Agalsidase-beta, a glycosylated human a-galactosidase A enzyme which is the active ingredient in the medicinal product Fabrazyme (RTM). This product is used to treat Fabry disease where a deficiency in this enzyme means that those with this disease cannot break down a specific glycolipid leading to renal, cardiovascular and cerebro-vascular problems.This decision is also of note in that it considers third party observations made under Section 21 of the Patents Act 1977 -- which can be made in respect of the grant of an SPC. The Hearing Officer confirmed that the examiner correctly took such observations (made in this case by Genzyme Corporation) into account when reaching his decision and reiterated that a third party making such observations does not thereby become a party to the proceedings.
The applicant considered that the application met the requirements of Article 3(a) of the SPC Regulation because the wording of the process claim of EP(UK) 2210947 B1 filed in support of the application identifies the product which is the subject of their SPC application. The applicant argues that this is sufficient to satisfy Article 3(a) in light of the decision of the Court of Justice of the European Union (CJEU) in C-630/10 (University of Queensland, CSL Ltd v Comptroller-General of Patents, Designs and Trade Marks).
After considering the relevant case law, including C-630/10, the hearing officer found that in order to satisfy Article 3(a), the product of the SPC application has to be identified in the wording of the claims of the basic patent as the product deriving from the process in question. The key step is to establish what is the product that is identified in the claim and decide if this is the product for which the SPC is being sought. A further consideration of whether the product for which the SPC is sought is (or could be) produced directly by the process claimed in the basic patent is not relevant to the basis for granting an SPC under Article 3(a).
The hearing officer examined what was the product that was identified in the process claim of the basic patent and was satisfied that this was the same product approved by the marketing authorisation and for which the SPC was sought. As the product of the SPC application was indeed identified in the wording of the claims of the basic patent as the product deriving from the process in question, the hearing officer thus concluded that the application met the requirements of Article 3(a) of the Regulation. The case was remitted back to the examiner.
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