The following is written in substantial reliance on a very helpful note prepared by Hugh Goodfellow (Carpmaels & Ransford), sent to this weblog by his colleague Edward Oates.
Yeda held a basic patent for a therapeutic composition that includeda monoclonal antibody and an anti-neoplastic agent. The marketing authorisation which Yeda cited in support of its SPC application related to a medicinal product (Erbitux) which contained the antibody alone (cetuximab) but mentioned that the antibody was indicated to be used in combination with the anti-neoplastic agent (irinotecan).
In its SPC filing strategy, Yeda attempted to cover two options, by filing one SPC application that identified the product merely as "cetuximab" and another application for "cetuximab in combination with irinotecan". The UK IPO refused both SPC applications.
- The "cetuximab" SPC application was refused for failing to satisfy the requirements of Article 3(a) of the SPC Regulation because the basic patent did not protect the specified product.
- The combination SPC application was refused under Article 3(b) of the Regulation because the referenced marketing authorisation related to the active ingredient cetuximab alone.
Yeda appealed this decision to the High Court for England and Wales, arguing that its patent allowed it to oppose any use by a third party of the active ingredient cetuximab, including use as a single agent treatment, because such use would constitute indirect (or contributory) infringement of its patent for the purpose of Section 60(2) of the UK Patents Act 1977. Yeda therefore said that, for the purposes of the application of Article 3(a), the active ingredient at issue was protected by the patent. While this initial appeal was unsuccessful, the Court of Appeal was persuaded that the law was not clear and referred the matter to the Court of Justice for a preliminary ruling.
The Court of Justice considered that the referred question was, for all essential purposes, answered by the judgment in Medeva (C-322/10) and therefore delivered a Reasoned Order. The Court's language is closely modelled on that used Medeva and concludes that Article 3(a) precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent. The ruling of the Court is therefore as follows:
"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".Observing that this Order will come as no surprise to commentators in the field following Medeva, Hugh adds that we might expect to see further Reasoned Orders, for example in the Queensland and Daiichi referrals. He continues:
"It will be interesting to see whether the Court's reasoning in this case could be avoided in future cases by using different claim language, e.g. by using method features to define the combination therapy. Would such claims still be considered to specify the active ingredient as "forming part of a combination in conjunction with another active ingredient? Another approach, which does not appear to have been pleaded in Yeda, would have been to argue that the patent is for an "application" of the active ingredient in the sense of Article 1(c) (with the "application" being a combination therapy with the other active ingredient). Unfortunately, however, the CJEU's order is couched in terms that will make it difficult to run such an argument in the future".