In a judgment issued 3 May 2019, the Swedish Patent and Market Court of Appeal has referred the following question to the CJEU:
“Does Article 3(c) <of the SPC Regulation>… prevent an applicant which previously has been granted an SPC for a product protected by a valid basic patent for that product per se, from being granted an SPC for a new use of the product in a case where the new use constitutes a new therapeutic indication which is specifically protected by a new basic patent?”
The referral is now pending before the CJEU as case C-354/19.
Article 3(c) of the SPC Regulation requires that:
“the product has not already been the subject of <an SPC>”
The question arises in the context of Novartis’s application 1390061-8 for an SPC to canakinumab based on EP1940465 and a 2013 decision to amend a 2009 marketing authorisation, EU/1/09/564. The amendment additionally authorises the product for the treatment of systemic juvenile idiopathic arthritis (SJIA). The claims of EP1940465 are limited to use of canakinumab for SJIA and so they exclude other uses. The same will apply for any resulting SPC, which would expire in 2028.
The Swedish Patent Office rejected the application on the grounds that Novartis holds an earlier granted SPC to canakinumab based on a different basic patent, EP1313769, and the original 2009 marketing authorisation which refers to a different therapeutic indication (cryopyrin periodic syndromes). The claims of EP1313769 are to the product per se with no limitation as to use. Thus, during its term (which expires in 2024) the earlier SPC will also cover any additional authorised uses, such as those included in the amended marketing authorisation.
The referral here is interesting, in that it explores territory similar to that dealt with in the longstanding Neurim decision C-130/11 and the more recent Abraxis decision C-443/17 (see our briefing on Abraxis here). That is, in each instance the courts were seeking to clarify the extent to which SPCs may be available for inventions relating to second (and further) medical uses of known products, rather than being strictly limited to new products. This is significant since, as the Swedish Court mentions in its referral, the underlying intent of the SPC Regulation is widely understood to have been the promotion of “pharmaceutical research” in general, not only the development of new products.
The Swedish referral is distinct from the earlier cases, since the Neurim and Abraxis decisions were concerned with the interpretation of Article 3(d) of the SPC Regulation, rather than Article 3(c). Article 3(d) of the SPC Regulation requires that:
“the authorisation …<relied upon>… is the first authorisation to place the product on the market as a medicinal product.”
In Neurim and Abraxis the applicants did not hold earlier SPCs and so Article 3(c) was not relevant. Thus, although Abraxis appears to have confirmed that SPCs may be available for new uses (but not new formulations) of previously authorised active ingredients1, it did not directly consider whether or not this will apply when the same applicant already holds an earlier SPC. The Swedish Court has found it necessary to request clarification of this point, and the CJEU’s response will be awaited with interest.
1 Although note that there is a further pending referral with respect to Article 3(d) from the French Courts in Santen C-673/18.