France: Update on the validity requirements for SPC combination products

During the second half of 2017, two important decisions have clarified the validity requirements for a supplementary protection certificate (hereinafter “SPC”) on a combination of active ingredients.

Both decisions discussed below - the first handed down on a request for a preliminary injunction (Paris Court of First Instance, Interim Judge, 05 September 2017, No. 17/57110), the second rendered in the context of a revocation action against a SPC (Paris Court of First Instance, 30 November 2017, No. 16/14466) - have been rendered in a Pan-European context and in light of the Court of Justice of the European Union (CJEU) case law.

In the first case, a generic manufacturer (hereinafter company X) obtained, on 16 December 2016, a generic marketing authorization for the combination “Emtricitabine/ Tenofovir disoproxil”, whose reference product is TRUVADA®.

Upon the expiry of the European patent (ie on 26 July 2017) owned by TRUVADA® manufacturer (hereinafter company G), company X has launched its generic version of TRUVADA®.

Under these circumstances, company G requested a preliminary injunction under urgency proceedings on the basis of its French SPC No. 05 C 0032, covering the following combination: “Tenofovir disoproxil and salts, hydrates, tautomers and solvates thereof in combination with other therapeutic compounds such as emtricitabine”. In reply, company X raised invalidity arguments before the interim judge.

In the second case, the same generic manufacturer filed a revocation action against the French SPC No. 08 C 0021 owned by company M. This SPC covers the combination of three following active ingredients: Efavirenz, Emtricitabine and Tenofovir disoproxil.

The Pan-European context

 For more than a year, the national courts and offices have been dealing with the assessment of the validity of the SPCs covering, on the one hand, the combination of Tenofovir disoproxil with Emtricitabine and, on the other hand, the combination of those two active ingredients with Efavirenz.

The national equivalents of the French SPC No. 05 C 0032 are subject to pending revocation actions in Italy, in Germany and in the United Kingdom.

In that regard, in the United Kingdom, Mr Justice Arnold referred the following question to the CJEU on the construction of the Regulation No. 469/2009: “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?” The CJEU ruling is expected some time in the first half of 2018.

Moreover, in Spain and Germany, the preliminary injunction applications requested on the basis of the national SPCs covering the combination of Emtricitabine with Tenofovir, have been dismissed.

As regards the national equivalents of the French SPC No. 08 C 0021, on the combination of Emtricitabine, Tenofovir with Efavirenz, revocation actions had been introduced against them in Italy and in the United Kingdom.

In the United Kingdom, the corresponding SPC has been held invalid by the High Court on 21 March 2017.

Position of the French judge

In the decisions discussed below, the judge has adopted a highly similar reasoning to reach an identical conclusion: the SPCs covering, on the one hand, the combination of Emtricitabine with Tenofovir, and on the other hand, the combination of those two active ingredients with Efavirenz, do not fulfil the requirements set by Article 3 of the Regulation No. 469/2009.

In particular, it has been found that the subject of the SPCs at stake was a combination of active ingredients which was not protected by the basic patent, according to Article 3(a) mentioned above.

In those cases, the judge recalled the CJEU case law regarding Article 3 of the Regulation No. 469/2009:

As regards the construction of Article 3(a) of the Regulation No. 469/2009:

  • In the Medeva (Case C-322/10) and Queensland cases (Case C-630/10), the CJEU laid down the principle that the active ingredient covered by the SPC has to be specified in the wording of the claims of the basic patent.

Both decisions recall that the CJEU has rejected the criterion of infringement: the product covered by the basic patent should not be understood as referring to any product that could be judged as constituting an infringement of the basic patent.

  • In the Eli Lilly case (Case C-493/12), this principle has been tempered by the CJEU stating that it is not necessary for the active ingredient to be identified in the claims of the basic patent by a structural formula.

Where the active ingredient is covered by a functional formula in the basic patent claims, a SPC can be granted if, it is possible for the skilled person to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.

As regards the construction of Article 3(c) of the Regulation No. 469/2009:

  • In the Sanofi case (Case C-443/12), the CJEU postulated as a principle that the products that the patent protects as such are necessarily the “core inventive advance” embodied by the basic patent.

Combining the construction of Articles 3(a) and 3 (c), the judge has summarized, in identical terms in both decisions, the validity requirements for a SPC on a combination of active ingredients:

It is necessary that none of the products would have already been the subject of a first SPC, that the combination is itself identified in a claim, and the product added to a first molecule should be defined either explicitly or implicitly but necessarily and in a specific manner pursuant to the provisions of Article 69 EPC; in addition, this combination should constitute the core of the invention.

The second active ingredient should not be defined in generic terms.

If there is a functional claim involved, the claim does not need to repeat the structure of the combined product but the product thus claimed must be necessarily and specifically identifiable by the person skilled in the art.

Pursuant to these validity requirements the interim judge found that the combination of Emtricitabine with Tenofovir, as referred to in the SPC, was not identified in the wording of the claims of the basic patent.

The claim at stake was drafted as follows: “A pharmaceutical composition comprising a compound according to the one of claims 1 to 25, together with a pharmaceutically acceptable carrier, and optionally, other therapeutic ingredients”. The judge found that the claim is drafted so broadly that it does not cover the combination of Tenofovir disoproxil and Emtricitabine, as referred to in the SPC.

In the second case, the claims of the basic patent covered:

  • the combination of Efavirenz with a nucleoside analog, and
  • the combination of Efavirenz with one or several inhibitors of HIV.

According to the Paris Court of First Instance, it cannot be supported that the combination of the three active ingredients is covered by those claims:

  • Neither Tenofovir nor Emtricitabine were identified in the basic patent, whether individually or collectively in a composition;
  • No indication makes it possible for the skilled person to select Emtricitabine and Tenofovir as nucleoside analogs; and
  • No combination with Emtricitabine and Tenofovir could be evaluated since those two active ingredients were not even known as anti-HIV drugs at the priority date of the basic patent.

In both cases reviewed, it has been found that the SPCs did not cover a combination protected by the basic patent.

As a second step, although the claims at stake of the basic patents were not considered as functional, the judge applied the principles laid down in the Eli Lilly case for the purpose of assessing the validity of the challenged SPCs, in both cases.

In the decisions reviewed, the judge relied upon the test performed by the Dutch patent office leading to the rejection of the SPC application on the combination of Emtricitabine with Tenofovir in order to assess whether:

  • Emtricitabine is sufficiently taught by the basic patent as being the necessary therapeutic ingredient referred to in the claim at stake (first case); and
  • Emtricitabine and Tenofovir are sufficiently taught by the basic patent as being the necessary therapeutic ingredients referred to in the claims at stake (second case).

A four-step test was described in the Dutch decision:

  • Would the skilled person have thought that the therapeutic ingredient identified in the claim at stake is an active therapeutic ingredient?
  • Would the skilled person have immediately thought of antiviral agents?
  • Would the skilled person have immediately thought of anti-HIV agents?
  • Would the skilled person have immediately thought of Emtricitabine as anti-HIV agent?

In the two cases, the French judge pointed out that no relevant element had been reported in the patent description to suggest that the skilled person would have chosen the active ingredient(s) as therapeutic ingredient(s).

Thus, notwithstanding the appropriate qualification of the claims in the basic patent, in both cases, the French judge concluded that Article 3(a) of the Regulation no. 469/2009 has been breached.

The discussed decisions evidence that it seems that there is convergence of views between the national courts and offices as regards the criteria for determining whether a product covered by a SPC is protected by the basic patent, in accordance with Article 3(a) of the Regulation no.469/2009.

Nevertheless, the standardization is not perfect, as highlighted by the referral question submitted by the British judge on this occasion.

Indeed, according to Mr Justice Arnold, the implementation of the requirements set by the CJEU in the context of the Eli Lilly case is necessary but insufficient: in addition, the combination of active ingredients, as such, shall constitute the technical contribution of the basic patent, whether the claim is structural of functional.

One notes that the French judge seems, on the contrary, to consider that this requirement should only apply in cases where the claim is structural.

At the end of the day, the CJEU interventions on the construction of Article 3(a) of Regulation No. 469/2009 do not provide the appropriate clarifications that we could expect on this sensitive issue.

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