Skin-Cure Spc Application Goes To Ecj

Here's around other patent example that has been picked upward past times the LexisNexis All England Direct subscription service: Yissum Research as well as Development Co of the Hebrew University of Jerusalem v Comptroller-General of Patents [2004] EWHC 2880 (Pat), a determination of Richard Arnold QC sitting inwards the Patents Court equally a deputy gauge terminal Friday.

Yissum, who owned a patent for cosmetic as well as dermatological compositions containing 1-alpha-hydroxycholecalciferol used inwards the topical handling of certainly peel disorders, applied for a supplementary protection certificate (SPC) for calcitriol, a production for which UK marketing ascendance had been granted. The Comptroller refused the application on the grounds that, if the production to travel protected was defined equally calcitriol, the application did non comply amongst Article iii of Council Regulation 1768/92 which states:

"A certificate shall travel granted if, inwards the fellow member nation inwards which the application … is submitted as well as at the appointment of that application …(b) a valid ascendance to house the production on the marketplace seat equally a medicinal production has been granted inwards accordance amongst Council Directive (EEC) 65/65 …; (d) the ascendance referred to inwards (b) was the rootage ascendance to house the production on the marketplace seat equally a medicinal product".

Yissum appealed, alleging that the production to travel protected was either "calcitriol for the topical handling of psoriasis" or that it was "a combination of calcitriol as well as an ointment base". In this context a dispute arose betwixt the parties equally to the interpretation of Article 1(b) of the same regulation which states:

"(a) ‘medicinal product’ agency whatever amount or combination of substances presented for treating or preventing illness …; (b) ‘product’ agency the active constituent or combination of active ingredients of a medicinal product;…(d) ‘certificate’ agency the supplementary protection certificate".

The parties each argued that their respective interpretations of the regulation were acte claire but that, if the courtroom did non convey their interpretation, the query of interpretation should travel referred to the European Court of Justice (ECJ).

Richard Arnold QC ruled that, if an interpretation of the Regulation were to travel considered acte claire, the courtroom had to travel certainly equally to both (i) what the correct interpretation was as well as (ii) that the ECJ as well as the other courts inwards the European Union would convey the same view. The courtroom had a discretion to practice equally to whether to brand a reference fifty-fifty if it did non regard that the interpretation of the regulation was acte claire. However, inwards the low-cal of the recent reference to the ECJ from the High German Federal Supreme Court of similar questions relating to the regulation, a reference inwards the 2nd example would avoid the opportunity of an appeal 1 time the results of the High German reference were known. Accordingly, inwards the practice of its discretion, the courtroom would cite the questions relating to interpretation of the regulation to the ECJ.

is disappointed that the All England regime annotation didn't explicate to a greater extent than on the background to the reference. Meanwhile, he has dug this upward from Thomson's Current Drug Gazette (1 Oct 2004):

"This week’s PDJ likewise noted that the Yissum R&D Company of the Hebrew University of Jerusalem had lodged an appeal against the rejection of their 2002 UK SPC application, based on the Marketing Authorisation of Dec 2001 roofing certainly Calcitriol formulations. The SPC had been rejected amongst the examiner citing before authorisations for calcitriol. Yissum proposed that the before authorisations were non relevant equally they did non relate to the same therapeutic indication, precisely the hearing officeholder did non permit this proposal.

An choice example proposed that the production was a combination of calcitriol as well as an ointment base of operations as well as thence dissimilar to the before authorisations roofing calcitriol alone. The patent claim did comprehend this Definition of a product, precisely the hearing flora that this wide Definition of the production was non compatible amongst the narrower reach of the marketing ascendance as well as and then the application was rejected. An SPC application had already been rejected inwards Switzerland inwards 1996 and
the European patent expired inwards Apr 2004".

More on calcitriol here
Calcitriol for cats as well as dogs here