No SPCs for new therapeutic applications of old drugs – CJEU overturns Neurim

The judgement of the CJEU in case C-673/18 (Santen SAS v Directeur général de l’Institut national de la propriété industrielle) brings some much needed clarity to the question of whether an SPC can be granted based on a marketing authorisation (MA) for a new therapeutic application of a drug, where that same drug has already been the subject of a previous marketing authorisation (MA) for a different therapeutic application. The CJEU have answered the question squarely in the negative, closing the door on the apparent possibility of such SPCs, which had existed since the same court’s earlier decision in Neurim (C-130/11).

Background

The Santen case turned on the interpretation of Article 3(d) of the SPC Regulation (Regulation No 469/2009). Article 3 sets out the conditions for obtaining an SPC and requires the following:

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive [2001/83] or Directive [2001/82], as appropriate;

(c) the product has not already been the subject of [an SPC];

(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.

Ever since the CJEU’s decision in Neurim, which also considered the meaning of Article 3(d), it had been thought that the existence of an MA for a particular product did not preclude the possibility of obtaining an SPC based on a new MA directed to “a different application of the same product” and a second medical use patent covering that new use, provided that the use authorised in the earlier MA did not fall within the scope of the second medical use patent. In other words, in Neurim, the Court appeared to interpret Article 3(d) as saying “the authorisation referred to in point (b) is the first authorisation [falling within the scope of the basic patent relied upon] to place the product on the market as a medicinal product”. In practical terms, what that meant was that if a drug had previously been authorised for treating, say, diabetes and a new MA and a second medical use patent for treating, for example, bone cancer were subsequently obtained, then the holder of the second medical use patent should be entitled to an SPC extension.

As might be expected, Neurim was received very well by the innovative pharma industry, who considered it as an important incentive to investigate new uses of known drugs, thus bringing the SPC system into line with the patent system, which had long allowed patents on second and further medical uses of drugs. Nevertheless, the reasoning of Neurim was inconsistently applied by different national patent offices and there was uncertainty about what exactly “a different application of the same product” meant. This uncertainty was not helped by the rather peculiar set of circumstances that had led to the Neurim decision, in particular the fact that the earlier MA had been granted for a veterinary use, whereas Neurim had obtained an MA for a human use. Accordingly, another referral was required to clarify the situation.

Facts of the case

Santen is the holder of EP patent 1809237 (“the basic patent”) which protects an ophthalmic emulsion containing the active ingredient ciclosporin, an immunosuppressive agent. In 2015, Santen obtained a European MA for their medicinal product “Ikervis”, the active ingredient of which is ciclosporin. Ikervis is used to treat severe keratitis in adult patients with dry eye disease.

Santen filed an application for an SPC at the French Patent Office (INPI) for a product directed to “Ciclosporin for use in the treatment of keratitis”. INPI rejected the SPC application, taking the view that Santen’s MA was not the first MA for ciclosporin, according to Article 3(d) of the SPC Regulation. INPI’s rejection was based on the ground that, in 1983, an MA had been granted for a medicinal product, marketed under the name "Sandimmun", that also had ciclosporin as its active ingredient. Sandimmun was indicated for, amongst other things, preventing the rejection of organ and bone marrow grafts, i.e. a treatment relying on the immunosuppressive properties of ciclosporin. In response, Santen appealed INPI’s rejection to the Paris Court of Appeal, who considered that there was sufficient uncertainty around the interpretation of Neurim to refer a number of questions to the CJEU.

The referred questions were designed to tease out the exact scope of the judgement in Neurim, in particular, what exactly was meant by “a different application”. In particular, should “a different application” be interpreted as being limited to the situation where an application for human use follows a veterinary application? Or does the phrase “different application” mean an indication within a new therapeutic field as compared with the earlier MA, or does it mean a medicinal product in which the active ingredient acts differently from the way in which it acts in the medicinal product to which the first MA related? Alternatively, must the concept of a “different application” be interpreted more broadly that is to say, as including not only different therapeutic indications and diseases, but also different formulations, posologies and/or means of administration? Finally, the Paris Court also asked the CJEU whether the expression “[application] within the limits of the protection conferred by the basic patent” meant that the scope of the basic patent must be the same as that of the MA relied upon and, therefore, be limited to the new medical use corresponding to the therapeutic indication of that MA.

Reasoning of the CJEU

The CJEU succinctly summarised the primary issue before them in paragraph 37 of the judgement, as follows:

37 Thus, in order to provide a useful answer to the referring court, it is necessary to examine whether Article 3(d) of Regulation No 469/2009 must be interpreted as meaning that an MA may be considered to be the first MA, for the purpose of that provision, 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 seeking to answer the question, the CJEU recalled that the MA as referred to in Article 3(d) must be granted for a specific product. Accordingly, it was therefore necessary to determine whether the concept of a product as referred to in the SPC Regulation is dependent on the therapeutic application of the active ingredient. In other words, does a new therapeutic application mean you have a new product?

The CJEU’s answer was a clear no. They considered that the term “product”, according to the Regulation, is simply defined as “the active ingredient or combination of active ingredients of a medicinal product”, and it is not necessary or appropriate to limit the scope of the term “product” to only one particular therapeutic application. It therefore follows that the term “product” within the meaning of the SPC Regulation is not dependent on the manner in which that product is used. Expressed otherwise, a new therapeutic application does not mean you have a new product.

The CJEU then moved onto the question of whether an MA granted for a new therapeutic application of a product may be regarded as being the first MA according to Article 3(d), in the case where that MA is the first MA to fall within the limits of the protection of the basic patent relied on in support of the application for an SPC. In that regard, the CJEU simply noted that Article 3(d) says nothing about the limits of protection of the basic patent and further that the reference to the “first authorisation” in Article 3(d) simply means the first MA for a product irrespective of the therapeutic application of that product. The CJEU then, perhaps surprisingly to some, explicitly rejects its own earlier ruling in Neurim, by stating: “[i]t follows that, contrary to what the Court held in paragraph 27 of the judgment in Neurim, to define the concept of ‘first [MA for the product] as a medicinal product’ for the purpose of Article 3(d) of Regulation No 469/2009, there is no need to take into account the limits of the protection of the basic patent”.

In order to confirm their reasoning, the CJEU then took a look back at some of the motivations underpinning the development of the SPC regime, in particular the Explanatory Memorandum that accompanied the SPC Regulation in its original incarnation[1]. In that Memorandum, the Court noted that, in establishing the SPC regime, it was not the intent of the legislator to protect all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product. Such an objective would be undermined if it were possible to fulfil Article 3(d) by taking into account only the first MA to fall within the limits of the protection of the basic patent covering a new therapeutic application of a product, and to disregard an MA which had been granted previously for a different therapeutic application of the same product. In the Court’s view, taking such a position allows a fair balance to be struck between, on the one hand, the need to encourage pharma companies to undertake research into new drugs by giving them the market exclusivity (and therefore high drug prices) provided by the SPC system and, on the other hand, the need to ensure that the exclusivity provided by the SPC system does not persist too long, thus hurting the public health sector (and ultimately the tax payer), who must bear the burden of those high drug prices.

Taking into account all of the above reasoning, the CJEU therefore concluded as follows:

• an MA for a therapeutic application of a product cannot be regarded as the first MA for that product, for the purpose of Article 3(d), where another MA was previously granted for a different therapeutic application of the same product;
• the fact that the most recent MA is the first MA to fall within the limits of the protection of the basic patent relied on in support of the SPC application is not relevant;
• the answer to the questions referred is therefore that Article 3(d) must be interpreted as meaning that an MA cannot be considered to be the first MA, for the purpose of that article, where it covers a new therapeutic application of a product, and that product has already been the subject of an MA for a different therapeutic application.

Closing remarks

It can be seen from the above that the Paris Court of Appeal perhaps got more than they bargained for from the CJEU. It seems apparent from their referred questions that they were asking the CJEU to confirm the exact scope and applicability of the Neurim decision. Instead, what they got from the CJEU was a complete sweeping away of the Neurim doctrine. Thus, whilst the decision in Santen certainly brings some much-needed clarity and simplicity to the SPC system, its implications will not be welcomed by those, particularly in the innovative pharma industry, who have an interest in seeing the scope and reach of the SPC system extended.

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[1] Regulation No 1768/92