When Can An SPC Be Granted For Combination Medicinal Products?

Opinion of the Advocate General regarding joined cases Teva II (C-119/22) and MSD (C-149/22)

Two referrals have been made to the Court of Justice of the European Union (CJEU), one originating from the Finnish Market Court (C-119/22) and another originating from the Supreme Court Ireland (C-149/22). Both cases are highly similar in substance and effectively ask for clarity on how to correctly interpret Article 3(a) and 3(c) of the 'SPC Regulation' (469/2009/EC) when seeking to obtain an SPC for a combination medicinal product.

The two cases have been joined and Advocate General (AG) Emiliou delivered a non-binding opinion on 6 June 2024. Encouragingly, the AG proposes a simplified test for applying Article 3(c) relative to earlier decisions. However, as is often the case with SPC case law, the approach recommended for interpreting Article 3(a) potentially raises more questions than it answers.

Facts of the two joined cases

In both cases, Merck obtained a first SPC to a single active ingredient ("A") based on a marketing authorisation concerned with that same substance for use as a monotherapy in treating certain diseases or health conditions. Subsequently, Merck obtained a second SPC to a combination containing active ingredient "A" plus another active ingredient "B" already in the public domain and used to the same effect. In both cases, the basic patents relied upon related to the novel and innovative properties of active ingredient "A", and included claims to the single active. The basic patents also included claims to "A" when used in combination with known drug "B", but did not include any data relating to the efficacy of the combination.

In the Finnish case (C-119/22), generics company Teva filed a declaration of invalidity of Merck's 2^nd SPC before the Market Court arguing: (i) that Article 3(a) was not satisfied because the combination product was not 'protected' by the basic patent and (ii) that Article 3(c) precluded the grant of an SPC to the combination of "A+B" because an SPC had already been granted for product "A". The Market Court Finland stayed the proceedings and requested a preliminary ruling from the CJEU.

In the Irish case (C-149/22), Clonmel Healthcare Limited launched a generic version of the combination product Inegy once Merck's 1^st SPC for ezetimibe has expired. However, Merck brought infringement proceedings before the Irish High Court claiming infringement of their 2^nd SPC. In defence, Clonmel claimed invalidity of the 2^nd SPC for breaching Article 3(a) and 3(c). The High Court revoked the 2^nd SPC, a decision that was upheld by the Irish Court of Appeal. Merck appealed to the Supreme Court, who stayed the proceedings and requested a preliminary ruling from the CJEU.

AG opinion on Article 3(c)

The referring courts wish to know whether Article 3(c) precludes the grant of an SPC to a combination of actives "A+B" when a certificate has already been granted to active "A". The AG was quick to dismiss the conclusions from two earlier cases, Actavis I (2013) and Actavis II (2015) (which answered the question in the affirmative), suggesting that in those cases the CJEU had conflated the requirements of Article 3(a) and 3(c) and overrode the clear wording of the regulation. To the AG, Article 1(b) of the regulation provides a simple definition of the concept of a "product" and confirms that a combination of active ingredients "A+B" constitutes in itself a product that is distinct from product "A". Since no prior SPC has been granted for the combination of "A+B", Article 3(c) is satisfied.

AG opinion on Article 3(a)

To answer the question of whether a combination product "A+B" is protected by the basic patent, the AG took the opportunity to provide a brief history of the case law relating to Article 3(a). The AG noted that the term "protected" is not defined anywhere in the regulation, which has resulted in diverging conclusions from the national courts and much legal uncertainty.

• In Medeva (2011) and Eli Lilly (2013), the CJEU proposed what the AG has referred to as "the identification test". Under this test, a combination of "A+B" would be eligible for an SPC only if it were expressly referred to or at least identifiable with a sufficient degree of specificity in the claims.
• In parallel, in Actavis I (2013) and Actavis II (2015), the CJEU presented what the AG has referred to as "the invention test". Under this test, a combination of "A+B" is eligible for an SPC if it corresponds to the invention for which the patent is sought. In those cases, the court did not refer to the claims of the patent but instead based their reasoning on what was the 'core inventive advance' or 'sole subject matter of the invention' presented by the patent.
• In an attempt to clarify whether one test is preferred, or if indeed both must be satisfied, the judgement of Teva I (2018) laid down what the AG has referred to as "the definitive test". Unfortunately, the situation remains obscure, as evidenced by the current referrals in which the parties have provided two differing interpretations of the supposed definitive test of Teva I. Merck for instance have argued that the definitive test is intended to be a further refinement of the identification test. In contrast, the generics companies Teva and Clonmel Healthcare Limited have argued that the definitive test is intended to be an endorsement of both the identification test and the invention test, requiring both to be satisfied to comply with Article 3(a).

So which is the correct reading of the judgement in Teva I?

According to the AG, the second reading put forward by the generics companies is the correct one. It is proposed that the judgement of Teva I should be regarded as a two-pronged test, one to determine whether the product passes "the identification test", and one to determine whether the product passes "the invention test". Both tests must be satisfied in order to comply with Article 3(a).

Implementing the first prong of the test has already been extensively discussed in the judgment in Royalty Pharma (2020) which provides some guidance on when a product is "specifically identifiable" by the patent. For the second prong of the test, it is less clear how an assessment of 'fall under the invention' should be carried out. The AG was keen to stress that this second prong of the test is not akin to an inventive step assessment under Article 56 EPC, but is instead an ex post assessment of what the patent discloses. Throughout the opinion, the AG refers to the purpose of the SPC system to reward genuinely innovative combinations that display a synergistic effect, going beyond their mere additive effect. Following this theme, the AG proposes that a combination product may 'fall under the invention' if the patent describes "the use of A+B given their combined, synergistic effects on the human body, to solve a certain technical (medical) problem".

In our view, a requirement for an observable synergistic effect is wholly unsupported by SPC law, and could impose a much higher bar for innovation than what is required for patentability. We see genuinely innovative combination products being developed in the clinic that lack an observable synergy, for example those that show an unexpectedly positive safety profile or that have previously been difficult to co-formulate. Surely, the SPC system is intended to also reward these innovations.

Of course, the AG's opinion is non-binding, and it will be interesting to see whether the CJEU adopts the same position. Practitioners and SPC holders will want to pay particular attention to whether the CJEU will provide further guidance on how the second prong of the test ("the invention test") should be applied. We will, of course, provide an update as soon as the decision is handed down.

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