A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Thursday 30 August 2012

SPC seminars: three more from FORUM

From Rechtsassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of three SPC-related seminars which he is organising. They are as follows:
1. 'Supplementary Protection Certificates', the second edition of FORUM's English SPC seminar with Dr Christopher Brückner, the author of the SPC commentary (which participants will receive on top of course documentation). Date: 4 and 5 October 2012; venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,160 instead of € 1,290).

2. 'Ergänzende Schutzzertifikate', the second edition of FORUM'S SPC seminar in German, also with Dr Christopher Brückner and his SPC commentary as an add-on. Date: 23 and 24 October 2012; Venue: Frankfurt. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,160, down from € 1,290).

3. 'SPC FORUM' - the first German round-table where German speaking SPC experts from both pharmaceutical and crop science can discuss new cases from Iodosulfuron to Neurim with industry speakers, Merck KGaA's Dr Arno Hartmann and Bayer's Dr Bettina Wanner. Date: 11 October 2012; venue Cologne. More information is available here. SPC Blog readers are entitled to a 10% discount for this event (€ 880 instead of € 980).
In order to register for the reduced fee, SPC Blog readers need only to forward this blog to Jean-Claude at jc.alexandreho@forum-institut.de, or call him, quoting The SPC Blog (+49 6211 500-675) and specifying which event(s) they would like to attend.

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.