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SPCs and combination products: Gilead's Truvada SPC held invalid

Posted on 30 October 2018 by David Rose and Victoria Wilson

SPCs and combination products: Gilead's Truvada SPC held invalid

The UK Patents Court in Teva & ors v Gilead has decided the SPC for Truvada - a fixed-dose combination of two antiretroviral medications (tenofovir disoproxil and emtricitabine) used to treat and prevent HIV infection - is invalid. The judgment follows the CJEU's decision on questions referred by the Patents Court as to the criteria for deciding whether a product is 'protected by a basic patent in force' under Article 3(a) of the SPC Regulation. The outcome in the Patents Court, together with the CJEU's judgment, bring welcome clarity to the approach for determining whether a product is 'protected by a basic patent in force' under Article 3(a); and will be welcome news to generics and healthcare providers seeking to bring this particular combination therapy for the prevention of HIV infection to the market.

Background

We discussed the background to the reference in our April 2017 edition.  In summary, a number of generic pharmaceutical companies challenged Gilead's SPC for Truvada, a product described as a "composition containing both Tenofovir disoproxil, [TD] optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine".  However, emtricitabine is not mentioned or referred to in the patent upon which the SPC is based.  Gilead maintained that the combination of TD with the active ingredient emtricitabine fell within the scope of claim 27 of the basic patent when construed in accordance with Art.69 of the European Patent Convention.  Claim 27 provided for "a pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and potentially other therapeutic ingredients".

The CJEU decision

In July 2018, the Grand Chamber of the CJEU gave its preliminary ruling and held that a combination product will be protected by a basic patent within the terms of the SPC Regulation where, even if the combination of active ingredients is not expressly mentioned in the claims of the patent, those claims 'relate necessarily and specifically to that combination'.  This required an assessment of whether, from the point of view of a person skilled in the art and on the basis of the prior art at the filing/priority date of the patent:

  1. The combination of those active ingredients necessarily, in the light of the description and drawings of the patent, fall under the invention covered by the patent. This requires more than that the product falls within the scope of the claim; the skilled person must understand, on the basis of the description, the drawings and the common general knowledge, that the combination product to which the claims of the patent relate embodies the technical contribution made by the patent.
  2. Each of those active ingredients is specifically identifiable, in the light of all the information disclosed in the patent.

The Patents Court decision

The Patents Court has now applied the CJEU's two-stage test, and concluded that the Truvada SPC fails on both counts:

  1. From the point of view of a person skilled in the art and on the basis of the prior art at the priority date, in the light of the description and drawings of the patent, the combination of active ingredients did not necessarily  fall under the invention covered by that patent:

    "The Patent says nothing about the possibility that TD and emtricitabine may be combined to treat HIV. Indeed, it does not even mention emtricitabine. All it says…is that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients. Accordingly…there is no basis for the skilled person to understand that the combination embodies the technical contribution of the patent. TD embodies the technical contribution of the Patent, but that is a different matter."  
     
  2. From the point of view of a person skilled in the art and on the basis of the prior art at the priority date, in the light of all the information disclosed by the patent, emtricitabine is not specifically identifiable (even though TD was):

    "[Emtricitabine] is not mentioned in the Patent, nor is it even a member of a specific class of compounds mentioned in the Patent, whether by reference to their structure or activity, as being suitable for combination with the compounds of the invention. Furthermore, although emtricitabine was known at the priority date, there is no evidence that it was known that emtricitabine was an effective agent for the treatment of HIV in humans, still less that this was common general knowledge to the person skilled in the art to whom the Patent is addressed."

The Court confirmed  that the CJEU's two-stage test does not depart from its case law on the interpretation of Article 3(a) of the SPC Regulation, but represents an elaboration and elucidation of the CJEU's test in Eli Lilly, whereby the claims must relate implicitly but necessarily and specifically to the active ingredient in question.

Mishcon de Reya acted for Lupin Ltd and Lupin (Europe) Ltd, one of the claimants in this matter.

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