Condensed Aminodihydrothiazine Derivative & The Patents Act 1992

• Jurisdiction: Ireland
• Judge: Mr. Justice Denis McDonald
• Judgment Date: 31 July 2018
• Neutral Citation: [2018] IEHC 467
• Docket Number: 2017 No. 1 PAP
• Court: High Court
• Date: 31 July 2018

[2018] IEHC 467

THE HIGH COURT

COMMERICAL

McDonald J.

2017 No. 1 PAP

IN THE MATTER OF European Patent (IE) 2 233 474 entitled 'Condensed Aminodihydrothiazine Derivative' filed on 16 January 2009 and registered in the name of Eisai R&D Management Co. Ltd

IN THE MATTER of the Patents Acts 1992 (as amended)

Patent – Revocation – Stay – Patentee seeking an order staying patent revocation proceedings – Whether the balance of justice favoured the refusal of a stay

Facts: Eli Lilly & Company, on 27 October, 2017, presented a patent revocation petition in relation to Patent No. (IE) 2 233 474. A motion was brought seeking to enter the patent revocation proceedings into the Commercial List. The patentee, Eisai R&D Management Co. Ltd, issued a motion on 11 April, 2018, seeking an order staying the proceedings pending the determination of European Patent Office (EPO) opposition proceedings which were pending before the Technical Board of Appeal (TBA) in Munich. In support of its application for a stay, Eisai drew attention to the fact that the hearing of the proceedings would involve a consideration of complex technical scientific matters in relation to at least four specialist fields, namely: (a) medicinal chemistry; (b) synthetic organic chemistry; (c) computational chemistry; and (d) biological assays. In addition to drawing attention to the significant costs and resources that would have to be invested in the Irish proceedings, Eisai also suggested that, in any event, it was unreal to suppose that Eli Lilly needed to have the proceedings determined as speedily as it suggested. Eli Lilly submitted that the concerns expressed by Eisai must be balanced against the implications of the commercial uncertainty and potential revenue losses that would be engendered by the grant of a stay, and that the balance of justice favoured the refusal of a stay.

Held by the High Court (McDonald J) that, in all of the circumstances, it was appropriate that the steps necessary to allow this case to go forward for hearing should not be stayed. While it seemed to McDonald J that a stay should be imposed on a trial (at least up to November 2019), he believed that there were very good reasons why the stay should not apply to the further steps that have to be taken in the proceedings in order to put them in a state of readiness for trial. It seemed to McDonald J that the stay on the trial should continue until 30 November, 2019 in the hope that by then, a decision of TBA would be available.

McDonald J held that the order of the court would be to stay the fixing of a trial date of the proceedings until after 30 November, 2019, and to refuse a stay on discovery, the carrying out of experiments or the other interlocutory steps that would require to be taken in order to put the proceedings in a state of readiness for trial.

Judgment approved.

JUDGMENT of Mr. Justice Denis McDonald delivered on the 31st day of July 2018

Introduction

1 In these patent revocation proceedings, the patentee, Eisai R&D Management Co. Ltd ('Eisai') seeks an order staying these proceedings pending the determination of European Patent Office ('EPO') opposition proceedings which are currently pending before the Technical Board of Appeal ('TBA') in Munich.

2 The proceedings in Ireland relate to Patent No. (IE) 2 233 474 ('the Patent'). The Patent is entitled ' Condensed Aminodihydrothiazine Derivative'. The Patent was granted on 5 August, 2015. The Patent devolves from a European patent (EP 2 233 474) pursuant to the arrangements established under the European Patent Convention ('EPC') by means of its designation for protection in Ireland. As such, under Section 119 of the Patents Act, 1992 (as amended) (the 'Act'), the Patent takes effect under Irish law as an Irish national patent.

3 The subject matter of the Patent comprises compounds that are said to potentially treat Alzheimer's disease by inhibiting the production of amyloid-beta (amyloid-P). This is a protein found in the brain that is associated with Alzheimer's disease. The compounds are claimed in the Patent as a treatment for neurodegenerative diseases, including Alzheimer's disease.

4 The Revocation Petition was presented on behalf of Eli Lilly & Company ('Eli Lilly') on 27 October, 2017. Shortly thereafter, a motion was brought seeking to enter the proceedings into the Commercial List. The pleadings have been closed since 5 March, 2018. The present motion seeking a stay of the proceedings was subsequently issued on 11 April, 2018. There have also been exchanges of requests for discovery on both sides which have led to motions for discovery by both parties. The motions for discovery have not yet been heard. They were listed for mention only before me at the hearing of the present motion which took place over a period of two days on 5 and 6 July, 2018.

The proceedings before the EPO

5 Eli Lilly filed with the EPO a Notice of Opposition in respect of the European Patent on 5 May, 2016. It should be noted at this point that there is a nine month window from the date of grant of a patent in which to file a Notice of Opposition. The opposition is restricted to claims 1-8 and dependent claims 12-14 of the European Patent. An oral hearing was held on 26 January, 2018 by the Opposition Division of the EPO. Following that oral hearing, a written decision was issued by the Opposition Division on 13 February, 2018 maintaining the European Patent as granted. That decision has now been appealed by Eli Lilly to TBA. According to Dr. Jan Carl Zillies, a European patent attorney who has sworn an affidavit on behalf of Eisai, a request could be made by Eli Lilly for an expedited hearing of the appeal before TBA and Dr. Zillies has said (based on conversations he had with the Registrar of TBA) that a hearing in or about one year from the date the TBA agrees to accelerate the proceedings would be 'possible'.

The application for a stay of the Irish proceedings

6 In support of its application for a stay, Eisai has drawn attention to the undoubted fact that the hearing of these proceedings will involve a consideration of complex technical scientific matters in relation to at least four specialist fields, namely:-

(a) medicinal chemistry;

(b) synthetic organic chemistry;

(c) computational chemistry; and

(d) biological assays.

7 Eisai has also drawn attention to the fact that when previous revocation proceedings were commenced in London in May 2016 in respect of the equivalent U.K. patent, the Patents Court gave each party permission to call four expert witnesses, one in each of these fields. For completeness it should be noted that the proceedings in London were resolved on 6 April, 2017 when an order was made on Eisai's own application seeking the amendment of the U.K. equivalent patent and the dismissal of its own claim. This involved the deletion of claims 1-8 of the U.K. Patent together with consequential amendments to claims 9-14. According to Dr. Kevin Stansfield (the Head of Intellectual Property at Eisai Europe) in his affidavit sworn on 9 April, 2018, this was done by Eisai for purely commercial reasons, and in particular for the purposes of avoiding significant litigation costs. It appears from the subsequent affidavit sworn on behalf of Eli Lilly by Andrew Smith on 10 May, 2018 that Eisai also agreed to pay Eli Lilly's costs of the English proceedings. I should record, at this point, that the attack on the U.K. designation of the Patent by Eli Lilly focused exclusively on claims 1-8 and on certain aspects of claim 9-14. As Mr. Smith explains in his affidavit, the voluntary application by Eisai to delete all the claims under challenge and to pay Eli Lilly's costs rendered the action in London ' nugatory' as Eli Lilly had obtained all that it had sought in those proceedings.

8 In support of its application for a stay, Eisai maintains that a tremendous amount of resources will need to be invested by both Eisai and Eli Lilly in these proceedings in engaging experts and preparing the matter for hearing. It is suggested that this is not a cost effective or an appropriate use of the resources of the court where, if an accelerated hearing is granted in respect of the appeal before TBA, the proceedings before the EPO should be finally concluded prior to the determination of these proceedings at first instance by the court. In the course of the hearing before me, it was suggested by counsel on behalf of Eisai that, by the time discovery is completed in this case, and by the time appropriate experiments have been agreed and carried out, it would be unrealistic to think that a hearing could be assigned to the case prior to Michaelmas Term 2019. This was not seriously challenged by counsel on behalf of Eli Lilly. While counsel for Eli Lilly suggested that the court might be in a position to give judgment in the matter also within Michaelmas Term 2019, I made it clear that in my view (and this remains my view), this is unrealistic. In a complex case of this kind (which both parties estimate could last in excess of six weeks and which may well require the appointment of an expert assessor to assist the court), it is simply not feasible to think that the court would be in a position to give judgment in the matter prior to the end of Michaelmas Term 2019. In my view, the earliest that the court would be in a position to give a decision in the matter would be in Hilary Term 2020.

9 In addition to drawing attention to the significant costs and resources that will have to be invested in the Irish proceedings, Eisai also suggests that, in any event, it is unreal to suppose that Eli Lilly needs to have these proceedings determined as speedily as it suggests. In particular, Eisai suggests that the launch date of any product by Eli Lilly is unlikely to occur until several years in the future. This is in circumstances where Eli Lilly is still undertaking clinical trials and...