Article 3(a) of the SPC Regulation – clarity at last?
Since we blogged on the CJEU's judgment in Teva v Gilead (C-121/17) in July 2018, Arnold J has decided that Gilead's SPC for the combination of Tenofovir Disoproxil (TD) and Emtricitabine does not comply with Article 3(a) and must be revoked (see [2018] EWHC 2416 (Pat)).
CJEU ruling
In its judgment, the CJEU determined that Article 3(a) 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.’
High Court's decision
Following the CJEU's ruling, Gilead applied to the English High Court for permission to adduce further expert evidence, directed to what they say was a new test articulated by the CJEU, and directions for a second trial. The claimants issued applications for a final judgment to revoke Gilead's SPC.
Arnold J rejected Gilead's application on the basis that it amounted to an abuse of process because it was effectively an attempt to adduce fresh evidence after the trial and get a 'second bite at the cherry'. The evidence could and should have been brought before the trial. Arnold J also considered that it would not be in accordance with the overriding objective to give Gilead permission to adduce further evidence and direct a second trial, with the additional expense and delay which would result. Of particular note was Arnold J's analogy of the current situation with attempts to amend patent claims after trial – an issue currently before the Supreme Court in Generics v Warner-Lambert which was heard in February 2018 and on which a decision is keenly awaited (see our blog for further details).
Arnold J reached the following conclusions in relation to Emtricitabine and its combination with TD:
- The combination of TD and Emtricitabine did not necessarily, in the light of the description and drawings of the basic patent, fall under the invention covered by the basic patent. This was not a simple extent of protection test – instead the combination must be one which the skilled person would understand (on the basis of the description and drawings and their common general knowledge) to embody the technical contribution of the patent. TD embodies the technical contribution but there was nothing in the basic patent to suggest that TD and Emtricitabine could be combined to treat HIV.
- Emtricitabine was not specifically identifiable by the skilled person on the basis of the prior art at the priority date, in light of the information disclosed by the basic patent. TD is, but emtricitabine is not mentioned in the patent and is not even a member of a specific class of compounds listed in the patent. Further, there was no evidence that it was known, still less that it was common general knowledge, that emtricitabine was an effective agent for the treatment of HIV.
On this basis, Arnold J concluded that Gilead's SPC did not comply with Article 3(a) of the SPC Regulation and should therefore be revoked.
Comment
Arnold J has now set out his understanding of the test articulated by the CJEU and robustly applied that test to the facts in this case, closing the door to the hearing of further evidence.
Interestingly, the CJEU determined that the question of whether a product is protected under Article 3(a) of the SPC Regulation falls to be judged by the skilled person on the basis of the prior art at the filing or priority date of the basic patent – and this was applied by Arnold J. Prior to the CJEU decision it had been argued and accepted in the English courts that the relevant date was when the product was known. The CJEU's test seems to be a more stringent one which national patent offices will have to keep in mind when deciding whether to grant SPCs for products devised after the filing or priority date of the basic patent.