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New Referral to the CJEU on Article 3(c) and the Validity of Combi-SPCs

6 December 2021

The Finnish Market Court has referred a new question to the CJEU, asking whether a second SPC to a combination of active ingredients can be granted to the holder of a first SPC to one of the active ingredients, when both SPCs are based on the same basic patent. The specific wording of the referred question is not yet clear, but we understand that it relates to the interpretation of Article 3(c) of the SPC Regulation. Article 3(c) requires that:

“A[n SPC] shall be granted if … the product has not already been the subject of a certificate”

The case at issue before the Finnish Market Court concerned invalidation proceedings initiated by Teva B.V. and Teva Finland Oy (Teva) against the SPC for the product of Janumet® as granted to Merck Sharp & Dohme Corp (MSD). The product of Janumet® comprises a combination of the active ingredients sitagliptin and metformin. MSD had already obtained a first SPC in Finland directed to the product of Januvia®, which comprises sitagliptin alone. This first SPC is based on the same basic patent as the SPC at issue, EP1412357, but a different, earlier marketing authorisation (MA). In the proceedings before the Finnish Market Court Teva argued, amongst other things, that the second SPC was not allowable under Article 3(c) because MSD’s earlier SPC to sitagliptin alone amounted to an earlier SPC for the same “product”.

Previously, in C-443/12 (Actavis I), the CJEU held that Article 3(c) of the SPC regulation precludes a rights holder from obtaining, based on the same basic patent disclosing an active ingredient, both (i) a first SPC arising from an MA for monotherapy using that active ingredient (a “mono” SPC), and (ii) a second SPC arising from a (later) MA for combination therapy using that active ingredient in combination with another active ingredient (a “combi” SPC), if the second active agent is not protected “as such” by the basic patent. Subsequently C-577/13 (Actavis II) provided some further clarification, stating that in order for a basic patent to protect an active ingredient “as such” within the meaning of Articles 1(c) and 3(a) of the SPC regulation, that active ingredient “must constitute the subject-matter of the invention covered by that patent” (a test that has become known more commonly as the “core inventive advance” test).

However, in more recent decisions C-121/17 (Teva) and C-650/17 (Royalty Pharma) concerned primarily with Article 3(a) of the SPC regulation, the CJEU has taken a different approach to assessing whether a product is “protected by a basic patent in force” (the requirement of Article 3(a)). In these decisions, the CJEU rejected the notion that a “core inventive advance” test should apply. Instead, the court ruled that what is determinative is whether (i) the [combination] product necessarily falls under the invention covered by the basic patent, and (ii) the skilled person can identify the [combination] product specifically in light of all the information disclosed in the patent.

Thus, the reasoning of the CJEU in these later “3(a) decisions” seems to contradict the approach taken in the “3(c)/(a) decisions” of Actavis I and II when considering the meaning of “product”. It is hoped that the new referral will provide some much needed clarity regarding both Article 3(c) and more generally regarding the interpretation of “product” in the regulation as a whole. It would be helpful for the CJEU to confirm in particular whether or not an analysis under Article 3(c) of the regulation requires the term “product” to be interpreted differently from a corresponding analysis under Article 3(a). If the same interpretation is to be used throughout, it would be helpful for this to be clearly set out.

Even if the eventual decision focusses entirely on Article 3(c), it will likely have a considerable impact on protection strategies for medicinal products. Combi SPCs are attractive to applicants because combination products are generally developed (and authorised) later than their monotherapy cousins, and hence have later expiry dates. The pharmaceutical industry will be watching developments with interest.

For more information contact Graham Lewis and James Egleton or your usual J A Kemp adviser.

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