SPCs based on a second marketing authorisation - the fight continues (Novartis C-354/19)

Hot on the heels of the CJEU Supplementary Protection Certificate (SPC) decision in Abraxis (C-443-17) earlier this year (IPKat), another question relating to SPCs for a second indication of a product has been referred to the CJEU (C-354/19).

The purpose of the SPC Regulation (Regulation (EC) No 469/2009) is to compensate a patentee for the lengthy process of achieving marketing authorisation. SPCs are national rights that provide an additional period of patent protection (max 5 years) for an active pharmaceutical ingredient. The active ingredient must be subject to a valid marketing authorisation and be protected by a patent (Regulation (EC) No 469/2009, Article 3(a)). In Europe, patent protection may be obtained for a second medical use of a known product (Article 54(5) EPC). These further medical uses of a known product also require a further marketing authorisation. Previous referrals to the CJEU have sought clarity over whether SPCs may be granted for the same active ingredient based on such a second marketing authorisation.

In Neurim (C-130/11) the CJEU found that an earlier marketing authorisation obtained for a veterinary medicinal product did not prevent the grant of an SPC for a different application of the same product for which a different marketing authorisation had been granted. In Abraxis (C-443/17) Mr Justice Arnold asked whether, following Neurim (C-130/11), Article 3(d) of the SPC Regulation (Regulation (EC) No 469/2009) permitted grant of an SPC if the active ingredient has previously received marketing authorisation, but the new marketing authorisation is for a product in the form of a new formulation of the active ingredient. The CJEU answered to the negative (IPKat posts here and here).

The Swedish court has now referred another question to the CJEU on whether an SPC may be granted based on a second marketing authorisation (C-354/19). This latest question relates to another article of the SPC Regulation; Article 3(c). The referral arose from an SPC application by Novartis for its antibody drug Illaris. The referral asks the question of whether a second SPC may be granted for the same product, based on a second medical use and second marketing authorisation.

Ilaris

Ilaris is the brand name of Novartis's anti-inflammatory human monoclonal antibody drug canakinumab (ACZ885). The basic patent for Ilaris (EP1313769) was granted in 2008. Novartis first received marketing authorisation for Ilaris in 2009 for the treatment of two forms of Cryopyrin-Associated Periodic Syndrome (CAPS), a rare and severe inherited inflammatory disorder. Novartis was granted an SPC based on EP1313769 and the 2009 marketing authorisation. The term of the SPC will expire in 2024.

Novartis owns a second medical use patent relating to Ilaris for the treatment of juvenile rheumatoid arthritis (EP1940465). Marketing authorisation for this second use of Ilaris was granted in 2013. Novartis's new SPC application is based on the second medical use patent and the 2013 marketing authorisation. If the new SPC application were to be granted the term would expire in 2028.

The latest SPC referral relates to an apparent conflict between the SPC Regulation for Medicinal Products (Regulation (EC) No 469/2009) and the SPC Regulation for Plant Products (Regulation (EC) No 1610/96). The SPC Regulation for Medicinal Products states that only one SPC may be granted for the same product. The SPC Regulation for Plant Products contradicts the SPC Regulation for Medicinal Products by stating that more than one SPC may be granted for the same product, if the respective patents (and thus SPCs) are owned by different owners.

Stockholm:
Location of the Patent- och marknadsöverdomstolen

Article 3(c) of the SPC Regulation for Medicinal Products states that an SPC shall only be granted if at the date of that application "the product has not already been the subject of a certificate". Article 3(2) of the SPC Regulation for Plant Products similarly states that the holder of more than one patent for a product shall not be granted more than one SPC for that product. However, Article 3(2) of the SPC Regulation for Plant Products adds the proviso that two SPCs may be issued for the same product in situations where two different parties each hold their own patent for the product. Recital 17 of the SPC Regulation for Plant Products also states that Article 3(2) of the SPC Regulation for Plant Products should be used to interpret Article 3 of the SPC Regulation for Medicinal Products.

Novartis already owns an SPC for Ilaris, albeit for a different marketing authorisation. Therefore, following Novartis's application for a second SPC for Ilaris, the Swedish Patent and Market Court of Appeal (Patent- och marknadsöverdomstolen) referred the question:

“In view of the fundamental purpose which the supplementary protection certificate for medicinal products is intended to fulfil, namely that of stimulating pharmaceutical research in the European Union, does Article 3(c) of Regulation No 469/2009, having regard to Article 3(2) of Regulation No 1610/96, preclude an applicant who has previously been granted a supplementary protection certificate in respect of a product protected by a basic patent in force in respect of the product per se, from being granted a supplementary protection certificate for a new use of the product in a case such as that at issue in the main proceedings in which the new use constitutes a new therapeutic indication which is specifically protected by a new basic patent?”

There are now 4 pending referrals to the CJEU relating to SPCs. Referral C-673/18 (Santen) relates to a similar question to that of C-443/17 Abraxis, particularly the interpretation of Article 3(d) of the SPC Regulation. The latest referral (aside from providing some variety by relating to a different Article) is also of interest because it relates to a biologic drug (more difficult and expensive to produce than a small molecule drug) and concerns two different marketing authorisations by the same party, each marketing authorisation requiring its own clinical trials.

Achieving marketing authorisation for a second indication of a known product is not straightforward. Interestingly, Novartis recently withdrew its application for marketing authorisation of Ilaris for cardiovascular indications following a disappointing phase 3 clinical trial. The question from the Swedish Court particularly asks the CJEU to consider the issue in question in view of the fundamental purpose of the SPC regulation in stimulating pharmaceutical research in the EU. Will the CJEU oblige? This Kat awaits the outcome of these referrals with interest.