Patent decision
- BL number
- O/0257/24
- Concerning rights in
- EP2163643 EP2405015
- Hearing Officer
- Dr L Cullen
- Decision date
- 27 March 2024
- Person(s) or Company(s) involved
- Halozyme, Inc.
- Provisions discussed
- Regulation (EC) 469/2009 (Medicinal Products) Article 1, Article 3(c), 3(d)
- Keywords
- Supplementary Protection Certificates
- Related Decisions
- None
Summary
This decision concerns two applications: SPC/GB15/047 for the combination of trastuzumab (an antibody) and recombinant human hyaluronidase (rHuPH20, an enzyme); and SPC/GB16/039 for the combination of rituximab (an antibody) and rHuPH20. The marketing authorisations (MAs) for the medicinal product Herceptin (RTM) and MabThera (RTM) cited in support of these SPC applications are based on line extensions for subcutaneous injection to the respective MAs.
Having considered the relevant law and case law (from the Court of Justice of the European Union (CJEU) and from the UK Patents Court) and the further materials presented in relation to role of rHuPH20, the hearing officer (HO) concluded that, in order for a substance to be considered as an active ingredient under Article 1(b) of the SPC Regulation, it is necessary that the summary of product characteristics (SmPC) and the related European Public Assessment Report (EPAR) to indicate that the substance in question gives rise to a pharmacological, immunological or metabolic effect of its own for the therapeutic indication for which marketing approval was granted. Further materials can add additional support but the basis must be in the SmPC & EPAR. The HO came to the view that the SmPC & EPAR for Herceptin and MabThera both indicate that the rHuPH20 is acting as an excipient facilitating the delivery of the relevant active ingredient. The SmPC & EPAR do not support the view that rHuPH20 is acting as an active ingredient with a pharmacological, immunological or metabolic effect on HER2 breast cancer (for Herceptin) or Non-Hodgkin’s Lymphoma (NHL) (for MabThera). As a consequence, trastuzumab alone and rituximab alone were considered to be the respective active ingredients, rather than their respective combination with rHuPH20. The HO concluded that neither of these SPC applications meets the requirement of Article 3(d) of the Medicines SPC regulation. Further, in relation to SPC/GB15/047, an earlier SPC has already been granted for trastuzumab and so this application also does not meet the requirements of Article 3(c). Both SPC applications were refused under Article 10(2) of the Regulation.
Full decision O/0257/24 636Kb