Today, the CJEU handed down its long-awaited judgment in Teva v Gilead C-121/17.
This case relates to fundamental questions regarding Article 3(a) of the SPC Regulation and the type of patents that can be used to obtain SPCs for medicinal products that contain multiple active ingredients. Article 3(a) states that an SPC may be granted if the authorised active ingredient or combination of active ingredients is “protected” by a patent, but “protected” in this context has been interpreted in numerous different ways by courts and patent offices around Europe. This divergence has not been helped by a series of judgments from the CJEU that have been widely criticised as failing to provide legal certainty.
Following a reference from the UK High Court in litigation between Teva and Gilead relating to Gilead’s SPC for Truvada® (a combination of tenofovir disoproxil and emtricitabine), the CJEU was asked to provide clarity on how Article 3(a) is to be applied for combination products.
In today’s judgment, the CJEU confirmed that active ingredients do not need to be expressly mentioned in the claims to be ”protected”, and set out the following criteria that a patent must satisfy in order to “protect” a combination for the purpose of obtaining an SPC:
“Article 3(a) […] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
- each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.”
Whether active ingredients “fall under the invention covered by the patent” and are “specifically identifiable in the light of the information disclosed by the patent” are factual enquiries that must be performed by the patent office or national court reviewing the allowability of the SPC. In the case of Gilead’s Truvada® SPC, the CJEU remitted these questions back to be considered by the UK High Court.
It remains to be seen whether the criteria established by the CJEU in this judgment will provide the certainty that rightsholders require. However, further clarification on how Article 3(a) is to be applied to Markush claims and functionally worded claims may be provided later in the year when the CJEU’s rulings in two other pending references (the Sitagliptin case (C-650/17) and Sandoz v Searle (C‑114/18)) are expected to be handed down.
Gilead is a client of the firm, which is the agent of record for the UK SPC underlying C-121/17.