The SPC is invalid if the combination of the active ingredients is not protected by its basic patent

Wednesday, 20 of March of 2019

When a medicinal product of a combination of several active ingredients can be considered protected by the basic patent in order to fulfil the requirement to obtain a Supplementary Protection Certificate (hereinafter "SPC")?

This is what the Court of Justice of the European Union has had to clarify (hereinafter "CJEU") in its Judgment of 25 July 2018 in the Case C‑121/17, following a request for a preliminary ruling from the High Court of Justice (England & Wales), Chancery Division (Patents Court) handling the judicial proceedings dispute between TEVA, MYLAN and others against GILEAD. The answer to that question has been given by the CJEU In the aforementioned Judgement, in which it declares that Article 3 (a) of Regulation (EC) nº 469/2009 of the European Parliament and of the Council, of 06.05.2009, concerning the SPC for medicinal products(hereinafter “SPC Regulation”), 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”.

In this sense, Section nº 15 of Barcelona Appellate Court has already had to apply the aforementioned interpretation of the CJEU in a litigation in Spain: in its Order of 18 December 2018 (Auto nº 183/2018), which dismisses the appeal against the decision of the Commercial Court that lifted preliminary injunction granted ex parte. The Appellate Court maintains the decision of first instance having reached the conclusion that the SPC seems to be invalid because the combination of active ingredients of the medication object of the SPC is not protected in the basic patent.

Origin of the dispute

The plaintiff GILEAD filed claims (accumulated with preliminary injunction applications) against TEVA and MYLAN, for the infringement of its SPC C200500034 (hereinafter “SPC 034”), whose basic patent is ES2198003, which protects the medicine composed of the combination of emtricitabine + tenofovir disoproxil, which is marketed in Spain for the treatment of HIV infection under the trademark Truvada®. The purpose of these claims and preliminary injunction applications was to ban TEVA and MYLAN from marketing their generic medicines with the same combination of active ingredients. The Court of first instance initially granted the preliminary injunction ex parte. Subsequently, TEVA and MYLAN opposed essentially arguing that SPC 034 is null for infringing article 3 (a) of the SPC Regulation since the basic patent does not protect, in the sense required by the CJEU, a combination of emtricitabine + tenofovir disoproxil, but only tenofovir (since emtricitabine was not even described). The first instance Judge found in favor of the defendants and issued the Order of 20.10.2017 upholding the opposition and lifting the preliminary injunction. GILEAD then appealed before Barcelona Appellate Court.

SPC subject matter

Claim 27 (hereinafter “C27”) of the basic patent claims a medicine “comprising a compound according to any of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic agents”. As its claim 25 claims a medicine with the active ingredient tenofovir disoproxil, in theory the C27 of GILEAD´s patent protects a medicine comprising tenofovir disoproxil combined with emtricitabine (“another therapeutic agent”), which is precisely the medicine that is marketed under the trademark Truvada®. Based on this interpretation of C27 of the basic patent, SPC 034 was granted to extend Truvada®´s protection term.

The active ingredients of the medication subject of the SPC (Truvada®) are not protected by the basic patent

The Barcelona Appellate Court states that, according to the aforementioned Judgment of the CJEU, in order for the SPC 034 to be valid the skilled person must be able to conclude that the combination of the active ingredients of Truvada® (emtricitabine + tenofovir disoproxil) must necessarily, in light of the description and drawings of the basic patent, fall under the invention covered by that patent.

In addition, referring to another Judgment of the CJEU (Judgment of 12 december 2013 in Case C-493/12), the Court recalls that it is possible that an active ingredient which is given a functional definition in the claims of a patent being regarded as protected by said patent, on condition that on the basis of such claims, interpreted inter alia in light of the description of the invention (as required by Article 69 of the European Patent Convention and its interpretative Protocol), that these claims necessarily relate specifically, although implicitly, to said active ingredient.

Therefore, it is not enough that emtricitabine responds to the functional definition of “therapeutic agents” of C27, but it is rather necessary that the skilled person could conclude, on the priority date, that C27 by mentioning the functional definition “therapeutic agents” was implicitly and necessarily referring specifically to emtricitabine.

However, it is an uncontroversial fact that emtricitabine is neither explicitly mentioned in the claims of the basic patent, nor on its description. Therefore, according to the Appellate Court, the absence of any reference to the active ingredient cannot be replaced by the perspective of the skilled person who, according to GILEAD, could know that emtricitabine had anti-HIV activity and was being tested in clinical trials (phase I). The Appellate Court finds that this does not meet the requirement established by the CJEU as in this case it does not appear that C27 necessarily referred to said active ingredient. Thus, although a skilled person, at the priority date, based on his knowledge could consider such a combination of active ingredients as a hypothesis for the treatment of HIV, according to the doctrine of the CJEU that mere probability is insufficient. In fact, for the combination of emtricitabine + tenofovir disoproxil to be considered protected by the basic patent and could be subject to the SPC it would be essential for the skilled person to consider that the C27 of the basic patent necessarily refers to said combination, a really difficult thing to admit taking into account that, at the priority date (1996) the emtricitabine was simply being tested and its results evaluated; and that it would not be until 2003, seven years later, when its use was authorized by the health authorities.

Consequently, the Appellate Court concludes, at least provisionally (this judgment was issued on a preliminary injunction procedure), that the combination of active ingredients of Truvada® is not protected in the basic patent and, hence, that the SPC is invalid.