Can an authorisation for a human medicinal product provide basis for an SPC where its active was previously authorised in a veterinary medicinal product?

03 May 2011

Trevor Cook

As exemplified by Cases 195/09 Synthon v Merz and C-427/09 Generics (UK) v Synaptech (reported above), currently pending before the Court of Justice of the European Union (CJEU), the recent opinions of the Advocate General which are discussed elsewhere in this update, one perennial source of controversy under the Supplementary Protection Certificate (SPC) Regulations is what sort of authorisation constitutes a “first marketing authorisation in the Community.”  This matters because it can affect the availability of an SPC where such an authorisation had been already granted in the same EU Member State (by virtue of Article 3(d) of the medicinal products SPC Regulation), or, where it has already been granted in a different EU Member State, either its availability or its term, which cannot only exceed five years from expiry of the basic patent but must be such as to expire no more than 15 years after the first such authorisation in the EU.  On 8 March 2011 the English Court of Appeal referred yet another aspect of this particular controversy to the CJEU in Neurim Pharmaceutical (1991) Ltd v Comptroller General of Patents. This time it concerned in effect whether a marketing authorisation for a veterinary medicinal product constitutes a first “marketing authorisation in the Community” in the context of an application for an SPC based on a subsequent marketing authorisation for the same active as a human medicinal product.  

At first sight it would appear that the answer should be yes, as Article 3(d) of the medicinal products SPC Regulation, which requires that the marketing authorisation on which the application for an SPC is based be the first in that Member State, makes no distinction by virtue of its cross-reference to Article 3(b) as between marketing authorisations secured under Directive 2001/83/EC (formerly 65/65/EEC, as to human medicinal products) and those secured under Directive 2001/82/EC (formerly 81/851/EEC, as to veterinary medicinal products).  This was certainly the view that had been taken in the Patents Court and in the UK Patent Office in this case, applying the CJEU‘s earlier ruling in Case C-31/03 Pharmacia Italia v Deutsches Patentamt

Here however the Court of Appeal were attracted by an argument advanced by the applicant for the SPC and which sought to distinguish the previous case law on the basis that the basic patent in this case only had claims to use of the active in issue in humans and so could never have constituted a basic patent for an SPC based on the earlier veterinary marketing authorisation.   The applicants drew support from the Explanatory Memorandum for the medicinal products SPC Regulation, and the purpose behind it, for their interpretation of Article 3(d) that the authorisation on which the SPC is based must be the first relevant authorisation (i.e. authorisation of a product within the scope of the basic patent) to place the product on the market as a medicinal product.  The Court of Appeal felt that to hold otherwise would mean that the SPC Regulation “would not have achieved its key object for large areas of pharmaceutical research”, namely that protected by second use patents. 

If the CJEU were to agree with the Court of Appeal in their interpretation, the consequences could be much wider than for those actives that are the subject of authorisations both as human and as veterinary medicinal products; thus there is no reason then why the principle should not extend so as to enable applicants for SPCs in respect of human medicinal products to disregard earlier authorisations as human medicinal products where these are outside the scope of the basic patent on which they seek to rely.  For this reason it seems unlikely that the CJEU will agree with the Court of Appeal no matter how unfair this may seem on the facts of this particular case; moreover the applicant will now also have to deal with the reasoning set out in the Advocate General's opinion in Case 195/09 Synthon v Merz, delivered after the decision of the Court of Appeal, and in which the Advocate General considered that “the first marketing authorisation for the product [ie active] as a medicinal product must be regarded as the first marketing authorisation in the Community, regardless of the kind of medical use which constitutes the subject matter of that authorisation and regardless of whether that use may possibly be the same as the use protected by the basic patent.“