On 25 April, Advocate General Wathelet issued his opinion on the interpretation of Article 3(a) SPC Regulation in the referral from the UK Patents Court in Teva & ors v Gilead following a hearing before the Grand Chamber of the Court of Justice of the EU in February 2018. The Advocate General's opinion is that a product will be protected by a basic patent if, at the priority date, 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. No date has yet been given for the decision of the CJEU itself, but we will report on this in due course.
Background
We discussed the case in our April 2017 edition. A number of generic pharmaceutical companies have challenged Gilead's SPC/GB05/041 for a product described as a 'Composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine', i.e., Gilead's Truvada product. The Patent upon which the SPC is based does not mention or refer to emtricitabine. Instead, claim 27 is 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".
Arnold J in the Patents Court had considered that the existing EU case law on SPCs and combination products (Medeva and the subsequent line of case law) was not sufficiently clear. His view was that the appropriate approach was to consider whether the product would infringe the Patent because it contains an active ingredient, or combination of them, which embodies the 'core inventive advance' (or technical contribution) of the Patent. This is not the first time that Arnold J has suggested this. In the proceedings before the CJEU, the generic pharmaceutical companies and the UK Government supported this approach, the latter submitting that it properly reflects the balance between the competing interests underlying the SPC Regulation because national IP offices are not required to undertake an assessment of inventive step (albeit it did propose a three stage approach to the assessment).
Advocate General Opinion
However, the Advocate General has not accepted Arnold J's suggestion. The Advocate General's opinion reiterates that the basis of determining whether a basic patent protects an active ingredient can only be found in the wording, or interpretation of the wording, of the claim. Adding a requirement that the active ingredient embody the 'inventive advance' would, he says, run the risk of confusion with the criteria for determining whether an invention is patentable.
The Advocate General also rejected Gilead's argument that it is sufficient for the product to fall within the scope of protection of at least one claim of the basic patent, opining that this was a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a).
Instead, the Advocate General framed the question as 'with what degree of specificity or abstraction should a product be 'specified' in the claims of a basic patent?'. His suggested answer is that a product is protected by a basic patent if, 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 patent claims" (or, for a combination product, that each active ingredient is so identifiable). This would not however require the name of the active ingredient to be referred to expressly in the claims.
If the CJEU were to follow the Advocate General's opinion, this appears to be more aligned to the Medeva requirement, albeit in a different form of wording, to have something specified in the claim.
Applying this approach to Gilead's Patent, the Advocate General's view is that (subject to verification by the Patents Court) the Patent does not protect the product within the meaning of Article 3(a) as the active ingredient emtricitabine is claimed solely through the use of 'completely indeterminate expressions' such as 'comprising' and 'optionally other therapeutic ingredients' – terms which 'may cover multiple substances that are not specifically and precisely identifiable' as at the priority date of the Patent. Further, he notes that, subject to confirmation by the Patents Court, as at the priority date, it would not have been obvious to a person skilled in the art that emtricitabine was specifically and precisely identifiable in the wording of the claims of the Patent.
The decision of the CJEU is awaited, alongside the outcome of two further references, which are yet to be heard – Royalty Pharma's application (a referral from the German Bundespatentgericht concerning Sitagliptin) and Sandoz v Searle a referral from the Court of Appeal concerning a Markush formula, discussed in our March 2018 edition. The CJEU also heard a further reference (made around the same time as the one in Teva v Gilead) relating to new formulations of old ingredients (Abraxis, discussed in our April 2017 edition) on 21 June.
Mishcon de Reya is acting for Lupin Ltd and Lupin (Europe) Ltd, one of the claimants, in this matter.