First published in our Biotech Review of the year – issue 8.

In this respect, 2020 was no different as the CJEU handed down judgments in two preliminary references – Case C-650/17 (Royalty Pharma)[1] and Case C-673/18 (Santen)[2].

Royalty Pharma & functional claims

Functional claims are of particular importance in some biotech inventions, not least, for example in relation to antibody products that are frequently claimed by reference to their binding characteristics. Despite the fact that the CJEU stated in Case C-493/12 (Eli Lilly)[3] that an active ingredient could be protected by a functional claim where ‘the claims relate, implicitly but necessarily and specifically, to the active ingredient in question’, the ability of such claims to form the basis of an SPC application, under Article 3(a) of the SPC Regulation, has remained an area of some debate.

In 2017, the Federal Patent Court of Germany (Bundespatentgericht) made a reference to the CJEU in Royalty Pharma regarding the interpretation of Article 3(a) of the SPC Regulation in the context of functional claims.

Royalty Pharma held a patent for the use of DPP-IV inhibitors in the treatment of diabetes. They sought an SPC in Germany based upon this patent and the MA for a DPP-IV inhibitor, sitagliptin. Sitagliptin fell within the scope of Royalty Pharma’s patent, but was not individually claimed or disclosed. Furthermore, and a separate point of interest for this case, sitagliptin was independently developed and sold by Merck Sharp & Dohme, which itself holds a later patent for the sitagliptin compound.

The German court referred three questions to the CJEU, asking whether a product is protected by a basic patent in force when it is:

1. part of the subject matter of protection defined by the claims and is provided as a specific embodiment;
2. within a functional claim, but not provided as a specific embodiment elsewhere in the patent; or
3. within a functional claim, but was developed after the filing date of the patent as a result of an independent inventive step.

In its decision, the CJEU confirmed that the relevant test for Article 3(a) had been set by the CJEU in Case C-121/17 (Teva)[4] and that this test applied to all products, not just the combination products which were the subject of the preliminary reference in Teva.

To recap, the test in Teva states that for a combination product to be ‘protected’ by the basic patent under Article 3(a), the claims need not expressly mention the combination but must relate to it necessarily and specifically. This will be the case, if from the point of view of the skilled person and on the basis of the prior art at the filing date or priority date of the basic patent:

1. the combination itself necessarily falls under the invention; and
2. each of the elements in the combination must be specifically identifiable in light of all the information disclosed in the patent.

In its decision in Royalty Pharma, the CJEU has clarified that a functional claim is not precluded from protecting a product under Article 3(a) of the SPC Regulation, provided that the claims can be understood, in light of the description of the invention, to relate ‘implicitly but necessarily’ to the product in question. The CJEU confirmed that this assessment is undertaken by the skilled person at the priority date in light of their ‘general knowledge’ as well as the ‘state of the art’. The CJEU further clarified that the product does not need to be included as a specific embodiment provided it can be specifically identified by the skilled person at the priority date of the patent.

The decision is therefore important in reconfirming that SPCs are available for products covered by functional claims. However, it remains to be seen how the test set out by the CJEU in Royalty Pharma may be applied in the context of antibody products. Perhaps unsurprisingly, given that sitagliptin is a small molecule, the CJEU gave no guidance as to how an antibody claimed by reference to its binding characteristics could satisfy the test in Teva (as interpreted by the CJEU in Royalty Pharma) in circumstances where it is not individually named or depicted in the patent.

The decision also raises some further questions which will be of general interest to the industry. In answering the third question above, the CJEU held that a product which is developed after the priority date of the basic patent in question as the result of an ‘independent inventive step’ cannot be considered to be protected by that basic patent for the purposes of Article 3(a) of the SPC Regulation. This is irrespective of whether it falls within the scope of protection conferred by a functional definition.

The Court noted that to allow post-filed data into an assessment of whether a product is covered by a patent for the purposes of granting an SPC could unduly benefit the patentee, and that rewarding research that was the subject of a separate invention made after the patent filing undermined the fundamental purpose of the SPC regime. As there is no further explanation of ‘independent inventive step’, the interpretation of this aspect of the CJEU’s judgment may well be the subject of further references in the future.

Santen & new therapeutic applications

Article 3(d) of the SPC Regulation requires that the MA relied on for the purpose of the SPC application is the first MA to place the product on the market as a medicinal product. It was this provision of the SPC Regulation that was in issue in Santen.

In brief summary, Santen had applied for an SPC for ‘ciclosporin for use in the treatment of keratitis’, relying on a basic patent for an oil-inwater ophthalmic emulsion of ciclosporin (the active ingredient) and an MA for the medicinal product Ikervis®, which contained ciclosporin. Ikervis is used to treat severe keratitis (which is an inflammation of the cornea).

The French Patent Office refused the SPC on the basis that the MA for Ikervis was not the first MA to place the product on the market. Instead, the earlier MA for Sandimmun® was the first MA for the purpose of the SPC Regulation. Sandimmun also contained the active ingredient ciclosporin but indicated for use in, inter alia, preventing the rejection of organ and bone marrow grafts and the treatment of uveitis (which is an inflammation of all or part of the uvea, a different part of the eye from the cornea).

In other words, the MA for Sandimmun concerned a different application of the same active ingredient. Following an appeal from Santen, the Paris Court of Appeal referred two questions to the CJEU.

The questions referred considered the scope of the CJEU’s judgment in Case C-130/11 (Neurim)[5] . By way of reminder, in Neurim the CJEU had held that ‘the mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that that application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC’ (emphasis added).

In its first question, the Paris Court of Appeal asked the CJEU to confirm whether a strict or broad interpretation of ‘different application’ should be adopted. By its second question, the Paris Court of Appeal asked the CJEU to confirm what was meant by ‘the limits of protection conferred by the basic patent’.

With reference to Article 1(b) of the SPC Regulation (and the definition of ‘product’ contained therein), the CJEU held that the fact that an active ingredient (or combination of active ingredients) is used for a new therapeutic application does not confer on it the status of a ‘distinct product’ if that active ingredient (or combination of active ingredients) has already been used for a different therapeutic application. Consistent with this, the CJEU found that an MA cannot be considered to be the first MA where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application.

In reaching this conclusion, the CJEU expressly found that ‘contrary to what the Court held in paragraph 27 of [Neurim]’ there is no need to take into account the limits of protection of the basic patent when identifying the first MA for the product.

Whilst it will be for the referring Court to apply the CJEU’s guidance, it seems likely that the French Patent Office’s objection to the SPC Application will be maintained. It also seems likely that the CJEU’s judgment will have ramifications for other SPCs for new therapeutic uses of known active ingredients (which have already been authorised for use as medicinal products).

What next?

As a number of the recent decisions have related to small molecule products, there is relatively little guidance from the CJEU about how the tests set out in the case law should be applied in the context of biotech products such as antibodies. In this regard, from a UK perspective, it is worth noting the position adopted by Arnold J (as he then was) in Eli Lilly v Genentech[6]. In that case, Arnold J held that an antibody was specifically identifiable by the skilled person at the priority date by reference to a claimed function (namely, its binding characteristics). For this purpose, Arnold J also considered that it was irrelevant that the antibody was not created until after the priority date.

Notwithstanding the latest guidance from the CJEU, it seems inevitable that there will be further references regarding Article 3 of the SPC Regulation (albeit not from the UK Courts). However, now that the Brexit transition has ended, new judgments from the CJEU are no longer binding on the UK Courts (although they may still be considered). Moreover, at the time of writing, the UK Government is set to implement the proposal that both the English Court of Appeal (and its equivalent in the other UK jurisdictions) and the Supreme Court can depart from retained EU case law (except where a higher Court has previously adopted the CJEU’s decisions)[7]. It will be interesting to see how the UK Courts grapple with these issues.

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[1] Case C-650/17 Royalty Pharma Collection Trust v Deutsches Patent- und Markenamt ECLI:EU:C:2020:327
[2] Case C-673/18 Santen SAS v Directeur général de l’Institut national de la properiété industrielle ECLI:EU:C:2020:531
[3] Case C-493/12 Eli Lilly and Company Ltd v Human Genome Sciences Inc. ECLI:EU:C:2013:835
[4] Case C-121/17 Teva UK Ltd & Ors v Gilead Sciences Inc. ECLI:EU:C:2018:585
[5] Case C-130/11 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents ECLI:EU:C:2012:489
[6] Eli Lilly Company & Ors v Genentech, Inc [2019] EWHC 388 (Pat). For completeness, it is noted that this judgment was handed down before the CJEU’s decision in Royalty Pharma
[7] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/ attachment_data/file/926811/departure-eu-case-law-uk-courts-tribunals-consultationresponse.pdf