England and Wales High Court (Patents Court) Decisions

IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT

		Royal Courts of Justice Strand, London, WC2A 2LL
		2nd November 2006

RICHARD ARNOLD Q.C. :

1. By order dated 10 December 2004 I referred to the Court of Justice for the European Communities under Article 234 EC the following questions as to the interpretation of Council Regulation 1768/92/EEC of 18 June 1992 ("the Regulation"):

(1) In a case in which the basic patent protects a second medical application of a therapeutic agent what is meant by "product" in Article 1(b) of the Regulation and in particular does the application of the therapeutic agent play any part in the definition of "product" for the purpose of the Regulation?

(2) Does the term "combination of active ingredients of a medicinal product" within the meaning of Article 1(b) of the Regulation mean that each component of the combination must have therapeutic activity?

(3) Is there a "combination of active ingredients of a medicinal product" where a combination of substances comprises two components of which one component is a substance with a therapeutic effect for a specific indication and the other component renders possible a form of the medicinal product that brings about efficacy of the medicinal product for that indication?

2. These questions were referred in the context of an appeal by Yissum Research and Development Company of the Hebrew University of Jerusalem ("Yissum") from a decision of Mr R.J. Walker on behalf of the Comptroller-General of Patents dated 29 July 2004 (BL O/222/04) in which the hearing officer essentially refused Yissum's request for the grant of a Supplementary Protection Certificate in respect of its European Patent (UK) No. 0129003B2 entitled "Cosmetic and dermatological compositions containing 1-alpha-hydroxycholecalciferol".
3. As appears from my judgment of 10 December 2004 [2004] EWHC 2880 (Pat), a major reason for the reference was that the Bundesgerichtshof had then recently referred two questions concerning the interpretation of the Regulation to the Court of Justice. Questions 2 and 3 above are very similar to the questions referred by the Bundesgerichtshof. On 4 May 2006 the Court of Justice ruled upon that reference in Case C-431/04 Massachusetts Institute of Technology (now reported at [2006] RPC 34).
4. Subsequently the Registrar of the Court of Justice asked whether the High Court wished to maintain the reference in the present case, which is pending before the Court of Justice under the reference C-205/05, in the light of the Court of Justice's ruling in Case C-431/04. I invited written submissions from the parties with regard to that question. This is my decision upon it.
5. The parties are agreed that it is no longer necessary to ask the Court of Justice to answer questions 2 and 3 above since the ruling in Case C-431/04 is determinative of those questions. I too agree with this. Accordingly, questions 2 and 3 are hereby withdrawn from the reference.
6. As to question 1 above, the parties are agreed that it remains necessary to seek a ruling from the Court of Justice on this question since the answer to it is not clear from the ruling in Case C-431/04. Again, I too agree with this, particularly since I understand that a number of different answers to the question have been proposed by those who have filed observations with the Court of Justice. Accordingly, the reference is maintained with regard to question 1.