SPCs for second medical use patents

The CJEU, Europe’s highest court, severely restricts availability of Supplementary Protection Certificates (SPCs) for products based on second medical use patents

Ulla Klinge reports

On 9 July 2020, the Court of Justice of the European Union (CJEU) handed down its decision in Santen (C-673/18), holding that it is not possible to obtain an SPC for a product based on a marketing authorisation for a new use of a previously-authorised product.

Background

One of the requirements for obtaining an SPC is that the marketing authorisation relied on is the first authorisation to place the product on the market as a medicinal product, cf. Art. 3(d) of the SPC Regulation. A “product” is defined as “the active ingredient or combination of active ingredients of a medicinal product”, cf. Art. 1(b).

The CJEU traditionally interpreted the term “product” narrowly and held in a number of judgments that an SPC could not be granted on the basis of a marketing authorisation for a new use if the same active ingredient had been authorised previously for a different use, cf. Yissum (C-202/05) and Pharmacia Italia (C-31/03).

However, in the ground-breaking decision in Neurim (C-130/11) the CJEU took a different approach and indicated that SPCs would be available for second medical uses of known active ingredients.

The Neurim case concerned a patent covering a pharmaceutical formulation comprising melatonin for use for the treatment of insomnia, authorised and marketed as Circadin by the company Neurim. Neurim’s SPC application was refused by the UKIPO on the basis that there was an earlier marketing authorisation for a veterinary product, Regulin, also containing melatonin as active ingredient, the Regulin product being used for regulating the seasonal breeding activity of sheep. The question of whether an SPC could be obtained in such circumstances was ultimately referred to the CJEU.

In reaching its decision in Neurim the CJEU noted that the fundamental objective of the SPC Regulation is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health. Therefore, if a patent protects a new therapeutic application of a known active ingredient, this may enable its proprietor to obtain an SPC for the new use of that active ingredient, even if the active ingredient has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications. In Neurim the CJEU thus amended the concept of “product” to include the concept of “scope of protection of the basic patent” in the interpretation of what constitutes a first authorisation to place the product on the market as a medicinal product.

Ever since the judgment in Neurim in 2012 there has been debate as to how broadly the Neurim decision should be interpreted as to its applicability for products based on second medical use patents.

A first restriction of the scope of Neurim was introduced with the judgment in Abraxis (C-443/17). The CJEU found in Abraxis that a marketing authorisation granted for a new formulation of an old active ingredient cannot be regarded as being the first MA granted for that product as a medicinal product within the meaning of Art. 3(d) of the SPC Regulation, when that active ingredient has already been the subject of a marketing authorisation.

Santen (C-673/18)

In Santen (C-673/18) the CJEU was specifically asked to decide on the interpretation of the scope of Neurim. The Santen case related to an SPC application for the medicinal product Ikervis, eye drops in emulsion, the active ingredient being ciclosporin, for use for the treatment of severe keratitis. The SPC application was refused as being in conflict with Art. 3(d) of the SPC Regulation, on the basis that an earlier marketing authorisation for the medicinal product Sandimmun existed, which also contained ciclosporin as active ingredient, for oral use for a number of indications, including endogeneous uveitis. Santen therefore argued that Ikervis was distinguished from Sandimmun by at least its indication and its method of administration. 

The CJEU in Santen took a strict approach and referred to Art. 1(b) of the SPC Regulation where the term ‘product’ is defined as an ”active ingredient or combination of active ingredients” and not by reference to the therapeutic application thereof. The CJEU therefore found that the fact that an active ingredient, or a combination of active ingredients, is used for a new therapeutic application does not mean that it is a different product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application.

The CJEU therefore found that a marketing authorisation for a therapeutic application of a product cannot be regarded as the first marketing authorisation for the purpose of Art. 3(d) of the SPC Regulation, where another marketing authorisation was granted previously for a different therapeutic application of the same product.

The CJEU in Santen thus effectively overturns Neurim by holding that there is no need to take into account the limits of the protection of the basic patent to define the concept of ‘first [MA for the product] as a medicinal product’ for the purpose of Article 3(d) of the SPC Regulation. The Santen case thus effectively excludes SPC protection for inventions based on second medical use inventions except for the (probably rare) circumstances, where the ”known” product never was the subject of a marketing authorisation.