Patent decision

BL number

O/222/04

Concerning rights in

SPC/GB/02/023

Hearing Officer

Mr R Walker

Decision date

29 July 2004

Person(s) or Company(s) involved

Yissum Research & Development Company of the Hebrew University of Jerusalem

Provisions discussed

Council Regulation (EEC) No. 1768/92, Art. 3(d)

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

The applicant filed an application for a supplementary protection certificate (SPC) based on a UK marketing authorisation for Silkis (RTM) ointment comprising calcitriol and certain excipients and requested protection for the product 'calcitriol'. The examiner objected that the application did not comply with Article 3(d) citing earlier authorisations for calcitriol. At the hearing the applicant proposed that the earlier authorisations were not relevant as they did not relate to the same therapeutic indication of calcitriol. The hearing officer was not persuaded by this argument finding that such an interpretation of the Regulation would leave Article 4 unclear by not giving the patent its proper role in determining the scope of the SPC, in respect of those subsequent uses of the product not covered by the first authorisation.

The hearing officer also considered the applicants alternative case which proposed the product to be a combination of 'calcitriol and ointment base'. This combination would not offend Article 3(d) in respect of the earlier authorisations provided by the examiner, however it remained for the hearing officer to decide if such a combination was a 'product' in the terms of the Regulation. To answer this question the hearing officer found himself directed by paragraph 28 of the explanatory memorandum and Jacob Js comments in Draco A.B.s SPC Application 1996 RPC 417 at page 439 lines 48-50 to refer to the scope of the patent rather than the active ingredients indicated in the marketing authorisation. A claim encompassing a composition of calcitriol and suitable carriers to manufacture an ointment provided limits of protection within which the product could be drawn, however such a broad definition of product would not be acceptable having regard to the narrower scope of the marketing authorisation. Therefore the hearing officer rejected the applicants alternative case but granted an opportunity to amend.