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CJEU Issues Further Guidance on Article 3(a) for Supplementary Protection Certificates

On 25 July 2018 the CJEU gave its ruling in C-121/17 Teva UK Ltd and others v Gilead Sciences Inc.

Background

The case concerned Gilead’s SPC for a combination of tenofovir disoproxil (TD) and emtricitabine, based on a marketing authorisation for TRUVADA. This is a medicinal product comprising the two active ingredients for the treatment of HIV. The underlying basic patent discloses a series of molecules as helpful in the treatment of viral infections in humans and animals, in particular HIV. The general formula for these molecules encompasses TD, which is also expressly mentioned in claim 25. TD was authorised as the (sole) active ingredient of Gilead’s VIREAD in February 2002, less than five years from the basic patent filing date. As such no SPC was available for TD. If such an SPC had been available, it would have extended to TRUVADA even though TRUVADA contained an additional active ingredient.

In the underlying patent, combinations with ‘other therapeutic ingredients’ are discussed only in general terms, giving rise to claim 27:

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.

The words ‘other therapeutic ingredients’ are nowhere defined or explained, and emtricitabine is not mentioned. At the priority date emtricitabine was neither known nor authorised for treatment of HIV.

The point at issue is essentially whether or not ‘other therapeutic ingredients’ adequately covers emtricitabine for the purposes of Article 3(a) of the SPC Regulation. Article 3(a) requires that the product of the SPC, in this case the combination of TD and emtricitabine, is “protected by a basic patent in force".

The referring UK court deliberately chose to refer a broad question 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?

The Ruling

In paragraph [57], the CJEU conclude as follows:

“…the answer to the question referred is that Article 3(a)… <of the SPC Regulation>…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’ … where, even if the combination of active ingredients … 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."

[emphasis added]

The case is now retuned to the referring UK court to decide whether or not the above requirements are met for the combination of TD and emtricitabine. The CJEU have hinted that (unsurprisingly) they do not consider this to be case.

The Implications

At the most basic level, the ruling can be interpreted as simply confirming the general position in Medeva (C‑322/10). A (further) SPC will not be allowed for a combination product comprising multiple active ingredients, where “the invention” of a basic patent is primarily concerned with only one of those active ingredients (see paragraph [42]). It is implicit that, by contrast, an SPC might be available for a combination of active ingredients if that combination is itself an independent invention.

However, the implications of this decision are likely to go beyond combination products. It appears that the CJEU may have intended the ruling to be restricted to such products (see emphasis added to the quotation above), but they have not explicitly indicated this to be the case and the referred question was of course much broader. As mentioned above, Medeva was also concerned with a combination product, but this has not prevented its findings from being applied far more generally. Medeva’s test that an active ingredient should be “specified in the wording of the claims” is not usually seen to be limited only to the further active ingredients in a combination. It is therefore to be expected that elements of the present ruling will also be applied to products comprising single active ingredients.

We see effectively two questions outstanding:

  1. What is the appropriate test for whether or not an active ingredient “falls under the invention” covered by the basic patent?
  2. What level of specificity is required for an active ingredient to be considered “specifically identifiable” in the basic patent?

Some guidance for question 1 is provided in paragraphs [48] - [52] of the ruling. It is clear that assessment of “the invention” should consider the content of the patent specification as a whole and the background knowledge of the skilled person (referred to as the “prior art”) at the effective filing date of the patent. Of particular note is paragraph [48] which states that:

“…the product … is a …solution of the technical problem disclosed by that patent.”

An assessment of this type will be familiar to practitioners of European patent law, given that it echoes the EPO assessment of inventive step. However, such practitioners will also be aware that the technical problem solved by a patent can change depending upon the choice of closest prior art. Most would also agree that examination of SPC applications should preferably not involve a further consideration of the inventive step of the underlying patent.

Setting that aside, however, question 2 is likely to be of greater concern to many applicants. That being the case, it is disappointing that the CJEU have provided comparatively little guidance in respect of the meaning of “specifically identifiable”. Turning again to paragraphs [48]-[52], the CJEU conclude in [52] that:

“Having regard to all the foregoing considerations, a product is ‘protected by a basic patent in force’ … in so far as, if that product is not expressly mentioned in the claims of the basic patent, one of those claims relates to it necessarily and specifically.

For that purpose, that product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by that patent. The person skilled in the art must be able identify that product specifically in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the patent concerned.”

[emphasis added]

The meaning of “specifically identifiable” should of course be read in the light of previous CJEU case law on Article 3(a). This means in particular Medeva’s “specified in the wording of the claims” and also the finding in Eli Lilly (C-493/12) that a functional definition may be sufficient for Article 3(a), provided the claims relate “implicitly but necessarily and specifically” to the product. This latter wording is echoed in the extract from paragraph [52] shown above.  

This serves to highlight that the only completely clear point in the present ruling is that a product need not be “expressly mentioned” in the claims in order to be “specifically identifiable”. Applicants are left with a great deal of uncertainty as to how to determine whether the requirements of Article 3(a) are met when a product is not expressly mentioned.

Given the strictest possible interpretation, the CJEU’s choice of phrasing could be taken to mean that a product need not be expressly mentioned in the claims, but must be expressly mentioned at least somewhere in the patent specification. A less strict, but still restrictive, interpretation would require that a product need not be expressly mentioned anywhere in the patent, but must be expressly (individually?) identifiable based on the teaching in the patent, assessed at the effective filing date. 

This would seem to require a test in which the skilled person “looks forward” to see if the product could have been envisaged at the filing date, rather than “looking backward” to see if the product is encompassed by the claimed invention. Even if the problems with such an approach are ignored, again there is a lack of clarity as to the level of precision with which the skilled person must be able to identify a particular product. The strictest interpretation here could impose a requirement that the skilled person must literally have been able to identify the precise structural and/or functional characteristics of an individual product based on the teaching of the patent at the effective filing date.

Such an interpretation is likely to be of concern to innovators holding broader, earlier patents to a general therapeutic concept. Such patents may not expressly identify any individual products, and under such circumstances it may be difficult to argue that the precise characteristics of a product could have been identified at the effective filing date. This would amount to a bar on SPCs based on patents 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.

It is therefore disappointing that the CJEU did not take the opportunity to provide further clarity, and additional referrals on Article 3(a) are to be expected. We await with interest the CJEU’s decisions in two such referrals that are already pending, C-650/17 (QH/Royalty Pharma) and C-114/18 (Sandoz v Hexal).

26 July 2018

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