Given the propensity of SPC cases to end up with references to the Court of Justice of the European Union (CJEU) for preliminary rulings, it's not surprising that ViiV, the claimant, contemplated the prospect of such a reference in this action. Viiv however felt that it might be a good idea to start with the preliminary reference, so John Baldwin QC was called up to deal with the application for the reference even before the (in)validity of ViiV's Kivexa/Trizivir patent could be established and before a decision on conditional application to amend that patent was necessary. Teva opposed the application for a CJEU reference and argued that, first, it was unnecessary since the questions that ViiV wanted to pose were acte clair and there was therefore no basis for referring them, and secondly that it was premature to make such a reference ahead of the making of some essential findings of fact.
- This is an application for a reference to the Court of Justice of the European Union (CJEU) in an action in which the Claimant (ViiV) seeks a declaration as to the proper interpretation of Article 3 of Regulation (EC) No 469/2009 (the Regulation) in the context of a Supplementary Protection Certificate (SPC) granted in 2005 in respect of
"A combination comprising abacavir, optionally in the form of a physiologically functional derivative and lamivudine, optionally in the form of a physiologically functional derivative."It is sufficient for present purposes if the SPC wording is expressed as
"A combination comprising A + B."
- The application is resisted by the Defendant (Teva) on two main grounds. First it is contended that the answers to the proposed questions are acte clair, and second it is contended that there should be no reference to the CJEU until some important essential facts have been found.
- The SPC was granted on the basis of EP (UK) 0817637 (the Patent), which was applied for on 28 March 1996, and a marketing authorisation ("MA") notified on 22 December 2004 for a medicinal product containing abacavir (as a sulphate salt) and lamivudine (i.e. A + B) for the treatment of HIV. The product ViiV market pursuant to this MA is called Kivexa. The language of the SPC is substantially the same as the language of claim 1 of the Patent.
- ViiV also market another product for the treatment of HIV. It is called Trizivir and an MA was notified in respect of this on 2 January 2001. Trizivir is a combination of abacavir, lamivudine and AZT, i.e. is a product comprising A + B + C using the short hand nomenclature. As such, Trizivir also falls within claim 1 of the Patent. However, this triple combination is also protected by claim 3 of the Patent, which is in these terms:
- An MA for Trizivir was granted within 5 years of filing of the Patent and, accordingly, an SPC with a positive term has never been available based on this MA.
- ViiV issued proceedings for a declaration on 26 November 2014 and by Defence and Counterclaim served on 22 December 2014 the Defendant (Teva) sought revocation of the SPC. Sometime in February 2015 Teva indicated its intention to amend its Counterclaim to seek, in addition, an order revoking the patent upon which the SPC is based, and the amended version was filed and served on 8 April 2015.
- It is common ground that the patent revocation proceedings should progress to trial whether or not a reference is made and it is anticipated that the trial will take place in March 2016, with a Court of Appeal judgment following about a year later.
- Article 267 of the Treaty on the Functioning of the European Union provides:
- The CJEU's "Recommendations to national courts and tribunals in relation to the initiation of preliminary ruling proceedings" (2012/C 338/01) include the following:
- Over 40 years ago Lord Denning MR said in the context of Article 267 (ex Article 177) and in a section of his judgment where he set out a number of guide lines as to whether or not it was appropriate to refer a matter (Bulmer v Bollinger [1975] RPC 321, 341):
"A combination comprising abacavir or a physiologically functional derivative thereof, AZT or a physiologically functional derivative thereof, and lamivudine or a physiologically functional derivative thereof."
The approach to references to the CJEU
The Court of Justice of the European Union shall have jurisdiction to give preliminary rulings concerning:
(a) the interpretation of the Treaties;
(b) 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 appropriate stage at which to make a reference for a preliminary ruling
18. 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. It is that court or tribunal which is in fact in the best position to decide at what stage of the proceedings such a request should be made.
19. It is, however, desirable that a decision to make a reference for a preliminary ruling should be taken when the national proceedings have reached a stage at which the referring court or tribunal is able to define the legal and factual context of the case, so that the Court of Justice has available to it all the information necessary to check, where appropriate, that European Union law applies to the main proceedings."
"It is to be noticed too, that the word is "necessary". This is much stronger than "desirable" or "convenient". There are some cases where the point, if decided one way, would shorten the trial greatly. But, if decided the other way, it would mean that the trial would have to go to its full length. In such a case it might be "convenient" or desirable to take it as a preliminary point because it might save much time and expense. But it would not be necessary at that stage. When the facts were investigated, it might turn out to have been quite unnecessary. The case would be determined on another ground altogether. As a rule you cannot tell whether it is necessary to decide a point until all the facts are ascertained. So in general it is best to decide the facts first."This was said in the context of a sub-heading entitled 'Decide the Facts first' and I found it helpful to be reminded of the whole of Lord Denning's section on The Guide Lines in relation to references to the CJEU.
- More recently, Warren J in Eli Lilly v Human Genome Sciences [2012] EWHC 2290 (Pat) said:
- The parties have cooperated in producing drafts of an Agreed Statement of Facts and of Questions To Be Referred To The CJEU. The draft Agreed Statement of Facts is not, to my mind, quite what it purports to be. Thus the last four 'Facts' are:
- With respect to Fact 18, Teva did not agree that the matter surrounded by {} should be included. In any event, Fact 18 is not a fact but a matter which will or may be decided at the forthcoming trial. In addition, Teva took issue with the word 'innovation' contending that it was not clear what it meant in the present context.
- With respect to Fact 19, Teva did not agree that the matter surrounded by {} should be included. The issue of whether any amendments are allowable on conventional grounds will or may be decided at the forthcoming trial. Moreover, at the time of the hearing before me, ViiV had two different conditional applications to amend in play. Since the hearing I was told that one of these has been abandoned and will be replaced by a further application, the object of which is to make clear beyond doubt that protection for a combination of A+B+C will, if necessary, be excised from the Patent. Teva relies on the additional uncertainty created by this state of affairs as a further reason why it is premature to consider any reference to the CJEU. ViiV contends it is merely a contingency and the CJEU should be asked to give useful guidance upon whether or not it is necessary for ViiV to amend to save its SPC.
- Fact 20 is not a fact at all. It relates to a topic addressed by questions 1 and 4 in the reference made in Actavis v Boehringer C-577/13 at [24] (albeit those questions were in the context of Art.3(a) and not Art.3(d)) but which were not answered by the CJEU, even though fully argued, because its answers to other questions rendered these questions academic. 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.
- With respect to Fact 21, ViiV did not agree that the matter surrounded by {} should be included. Again, Fact 21 is not a fact. It is more an indication of an area which will be explored at trial. In particular, it may well be relevant to explore whether A and B also interact synergistically in the presence of C, or whether C has some (and if so what) influence thereon. And it is impossible to predict now what will be the likely outcome of the debate, or even whether the question is a simple binary one.
- 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).
- As for the draft questions to be referred, there is presently disagreement over their form and utility but I think it is likely that matters could be resolved if I thought it otherwise appropriate to make a reference. In brief, the questions concern Article 3(d) of the Regulation and address the circumstance where there has been an earlier MA for a product consisting of A+B+C, there is a later MA for A+B and there is an SPC for a product comprising A+B. There are additional questions which depend on whether there is synergy between A and B and/or C and upon whether use of a product consisting of A+B constitutes a separate innovation (perhaps invention is a better word, ViiV was content with either, Teva with neither) from use of a product consisting of A+B+C (for treatment of the same disease). There are also questions relating to the form of the claims of the patent and the content of the SPC as well as questions similar in content (although not form) to questions 1 and 4 of Actavis v Boehringer.
- Article 3 of the Regulation is in these terms:
- With respect to the SPC in relation to Kivexa, a) is satisfied by the Patent, b) is satisfied by the MA notified on 22 December 2004, c) is true as a fact, and that leaves d). Teva contends that the MA granted in respect of Kivexa was not the first authorisation to place the 'product' in question on the market as a medicinal product. It contends that the first such authorisation was that notified in January 2001 in relation to Trizivir. Further, it contends that, in the light of the case law which has already emerged from the CJEU, the matter is acte clair.
- ViiV, on the other hand, submits that the matter is not so clear at all, especially in circumstances where there is 'innovation' in a combination of A+B over A+B+C, a scenario which has not previously been before the CJEU, or where there is synergy between A and B and/or C. The questions which it wishes to refer to the CJEU directly address these points and ViiV contends that the sooner this court knows the answer to those questions the better. ViiV also points to the timing benefits which will be gained if a reference is made now. It suggests that, with a reference, the proceedings will conclude at more or less the same time as the UK Court of Appeal will conclude any appeal on patent validity (end of 2016 or so), whereas if no reference is made until then, the proceedings will go on for another two years thereafter, perhaps longer. ViiV submits that the question of whether or not to make a reference is essentially one of case management and that the 'overriding objective' is best served by making a reference now.
- ViiV urged upon me that a reference to the CJEU would not be that expensive, that payment of any costs thrown away would not be a problem and that, bearing in mind the commercial value of Kivexa (very substantial, according to ViiV) and the timetable, a reference was justified when there was a potential for answers to the questions to be of real value.
- In the context of ViiV's conditional applications to amend, counsel submitted that, if the court were satisfied that the amendments were otherwise allowable (i.e. there were no valid objections on conventional grounds), then ViiV was entitled to take the position that it would amend if it was necessary to preserve the validity of the SPC but not otherwise, and that the judge would not be able to decide upon whether it was necessary for ViiV to amend without a reference to the CJEU. Accordingly, it was appropriate to make a reference now so that the judge would be equipped to deal with any eventualities.
- I am far from satisfied that this is the right approach to take. In effect, ViiV wishes for guidance from the CJEU upon a number of hypothetical scenarios so as to be better placed to decide whether to make any application to amend the Patent, the prime objective being to maximise the protection surrounding Kivexa whilst maintaining as wide a patent monopoly as possible.
- That, however, seems to me to go to desirability, and what may be desirable from ViiV's point of view may not be so from Teva's point of view (and Teva contends it is not). Moreover, the issue is not desirability from the perspective of the parties (which may or may not coincide with that of the court), but necessity from the perspective of the court.
- I am not satisfied that this court should 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. That seems to me to be way beyond the ambit of Article 267 and my attention was not drawn to any authority which approved this use of the CJEU's resources.
- I am satisfied, however, that it is 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. Finally, I am not satisfied that the proposed Statement of Facts is sufficiently precise to give the CJEU a firm basis on which to make a decision. There are too many contingencies.
- In these circumstances I do not need to decide now whether the points ViiV wish to raise are acte clair or not. Indeed, they may never call for decision. I dismiss the application.
"107 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."The application of that approach to the facts
18 The Claimant alleges (and the Defendant disputes) that a combination consisting of [A+B] for the treatment of HIV infection was a separate innovation from a combination consisting of [A+B+C] for the treatment of HIV infection, {and/or that the use of a product consisting of A and B for the treatment of said disease constitutes part of the subject matter of the invention covered by the basic patent relied upon for the purposes of the application for an SPC,} and/or that a claim to a combination consisting of [A and B] is independently valid over a claim to a combination comprising [A+B+C].
19. Further the Claimant has made a conditional application to amend the Patent if the Kivexa SPC would otherwise be invalid, inter alia, to include a claim to a combination consisting of [A+B], or alternatively to include a claim to a combination comprising two compounds selected from [A, B and C] provided that the two compounds are not [B and C]. The Defendant does not accept that the Claimant's proposed amendment is allowable under the relevant provisions of the EPC and national patent law. {The Claimant has also made a further conditional application to amend the Patent if the Kivexa SPC would be otherwise invalid, inter alia, to amend the claims to a combination comprising [A+B] to claims to a combination consisting of [A+B], or alternatively to include a claim to a combination comprising two compounds selected from A, B and C provided that the two compounds are not [B and C], and in each case so as to delete claims to a combination comprising [A, B and C].}
20. The Claimant contends that, if it is necessary for it to make its application to amend the patent and the amendment is granted, the Patent as amended should be treated as the basic patent on which the Kivexa SPC application is based for the purposes of assessing the validity of the Kivexa SPC, in particular for assessing whether the requirements of Article 3(d) of the SPC Regulation have been met in relation to the Kivexa SPC. The Defendant does not accept the Claimant's contention.
21. The Claimant contends that [A and B] in Kivexa interact synergistically with each other in the treatment of HIV infection. The Defendant does not accept this contention {and relies, inter alia, upon the facts that (i) the Claimant's predecessor in title, when applying for Kivexa's MAs, represented to the European Medicines Agency that there was no synergistic effect arising from combining [A and B] and (ii) the European Medicines Agency granted the Kivexa MAs with a Summary of Product Characteristics stating that [A and B] were additive in effect (i.e. were not synergistic).}
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:
a) the product is protected by a basic patent in force;
b) a valid authorisation to place the product on the market as a medicinal product has been granted…;
c) the product has not already been the subject of a certificate;
d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
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