Has it become harder to obtain patent and specifically supplementary protection for pharmaceutical combination products?

Introduction and background

The extension of the protection term of a pharmaceutical patent through application for a Supplementary Protection Certificate (SPC) is a key opportunity or risk, depending on whether you are the patent holder or a competitor wishing to explore the patented technology. The issue concerns the very heart of the patent system: disclosure of an advance in technology in exchange for time-limited protection. The essence of SPCs is that, following their introduction as a response to the time-consuming process of patent prosecution and associated regulatory processes in the pharmaceutical field, they pose a challenge in relation to the time limitation and thus the focus of attention for stakeholders in the field. The Court of Justice of the European Union (CJEU) has introduced an ‘invention test’ for assessing whether applications for SPCs covering combination products (a pharmaceutical product containing more than one active ingredient) satisfy Article 3(a) of Regulation (EC) 469/2009. The Swedish Patent and Market Court of Appeal (PMCA) applied this test in an AstraZeneca case in mid-2025, a decision now digested and which may have significant implications for pharmaceutical patent strategy.

Article 3(a): a distinct SPC concept

In the joined cases C-119/22 and C-149/22 (19 December 2024), the CJEU clarified the SPC requirement that a product to be considered for SPC protection must be “protected by a basic patent in force”, i.e. the patent on the basis of which the SPC is sought. The clarification concerned the requirement having a meaning specific to the SPC Regulation, a meaning distinct from the normal interpretation of the scope of protection under national patent law.

Evolution of the case law

Farmitalia (C-392/97): Because patent law is not harmonised, Article 3(a) is assessed under the rules governing the basic patent.

Eli Lilly v HGS (C-493/12): The relevant rules for assessing the scope of protection are those establishing the scope of the invention (including the EPC and its Protocol on the Interpretation of Article 69 for EPO-granted patents); it was also concluded that an infringement test could not be applied.

Teva v Gilead (C-121/17): For combination products, the combination is protected if (1) it is necessarily covered by the invention in light of the description and drawings, and (2) each ingredient is specifically identifiable from the patent (the ‘Teva test’).

The new invention test (cases C-119/22 and C-149/22 from December 2024)

The Teva test produced divergent national practice, particularly in relation to products constituting combinations of a new ingredient (A) with a known ingredient (B). The CJEU in the captioned cases held that:

• Express mention of A+B in the claims alone satisfies only the second limb (2) of the Teva test.
• Where A+B is in the claims and the description states A may be used with B, the Teva test is satisfied only if A+B is necessarily covered by the invention protected by the patent.

It is therefore not sufficient that the patent merely protects or describes A+B: the combination in itself must constitute an invention going beyond monotherapy with A or B alone. The SPC Regulation aims to incentivise pharmaceutical research, not to extend protection beyond what the basic patent actually has contributed or ‘invented’. Unfortunately, the CJEU provided no guidance on how to conduct the new invention test, or indeed on how we or the national courts are to define the core terms ‘invention’ and ‘problem’ in relation to assessing whether the combination A+B is required to solve the technical problem in order to conclude that the combination “falls under the invention”. The CJEU also did not comment on the potential situation that there may be more than one ‘invention’ or ‘problem’ in the basic patent, or at what point the applicant must be able to prove that the combination constituted an invention, i.e. on the application date or at a later date. Last year, however, it fell upon the PCMA to apply both the Teva test and the new invention test.

A practical application: AstraZeneca (PMCA, 10 June 2025 in case PMÄ 15113-22)

The background is that the Swedish PTO refused an SPC for a dapagliflozin/metformin combination product; the Swedish Patent and Market Court then dismissed AstraZeneca’s appeal, upon which the PCMA did the same. This was followed by a procedural assessment in the Supreme Court, and the case was referred back to the PCMA for review. After referring questions, and a stay pending the CJEU ruling, the PMCA finally dismissed AstraZeneca’s appeal, finding that:

• Claim 1 identified dapagliflozin; dependent Claim 7 covered the combination with metformin — Teva’s second limb (2) was thereby considered satisfied.
• Regarding the first limb (1), the technical problem concerned developing safe new oral diabetes treatments to complement existing therapies.
• The patent stated merely that “it is believed” that the combination produced greater therapeutic effects, with no (or at least insufficient) supporting evidence in the specification.
• The above mere assumption could not establish a combined effect beyond simple aggregation; no such effect could be identified as a result of the research supporting the patent. The requirements under Article 3(a) were therefore considered unmet.

Strategic implications

The invention test reasonably changes SPC practice and the patent filing strategy for research-based pharmaceutical companies but also might defer from including more speculative combination claims or suggestions in patent applications. Key considerations in this context may include filing separate applications for monotherapy (A) and combination therapy (A+B) where possible, increasing efforts to demonstrate that the combination is itself an invention — ideally the principal invention — supported by experimental data and examples, balancing the value of including additional experimental data against the risk of third-party publication or filing and ultimately to consider whether the monotherapy and combination inventions may be so closely linked that an early monotherapy filing could destroy the inventiveness for a later combination patent.

Conclusion

Securing meaningful protection, including SPCs, for combination products has become more difficult. It is doubtful that the CJEU fully appreciated the consequences of the new invention test, and my personal opinion is that we might well see the CJEU forced to deal with new clarification requests. The bottom line: an SPC is not intended to allow a broader scope of protection than that provided by the basic patent.