Thursday, 14 May 2015

Viiv and Teva to fight SPC dispute without benefit of premature CJEU ruling

ViiV Healthcare UK Ltd v Teva UK Ltd [2015] EWHC 1074 (Ch), a Patents Court, England and Wales, decision of John Baldwin QC, sitting as a Deputy Judge of the High Court, is a bit of a curiosity -- a case on supplmentary protection certificates (SPCs) for pharmaceutical patents that did not result in a reference to the Court of Justice of the European Union for a preliminary ruling (it seems quite ironical that it's SPC cases that get referred to the CJEU so often when the mere fact of a reference can add a couple of years to the length of a trial while the SPC itself is for such a short period of time).

In short, Viiv had an SPC on the basis of its UK patent for a medicinal product containing abacavir and lamivudine for the treatment of HIV. Viiv issued proceedings for a declaration as to the proper interpretation of Article 3 of Regulation 469/2009 (the SPC Regulation) in the context of its 2009 SPC for "a combination comprising abacavir, optionally in the form of a physiologically functional derivative and lamivudine, optionally in the form of a physiologically functional derivative". In response, Teva applied to revoke the patent and the SPC.

Both parties agreed that the patent revocation proceedings should progress to trial regardless of whether a reference was made, and the trial was expected to take place in March 2016, with a Court of Appeal judgment following about a year later. The parties had cooperated in producing drafts of an agreed statement which set out their factual contentions.

In these proceedings Teva argued that there was no need to make a reference to the CJEU until essential facts had been found. No, said Viiv: the question of whether to make a reference was essentially one of case management, and the overriding objective of the Civil Procedure Rules was best served by making a reference now so that it would be better placed to decide whether to make any application to amend the patent.

John Baldwin QC refused the application, making the following observations:

* The CJEU's "Recommendations to national courts and tribunals in relation to the initiation of preliminary ruling proceedings" stated that
"A national court or tribunal may submit a request for a preliminary ruling to the Court as soon as it finds that a ruling on the interpretation or validity of European Union law is necessary to enable it to give judgment."
* Case law made it clear that, as a rule, the court could not tell whether it was necessary to decide a point until all the facts were ascertained, so in general it was best to decide the facts first; it followed that, in principle, a reference should only be made in the context of facts agreed or determined by the national court,

* On references to the CJEU, it was not unusual to include facts in "Agreed Statements of Facts" which were not actually facts but which were parties' factual contentions. There might be circumstances where that was appropriate -- but that should not be the norm as it was contrary to the concept that references were only made when a decision on the question was necessary to enable the court to give judgment.  The issue was not desirability from the parties' perspective but necessity from the court's perspective.

* It was wrong for the court to make a reference to the CJEU merely to enable a party to be better informed as to whether to go forward with an application to amend its patent.

* In this particular case it was far too early to make a reference. The proposed statement of facts was not sufficiently precise to give the CJEU a firm basis on which to make a decision and there were too many contingencies. In any event, if the patent was revoked at the validity trial, all questions relating to the SPC would become irrelevant.

This blogger thinks that the Deputy Judge got it right, even if this ruling does rather spoil the fun for those of us who enjoy watching the continuing evolution of CJEU jurisprudence and measuring it up against the twin criteria of commercial necessity and common sense.

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