The stage is set for another referral to the Court of Justice of the EU (CJEU) on the eligibility criteria for Supplementary Protection Certificates (SPCs) for “combination products” - those comprising two or more active ingredients.
It is common for innovators to develop a medicinal product with a single active ingredient and subsequently obtain authorisation for combination products comprising the single active ingredient and one or more additional active ingredients. These are sometimes described together in the same granted patent and innovators have tried to obtain separate SPCs for the respective single and combination products.
Under Article 1(b) SPC Regulation, a “product” is defined as the active ingredient or combination of active ingredients of a medicinal product. The literal wording of Article 3(c) SPC Regulation requires that “product” to not have already been the subject of an SPC.
When interpreting this requirement in C-443/12 (Actavis I) and C-577/13 (Actavis II), the CJEU reasoned that an SPC for a combination product could not also be granted if the applicant already had an SPC for the single active ingredient that embodied the core inventive advance of the same basic patent. It did not matter that the “product” was different as between the “monotherapy SPC” and the “combination SPC”; rather the question was whether the other active ingredient in the combination embodied the core inventive advance of the patent. The aim was to prevent so-called ‘evergreening’ brought by later-expiring SPCs for combination products arising from the same patent as the new single active ingredient.
The “core inventive advance” has been referenced in subsequent judgments by national courts as well as the CJEU. The decisions of the CJEU in Teva v Gilead (C-121/17) in 2018 and in Royalty Pharma (C-650/17) in 2020 considered the interpretation of Article 3(a) SPC Regulation, which requires the product to be “protected by a basic patent in force”. These two CJEU decisions provided new legal tests for determining whether a product is “protected” in the sense of Article 3(a), but specifically disavowed taking into account the “core inventive advance”. For combination products, the CJEU decided (in Teva) that the product is protected by a basic patent in force under Article 3(a) if it is either expressly mentioned in the claims of the patent (see Paragraph 37 of Teva) or “falls under the invention covered by that patent” and each component is “specifically identifiable” in light of the disclosure of the patent, the prior art and/or general knowledge, assessed by the skilled person at the filing date or priority date.
As Teva v Gilead and Royalty Pharma related solely to Article 3(a), it is unclear what if any effect the CJEU’s obiter comments about the “core inventive advance” in respect of Article 3(a) have on the interpretation of Article 3(c), and whether there should be a harmonised assessment between Articles 3(a) and 3(c). In particular, is it sufficient for Articles 3(a) and 3(c) for a combination product that the other active ingredient is expressly mentioned (or “specifically identifiable”), or is an assessment still needed of whether the other active ingredient reflects an inventive advance of the patent?
Courts in Finland and Ireland made referrals in 2022 to the CJEU for further clarification on Article 3(c) in view of the above decisions about Article 3(a) (see C-119/22, Teva v MSD, and our article here; also C-149/22, MSD v Clonmel, and our article here).
THE STAGE IS SET
We now report that in December 2022 the Swedish Supreme Court has ruled that the Swedish Patent and Market Court made a serious error by refusing AstraZeneca’s SPC application for its Xigduo® combination product (dapagliflozin and metformin) without having made its own referral to the CJEU about the interpretation of Article 3(c). AstraZeneca already has an SPC relating to its Forxiga® product containing the single active ingredient dapaglifozin. The Swedish Supreme Court held that the interpretation of Article 3(c) is not clear nor has it been properly (re‑)considered by the CJEU in light of the intervening decisions in Teva v Gilead and Royalty Pharma.
In its decision, the Supreme Court explained:
“However, it is not possible to draw any conclusion… with certainty regarding whether the statements made in the legal cases Teva and Royalty Pharma have any significance for how Article 3 c should be interpreted. That issue has not been examined by the European Court of Justice.
“All in all, the previous rulings from the European Court of Justice cannot be considered to unequivocally answer the questions that were relevant in the Patent and Market Supreme Court's case” (unofficial English translation, paragraphs 20 and 24).
The case has now been handed back to the Swedish Patent and Market Court for further processing, which is expected to include making a referral to the CJEU (as it appears unlikely that decisions in Teva v MSD and MSD v Clonmel will be handed down soon). At this stage we do not know what questions the Court may refer.
We will of course continue to monitor and report on further developments in this area. In the meantime, if you have any queries relating to extending protection for your products, please contact one of the patent attorneys in our SPC and regulatory team who will be happy to assist.