High Court refuses to refer questions on the interpretation of the SPC Regulation at a preliminary stage

13 May 2015


The High Court has refused to refer to the Court of Justice of the European Union (CJEU), at a preliminary stage, questions on the interpretation of the Supplementary Protection Certificate (SPC) Regulation, in a dispute between ViiV Healthcare UK Ltd and Teva UK Ltd regarding HIV medicine Kivexa.

The dispute includes a challenge to the validity of ViiV's patent and SPC in relation to ViiV's HIV medicine Kivexa.

ViiV sought a reference to the CJEU at an early stage of the English proceedings with a view to obtaining a ruling clarifying the interpretation of Article 3(d) of Regulation 469/2009 (the SPC Regulation) at more or less the same time as the UK Court of Appeal would conclude any appeal on patent validity (end of 2016 or so).

Background facts

Order of events

  • ViiV's patent granted (1996) with claims including A+B and A+B+C,
  • Marketing authorisation (MA) for A+B+C (2001) - HIV medicine Trizivir
  • MA for A+B (2004) - HIV medicine Kivexa
  • SPC granted based on ViiV's patent and the 2004 MA for A+B

Litigation so far

Teva has sought revocation of ViiV's patent and SPC. Teva contends that ViiV's 2004 MA for A+B does not satisfy the conditions of Art 3(d) of the SPC Regulation. Article 3 of the SPC Regulation is in these terms:

"A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

  1. the product is protected by a basic patent in force;
  2. a valid authorisation to place the product on the market as a medicinal product has been granted...;
  3. the product has not already been the subject of a certificate;
  4. the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product."

When should a reference be made?

The deputy judge, Mr John Baldwin QC, referred to the wording of Article 267 of the Treaty on the Functioning of the European Union (TFEU), which provides:

"The Court of Justice of the European Union shall have jurisdiction to give preliminary rulings concerning:

  1. the interpretation of the Treaties;
  2. the validity and interpretation of acts of the institutions, bodies, offices or agencies of the Union;

Where such a question is raised before any court or tribunal of a Member State, that court or tribunal may, if it considers that a decision on the question is necessary to enable it to give judgment, request the Court to give a ruling thereon.

Where any such question is raised in a case pending before a court or tribunal of a Member State against whose decisions there is no judicial remedy under national law, that court or tribunal shall bring the matter before the Court."

The deputy judge emphasised the word necessary. He referred to guidance from Lord Denning MR in Bulmer v Bollinger [1975] RPC 321 explaining that 'necessary' is a much stronger requirement than 'desirable' or 'convenient'. Lord Denning MR concluded:

"...as a rule you cannot tell whether it is necessary to decide a point at all until the facts are ascertained. So in general it is best to decide the facts first."

The deputy judge also referred to more recent jurisprudence from Warren J in Eli Lilly v HGS [2012] EWHC 2290 (Pat):

"In principle, a reference should only be made in the context of facts agreed or determined by the national court. That is, perhaps, not an entirely rigid rule in the sense the ECJ will give answers to questions on the basis of facts contained in the reference even if those facts have not yet been found. But that is an inherently undesirable procedure."

A reference at the present time was not necessary in the present dispute

The deputy judge then turned to the dispute before him. The parties had cooperated to produce a draft Agreed Statement of Facts, some text of which was not agreed. In the deputy judge's view they were not true facts, much of the document reciting contentions and areas to be explored at trial. The deputy judge also said:

"I was told that, 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' contentions as to the facts. There may be circumstances where that is appropriate but it seems to me that such should not be the norm. The whole idea seems to be contrary to the concept that references are only made when "a decision on the question is necessary to enable [the court] to give judgment" (cf Article 267)."

ViiV contended that from a case management perspective, a referral at this stage would enable a ruling from the CJEU by the time of any hearing before the Court of Appeal on the validity of the patent.

Although such guidance might be desirable for ViiV, in that it might assist ViiV with deciding its strategy on amendments, it was a different matter for Teva. But in any case, desirability was beyond the ambit of Art. 267 of the TFEU.

The deputy judge considered it far too early to make a reference in this case, principally for the following reasons:

"First, if the patent is revoked at the validity trial, all questions relating to the SPC become irrelevant. Second, if ViiV's conditional applications to amend are not allowable for conventional reasons, then all questions relating thereto or contingent thereon become irrelevant. Third, if the combination of A+B is not innovative over the combination of A+B+C, then an important if not the main plank of ViiV's argument that its SPC is valid falls away and the questions in relation thereto become irrelevant. Likewise with respect to whether or not there are any synergistic interactions between A or B or C or any combination of them and if so what significance should be attached thereto. Each of these matters may or will be decided at the trial and a decision as to whether a reference is necessary cannot, in my view, be meaningfully made before that time, at least."

The deputy judge also noted the CJEU's failure to rule on questions in Actavis v Boehringer C-577/13 (albeit those questions were in the context of Art.3(a) and not Art.3(d) of the SPC Regulation). He stated:

"This failure to answer fully argued academic questions is a good indication that the CJEU is not interested in questions other than those necessary to resolve any particular case."

Conclusion

The High Court has confirmed that although a reference to the CJEU for a ruling on the interpretation of the SPC Regulation can add years to the duration of litigation in national courts, this does not justify expedition of a reference before it is 'necessary' to enable the English Court to give judgement. As a general rule, a reference will not become necessary until the relevant facts have been determined.


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