Germany: CJEU rules on SPCs for combination products
Managing IP is part of the Delinian Group, Delinian Limited, 4 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2023

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).



Annelie Wünsche

Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH

Elisenhof, Elisenstr 3D-80335, Munich, GermanyTel: +49 89 74 72 660 Fax: +49 89 77 64

more from across site and ros bottom lb

More from across our site

Sources debate the implications of an opinion by Delaware’s chief judge Colm Connolly that lambasted the NPE IP Edge
Five partners reveal how delays in examining trademark applications are affecting their advice to clients and how they pitch new work
We provide a rundown of Managing IP’s news and analysis coverage from the week, and review what’s been happening elsewhere in IP
Partners at Quinn Emanuel explain how walkie-talkie and real-estate analogies helped them win over a jury at the Eastern District of Texas
The heads of Malaysian firm HHQ’s new technology practice group say they can be frontline advisers on the intersection between AI, blockchain, and IP
Darren Jiron, Finnegan’s managing partner in London, discusses the firm’s growth plans and misconceptions about US firm culture
The EMEA region research cycle has commenced - do not miss this opportunity to nominate your work from 2023!
A former partner at Stroock & Stroock & Lavan, which voted to dissolve in October, has joined McCarter & English
As ChatGPT celebrates its first birthday, we are still grappling with a multitude of IP concerns
Sources say an official role at an IP industry body is great for generating business leads, but that shouldn’t be the only motivation behind taking on the responsibility