knowledge 21 October 2026 |

New Indication? Same Product: High Court Clarifies Scope of SPC for Second Human Medicinal Use Products

Introduction

A clock starts for innovative pharma companies before a drug is even approved; generally, a patent for a pharmaceutical invention must be filed many years before the associated medicinal product will obtain a marketing authorisation that will allow it to be put on the market, with the result that the company does not benefit from the full 20 year term of patent market exclusivity. This significant issue for the life sciences industry is addressed in the EU by Regulation (EC) 469/2009 (the “SPC Regulation”) which provides for the grant of Supplementary Protection Certificates (“SPCs”). An SPC compensates companies for some of the time needed to bring a product to market by providing an additional period of protection, effectively extending the period of protection under the patent, up to a maximum of 5 years. By providing this additional protection, the SPC regime plays a crucial role in supporting lengthy and costly research and development in the life sciences sector by ensuring that it is properly incentivised.

Yet, for life science companies developing second medicinal use products, including those that span both human and veterinary use medicinal products, the SPC regime, as it currently stands, may exclude from protection certain types of innovation and research that it was designed to protect. This includes inventions comprising new formulations of an active ingredient where the active ingredient has already featured in an authorised product, even though the new formulation might have significant benefits to patients and required lengthy and expensive research, as was the case, for example, with the formulation of nab-paclitaxel, which was the subject of the CJEU’s decision in Case C-443/17 Abraxis Bioscience LLC v Comptroller General of Patents (2019).

A question arises, however, as to whether SPC protection is available where an active ingredient is authorised for an entirely different therapeutic use. Significantly, in Case C-687/18 Santen SAS v Directeur Général de L’Instittut National de La Propriété Industrielle (2020) (“Santen”), the CJEU maintained that SPC protection is unavailable where the product – being the active ingredient or combination of active ingredients – has already been the subject of an earlier marketing authorisation, even where it is the result of significant research that has led to a new therapeutic use. The recent decision of the High Court in Merck confirms that position in Ireland. These decisions mark a departure from what was widely understood to be the position pursuant to the earlier CJEU judgment in Case C-120/11 Neuirm Pharmaceuticals Ltd v Comptroller-General of Patents (2012) (“Neurim”). The case law raises important and fundamental policy issues and places the possibility of SPC reform firmly into focus.

SPC Regulation

To qualify for SPC protection, companies must meet criteria under the SPC Regulation. Article 1 defines “product” as the “active ingredient” (or combination of active ingredients), of a “medicinal product” which is the substance or combination of substances presented for treating or preventing disease (the therapeutic use)).  

Article 3 concerns the criteria that must be met:

“An [SPC] shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

1. the product is protected by a basic patent in force;
2. a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive [2001/83] or Directive [2001/82], as appropriate;
3. the product has not already been the subject of an [SPC];
4. the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.”

Although these requirements have been the subject of many disputes and references to the CJEU, Articles 3(a) and 3(c) in particular, it is Article 3(d) that is the focus of the judgments under discussion here. 

Innovation & Policy

Prior to Santen, the leading decision in this area was the decision of the CJEU in Neuirm, which concerned a veterinary product (melatonin used to regulate sheep reproduction) that was later authorised for human medicinal use (melatonin to treat insomnia).

In Neurim, the CJEU held that “[i]t is apparent from paragraph 29 of the explanatory memorandum to the proposal for [a SPC Regulation] that … a patent protecting a new application of a new or known product, such as that at issue in the main proceedings, may, in accordance with Article 2 of the SPC Regulation, enable an SPC to be granted.” Although in that case, the earlier marketing authorisation (“MA”) had been for a veterinary product, and the referred questions were limited in that sense, the judgment itself was stated more broadly and referred to “a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications”.  In essence, the CJEU held that the “product” for the purpose of the SPC Regulation should be read in light of the patent relied upon for the purposes of the application for the SPC and specifically the therapeutic use so protected.  

Santen

In Santen, the CJEU found that a strict view of the term “product”, being the active ingredient or combination of active ingredients of a medicinal product, without reference to its use, is the correct approach to the interpretation of the SPC Regulation. It considered that the protection conferred on the product by the SPC, although it extends only to the product covered by the MA, covers, on the other hand, any use of that product as a medicinal product which was authorised before the expiry of the SPC. It follows that, contrary to in the CJEU’s holding in Neurim, the determination of the “first [MA for the product] as a medicinal product” under Article 3(d) of the SPC Regulation, does not require consideration of the limits of the protection of the basic patent.

The CJEU, in reaching this conclusion, did not expressly consider any significance of Article 4 limiting protection under a SPC to that “within the limits of the protection conferred by the basic patent”. This limitation seems potentially relevant, when considering the balancing of interests, in so far as the scope of an SPC connected with a second medical use patent would be limited in that manner. It also raises the question, following the logic of the Court, as to whether the position should be different if the first SPC was granted further to a use limited patent such that the subsequent use fell outside of the scope of the first SPC.

Part of the motivation for the CJEU’s narrow approach may be reflected in the concerns expressed by the opinion of Advocate General Saugmandsgaard in Santen, which pointed out that permitting SPCs for second medicinal uses may lead to a concentration of “research efforts on safer and more marginal innovations (“incremental innovations”) rather than on risky innovations leading to real therapeutic breakthroughs (“fundamental innovations”).”

Either way, without ruling out the possibility of future twist and turns, in an area that has been fraught with legal uncertainty and multiple CJEU references, the bright line rule that appears to emerge from Santen would at least benefit from a relative ease of application, including before national patent offices.

Developments in Ireland

The application of Santen was subsequently tested in Ireland in Merck. On 9 February 2018, Merck applied to the Controller for an SPC in respect of Mavenclad. If granted, the SPC would have expired on 19 December 2030. Mavenclad is a product for the treatment of relapsing remitting multiple sclerosis (RRMS). The main active ingredient is a compound called cladribine, and its innovation relates to its dosage regimen. Cladribine was the active ingredient in another, earlier product, Litak, which was produced by a different company. Litak is authorised for use in the treatment of hairy cell leukaemia. Litak was the subject of an earlier marketing authorisation and an earlier patent.

The Controller refused Merck’s SPC application on the basis that that cladribine already had prior market authorisation and therefore could not satisfy the requirements of the SPC Regulation. Merck appealed the decision of the Controller to the High Court. Merck’s grounds of appeal largely focussed on the definition of the word “product” in the SPC Regulation, as well as the underlying policy of establishing SPC protection for innovative products requiring clinical trials and marketing approval and that this should extend to second medicinal use products.

Application of the SPC Regulation and Santen in Merck

The Court rejected Merck’s submission that the narrow view of “product” would preclude second medicinal use products from SPC protection, contrary to the intention of the SPC Regulation, holding that “in essence Merck is endeavouring to find an ambiguity [in the SPC Regulation and the case law] where none exists”. The Court refused the appeal on all grounds and declined to refer the case to the CJEU. It held that the Controller was correct to draw a distinction between new SPC applications for an existing product which has not previously been authorised as a medicinal product (SPC permissible), and new applications for a product which has an earlier marketing authorisation (SPC impermissible).

The Court considered the “CJEU has been very clear in its interpretation of Article 3(d) [in Santen], and that is a matter that binds this court.” It also considered that in Santen the Court expressly found that the strict definition of “product” and its application in the context of Article 3(d) achieved a balance between the need to protect the process of pharmaceutical research and the public health objectives of the SPC Regulation. While the Court noted that it “may well be arguable at a policy level that the balance struck by the Court in Santen […] is a balance that does not afford sufficient protection for the product of research that leads to MAs for second medical use products. That is a matter for the EU legislature and not a matter for this court. It is a policy argument about the manner in which the 2009 Regulation is drafted rather than a complaint about its interpretation.” Finally, after reaching its own conclusion, the Court also noted that its decision was consistent with comments by the Court of Appeal of England & Wales in Merck Serono SA v Comptroller-General of Patents [2025] EWCA Civ. 34.

Comment

While the decisions in Santen and Merck brings welcome certainty and a coherent definition of “product” across the EU, arguably the result is a situation where insufficient regard is paid to the effort and investment needed to test and obtain marketing approval for second medicinal use treatments, which can make valuable contributions to improving, treating or preventing diseases.

As the High Court observed “while Merck understandably is concerned about [Santen’s] implications [for research and innovation], those concerns in truth are directed to the policy in the Regulation rather than to the question of how the Regulation should be interpreted”. Notably, there are examples of a more flexible approach in practice and, for instance, the UK Patent Office has on occasion been prepared to grant SPCs based on new formulations of long authorised actives where the reformulation has taken place at molecular level, for example with liposomal formulations of antifungals. While that approach may sit uneasily with Santen, it also reflects the issues that have arisen with the application of the SPC Regulation to combination cases and the difficulty with applying a narrow concept of “product” across materially different pharma innovations. The pending referral to the CJEU in C-15/26 Boehringer Ingelheim v GPTO (2026) may provide further guidance on this issue. The case concerns an SPC sought for ciclesonide following its authorisation for the treatment of asthma in horses and its subsequent use for the treatment of asthma in humans. Notably, SPC protection has been granted in the Czechia, Austria and Italy, but refused in France, the Netherlands and Germany on the basis that the application failed to satisfy Article 3(d) of the SPC Regulation.

As reform to the SPC Regulation under proposals for the new European Biotech Act gathers momentum, the policy questions raised by Santen and applied in Merck may come under renewed scrutiny. In the meantime, the recent judgments provide clarity on the legal test for SPC protection under the current regime, at least in so far as second human medicinal use products are concerned.