14 May 2020

Royalty Pharma: CJEU answers SPC questions – and raises new ones

On 30 April 2020, the Court of Justice of the EU (CJEU) handed down the latest in a long line of decisions regarding the question of how precisely a product must be identified in a patent in order to be eligible to benefit from the further protection offered by an SPC. This latest decision will be welcomed for providing more clarity in some respects, but in others it raises new questions. These will doubtless be the subject of further debate and – most probably – further references to the CJEU in due course. In particular, the CJEU’s clarification of the level of disclosure required in the patent could potentially cause divergence in practice regarding small molecule pharmaceuticals and biologics, while its ruling that an SPC may not be granted for a product ‘developed’ after the filing date of the patent as the result of an ‘independent inventive step’ is certain to provoke controversy.

Background to the case

Royalty Pharma is the proprietor of a patent (EP 1084705) containing claims directed, in EPO-appropriate format, to the use of inhibitors of dipeptidylpeptidase IV (‘DPP-IV’) for the treatment of diabetes mellitus.

On the basis of the EP ’705 patent, Royalty Pharma applied to the German patent office (DPMA) for an SPC for the product sitagliptin. Sitagliptin is a DPP-IV inhibitor and therefore satisfies the functional definition provided in the patent. However, sitagliptin is not explicitly provided as an embodiment in the patent. In fact, sitagliptin was developed by a licensee of the patent after the patent was filed, and is itself the subject of a separate patent owned by the licensee.

The DPMA refused the SPC application on the grounds that, in the absence of a specific disclosure of sitagliptin in the patent, the requirements of Article 3(a) of the SPC Regulation (requiring that a product should be ‘protected by a basic patent in force’) were not met. Royalty Pharma appealed against this refusal and, on appeal, the German federal patent court turned to the CJEU in search of further clarification of Article 3(a). The questions which were referred to the CJEU concerned not only the necessary degree of specificity in the patent, but also a question regarding whether a product could be deemed ‘protected’ where, as in the underlying case, it had been developed only after the filing of the patent.

‘Protected by’ the patent –  (some of) the story so far

The requirement for a product to be ‘protected by’ a patent in order to be eligible for SPC protection appears, at first glance, to be a simple one. However, this has been the subject of controversy ever since the CJEU’s Medeva decision in 2011 introduced the requirement that a product should be ‘specified in the wording of the claims’ rather than merely falling within the extent of protection conferred by the claims with regard to infringement. National patent offices and courts have grappled with the question of the degree of specificity required, and repeated references to the CJEU on this point have failed to elucidate a clear and generally-applicable test.

As noted with some exasperation by the English courts, notably by Arnold J in Teva v Gilead [2017] EWHC 13 (Pat), it is clear in light of Medeva that ‘something more is required than the product falls within the scope of the basic patent’, but the ‘something more’ has remained elusive. CJEU decisions since Medeva seem to have clarified that an individual, explicit disclosure of the product is not necessarily required, but it remains uncertain what degree of abstraction is permitted.

Most recently, the CJEU’s 2019 decision in Teva v Gilead introduced a two-pronged test whereby a combination of active ingredients would be considered ‘protected’ by a patent if:

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.

Although this provided some further clarity, various questions remained open, including how an assessment of ‘fall[ing] under the invention’ was to be made, since the CJEU in Teva had not explicitly ruled out the idea (advanced in particular by the English courts, including in the case underlying the Teva decision) that the product should embody the ‘core inventive advance’ represented by the patent.

The CJEU’s decision in Royalty Pharma

In Royalty Pharma (C-650/17), the CJEU held as follows (translated from the German version of the decision as no official English version has been made available at the time of writing):

1.      Article 3(a) […] is to be interpreted as meaning that a product is protected by a basic patent in force […] if it corresponds to a general functional definition used in one of the claims of the basic patent and necessarily belongs to the invention protected by this patent, but without being individualized as a specific embodiment from the teaching of the patent, insofar as the product can be specifically identified, in the light of all information disclosed by the patent, by the skilled person on the basis of his general knowledge of the relevant area on the filing or priority date of the basic patent and taking into account the state of the art at that date.

2.       Article 3(a) […] should be interpreted as meaning that a product is not protected by a basic patent in force […] if, though it falls under the functional definition given in the claims, it was developed after the filing of the basic patent after an independent inventive step.

Analysis and implications for SPC applicants

The first point of the decision essentially reiterates the Teva test, and thus confirms that this applies to mono products as well as to combination products (as was the case in Teva). Notably, in reaching this conclusion the CJEU explicitly stated that the concept of the ‘core inventive advance’ was of ‘no relevance’ in the application of Article 3(a), thus closing the loophole left by the court’s failure to explicitly address this point in the Teva decision.

The CJEU’s reasoning provides some further information on how to assess whether a product can be ‘specifically identified’. According to the CJEU’s reasoning, this should include determining whether the product can be ‘directly and unambiguously derive[d] from the patent specification’, taking into account the prior art and the common general knowledge of the skilled person at the filing or priority date. This appears to be a conscious echo of the test applied by the European Patent Office (EPO) when determining whether an amendment to a patent application is permissible. If applied strictly by national patent offices, this test could impose a requirement for a high degree of specificity in the disclosure of the patent in order for a product to be considered ‘protected’.

Although the CJEU explicitly states that an individualised disclosure of the product is not required, applying an EPO-style ‘added matter’ analysis to determine whether a product can be ‘identified’ in a patent may nevertheless have divergent effects in different technical fields. In the case of small molecules, which can usually be defined via a series of ever-narrower general formulae and lists of substituent groups, it may in practice be more straightforward to meet the Teva test than in the case of biologics, where even a narrowly-framed functional definition will often leave room for debate as to whether any particular, individual product is disclosed within that definition.

The second point of the decision is likely to provoke the most controversy. The wording employed here is very similar to that employed by the German court which referred the questions underlying the decision. The CJEU justifies its finding by reference to underlying policy considerations, stating that an SPC holder would gain ‘unjustifiable benefit’ if an SPC were to be awarded on the basis of the results of research carried out after the filing of the application. However, the CJEU provides no explanation of how the criterion of ‘developed […] after an independent inventive step’ is to be assessed in practice.

In particular, it is unclear what standard should be applied when assessing whether or not an ‘independent inventive step’ is involved. Furthermore, it is not yet clear how a satisfactory distinction can be drawn between determining, on the one hand, whether a product involves an ‘independent inventive step’ over the disclosure of the patent (a test which is explicitly required by the CJEU) while also, on the other hand, avoiding an assessment of whether a product shares the same ‘core inventive advance’ embodied by the patent (a test which is explicitly ruled out).

The question of when a product can be said to have been ‘developed’ is also bound to generate further discussion. For example, in the case of new chemical or biological entities, is the product ‘developed’ when it is first synthesised or isolated, or only after clinical trials have been carried out in connection with the authorised indication? Does drug screening carried out on a computational basis, e.g. using an AI to predict whether a candidate compound will bind to a particular receptor, count as ‘development’? If clinical trials are required, what stage must have been reached in order for a product to be deemed ‘developed’?

As a further point of controversy, it might be noted that, in the case of small molecules, it is common for patents to include “paper” examples of individual compounds falling within the claim scope, which may nevertheless not yet have been synthesised and/or subjected to any clinical testing as of the filing date. At first sight it appears that such compounds would be deemed to meet the requirements of Article 3(a) as they are disclosed in the patent, and would therefore not be subject to the test of whether they were ‘developed after the filing of the basic patent after an independent inventive step’. However, this is difficult to reconcile with the policy-based rationale underlying the second point of the Royalty Pharma decision, namely that the SPC should not provide a reward for the results of research carried out only after the filing of the patent. Further questions may therefore arise as to whether this standard is applicable to all SPCs, not just those where the product is not individualised in the patent.

Application of the SPC Regulation going forward

Once again, therefore, in answering one set of questions the CJEU has opened up a range of new uncertainties in how the SPC Regulation should be applied. The introduction of an EPO-style requirement for products to be ‘directly and unambiguously’ derivable from a patent, alongside an assessment of whether a product is the result of an ‘independent inventive step’, raises the prospect of further divergence between different national patent offices in the application of such tests. SPC applicants should therefore bear in mind that, if a choice of patents is available as the ‘basic patent’ for a new SPC application, a patent having an individualised disclosure of the product in question – or, failing that, the narrowest available definition encompassing the product – is normally likely to be the safest option for getting over the Article 3(a) hurdle.

Our summary of an earlier stage of this Royalty Pharma case is available here (September 2019).

For further information on SPCs, visit our specialist page, or contact the author of this article, Alexander Robinson.