Tenofovir disoproxil and Emtricitabine – UK

Tenofovir disoproxil and Emtricitabine – UK

On Sep 18, 2018, UK high court revoked SPC for Gilead’s Truvada® challenged by generic filers.
In these proceedings the Claimants (Teva, Accord, Lupin & Mylan) challenged the validity of the Defendant’s (Gilead’) supplementary protection certificate SPC/GB05/041 for a product described in the SPC as “Composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine”. The SPC covers a product which is marketed by Gilead under the trade mark Truvada®. It is a combination product consisting of two active ingredients, namely (i) 245 mg tenofovir disoproxil (“TD”) in the form of 300 mg of the fumarate (“TDF”) and (ii) 200 mg emtricitabine (also known as FTC) in a single, fixed dose tablet. Mr. Justice Arnold in his judgment dated 13 January 2017 referred the question to Court of Justice of the European Union (CJEU) in this matter & asked the question, “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?”
On 25 July 2018 the Grand Chamber of the CJEU handed down its judgment in Case C-121/17. It ruled as follows:
“Article 3(a) of [the 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.”

Applying CJEU judgment Justice Arnold said that if the product is not expressly mentioned in the claims of the Patent, the claims must relate to the product necessarily and specifically. For the purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in the light of the limits of that invention, as it appears from the description and the drawings of that patent. The issue here is whether a claim such as claim 27 of the basic patent (EP 0915894) in fact covers a combination such as the TD/emtricitabine combination which is the subject of the SPC at issue. 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 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. There is no dispute that TD is specifically identifiable. Also it is clear that emtricitabine is not specifically identifiable. Once again, it is not mentioned in the Patent. It is not 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.
Accordingly the SPC does not comply with Article 3(a) and must be revoked.

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