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Pharma Update: More than one SPC for the Same Medical Product in case of a second Marketing Authorisation?

Date: 28 January 2020


On Thursday, Jan. 23, 2020, Advocate General (AG) Giovanni Pitruzella issued an opinion in a pending referral concerning SPCs to the Court of Justice of the European Union (CJEU) from the Paris Court of Appeal. The opinion is not binding to the CJEU but has some authoritative value. However, as the opinion, while favouring one outcome, provides alternative solution proposals, the final decision by the CJEU cannot yet be anticipated. It is to be expected somewhere around mid 2020.


Supplementary Protection Certificates (SPCs) are issued nationally by European Countries to compensate the long time required to fulfil the regulatory requirements associated with marketing approval (MA) of a drug. Up to 5.5 years and a maximum protection period of 25.5 years can thus be obtained if a patent for the API exists.


Article 3(d) of the SPC Regulation that forms the basis for this right was originally understood to provide that SPCs were only possible for products for a “first marketing authorisation” for a new active pharmaceutical ingredient (API) or novel API combinations.


However, in a landmark ruling in 2012 (C-130/11; “Neurim”), the CJEU seemed to open a door to the possibility that, even, where a first MA was already used as basis for a first SPC on an API, a further SPC might be grantable for a product with this API even where the API is not itself new. It was stated that the SPC might then be based on (i) a “different application” of the API if (ii) the product is “within the limits of the protection conferred by the basis patent (“Neurim Test”).


Santen applied for an SPC covering eyedrops for keratitis containing ciclosporin (trade name “Ikervis”). However, while some national patent offices granted an SPC, the French patent office rejected that SPC application for the reason that another ciclosporin product (Novartis’ Sandimmun) had received a first MA already in the 1980s, and Santen stated that Ikervis represents a “different application” of ciclosporin in the gist of Neurim. The Paris Court of Appeal referred the Santen case to the CJEU (C-673/18; “Santen”).


In the opinion issued by the AG, the AG invites the CJEU to abandon the Neurim Case law and to revert to the original strict interpretation of the SPC regulation so that only one “first” marketing authorisation may form the basis for an SPC. This would be of benefit for generics producers while originators would be at disadvantage. The AG (also referring to yet another CJEU decision (C-443-17; “Abraxis”) where the Court concluded that the development of a new formulation for a known API does not form a basis for a new SPC found it not acceptable to reconcile the “strict interpretation of the concept of “product” within the meaning of Article 1(b) of [the SPC regulation] with the reading of Art. 3(d), of this regulation adopted by the Neurim judgement”. The AG invites the CJEU to resolve the “antinomy” created by the contradiction between Abraxis and Neurim where the latter favors the protection of any research leading to a patent in contrast to being based on the first placing on the market of an active ingredient as was critically noted in Abraxis.


However, the AG also proposed alternative solutions: An SPC might exceptionally be granted for a product even with the same API if the product fulfils the conditions of the Neurim Test. Then an SPC might be awarded for an API if it covers “a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmaceutical, immunological or metabolic action of its own”.


Thus the AG´s opinion on the one hand suggests overturning the Neurim case law, on the other hand would not exclude a second SPC protection for Ikervis because it concerns a new (non-overlapping) medical indication and administration route when compared with Sandimmun. In contrast to many other Advocate General opinions, there is no simple yes or no decision to be expected by the Court.


It is to be expected with great curiosity which route the Court will take and whether it modifies or abandons the Neurim Case Law.