Another Chapter in the SPC Odyssey

Although Greek courts have dealt with SPC disputes on a number of occasions, there has been limited judicial analysis of one of the Regulation’s most fundamental concepts: the definition of a “product” under Article 1(b) of Regulation (EC) No 469/2009. A recent decision concerning Novartis’ heart failure medicine Entresto places this issue squarely in focus. The judgment of the Athens Court of First Instance, dated 8 July 2026, examines whether the term “product” is defined by the active ingredients in the medicinal product or by the specific solid-state form in which those active ingredients are present, and offers useful guidance on the relationship between active ingredients, forms, marketing authorisations and SPC protection.

Novartis is the proprietor of European Patent EP 1467728 (“EP 728”) with a claim to a pharmaceutical composition comprising sacubitril and valsartan (or pharmaceutically acceptable salts thereof).  Novartis relied on EP 728 and their marketing authorisation for Entresto to obtain an SPC in Greece for the product “sacubitril/valsartan including pharmaceutically acceptable salts thereof”. Entresto contains sacubitril and valsartan in the form of a complex of their sodium salts. The dispute arose after ELPEN, a Greek generic pharmaceutical company, sought to invalidate the SPC before the Athens First Instance Multi Member Court (IP division) on the basis that the requirements of Articles 3(a) and 3(b) of Regulation 469/2009 had not been met. ELPEN had obtained a marketing authorisation for VACUBIO, a generic medicine containing sacubitril and valsartan in the form of a physical mixture of sodium salts, rather than in the form of a complex.

The case centred on two questions: First, whether the SPC was supported by a valid marketing authorisation under Article 3(b); and second, whether the “product” protected by the SPC was protected by the basic patent under Article 3(a). Both issues depended on identifying the relevant “product” for SPC purposes. ELPEN argued that the complex in Entresto is a distinct “product” from the combination of sacubitril and valsartan disclosed in EP 728. Novartis argued that the “product” was simply the combination of those two active ingredients, irrespective of the form in which they were contained in the medicinal product.

Addressing Article 3(b), the Court emphasised that the “product” under Article 1(b) must have the same meaning for all four conditions of Article 3.  Further, following the CJEU case law in e.g. Forsgren (C-631-13) and MIT (C-431/04, the Court held that the “product” should be defined as the active substance(s) which produce a pharmacological, immunological or metabolic action of their own. Reviewing the EMA assessment documents, the marketing authorisation and the SmPC for Entresto, the Court found that the “product” under Article 1(b) is the combination of sacubitril and valsartan.  Based on the information in the marketing authorisation documents, it was clear that these were the only components having a pharmacological action of their own.

The Court rejected ELPEN’s contention that the complex form of sacubitril/valsartan constituted a single active ingredient distinct from the combination of sacubitril and valsartan.  The fact that the complex has different physicochemical properties was found to be irrelevant.  It did not create a new “product” for SPC purposes. The Court also pointed to the approval of ELPEN’s generic product, VACUBIO, as further support for its conclusion. Since generic authorisation under Article 10(2)(b) of Directive 2001/83/EC presupposes the same active substance(s) as the reference medicinal product, the approval of VACUBIO (which does not contain the complex) reinforced the view that the complex does not constitute a distinct ”product”. Likewise, ELPEN’s reliance on Novartis’ later complex patent (EP 828) was rejected, the Court noting that patentability and SPC validity are governed by different criteria.

Having concluded that the relevant “product” of Entresto was the combination of sacubitril and valsartan, the Court confirmed that the requirements of Article 3(b) were met.

Turning to Article 3(a), the Court considered whether that “product” was protected by EP 728. Applying the principles set out in C-119/22 and C-149/22 Merck, it noted that the active ingredients must not only be identifiable from the patent claims, but the patent must also disclose how their combination contributes to solving the technical problem underlying the invention.

The Court found that EP 728 clearly met this requirement. Claim 1 expressly identified valsartan and sacubitril, and the patent presented their combined administration as a feature required for the solution of the technical problem.. Accordingly, the combination was not merely a hypothetical combination of known substances but a core element of the patent’s technical teaching.

The Court therefore concluded that the combination of sacubitril and valsartan was protected by EP 728 and that both Articles 3(a) and 3(b) of Regulation 469/2009 were satisfied. The action was dismissed, the SPC was upheld, and ELPEN was ordered to pay Novartis’ costs.

The decision, which is open to appeal, is significant because it confirms that, for SPC purposes, the focus remains on the therapeutic active ingredients rather than the particular form in which they are delivered. It also provides useful guidance on the application of recent CJEU case law to combination products and reinforces the distinction between patentability of different forms of active ingredients and the definition of a “product” under the SPC Regulation.