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Sunday, 12 August 2012

No pre-emptive CJEU reference -- but Neutrokine α might still get to CJEU

Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) is a decision of Mr Justice Warren, Patents Court for England and Wales, of 3 August 2012 which touches on some interesting tactical issues relating to patent litigation in Europe as well as to SPCs in the wake of Medeva.

Eli Lilly
In short, Eli Lilly wanted to obtain a declaration that any SPC for which HGS might apply in respect of European Patent (UK) No 0 939 804 (Neutrokine alpha)--- which was expected to expire in 2016 -- would be invalid. Unusually, it applied for the Patents Court to make an immediate reference to the Court of Justice of the European  Union for a preliminary ruling regarding this claim for a declaration. This patent is one with which the British judiciary have become increasingly familiar: it has already been litigated all the way up to the Supreme Court on the question of industrial applicability (see posts here and here); the Supreme Court remitted the case to the Court of Appeal in November 2011 and the further decision of that court is keenly awaited.

Eli Lilly's application for a reference to the Court of Justice was made on two bases: (i) that it was impermissible for any party to apply for an SPC which was based upon an MA obtained by another party (such as, in this instance, Eli Lilly) when the two parties had no connection with each other (this was referred to  as the "third party SPC issue"); (ii) since HGS's patent did not specify or identify Eli Lilly's antibody in its claims, no valid SPC could be obtained even where the patent itself had been upheld as valid (this was referred to as the "specification issue"). HGS both opposed the application for an immediate reference for a preliminary ruling and sought to strike out the action on the basis that it was premature and incapable of resolution, given the current factual uncertainties.

Warren J ruled that Eli Lilly's application for declaratory relief should not to be struck out but should be allowed to proceed. However, the application would be stayed, pending the decision of the Court of Appeal. As to the application for an immediate reference to the Court of Justice for a preliminary ruling, his response was along the lines of "not yet, but maybe later". In the judge's view:

* The holder of a basic patent could apply for an SPC in reliance on an MA granted to a third party which had no connection of any sort with that holder; this issue was sufficiently devoid of doubt that there was no point in referring it for a preliminary reference;

* The 'specification issue' concerned the express words that a patent must contain in order to enable the grant of an SPC which related to an active ingredient within the scope of the patent. On this, the judge said at para.64:
" ... the law remains unclear in many aspects. Whilst sharing Arnold J's puzzlement with the reasoning in Case C-322/10 Medeva BV v Comptroller General of Patents, Designs and Trade Marks 24 November 2011, [2011] ECR I-0000 ("Medeva") and Case C-630/10 University of Queensland v Comptroller General of Patents, Designs and Trade Marks [2011] ECR I-0000 ("Queensland") (see at [37] and [49] of his judgment), it is not possible to disagree with what he says at [53] to the effect that the test laid down in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases or with his statement in [62] that it is inevitable that there will have to be further references to the ECJ.
Since this was a matter of European law to which the answer was unclear in the light of the guidance so far given by the Court of Justice, a further reference would be needed before the Patents Court was able to give an answer to the specification issue;

* The Patents Court had the power under the Civil Procedure Rules, CPR r.40.20, to make binding declarations regardless of whether any other remedy was claimed -- and where there was a commercial imperative that a clearly defined dispute should be adjudicated on, there was no reason why the Patents Court should not have jurisdiction to resolve that dispute by granting declaratory relief;

* The action for a declaration should not be struck out since there were powerful commercial reasons why Eli Lilly should be allowed to proceed, not least because the company was unable to invoke the procedures for challenging the grant of an SPC because no MA had yet been obtained and no application for an SPC could yet be made.

* While it was right for the court to assist in providing the certainty which Eli Lilly reasonably required, the action should not be allowed to proceed until the Court of Appeal had given its decision on the validity issue and any subsequent application for permission to appeal had finally been dealt with. If it turned out that the patent was invalid and no appeal to the Supreme Court was made, that would be an end of the matter and there would be no need for the declaration. If however the patent was held valid, the claim for a declaration should be allowed to proceed.

* There was no point in making any reference to the Court of Justice for a preliminary ruling for as long as the stay was in place. In this instance, no reference should be made unless the facts relevant to each of the third party SPC issue and the specification issue were established.

1 comment:

Anonymous said...

Interesting take on how much detail you need to "specify" an antibody in a claim to get an SPC. If this interpretation of Medeva is correct, then that decision has retroactively invalidated many granted SPCs for antibodies. Surely the CJEU would have said a bit more if it was fundamentally changing the law like that?

....Claim 13 is simply too broadly drafted to "specify" any antibody that binds full length hTNFSF13b or the extracellular domain of the hTNFSF13b polypeptide according to the test set out in Medeva. In particular, Claim 13 (a) provides no specified primary antibody sequence and (b) fails to disclose any functional information besides the broad assertion that the antibody binds full length hTNFSF13b or its extracellular domain.