SKIN-CURE SPC APPLICATION GOES TO ECJ

Here's another patent case that has been picked up by the LexisNexis All England Direct subscription service: Yissum Research and Development Co of the Hebrew University of Jerusalem v Comptroller-General of Patents [2004] EWHC 2880 (Pat), a decision of Richard Arnold QC sitting in the Patents Court as a deputy judge last Friday.

Yissum, who owned a patent for cosmetic and dermatological compositions containing 1-alpha-hydroxycholecalciferol used in the topical treatment of certain skin disorders, applied for a supplementary protection certificate (SPC) for calcitriol, a product for which UK marketing authorisation had been granted. The Comptroller refused the application on the grounds that, if the product to be protected was defined as calcitriol, the application did not comply with Article 3 of Council Regulation 1768/92 which states:

"A certificate shall be granted if, in the member state in which the application … is submitted and at the date of that application …(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Council Directive (EEC) 65/65 …; (d) the authorisation referred to in (b) was the first authorisation to place the product on the market as a medicinal product".

Yissum appealed, alleging that the product to be protected was either "calcitriol for the topical treatment of psoriasis" or that it was "a combination of calcitriol and an ointment base". In this context a dispute arose between the parties as to the interpretation of Article 1(b) of the same regulation which states:

"(a) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease …; (b) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product;…(d) ‘certificate’ means the supplementary protection certificate".

The parties each argued that their respective interpretations of the regulation were acte claire but that, if the court did not accept their interpretation, the question of interpretation should be referred to the European Court of Justice (ECJ).

Richard Arnold QC ruled that, if an interpretation of the Regulation were to be considered acte claire, the court had to be sure as to both (i) what the right interpretation was and (ii) that the ECJ and the other courts in the EU would take the same view. The court had a discretion to exercise as to whether to make a reference even if it did not consider that the interpretation of the regulation was acte claire. However, in the light of the recent reference to the ECJ from the German Federal Supreme Court of similar questions relating to the regulation, a reference in the instant case would avoid the risk of an appeal once the results of the German reference were known. Accordingly, in the exercise of its discretion, the court would refer the questions relating to interpretation of the regulation to the ECJ.

The IPKat is disappointed that the All England note didn't explain more on the background to the reference. Meanwhile, he has dug this up from Thomson's Current Drug Gazette (1 October 2004):

"This week’s PDJ also 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 December 2001 covering certain Calcitriol formulations. The SPC had been rejected with the examiner citing earlier authorisations for calcitriol. Yissum proposed that the earlier authorisations were not relevant as they did not relate to the same therapeutic indication, but the hearing officer did not allow this proposal.

An alternative case proposed that the product was a combination of calcitriol and an ointment base and therefore different to the earlier authorisations covering calcitriol alone. The patent claim did encompass this definition of a product, but the hearing found that this broad definition of the product was not compatible with the narrower scope of the marketing authorisation and so the application was rejected. An SPC application had already been rejected in Switzerland in 1996 and
the European patent expired in April 2004".

More on calcitriol here
Calcitriol for cats and dogs here