08 June 2017 - Authored by:Rafi Allos
The Court of Justice of the European Union (CJEU) has refused a request from the High Court of Justice (England and Wales) that the CJEU’s preliminary ruling in the Teva v Gilead SPC dispute (the High Court’s decision to make a reference is available here) should be expedited pursuant to Article 105(1) of the Rules of Procedure of the CJEU. The Order of the President of the CJEU refusing the request of 04 April 2017, which has recently become available, indicates the limited circumstances in which a CJEU reference will be expedited.
The Order states that the generic company claimants wish to market generics of Gilead’s Truvada as soon as the basic patent protecting it expires on 24 July 2017 and as such they had sought to challenge the validity of the Gilead’s SPC for Truvada in advance of the expiry of the basic patent. In support of its request for expedition, the High Court stated that, without expedition, the case will not be resolved before the expiry of Gilead’s basic patent and this will inevitably delay the availability of generics of Truvada for the National Health Service (NHS) which “will entail higher costs for, and place a more onerous budgetary burden” on the NHS.
In refusing the request, the President of the CJEU referred to the CJEU’s case-law that an impact on economic interests, including those liable to have an impact on public finances, does not justify expedition. Furthermore, the President noted that there is no suggestion of an imminent risk to public health which might constitute an “exceptional circumstance such as to justify the use of the expedited procedure”. Rather the President noted that it is clear that, whilst the availability of generics might be delayed from use of the ordinary non-expedited procedure, patients’ health would nevertheless not be affected as they could continue to be treated using Truvada.
As a result, the question referred by Arnold J to the CJEU, “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?“, which is hoped to provide clarity of this important criterion of the SPC Regulation will be addressed by the CJEU in the normal timeline. The last three SPC judgments from the CJEU were handed down approximately 12 months after the Court received the request for a preliminary ruling so one may expect to see a CJEU ruling in Teva v Gilead some time in the first half of 2018.