Supplementary Protection Certificates (SPCs): recent developments in EU case law

However, the interpretative twists and turns of the CJEU on the SPCR, especially in relation to Article 3(a) SPC, has given rise to several legal confusions. In 1999, the CJEU ruled for the first time on the product patent protection in the Farmitalia judgment (C-392/97) Following an application for SPC, the question arose whether Article 3(a) SPCR should be interpreted in the light of the wording or scope of the protection of the claims. The CJEU indicated that the question should be resolved according to national law.

This led to divergent practices in national courts on what constitutes a “product protected by a basic patent”. Generally, the different national courts developed three “tests” to determine when a product can be considered as protected by the patent for the purposes of Article 3(a) SPCR:

• the “infringement test”: which provides that a product infringes a patent if it mimics the claims without requiring additional criteria. This approach was prevalent for a long time, allowing infringement to be assessed in a straightforward and efficient manner
• the “specifically identifiable” or “claims” test: which asserts that a product approved for an SPC must fall within the claims of the basic patent, but also be clearly identifiable in those claims and the description of the basic patent
• the test for a “core inventive advance”: which asserts that the product for which SPC protection is sought must also constitute the “core” invention of the patent

Despite the development of the these tests a lack of European harmonization on patent law still prevailed, resulting in the Court of Appeal for England and Wales consulting the CJEU on the interpretation of Article 3(a) SPCR in Medeva.

Medeva case: the CJEU's commitment to the “claims test”

In this case, the CJEU ruled that in order to obtain supplementary protection, the APIs must be “explicitly” mentioned in the claims of the basic patent.

This ruling created further uncertainty about the interpretation of Article 3(a) SPCR, and limited the options for obtaining complementary protection, as it affected medicines containing several APIs not specifically mentioned in the claims.

Eli Lilly v HGS:

In this case, the CJEU ruled that in order for an API to be considered protected by the patent it is not necessary for the API to be mentioned in the claims of that patent by means of a structural formula, where that API is covered by a functional formula contained in the claims of a European patent.

The CJEU held that the designation of a functional formula, in the context of claims interpreted with reference to the description of the invention, would be sufficient to identify “specifically, implicitly but necessarily” the API concerned.

Actavis et al. v Sanofi et al “Actavis I”, and Actavis v Boehringer “Actavis II”: A new approach from the CJEU, this time towards the “core inventive advance” test

In Actavis I, the CJEU stated that the main objective of the SPCR is to compensate specifically for the delay in the commercial exploitation of “the core of the inventive step which is the subject of the basic patent”, and not for more general forms of commercialisation of the invention “such as, for example, all successive commercialisations of an API protected by the patent in combination with other APIs merely designated in the text of the claims in generic terms”.

In Actavis I, the CJEU stated that the main objective of the SPCR is to compensate specifically for the delay in the commercial exploitation of “the core of the inventive step which is the subject of the basic patent”, and not for more general forms of commercialisation of the invention “such as, for example, all successive commercialisations of an API protected by the patent in combination with other APIs merely designated in the text of the claims in generic terms”.

In Actavis II, the CJEU argued that Article 3(a) SPCR required the basic patent to protect the product “as such”, adding that the mere literal mention of a combination in one of the claims did not in itself satisfy the requirements of the SPCR. Teva v Gilead:

In this case, it was the Grand Chamber of the CJEU that introduced the “double condition test” for combined products, requiring that the combination of APIs be implicit in the description and drawings of the patent, and that each API be identifiable according to the patent disclosure.

Royalty Pharma:

Finally, in this case the CJEU confirmed that the subject matter of the protection conferred by an SPC must be limited to the technical features of the invention protected by the basic patent, as claimed, and that the concept of the “core of the inventive step” is therefore irrelevant.

The reference for a preliminary ruling raised by the Supreme Court of Ireland on 2 March 2022:

This legal dispute concerned the validity of Merck's SPC2, which concerned the combination of Ezetimibe (which in single-dose form had obtained a first SPC - SPC1) and Simvastatin. In the proceedings, it was not disputed that Ezetimibe and also Simvastatin were “specifically identified” in the basic patent. However, the respondent Clonmel requested that SPC2 be considered invalid as the “core inventive advance” criterion was not met.

Merck alleged that this test had been expressly rejected by the CJEU in Royalty Pharma. However, both the Irish High Court and the Irish Court of Appeal decided to accept Clonmel's arguments. Faced with this uncertainty, the Irish Supreme Court referred a number of new questions to the CJEU for preliminary ruling, which, as of today's date, have not yet been resolved.

II. The proposal for a comprehensive reform of the CCP legal regime of April 2023

As a result of the divergent positions adopted across Europe, the European Commission (“EC”) has proposed a comprehensive reform of the EU's intellectual property regime, to address the significant discrepancies in the enforcement of intellectual property between Member States. To avoid and mitigate these interpretative discrepancies, the EC is considering developing guidelines/recommendations, in cooperation with national patent offices, for the application of uniform rules on the interpretation of SPCs which will aim to standardize the qualification requirements for SPCs across Europe.

Read more in our global trade secrets and patents series:

• The Unified Patent Court: emerging trends from the first nine months
• A changing landscape for AI patenting in the UK
• Standard Essential Patents: key developments for SEPs and FRAND commitments
• The limitation of patents in ongoing revocation procedures in Spain
• What’s plausible? The UK Court of Appeal revisits the ever shifting concept
• Navigating the New Frontier: AI Patentability at the European Patent Office
• Global trade secrets update