On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-121/17 Teva UK and Others v Gilead concerning the validity of Supplementary Protection Certificate (SPC) protection for Gilead's combination HIV treatment TRUVADA (tenofovir disoproxil and emtricitabine). The CJEU held that an SPC can only be granted for a product if, in the basic patent on which the SPC is sought, that product "is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically." It is for the English High Court, as the referring court, to determine whether that test is met by Gilead's patent in this case; however, the CJEU stated (on the basis of the information provided by the referring court) that it does not seem possible that the combination of tenofovir disoproxil and emtricitabine necessarily falls under the invention covered by Gilead's patent.
Gilead's Truvada is a combination of the active ingredients tenofovir disoproxil and emtricitabine. In 2008, Gilead obtained an SPC to extend patent protection for Truvada, on the basis of its patent EP (UK) 0 915 894 (the Basic Patent). The claims of the Basic Patent only expressly mention tenofovir disoproxil, and not emtricitabine; the relevant claim of the Basic Patent is to "A pharmaceutical composition comprising a compound according to any one of claims 1-25 [i.e. tenofovir disoproxil] together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients." Pursuant to Article 3(a) of Regulation (EC) No 469/2009 (the SPC Regulation), an SPC may only be granted if the relevant product is "protected by a basic patent in force." The question before the CJEU, referred by the English High Court following a validity challenge to Gilead's SPC by Teva and others, was whether the Truvada combination is "protected" by the relevant claim of Gilead's Basic Patent, which only expressly mentions tenofovir disoproxil.
Gilead argued that it is both necessary and sufficient for an SPC to be granted that Truvada falls within the extent of the protection conferred by the Basic Patent, and that the expression "other therapeutic ingredients" in the claim relates implicitly but necessarily to emtricitabine. Teva and the other challengers argued that, in accordance with previous CJEU case law, both active ingredients in the Truvada combination must be "specified in the wording of the claims" in order for the Basic Patent to "protect" that combination, and the expression "other therapeutic ingredients" in the relevant claim of the Basic Patent does not specify emtricitabine, whether structurally or functionally. The English High Court held in Teva UK Ltd & Ors v Gilead Sciences Inc  EWHC 13 (Pat) that, despite multiple references to the CJEU having already been made on this point, the test to be applied to determine whether a product is "protected" by a basic patent remains unclear. In his judgment, Arnold J reviewed the previous case law of the CJEU on the interpretation of Article 3(a) of the SPC Regulation, and noted that "If confirmation that a reference is necessary, it can be found in the divergent decisions that have been reached around Europe as to the availability of an SPC on the facts of the present case and in the differing interpretations of Article 3(a) that have been adopted in the case law of the national courts".
The interpretation of Article 3(a) has been the subject of multiple references to the CJEU and countless articles, presentations and opinion pieces, and the reference attracted observations from the Commission and the UK, Greek, Latvian and Dutch Governments. However, today's judgment is relatively brief. The CJEU held that a combination product will only be "protected by a basic patent in force" for the purposes of Article 3(a) of the SPC Regulation if the product is either expressly mentioned in the claims of that patent or "those claims relate necessarily and specifically to that combination." Where the combination is not expressly mentioned in the claim, in order for that product to be "protected" by the basic patent:
"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."
Applying that general principle to the facts of this case, the CJEU held:
"In the present case it is apparent, first, from the information in the order for reference that the description of the basic patent at issue contains no information as to the possibility that the invention covered by that patent could relate specifically to a combined effect of TD [tenofovir disoproxil] and emtricitabine for the purposes of the treatment of HIV. Consequently, it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent. The onus is nevertheless on the referring court to check whether such is indeed the case. Secondly, it is also for that court to establish whether emtricitabine is specifically identifiable by that person skilled in the art in the light of all the information contained in that patent, on the basis of the prior art at the filing date or priority date of the patent in question."
The case will now return to the English High Court for a final determination.
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