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First Application of the Recent Medeva Decision on SPCs by the CJEU – The Yeda Order

First Application of the Recent Medeva Decision on SPCs by the CJEU – The Yeda Order

14/12/11

The CJEU have applied their recent judgment in the Medeva case for the first time in a Reasoned Order in the Yeda case (C-518/10).  A copy of the order can be accessed here:

http://curia.europa.eu/juris/document/document.jsf?text=&docid=116161&pageIndex=0&doclang=en&mode=req&dir=&occ=first&part=1&cid=304032

Background

Yeda had obtained a patent covering combination therapy using a monoclonal antibody and an antineoplastic agent.  On the basis of this patent, SPCs were applied for covering a) cetuximab (a monoclonal antibody) alone, and b) cetuximab in combination with irinotecan (an antineoplastic agent).  The SPCs were based on a Marketing Authorisation permitting the sale of cetuximab monotherapy.

The SPC covering cetuximab monotherapy was refused by the UK Intellectual Property Office, and the refusal was appealed firstly to the UK High Court and then to the Court of Appeal. 

The thrust of the appeal was that although the claims of the patent on which the SPC were based covered a combination of cetuximab and irinotecan, these did ‘protect’ the cetuximab monotherapy product, as it would not be possible to market the cetuximab mono product without infringing (by contributory infringement) the claims of the patent; the main approved indication for cetuximab monotherapy is combination therapy with irinotecan.

The Court of Appeal referred the following question to the CJEU:

‘If the criteria for deciding whether a product is “protected by a basic patent in force” under Article 3(a) of … Regulation [No 469/2009] include or consist of an assessment of whether the supply of the product would infringe the basic patent, does it make any difference to the analysis if infringement is by way of indirect or contributory infringement based on Article 26 of the [European] Patent Convention, enacted as Section 60(2) of the [UK] Patents Act 1977 in the United Kingdom, and the corresponding provisions in the laws of other Member States of the Community?’

Following the CJEU’s recent judgment in the Medeva case, the CJEU considered that the UK Court of Appeal’s referred question could plainly be answered in the form of a Reasoned Order, and that a full judgment was not required.

Application of the Medeva Judgment – the Reasoned Order

In explaining their order (see paragraph 33 thereof), the CJEU recharacterised the UK Court of Appeal’s referred question as being:

“Whether Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone.”

In other words, can an SPC for A be based on a patent claiming A+B?

Applying the judgment in the Medeva case to this question, the CJEU answered that it cannot, or in their own words, that:

"Article 3(a) ... must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone".