UK: AG's Opinion In Royalty Pharma C-650/17 And Sandoz C-114/18 Signals A Tougher Approach To Article 3(a) Of The SPC Regulation

Last Updated: 9 October 2019
Article by J A Kemp LLP

On 11 September 2019 Advocate General Hogan issued his Opinion in connection with the combined referrals to the CJEU in Royalty Pharma C-650/17 and Sandoz C-114/18. Both referrals concern the interpretation of Article 3(a) of the SPC Regulation, which requires that:

"A[n SPC] shall be granted if... the product is protected by a basic patent in force"

The full text of the Advocate General's Opinion is available here. The Opinion is not binding on the CJEU. It is the role of the Advocates General to propose to the Court, in complete independence, a legal solution to the cases for which they are responsible.

The referral in Royalty Pharma C-650/17 was made by the German Bundespatentgericht (Federal Patent Court) in a case concerning the refusal by the DPMA (German Patent Office) of an application for an SPC for the diabetes product Januvia® due to failure to comply with Article 3(a). The product comprises the active ingredient sitagliptin, a DP IV inhibitor. The basic patent EP1084705 effectively claims DP IV inhibitors defined as a functional class, for the treatment of diabetes. However, sitagliptin is not disclosed in individualised form in the EP1084705. It was developed after the filing date of the basic patent by a licensee which obtained a patent for it, on the basis of which it was granted its own SPC. The Bundespatentgericht considered that there were conflicting views regarding how to assess the requirements of Article 3(a), including the relevance of a so-called 'core inventive advance' test applied by the judge for a corresponding case in the UK.

Accordingly it referred the following questions to the CJEU:

"1. Is a product protected by a basic patent in force pursuant to Article 3(a) of Regulation (EC) No 469/2009 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?

2. 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?

3. 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?"

The referral in Sandoz C-114/18 was made by the Court of Appeal of England and Wales, in a case concerning a revocation action brought by Sandoz and Hexal against an SPC for the anti-retroviral Prezista® held by Searle and exclusively licensed to JSI. Sandoz and Hexal alleged failure to comply with Article 3(a) of the SPC Regulation. The product comprises the active ingredient darunavir, which is encompassed by the claims of basic patent EP0810209 as one amongst a very large number of compounds covered by a Markush formula. Darunavir itself comprises relatively unusual substituents and there is no reference to it anywhere in the specification. The Court of Appeal considered the level of specificity required by Article 3(a) to be unclear from the case law of the CJEU. Accordingly the following question was referred to the CJEU:

"Where the sole active ingredient the subject of a [SPC issued under Regulation No 469/2009] 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 [Regulation No 469/2009] 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?"

Both the Royalty Pharma C-650/17 and Sandoz C-114/18 referrals were made before the CJEU issued its judgement in C-121/17 Teva, which concerned the more general question:

"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?"

Our full briefing on the Teva judgement is available here. Briefly, it concerned the SPC for the anti-HIV combination therapy Truvada, based on a basic patent which referred only to one of the active ingredients in the product. The CJEU set out the following two-step test for the assessment of Article 3(a):

A product is covered by a basic patent according to Article 3(a) if, from the point of a view of a skilled person at the priority date of the patent:

(1) 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

(2) each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

Following issue of the judgement in Teva, the referring courts in both Royalty Pharma C-650/17 and Sandoz C-114/18 maintained their request for judgement from the CJEU. The former because the Teva judgement did not explicitly criticise the 'core inventive advance' test, the latter because the Teva judgement did not explicitly state that the two-step test applies also to drugs which are not combinations.

The Advocate General is clearly of the opinion that this latter point can be answered in the affirmative. Paragraph 49 of the Opinion indicates that there can be no "meaningful" distinction between a product consisting of a single active ingredient and a combination of active ingredients for the purposes of the test established in Teva. The Advocate General also states explicitly in paragraph 54 that the concept of the 'core inventive advance' is of "no relevance in the context of Article 3(a)". He goes on to advise the Court that the test established in Teva should be regarded as "technologically neutral", meaning that it is universally applicable to all claim types. In particular, it applies both to functional claims and Markush formula claims. He advises that Article 3(a) "does not preclude the grant of an SPC for an active ingredient which is covered by...[such claims]..., provided, however, that the two-part test set out in [Teva] is satisfied".

The Advocate General then sets out his view on how the two-part test should be applied. This is the section of the Opinion likely to be of most interest to parties following the evolution of CJEU case law on SPCs. The Advocate General concludes that:

"The two-part test must be applied 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 first part of the two-part test is not satisfied if the claims in a patent in relation to that product are not required for the solution of the technical problem disclosed by a patent;

The second part of the two-part test requires that it be established that a person skilled in the art would have been able, in the light of all the information contained in a patent, on the basis of the prior art at the filing date or priority date of the patent in question, to derive the product in question."

The Advocate General has applied a restrictive view of the Teva judgement in reaching the above conclusion, which tends towards excluding SPC protection based on a patent which does not individually disclose the active ingredient(s) of an authorised product. This is more likely to be problematic in the field of complex biological molecules (e.g. antibodies), for which it is difficult to see how the Advocate General's interpretation of the second part of the test from Teva could be satisfied in the absence of a literal disclosure of the individual molecule. By contrast, the small molecule field may be more forgiving. It could be argued, for example, that given a disclosure of C1-C6 alkyl and specific examples of "methyl" and "propyl", the skilled person would envisage "ethyl" without an individual disclosure of it.

Of course, it remains to be seen whether the CJEU will follow the Advocate General's advice. The court may be reluctant to do so in full, since it would arguably contradict their own earlier case law. In particular Eli Lilly C-493/12 states explicitly in the context of an antibody that individualised disclosure (at least in the claims) is not required to satisfy Article 3(a). In addition, if the CJEU adopt the Advocate General's advice this would arguably introduce a bar on grant of an SPC from a basic patent relating to early-stage fundamental research, as opposed to later-stage clinical development work. This was not the intention of the SPC Regulation, which was explicitly intended to encourage all forms of research leading to pharmaceutical products. The court may therefore be reluctant to issue guidance that would alter that policy position.

We await the CJEU's judgement with interest.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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