Recent work | November 25, 2021

Referral to the CJEU from the Finnish Market Court on the interpretation of Article 3(c) of the SPC Regulation

Roschier represents Merck Sharp & Dohme Corp. (MSD) in invalidation proceedings initiated by Teva B.V. and Teva Finland Oy against the Finnish Supplementary Protection Certificate protecting MSD's medicinal product Janumet®, which is used for the treatment of type 2 diabetes. On 5 November 2021, the Market Court informed the parties of its decision to refer a question to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the interpretation of Article 3(c) of the SPC Regulation.

In the invalidation proceedings before the Market Court, Teva has challenged the validity of MSD’s Finnish supplementary protection certificate (SPC) no. 342 in an attempt to clear the path for a potential market entry with a generic version of Janumet®.

The product subject to MSD’s challenged SPC no. 342 is a combination product, consisting of two active ingredients “Sitagliptin, optionally in the form of a pharmaceutically acceptable salt, in particular as monophosphate, and metformin, optionally in the form of a pharmaceutically acceptable salt, in particular as hydrochloride”.

Based on the same basic patent but a different marketing authorization, MSD has also been granted another SPC in Finland, namely SPC no. 343. The product subject to this SPC no. 343 is a so-called mono product, thus containing only one active ingredient “Sitagliptin, optionally in the form of a pharmaceutically acceptable salt”. The validity of SPC no. 343 has not been challenged.

Main legal questions

In the invalidation proceedings before the Market Court, Teva has argued that MSD’s later SPC, that is, SPC no. 342 granted for the combination product, would have been granted contrary to Articles 3(a), 3(c) and 3(d) of the EU Regulation No. 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation). The main legal questions in the proceedings have thus been:

  • whether the product subject to the SPC no. 342 is indeed protected by the MSD basic patent in accordance with Article 3(a);
  • whether the product has not already been the subject of a certificate, i.e., whether SPC no. 342 is indeed the first certificate granted for the product as required by Article 3(c); and
  • whether MSD’s Janumet® marketing authorization granted for the product is the first authorization granted in accordance with Directive 2001/83/EC that places the product on the market as a medicinal product in accordance with Article 3(d).

In addition to the interpretation and assessment of Art. 3 requirements, the dispute also concerns a question on the interpretation of the “product” definition laid down in Article 1(b) of the SPC Regulation and, in particular, whether the same or a different definition of the term “product” should be used depending on which Article 3 requirement is to be assessed.

This question is of particular importance since all the Article 3 requirements under which Teva has challenged the validity of SCP no. 342 include the defined term “product”. In addition, when comparing the recent CJEU rulings Teva UK (C-121/17) and Royalty Pharma (C-650/17) regarding the interpretation of Article 3(a) with the interpretation of Article 3(c) requirement laid down particularly in Actavis I (C-433/12) and Actavis II (C-577/13) rulings, the term “product” has been interpreted differently by the CJEU under Article 3(a) and 3(c).

An opportunity for further clarity

The main hearing in the case was held before the Market Court between 27 September and 8 October 2021, and following the main hearing, on 5 November 2021, the Market Court informed the parties of its decision to refer a question to the CJEU for a preliminary ruling on the interpretation of Article 3(c) of the SPC Regulation.

While this Market Court’s decision means that the judgment will be postponed until after the preliminary ruling has been given, this referral to the CJEU provides on opportunity to get further clarity on the interpretation of Article 3(c) of the SPC Regulation, and will thus also have implication beyond the present case.

Roschier’s core advisory team comprises Rainer Hilli, Juho Ohisalo and Eero Liikanen.