Sweden gets into the Article 3 SPC referral game in AstraZeneca dapagliflozin case

This Kat was recently made aware that there will soon be another referral to the Court of Justice of the European Union (‘CJEU’) on Article 3(c) of the Regulation concerning the supplementary protection certificate (‘SPC Regulation’). There are already two referrals pending before the CJEU made by the Finnish Market Court (C-119/22) and by the Supreme Court of Ireland (C-149/22) on Article 3 of the SPC Regulation, reported by PatKat here and here.

Background

AstraZeneca previously obtained an SPC for dapagliflozin based on patent EP 1 506 211 in February 2014. In July that year they applied to the Swedish Intellectual Property Office for another SPC for the combination of dapagliflozin and metformin based on claim 7 of the same patent. The application was rejected by the Swedish Intellectual Property Office, and the appeal by AstraZeneca dismissed by the Patent and Market Court.

The Patent and Market Court of Appeal again dismissed the appeal. In the judgment PMÖÄ 1213-20 it noted that a skilled person could understand based on claim 7 that the combination of dapagliflozin and metformin is covered for the purpose of Article 3(a) (p. 7, first para). The main question appears to be whether the reasoning in para 43 of Actavis (C-443/12) is always true: if a patentee already obtained an SPC on an innovative active ingredient, Article 3(c) imposes an obstacle for them from obtaining a second SPC for the combination of the active ingredient with another active ingredient which, as such, is not protected by the patent (p. 7, last para – p. 8, first two paras). The Patent and Market Court of Appeal considered that with the first mono SPC AstraZeneca was already able to oppose the use of dapagliflozin alone or in combination with other active ingredients such as metformin. Applying the reasoning in Actavis it concluded that Article 3(c) was an obstacle from granting another SPC for the combination of dapagliflozin and metformin (p. 8, last para – p. 9, first para). The Court of Appeal also relied on para 44 of Actavis to hold that even if Article 3(a) was fulfilled, Article 3(c) was not regardless (p. 9, second para).

Decision of Swedish Supreme Court

Under Article 267(3) of the Treaty on the Functioning of the European Union, a tribunal of a Member State has the duty to refer a case to the CJEU on the interpretation of the Treaties if there is no judicial remedy under national law against the decisions of that tribunal, unless when some exceptions apply such as when an answer has already been provided by a precedent (acte éclairé) or when the law is clear (acte clair).

The Swedish Supreme Court considered in the judgment Ö 5978-21 the famous SPC cases of Actavis, Georgetown (C-484/12), and Boehringer (C-577/13), Teva (C-121/17) and Royalty Pharma (C-650/17) and held that for Article 3(a) it is not necessary for the protection of a combined product that each active ingredient is explicitly mentioned in the patent claims (para 19). The Supreme Court also considered it unclear whether Teva and Royalty Pharma have any influence on the interpretation of Article 3(c) (para 20). The Supreme Court noted the submission of AstraZeneca that many Member States had found that Article 3(c) does not constitute an obstacle to the granting of corresponding SPCs, and that the interpretation of that article had led to a large number of preliminary rulings including the ones from the Finnish Market Court and the Supreme Court of Ireland (paras 22, 23). Accordingly, a preliminary ruling on the interpretation of Article 3(c) was needed. Since the Patent and Market Court of Appeal was the last instance court in this case, it was obliged to request a preliminary ruling (para 24). The lack of a referral meant that there was a serious procedural error, and the decision from the Court of Appeal must be set aside (para 32).

Comments

This is yet another proof that the interpretation of Article 3(a) and 3(c) is anything but clear. The later judgments Teva and Royalty Pharma seem contradictory to the earlier decisions with little guidance from the CJEU on which ones are more acceptable or indeed none is. It would be interesting to see how the referral questions are phrased by the Court of Appeal and whether the referral is joined with any pending one.