The company GILEAD markets under the name TRUVADA®, an antiretroviral drug indicated for the treatment of HIV patients. This medicine contains two active substances, tenofovir disoproxil and emtricitabine, which have a combined effect for this treatment.
Gilead is the holder of European Patent EP 0 915 894 (the basic patent) which relates to "Nucleotide analogues", useful for the therapeutic treatment of several viral infections in humans or animals, in particular HIV, and claims specifically tenofovir disoproxil.
The patent also claims that these compounds may be combined together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.
The terms "other therapeutic ingredients" are however not defined or explained in the basic patent.
Gilead has obtained a SPC on the basis of this basic patent and the MA of TRUVADA® in various European countries, including the United Kingdom. This SPC is directed to a composition:
“containing tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with emtricitabine”.
The question relating to the validity of this SPC under the provisions of Article 3 (a) of Regulation No. 469/2009 has been referred to the CJEU by the High Court of Justice (England & Wales), Chancery Division.
- The court first recalls basic principles:
- Regarding the application of Article 3 (a) of the Regulation
- In particular, the Court emphasizes that the role of the SPC is not to extend the scope of the protection conferred by the patent beyond the invention covered by the patent. It would indeed be contrary to the objective of Regulation No 469/2009 to grant a SPC for a product which does not fall within the scope of the invention covered by the basic patent, since such a SPC would not relate to the results of the research claimed by that patent.
- The protection conferred by a SPC shall be limited to the technical features of the invention covered by the basic patent, as claimed by that patent.
“the product is mentioned in the wording of one of the claims or at least, if not mentioned by name, is necessarily and specifically identifiable as such by the person skilled in the art”,
- “And that when it is a combination of active ingredients, each active ingredient is also mentioned in the claims or failing necessarily and specifically identifiable individually”,
- “being specified that it is possible to accept that to be considered as protected by the basic patent an active ingredient is not mentioned in the basic patent claims by means of a structural definition but simply a functional definition. it is also important to establish that these claims, interpreted inter alia in the light of the description of the invention, as prescribed by Article 69 of the Convention of 5 October 1973 on the Granting of European Patents (EPC) and its interpretative protocol, implicitly but necessarily aim at the active ingredient in question and specifically.”
It will be interesting to see how the Court of Justice will apply these criteria in the two pending cases:
Case C 650/17 QH lodged at the Registry of the Court on 21 November 2017 by the Bundespatentgericht.
- Is a product protected by a basic patent in force pursuant to Article 3(a) of Regulation (EC) No 469/2009 (1) only if it forms part of the subject matter of protection defined by the claims and is thus provided to the expert as a specific embodiment?
- Is it not therefore sufficient for the requirements of Article 3(a) of Regulation (EC) No 469/2009 if the product in question satisfies the general functional definition of a class of active ingredients in the claims, but is not otherwise indicated in individualised form as a specific embodiment of the method protected by the basic patent?
- Is a product not protected by a basic patent in force under Article 3(a) of Regulation (EC) No 469/2009 if it is covered by the functional definition in the claims, but was developed only after the filing date of the basic patent as a result of an independent inventive step?
Case C 114/18 Sandoz and Hexal lodged at the Registry of the Court on 14 February 2018 by the Court of Appeal United Kingdom.
Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] (1) is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?