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When is an Earlier Marketing Authorisation not an Earlier Marketing Authorisation?

When is an Earlier Marketing Authorisation not an Earlier Marketing Authorisation?


CJEU’s Decision in the Neurim SPC Case (C130/11)

In this case, the CJEU considered whether a Marketing Authorisation granted in 2001 permitting the sale of a drug (melatonin) for regulating the seasonal breeding activity of sheep prevented the award of an SPC covering the same drug which was based on a subsequent Marketing Authorisation (granted in 2007) for treating insomnia in humans.  The Court found that it should not and held that an SPC could be awarded to Neurim on the basis of the latter Authorisation. 

A copy of the judgment can be obtained here: http://curia.europa.eu/juris/document/document.jsf?text=&docid=125216&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=22543

Legal Background

Article 3 of the Regulation governing SPCs reads:

‘A certificate [SPC] shall be granted if, in the Member State in which the application referred to in Article 7 [for grant of the SPC] is submitted and at the date of that application:

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product has been granted …;

(c) the product has not already been the subject of a certificate;

(d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.’

In the present case, Neurim had obtained a patent, protecting the use of melatonin in the treatment of sleep disorders.  An Authorisation had also been obtained, enabling Neurim to market their product.  Thus, criteria 3(a) and (b) were met.  Further, no previous SPC had been awarded covering melatonin.

One of the key points for consideration in this case was the meaning of Article 3(d).  Under a literal, ‘black letter’ construction, Neurim’s authorisation was not the first authorisation to place melatonin on the market as a medicinal product; that product had already been authorised for a medicinal use (albeit veterinary) in 2001.  Indeed, the Patent Office refused the SPC on the grounds that it failed to comply with the requirements of Article 3(d) and the UK High Court upheld the Patent Office’s decision (although the Court did also acknowledge that there was a tenable argument in support of the contrary position).

The Decision

The CJEU held that the mere existence of an earlier Marketing Authorisation for a product does not preclude the grant of an SPC for a different application of the same product for which a Marketing Authorisation has been subsequently granted.

The CJEU also provided guidance as to when a previously granted Authorisation for the drug in question will be considered as the ‘first authorisation’ within the terms of Article 3(d).  It was held that, for the earlier Authorisation to constitute the ‘first authorisation’ and thus prevent a SPC being granted based on a subsequent Authorisation, the earlier Authorisation must relate to the same active ingredient and be authorised for a therapeutic use which is protected by the patent on which the SPC is based.

What This Means

This decision makes it clear that Article 3(d) does not automatically preclude the grant of an SPC where the SPC is not based on the first Marketing Authorisation (which was previously thought by many to be the case).  It also enables patent holders, in certain circumstances, to obtain a plurality of SPCs, limited to specific indications, for the same drug.

More generally, although this case involved a situation where the major distinction between the first and second Marketing Authorisations was the therapeutic use to which the authorised product could be put, the decision may encourage patent holders to apply for SPCs covering products which differ from previously approved products in other ways, for example, revised formulations, different salt forms or new dosage regimens.  It is likely that such applications will lead to the development of further case law in the field.