Patent decision

BL number

O/418/13

Concerning rights in

SPC/GB/04/031

Hearing Officer

Dr L Cullen

Decision date

22 October 2013

Person(s) or Company(s) involved

Genzyme Corporation

Provisions discussed

Council Regulation (EC) No. 469/2009; Articles 3 and 13; Council Regulation (EC) No 1610/96: Recital 17; Article 17(2); Patents Rules 2007, Rule 107(3)

Keywords

Correction, Extension for Paediatric Testing, Rectification of irregularities, Supplementary Protection Certificates

Related Decisions

None

Summary

Supplementary Protection Certificate SPC/GB/04/031 was granted for colesevelam hydrochloride, the active ingredient in the medicinal product Cholestagel [RTM] used to treat hypercholesterolaemia. As part of a request for an extension to the period of protection provided by the granted SPC, the applicant requested that date of expiry for the term of protection of this SPC (including the six-month extension) should be corrected. The applicant considered that the extended SPC should expire either on 11 September 2019 or, one day later, on 12 September 2019, and not on 9 September 2019 as proposed by the examiner.

Taking account of the Treaty on the Functioning of the European Union, in particular Article 297, the hearing Officer found that a decision of the Commission which is addressed to a specific entity does not take effect until the addressee receives this notification. The grant of a marketing authorisation to place a medicinal product on the market in the Community, thus takes effect not on the date of decision by the European Commission but rather on the date that this decision is notified to the applicant for the marketing authorisation. This date of notification is determined by the European Commission and is provided in the Official Journal of the European Union (OJEU). Thus, an SPC based upon a European marketing authorisation should take account of the date of notification to the addressee of the decision to grant the marketing authorisation and not the date of the decision itself.

In response to the request that the term of the SPC should be extended, under Rule 107(3) of the Patents Rules 2007 because of the irregularity of not applying Regulation (EEC, Euratom) No 1182/71 when calculating the SPC term, the hearing officer found that this regulation was not relevant for the purposes of calculating the duration of the SPC under Article 13 of the SPC regulation. While, the applicant argued that the time period of 15 years exclusivity referred to in recital (9) was the basis on which Regulation 1182/71 would apply to working out when this period of exclusivity should begin and end, the hearing officer found that it was not possible to do so without taking account of the provision in the SPC regulation, Article 13, which delivers the period of exclusivity referred to in this recital. Regulation 1182/71 does not apply to the algorithm in Article 13 because it does not relate to a period expressed in hours, days or weeks but rather to the relationship between three events - the date of application of the patent, the date that the marketing authorization takes effect and the date that the patent expires.

The SPC was remitted to the examiner to make the necessary arrangements to rectify the expiry date of the SPC term.