Recent ECJ case law and latest referrals for preliminary rulings on the SPC Regulation

In the life sciences industry, patent protection for innovative medicinal products is pivotal to the commercial success of new drug products. Before commercially exploiting such an invention, the patentee must obtain a regulatory marketing authorisation for the medicinal product from a competent health authority, such as the European Medicines Agency, which may take several years.

To compensate for the reduced time for effective commercial exploitation of such patents and to support innovation in the European Community, supplementary protection certificates (SPCs) were introduced in the European Union in the early 1990s by Regulation (EU) 1768/92. SPCs can extend the protection conferred by a basic patent covering the marketed medicinal product by a maximum of five years. The initial regulation on SPCs was later amended by Regulation (EU) 469/2009 (the SPC Regulation). A further six-month extension on medicinal products for use in paediatrics may also be available under Regulation (EU) 1901/2006.

Although they are accessory to patents, SPCs are an IP right sui generis, which must be applied for on a country-by-country basis and are granted to the owner of a basic patent by the applicable national authority. Even though their implementation by Regulation (EU) 1768/92 aimed for unitary application at European Community level, facilitating free movement of medicinal products within the European Community, it has proven difficult to prevent divergence by granting authorities and courts through different interpretations of the law and European Court of Justice (ECJ) case law, leading to a disharmonised situation contrary to the aims of the SPC Regulation.

This chapter highlights recent ECJ decisions regarding Article 3(a) of the SPC Regulation relating to one of the core aspects of SPCs – namely, the products considered to be protected by a basic patent, and the implications for patentees and generics companies. In addition, we report on two new referrals for preliminary rulings of the ECJ for issues regarding Article 3(c) of the SPC Regulation. This article requires that no SPC has been already granted for the same product. In the two pending referral cases, the SPC holder is seeking to clarify situations where SPCs have been granted for the respective mono-preparations on the basis of a basic patent and a further SPC was granted a for a further combination SPC on the basis of the very same basic patent, comprising also the mono-product.

Recent ECJ case law

Article 3 is the central provision of the SPC Regulation. It provides for the four cumulative requirements for granting an SPC for a given product. According to Article 3(a), a product is eligible for an SPC only if the product is “protected by the basic patent in force”. Article 3(a) has been subject to various preliminary ECJ rulings in the past decade to clarify the conditions that must be met for a product to be protected by a basic patent in force.

In Case No. C-121/17 (Teva), the ECJ was asked by the High Court of Justice of England and Wales to clarify the conditions under which a product is protected by the basic patent in force. The referring court also intended to clarify whether the core inventive advance approach is applicable for Article 3(a) of the SPC Regulation, according to which it is assessed whether the product is covered by the “core of the invention” of the basic patent but does not only relate to further variants thereof.

The underlying case in Teva involved an anti-HIV combination drug marketed by Gilead as Truvada, comprising the two active ingredients tenofovir disoproxil and emtricitabine. The first active, tenofovir, was explicitly disclosed in the basic patent. However, for the combination, the patentee had to rely on a claim that covered tenofovir but did not mention the second active, emtricitabine, instead referring to the rather general expression of “other therapeutic ingredients”. This, in addition, was an optional feature only. Neither emtricitabine nor its compound class was mentioned in the claims or description of the basic patent. Therefore, it had to be clarified whether the optional term “other therapeutic ingredients” was considered to necessarily fall under the invention covered and was a specific enough functional term for emtricitabine.

The ECJ confirmed that active ingredients do not need to be expressly mentioned in the claims to be protected and set out criteria that a basic patent must meet to protect a combination of several active ingredients with a combined effect.

In its decision, the ECJ defined that the claims of the basic patent must necessarily and specifically relate to the combination in question. For that purpose, the ECJ stated that, for a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent, the combination of those active ingredients must necessarily, in light of the description and drawings of that patent, fall under the invention covered by that patent. Further, each of those active ingredients must be specifically identifiable in light of all the information disclosed by that patent (Teva, Order).

The ECJ emphasised that the protection conferred by the SPC should not extend beyond the invention covered by the patent. According to the ECJ, this could be the case if the SPC did not relate to research results claimed under that patent (Teva, Item 40). For the determination of a product to be specifically identifiable, the skilled person may use the information disclosed in the basic patent itself and that in the prior art at the relevant effective date of the patent.

The ECJ did not, however, explicitly address the aspect of the core inventive advance approach in view of Article 3(a) of the SPC Regulation in its decision, so it remained unclear whether the ECJ rejected the concept itself or just used different terminology in this context.

It was hoped that the subsequent referral to be decided by the ECJ on Article 3(a), in Case No. C-650/17 (Royalty Pharma), would shed more light on the open aspects. In fact, the referring court explicitly maintained the referral after the issuance of Teva, emphasising the need for continued clarification on the core inventive advance concept. Therefore, it may not come as a surprise that the Royalty Pharma decision (at least) provides clarity on this aspect, but it may give rise to further issues in the context of Article 3(a).

The case underlying Royalty Pharma was concerned with a new use of DPIV inhibitors in the treatment of diabetes mellitus – a treatment method for the disease that had not been previously described in the prior art. The basic patent disclosed individual DPIV inhibitors and pointed out that, based on the data provided, the new treatment concept could be generally extended to the whole class of DPIV inhibitors. Sitagliptin, a DPIV inhibitor marketed for the treatment of diabetes, was not individually disclosed in the basic patent. The active ingredient was, however, developed by a licensee of the basic patent after its filing. Sitagliptin is also protected by a later-filed composition of matter patent to the licensee. The German Federal Patent Court referred the case for a preliminary ruling to the ECJ, requesting answers to the question of whether it was sufficient that the product in question met the general functional definition of a compound class mentioned in the claims, but apart from that was not individualised as a specific embodiment in the basic patent. Further, the German Federal Patent Court wanted to know if it matters whether the product in question was developed only after the filing date of the basic patent based on independent inventive activity.

The ECJ re-emphasised the pivotal importance of the claims for the interpretation and that the SPC would be limited to the technical features of the invention claimed in the basic patent but may not be extended to the “core of the inventive activity” (Royalty Pharma Item 31). Following the referring German Federal Patent Court’s interpretation, the ECJ rejected the application of the core inventive advance concept under Article 3(a).

Regarding the German Federal Patent Court’s referral questions directed to the degree of specificity of the disclosure for the product in question, the ECJ confirmed that the grant of an SPC is not prevented by the fact that the product in question was not disclosed in individualised form in the basic patent. In this context, the ECJ stated that the skilled person must be able to directly and unambiguously conclude that the product was covered by the subject matter protected by the patent (Royalty Pharma, Item 42). On the issues of the timing of the development of the product, the ECJ clarified that, if the possibility were provided to include results from research conducted only after the effective date of the patent, the SPC holder would unduly benefit from protection of results that were not available on the effective date. Therefore, the ECJ concluded that a product that was only developed after the effective date on the basis of “independent inventive activity” is not covered by the protection provided by the subject matter of the patent (Royalty Pharma, Items 44–49).

Pending ECJ referral questions

While the two decisions discussed above are the latest in a series of decisions on the interpretation of Article 3(a) of the SPC Regulation, in the past decade, only two other decisions have dealt with the interpretation of Article 3(c). The two pending referrals for a preliminary ruling of the ECJ in SPC matters both relate to combination products, for which for a mono- and a further combination SPC has been granted on the basis of the same basic patent. The case referred by the Finnish Market Court was directed to a combination product of sitagliptin and metformin based on EP 1 412 357 (ECJ Reference No. C-119/22), on which a basic patent, a mono-SPC for sitagliptin, had also been granted. The second referral, ECJ Reference No. C-149/22 originating from the Irish Supreme Court, dealt with the medicinal product Inegy, which related to a combination of ezetimibe and simvastatin. Based on the basic patent EP 0 720 599, a mono-SPC had been granted for ezetimibe and a combination SPC for ezetimibe and simvastatin.

In view of the ECJ decisions on Article 3(a) of the SPC Regulation discussed above, in which the application of the “core inventive advance” concept for Article 3(a) was rejected, the two referring courts basically asked whether there was a “tension” between the definition and interpretation of the term “product” in the earlier decisions issued by the ECJ (mainly) on the interpretation of this article and whether there was a contradiction with the recent Teva and Royalty Pharma decisions.

In the previous ECJ decisions on Article 3(c) of the SPC Regulation, in Case No. 443/12 (Actavis v Sanofi), the ECJ held that Article 3(c) precludes a patentee from obtaining, based on the same basic patent for an innovative active ingredient, both a first SPC for a mono-product relating to said innovative active ingredient and a second SPC arising from a (later) marketing authorisation for a combination product, the combination product being composed of the innovative active ingredient in combination with another active ingredient (not protected as such by the basic patent) and the combination cannot be regarded as a separate innovation (Actavis v Sanofi, Item 42).

In a subsequent decision in Case No. 577/13 (Actavis v Boehringer Ingelheim), even though by a different chamber of the ECJ, a similar fact pattern was decided. The ECJ stated that, 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”. The concept pursued in Actavis v Sanofi and Actavis v Boehringer Ingelheim is often referred to as the “core inventive advance” test, which was applied by the ECJ in the assessment of Article 3(c) of the SPC Regulation.

However, as discussed above, in the more recent Royalty Pharma decision focusing on Article 3(a) of the SPC Regulation, this concept was explicitly rejected by the ECJ for assessing whether a product is “protected by a basic patent in force” (the requirement of Article 3(a) of the SPC Regulation).

Before this background, the Finnish Court questioned whether the “core inventive advance” concept is still valid for Article 3(c) of the SPC Regulation. Therefore, in its referral questions, the Finnish Court asked for clarification of which criteria are to be applied to assess whether an SPC has already been granted for a product under Article 3(c) of the SPC Regulation and whether the assessment of Article 3(c) is different from the requirements of Article 3(a), and if so, where it differs.

Further, it was asked whether the interpretation of the ECJ in the recent decisions on Article 3(a) of the SPC Regulation would be relevant for Article 3(c), in particular the ECJ’s statements on the importance of the claims as well as the assessment of the facts from the skilled person’s view and the state of the art as at the effective date of the basic patent. This latter question appears to be directed at the fact that any alleged advantage of the combination product in question relied upon by the patentee is purely based on post-published information only, while the basic patent itself does not disclose any specific information on the combination in question.

In this context, the German Federal Patent Court, in Decision No. 3 Ni 2/20 relating to the parallel SPC for sitagliptin and metformin in Germany, decided that the patentee was not allowed to show by post-published data that the combination in question would constitute an innovation in itself (Item 2.3). The German Federal Patent Court also saw no need for a referral to the ECJ but relied on the existing ECJ case law on Article 3(c) of the SPC Regulation, which, in the court’s opinion, was explicitly confirmed in Teva by several references to these decisions. The SPC holder appealed Decision No. 3 Ni 2/20 in Case No. BGH X ZR 64/21.

The underlying case from the Irish referral has a very similar fact pattern as the case referred by the Finnish Market Court. It relates to a further combination, namely ezetimibe and simvastatin, for which combination and mono-product ezetimibe SPCs have been granted based on the same basic patent. The Irish High Court revoked the ezetimibe and simvastatin combination SPC for non-compliance with Article 3(a) of the SPC Regulation, as the court was convinced that more is required to fulfil the requirements of Article 3(a) than the mere mention of the applicable combination in the claims of the basic patent. The Irish Court of Appeal, in essence, confirmed the revocation of the SPC, agreeing with the Irish High Court’s conclusion that the basic patent did not cover the combination product since the product would not fall under the invention covered by the patent. The Irish Court of Appeal further concluded that, because the product covered by the basic patent was ezetimibe, the product for the purposes of Article 3(c) of the SPC Regulation must also be ezetimibe (ie, the requirements of Article 3(c) of the SPC Regulation would not be fulfilled).

However, the referring opined that in the various jurisdictions throughout Europe, the decisions have not uniformly been issued so that no acte claire situation could be relied on. In view of the diverging decisions, the Irish Supreme Court decided to refer questions to the ECJ for another preliminary ruling. The Irish Supreme Court questioned whether it sufficed for Article 3(a) of the SPC Regulation that the product in question is expressly identified in the claims or whether novelty and inventiveness had to be shown for the product in question, or whether a narrower concept described by the invention had to be fulfilled and, if the latter were the case, what must be established to obtain a valid SPC.

Moreover, the referring court asked, in essence, whether in the present situation a patentee could obtain an SPC for:

• the innovative compound alone;
• a product comprising the innovative active compound; or
• any or all of the combination products identified in the claims of the basic patent (eg, several SPCs based on lists of possible combination partners in the claims).

Moreover, the court wanted to obtain clarification on the issue of if the claims of a patent cover both a single novel molecule and a combination of that molecule with an existing and known drug or several such claims for a combination, does Article 3(c) of the SPC Regulation limit the grant of an SPC either to the mono-product (if marketed) or the first marketing of a product covered by the patent (irrespective of whether it is the mono- or combination therapy), or can the patentee elect whether to protect the mono- or combination product (irrespective of the date of the first marketing authorisation) – and, if so, why.

Again, as in the case of the combination of sitagliptin and metformin, the German Federal Patent Court issued a decision on the validity of the German SPC for the combination of ezetimibe and simvastatin (File No. 3 Ni 4/19). In Germany, as both SPCs were granted by the national authority on the same day, patentee argued that the requirements of the Article 3(c) were fulfilled since there was no earlier SPC. The German Federal Patent Court rejected the argument, referring to Actavis v Sanofi and arguing that the first SPC would not be determined by the order of grant but by the first marketing authorisation, since the SPC should only compensate for the delay in marketing of the invention, which would end with the first marketing authorisation (Actavis v Sanofi, Item 31). The German Federal Patent Court’s decision was not appealed by the patentee and, thus, is in its final stages in Germany.

Conclusion

It is to be expected that the developments in ECJ Reference Nos. C-119/22 and C-149/22 will be closely watched by the pharmaceutical industry, as these decisions may affect the protection strategies for medicinal products.

It remains to be seen how the national granting authorities and courts will interpret the criteria set by the ECJ. Whether a product that is not individualised in the basic patent requires an independent inventive activity may be difficult to assess for a national authority examiner or by a court. For example, in cases where no later patent for the individualised product in question exists, does the examiner have to assess on his or her own motion whether the product is – in view of the prior art at the effective date – to be based on independent inventive activity? Such an approach may require the assessment of inventive activity for the product in question in view of a basic patent and may include patentability assessments. Even where a later separate patent exists that individualises the product in question, this new criterion may still be problematic since it must be assessed whether the product is to be considered to be based on independent inventive activity. How the term “independent” should be interpreted in this context will certainly be the subject of future discussions.

If, however, in this context, the sole existence of a later patent individualising the product is considered sufficient to deny the fulfilment of the requirements of Article 3(a) of the SPC Regulation, this may question the validity of various SPCs granted in the past. For example, it is common practice that new compounds are disclosed and claimed in an initial application, as well as individually in their relevant pharmaceutically acceptable salts. Later studies on the compounds may show that a specific salt, not individualised in the initial application, exhibits beneficial properties, which result in additional (later) patent filings covering the specific salt. Would an SPC for a specific salt be considered invalid if that specific salt of the said compound is not individualised in the earlier basic patent, but in the later one?

If the courts pursue a narrow interpretation of the term “independent inventive activity”, it may well be that the granting practice of the national authorities will have to be adapted for such an interpretation. Therefore, patentees should carefully select suitable basic patents for their SPC applications. In view of the present decisions, generics companies should analyse whether the new criteria set by the ECJ will open new opportunities for early market entry.