Germany: AG provides an advisory opinion on Article 3(a) of the SPC Regulation

Managing IP is part of Legal Benchmarking Limited, 4 Bouverie Street, London, EC4Y 8AX

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

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

Germany: AG provides an advisory opinion on Article 3(a) of the SPC Regulation

At the end of April 2018, Advocate General (AG) Wathelet handed down an advisory opinion regarding the first of three recent referrals to the CJEU (C-121/17). This concerns the interpretation of Article 3(a) of Regulation (EC) No 469/2009.

In the main proceedings, Teva and others challenged the validity of Gilead's SPC/GB05/041 covering a composition containing tenofovir disoproxil (TD) and emtricitabine. The composition is used in the prevention and treatment of HIV and is marketed by Gilead under the trade mark Truvada.

The supplementary protection certificate (SPC) was granted based on the marketing authorisation and claim 27 of EP 0 915 894 B1, which relates to a pharmaceutical composition comprising TD and optionally other therapeutic ingredients.

Against this background, the referring UK court asked the CJEU which criteria needed to be applied in order to decide whether a product is protected by a basic patent in force and proposed applying the core inventive advance test to Article 3(a) of the regulation.

The AG emphasised the importance of the claims in determining whether a product is protected while rejecting the further assessment of whether the product constitutes the core inventive advance of the basic patent. According to the AG, this assessment could be confused with the criteria determining whether the invention is patentable, which is different from the question of product protection under Article 3(a).

The fact that a product falls within the scope of protection of a basic patent under Article 69 EPC does not necessarily mean it is protected by the patent under the regulation. The AG summarised that a product is protected within the meaning of Article 3(a) if it would have been obvious to a skilled person at the priority date of the basic patent, that the product (in a combination, each active ingredient in that combination) was specifically and precisely identifiable in the wording of the claims.

Since the term "optionally other therapeutic ingredients" would constitute the only identification of emtricitabine in the claims of the basic patent, the AG considered that the "specific and precise identification" criterion is not fulfilled. Although the opinion is non-binding, if followed, it might mean that EU authorities take a stricter approach to Article 3(a) than they have taken to date.

Since the opinion provides little guidance on what is meant by "specifically and precisely identifiable" regarding products defined by generic terms, it remains to be seen whether the CJEU will follow the AG's opinion and/or provide more concrete guidance on the interpretation of Article 3(a) of the regulation.

Sybille Pfender


Maiwald Patentanwalts GmbHElisenhof, 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

Managing IP considers some of the key themes from the 2025 Annual Meeting and offers some tips for London 2026
A comparison of the 2024 and 2025 editions of the Managing IP EMEA Awards reveals the firms and companies that have been dominating Europe’s IP market year after year
Tuesday's coverage includes BD tips for aspiring partners, and a foray into the world of SEPs
Exclusive data reveals law firms are failing to go above and beyond for their corporate clients, with in-house counsel saying advisers should consider more transparent billing processes
Arty Rajendra and Gary Moss discuss why ‘thorough and intense’ preparation, plus the odd glass of wine, led to a record FRAND victory for their client
Monday’s coverage includes news of a potentially 'game-changing' trademark development in China and how practitioners are using AI
Managing IP gives a taster of the numbers behind this year’s IP STARS trademark rankings, and looks back at our 2025 award winners
Updates from IP offices, the shifting requirements of in-house counsel, and news of London 2026 were among major talking points on Sunday
Etienne Sanz de Acedo discusses the association’s three-year plan, what he is looking forward to in San Diego, and why London came calling for 2026
Professionals from three organisations reveal what led them to sponsor Brand Action and why doing so can build camaraderie
Gift this article