Request for CJEU ruling withdrawn: Novartis C-354/19

Request for CJEU ruling withdrawn: Novartis C-354/19

Recently, the Swedish Patent and Market Court has retracted its demand for a CJEU ruling on the matter of interpretation of Article 3(c) of the SPC Regulation (EU Regulation 469/2009/EC). It has been asked of the CJEU to decide on whether a second SPC is allowed to be granted by Article 3(c) basis a second medical use patent where an applicant already has an earlier SPC to the same active ingredient, and where the earlier SPC is based on a basic patent for the product itself.

For an SPC application to be granted in Europe, it must meet four criteria that are set out in Article 3 of the SPC Regulation. In the instant case, Article 3(c) sets out the following requirement: "A certificate shall be granted if, in the member state in which the application … is submitted and at the date of that application… the product has not already been the subject of a certificate."

A deliberation of the meaning of the term, product, is central to the interpretation of Article 3(c) and at the heart of the Novartis case was the definition of this term. Keeping this in mind, Article 1(b) of the SPC Regulation states that this term means "the active ingredient or combination of active ingredients of a medicinal product."

Background and facts

The recommendation to the CJEU was based on an appeal filed against the Swedish Patent Office's (PRV's) decision to decline Novartis' SPC application directed to their product, Ilaris® which contains as active ingredient, canakinumab.

In 2009, Ilaris® received its first marketing authorisation for the therapeutic indication of Cryopyrin-Associated Periodic Syndrome (CAPS). Subsequently based on this marketing authorisation, Novartis applied for and was granted an SPC for canakinumab and a basic patent (EP1313769) filed in 2001 which claimed the active ingredient per se.

Novartis applied for the second SPC based on a different basic patent (EP1940465) with second medical use claims directed to treating juvenile idiopathic arthritis. The second SPC application was also based on a second marketing authorisation received for Ilaris® in which treatment of this type of arthritis was specified as therapeutic indication. The second SPC's expiry date was projected to be nearly four years later than that of the first SPC protecting canakinumab.

The PRV declined the second SPC application basis that Novartis had earlier been granted an SPC for canakinumab and that therefore a new SPC for the same product could not be granted in view of Article 3(c). The Swedish Patent and Market Court upheld the PRV decision in the first instance saying that the term "product" had to be interpreted in the strict sense to mean "active ingredient" and that a new therapeutic indication did not constitute a new "product" within the meaning of Article 1(b).

Unlike the first instance court however, the referring court aka the Swedish Patent and Market Court of Appeal considered as unclear the interpretation of Article 3(c). The CJEU's ruling in Neurim allowed for grant of SPCs when a patent protects a new use of a known product, the referring court said. Article 3's application had been given wider purpose of encouraging research into known products' new therapeutic uses although Article 3(c)'s strict interpretation meant that the same holder of many basic patents could not be granted more than one SPC for the same product. Therefore, the referring court referred to the CJEU a question with the purpose of making clear whether a second SPC can be granted to an applicant for a product where the second SPC concerns new therapeutic indication specifically protected by a new basic patent and where the applicant already has an earlier SPC to the same active ingredient, the earlier SPC being based on a basic patent for the product itself.

Recently, the CJEU issued an order in which it declared that the request for the referral had been cancelled by the Swedish Court.