Patent decision

BL number

O/136/22

Concerning rights in

SPC/GB14/029

Hearing Officer

Dr L Cullen

Decision date

16 February 2022

Person(s) or Company(s) involved

Ethicon, Inc., & Omrix Biopharmaceuticals, Inc

Provisions discussed

Regulation (EC) 469/2009 (Medicinal Products), Articles 1 and 3.

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

This decision concerns an application for a supplementary protection certificate (SPC) for a combination of three active ingredients: thrombin, fibrinogen and oxidised regenerated cellulose (ORC).

Having considered the SPC regulation and relevant case law from the Court of Justice of the European Union and from the UK Patents Court, the hearing officer (HO) concluded that, in order for a substance to be considered an active ingredient under Article 1(b) of the SPC Regulation, it is necessary that the summary of product characteristics (SmPC) that is annexed to the marketing authorisation and/or the European Pubic Assessment Report published by the EMA on the authorised medicinal product contain some indication that the substance in question gives rise to a pharmacological, immunological or metabolic effect of its own. Further evidence can be provided in support of this effect, but there must be something in the SMPC and EPAR to justify this.

Having considered the arguments provided by the examiner and the applicant, including further evidence in relation to ORC and the process of haemostasis provided by the applicant, the HO came to the view that the SmPC, and the EPAR for EVARREST, refer to ORC as a physical haemostat only, and are silent as to any pharmacological effect. The HO considered that there was not enough information in the SmPC and EPAR to justify a conclusion that ORC is acting as an active ingredient for the purposes of Rtcile 1(b) of the SPC Regulation. The HO considered that the SmPC and EPAR indicate that thrombin and fibrinogen are the active ingredients in EVARREST that actively achieve haemostasis with ORC acting as a physical barrier and matrix. Thus, ORC cannot be considered as an active ingredient in the same way as fibrinogen and thrombin. The combination of fibrinogen and thrombin has already been the subject of (two) previous marketing authorisations. As a consequence, the HO found that present application does not meet the requirements of Article 3(d) and is refused under Article 10(2) of the regulation.

Full decisionO/136/22  538Kb