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.