CJEU follows Advocate General in question over SPCs for combination drugs

The judgment is based on referrals from both the Finland Market Court and the Supreme Court of Ireland in disputes over MSD’s diabetes drug Janumet and its cholesterol-lowering drug Inegy. Both questions concern the scope of the supplementary protection certificate regulation with regard to combination drug products. The court thus ruled on both together. The national courts were mainly seeking clarification regarding the interpretation of Articles 3(a) and 3(c).

The judges around judge rapporteur Küllike Jürimäe, who is president of the Second Chamber but acted in this case as president of the Third Chamber ruled that (case ID: C-119/22):

“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.”

In this, the judges bench, including Niilo Jääskinen and Nuno José Cardoso da Silva Piçarra, largely followed the opinion of Advocate General Nicholas Emiliou issued in the summer. Thus, according to the ruling, an existing SPC for one of the active ingredients need not be an obstacle to granting the SPC for the combination. The CJEU thus provided clarity on this long-discussed issue. According to observers, however, the decision in relation to Article 3(a) raises further questions.

Following the Advocate General

Regarding Article 3(a) of the regulation, the CJEU stated in its guiding principles, it:

“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”.

Furthermore, the judges ruled that the 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”.

Questions remain

The judges broadly followed the opinion of the Advocate General. Furthermore, in their explanation they point out that the combined effect of a combination of two active ingredients must go beyond the mere addition of the effects of those two ingredients. However, the guiding principles that generally serve national courts as a guideline in their decisions do not include this statement.

Also, the judges do not mention further criteria clarifying what falls under the invention of the basic patent. One litigation observer expressed the fear to JUVE Patent that this could also lead to different opinions and decisions by national courts in the future.

Back to the national courts

The CJEU’s final decision will also have an impact on several pending proceedings. In both cases MSD has been battling different generic drug companies in parallel proceedings across Europe.

Concerning Janumet (combination of active ingredients sitagliptin and metformin), multiple parallel proceedings are ongoing in Germany, France, Belgium, Portugal, Greece, Italy, and the Czech Republic.

As for Inegy (combination of active ingredients ezetimibe and simvastatin), MSD is fighting against Clonmel in Ireland, but also against Biogaran, Teva, Viatris, Sandoz and EG Labo in France. Furthermore, generic companies are on the market with their products in Germany since a ruling from the Higher Regional Court in Düsseldorf.

Trusted advisors

In the CJEU proceedings, MSD relied on a team from Roschier. The Swedish-Finnish law firm has represented the pharma innovator in Finland for over 30 years. Partner Rainer Hilli, head of the firm’s IP practice, leads the case at the Market Court in Helsinki and also took the lead at the CJEU.

A joint team from the German IP practice of Bird & Bird and Finnish outfit Borenius represented Teva. Düsseldorf-based partner Oliver Jüngst, who was also active in the German proceedings for Teva, took the lead. He worked closely with Ben Rapinoja, IP partner at Finnish law firm Borenius. Patent attorney Jan van Dieck from the Munich office of Bird & Bird assisted.

Clonmel retained a team led by Laura Scott, partner at William Fry, who is also conducting the proceedings in Ireland.