Posts Tagged ‘Combination Product’
July 26, 2018 by IPAlchemist
The CJEU gave its ruling yesterday in case C-121/17 in the case of Teva v Gilead. This concerns the SPC for the combination of tenofovir and emtricitabine (marketed by Gilead as Truvada ®), which was granted in the UK and which Teva and others were seeking to revoke. There was no SPC for the tenofovir alone, as far as I can tell, because the EU marketing authorisation for the mono product was granted within 5 years of the application date of the basic patent EP 0915894. Gilead has successfully argued that the patent, which did not mention emtricitabine, could serve as the basic patent for a combination SPC following authorisation of the combination, because claim 27 referred to:
A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.
In proceedings in the Patents Court, Mr Justice Arnold considered that the CJEU jurisprudence on combination SPCs was still insufficiently clear, so he referred yet another question on Article 3(a) of the SPC Regulation to the CJEU:
‘What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation No 469/2009?’
He offered a view – that it related to the inventive advice or technical contribution of the patent – stating at :
In my view, the answer is that the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent.
The Advocate General disagreed and proposed that the criterion should be whether:
“on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.”
The CJEU has not gone with either of these proposals, but has instead set out a test which is a more nuanced version of the AG’s test and which I think, for the first time, is tolerably clear and can reasonably be applied to future cases.
The ruling states:
Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, 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.
While emphasising that this is a matter for the referring Court, the CJEU makes clear how the test should be applied to the facts of the underlying case:
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.
Like theologians poring over the latest papal encyclical, SPC enthusiasts have leapt on this judgment to try and work out what it really means. Unlike the gnomic utterances in Medeva (“specified in the wording of the claims of the basic patent”) and Lilly v HGS (“the claims relate, implicitly but necessarily and specifically, to the active ingredient in question”), some clarity and method is beginning to emerge.
What the CJEU is saying is that the active ingredient, or in the case of a combination product, each active ingredient in the combination, must specifically be indicated in the patent as being part of the invention. And by the “invention”, is not meant any consideration of the “clever bit” or inventive advance (as suggested by Arnold J) – the CJEU is relying only on the law that relates to the extent of protection and extent of invention – Article 69 EPC and Section 125 of the Patents Act. According to s125, the invention is “that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification”, and it is precisely that which the CJEU is referring to. The CJEU correctly rejected the AG’s opinion that focused on the claims alone, because Art 69 and s125 include the description and drawings as being part of the interpretative means. But the CJEU also said that the prior art can be taken into consideration, and it seems this would be relevant if the particular active ingredient in question was referred to in the patent indirectly in a manner that would lead the skilled person, in the light of the prior art, to the specific active ingredient.
By “specifically”, the CJEU means that the particular active ingredient must be somewhere indicated, and not simply a generic description that did not lead to the specific compound. The indication might be in the claims, in the description, or possibly in the prior art if, for example, the compound was sufficiently well known. How specific is needed is still a little unclear – obviously “other therapeutic ingredient” as in the current case is not enough (at least if the compound was not already known, but probably in any case). I would expect that a broad functional term would also not be enough. A therapeutic class might suffice, but I would expect that this might depend on how broad the class was, and how well known the particular active ingredient was within it. Hopefully two further CJEU cases will clarify this – in both the question is whether the term in the claim is specific enough to support an SPC. In the case of Sandoz v Searle, the claim specifies a broad structural formula, but not the exact combination of substituents leading to the specific compound, which is not disclosed in individualised form in the patent. In the Sitagliptin case, the term in the claims is a functional term. Good judgments in those cases would serve to clarify the situation a great deal.
So will patent attorneys now start adding lists of known drugs into patent applications for new chemical entities? And would this be effective to support a combination SPC? We may well see this happen, but I expect that if a whole pharmacopoeia of compounds is mentioned in the specification, the CJEU may ultimately rule that none of them is specifically disclosed as being part of the invention.
For the avoidance of doubt, I disagree with all of the jurisprudence on this topic. My preference would be a simple infringement test – if the active ingredient, combination or otherwise, would infringe the patent, then it should satisfy Art 3(a). But that ship has long sailed, and even the Swiss courts have now moved away from the infringement test. It seems that the best we can hope for now is clarity on the test that the CJEU intend to be used.