from that first combination granted an SPC?

4. If the claims of a patent cover both a single novel molecule and a combination of that molecule with an existing and known drug, perhaps in the public domain, or several such claims for a combination, does Article 3(c) of the Regulation limit the grant of an SPC;

(a) only to the single molecule if marketed as a product;

(b) the first marketing of a product covered by the patent whether this is the monotherapy of the drug covered by the basic patent in force or the first combination therapy, or

(c) either (a) or (b) at the election of the patentee irrespective of the date of market authorisation?

And if any of the above, why?