Germany: CJEU rules on SPCs for combination products

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Germany: CJEU rules on SPCs for combination products

We recently reported on the opinion of the advocate general (AG) in the case CJEU (C-121/17) concerning supplementary protection certificates (SPC) and the question of when a product, which is not explicitly mentioned in the basic patent, is protected by the basic patent, according to Article 3 (a) of Regulation (EC) No 496/2009. While it has been clarified that infringement rules cannot be applied, it is still not clear which test should be used for assessing the requirement of Article 3(a). Recently, the CJEU issued a judgment on this case which interestingly differs on this point from the opinion of the AG.

In the underlying case, the validity of an SPC for the combination of tenofovir and emtricitabine, marketed as Truvada by Gilead, is questioned. The focus of the basic patent is on tenofovir while emtricitabine is reflected in the patent claims only by the term "optionally other therapeutic ingredients". The patent specification does not mention emtricitabine or any other active for combination therapy.

For the assessment of whether the product of the SPC is protected by the basic patent, the AG suggested a rather strict disclosure test, requesting that each of the active ingredients is "precisely and specifically identifiable" in the patent. The AG also explicitly rejected an assessment of whether the SPC product makes use of the "core inventive advance" of the protected invention as was proposed by the referring UK court.

In its decision, the CJEU both avoids the terminology of "precisely identifiable" and also does not agree with the AG in explicitly rejecting the core inventive advance test. Notably, while the AG did not distinguish between combination products and mono products, the CJEU explicitly limits the order of the judgment to combination products.

For the purposes of determining what is protected under Article 3(a), the CJEU seems to advocate a two-pronged test. Firstly, whether the combination of the active ingredients, in light of the description of that patent, makes use of the invention needs to be assessed. Secondly, each of those active ingredients must be specifically identifiable in light of all the information provided by the patent. For the combination of tenofovir and emtricitabine the CJEU considers the above requirements not fulfilled, but emphasises that this has to be decided by the national courts based on the national rules defining the extent of protection.

This can hardly be seen as a rejection of the considerations underlying the core inventive advance test and an endorsement of a strict disclosure requirement. It remains to be elucidated what is meant by "specifically identifiable" and whether different requirements apply for mono products and combination products. The two pending referrals directed to mono products will further sharpen the requirements of Article 3(a).

wunsche

Dr

Annelie Wünsche


Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH

Elisenhof, Elisenstr 3D-80335, Munich, GermanyTel: +49 89 74 72 660 Fax: +49 89 77 64 24info@maiwald.euwww.maiwald.eu

more from across site and SHARED ros bottom lb

More from across our site

In major recent developments, the court also ruled on another request concerning access to documents and appointed a new panel to the Court of Appeal
A new foundation in Chile is giving women in the IP community the mentorship, and visibility they’ve long lacked
The EUIPO is keen to stress the benefits of mediation as a means of resolving IP disputes, but do roadblocks remain?
Åsa Gustafson, global patent paralegal manager at Zacco, provides insight into the world of a paralegal, explains how she keeps abreast of legal developments, and reveals a passion for weaving
Alif Gultom and Andrew Diamond of Januar Jahja & Partners explain why Indonesia must adopt reforms against bad-faith filings and safeguard its trademark system for the future
In the third episode of a podcast series celebrating the tenth anniversary of IP Inclusive, we discuss the ‘Women in IP’ network and the current state of diversity within the profession
Practitioners, including two ex USPTO directors, say the Patent Eligibility Restoration Act could restore clarity and predictability to US patent law, though concerns remain
News of an alliance between two Malaysian law firms and the launch of a self-help video aimed at supporting IP professionals through menopause were also among the top talking points
Speakers at the EUIPO’s IP Mediation Conference discussed how lawyers can act in tandem with clients during mediation, and the importance of showing a united front
A report that revealed top legal LinkedIn influencers are generating hundreds of thousands in advertising value is the push lawyers need to up their social media presence
Gift this article