Bayer Intellectual Property GmbH v Aspire Pharma Ltd

Hearing date: 25 March 2024

Approved Judgment

This judgment was handed down remotely at 2pm on 27 March 2024 by circulation to the parties or their representatives by e-mail and by release to the National Archives.

HIS HONOUR JUDGE Hacon

Introduction

The principal application before the court is brought by the First Applicant, seeking an interim injunction. During the hearing I gave permission for the Second and Third Applicants to be joined as co-applicants. I will refer to all the applicants individually and collectively as “Bayer”. Bayer seek to restrain the sale by the respondents of a pharmaceutical having the generic name rivaroxaban when sold for once-daily administration. The product was the subject of a trial heard by me concluding on 22 February 2024. The injunction sought is until the order to be made consequential upon the handing down of my judgment.

Bayer own a patent which protects rivaroxaban as a compound. That patent as extended by an SPC will expire on 1 April this year. Up to now Bayer has had the rivaroxaban market to itself, selling the product under its brand name Xarelto.

In a week's time others will be entitled to market rivaroxaban with the important qualification that Bayer is also the owner of European Patent (UK) No. 1 845 961 (“EP 961”). EP 961 has Swiss-form claims which, in broad terms, cover the use of rivaroxaban for the manufacture of tablets for once-daily oral administration to a human patient. It expires in January 2026.

The respondents to the application are all companies that wish to sell generic rivaroxaban. They have mostly indicated their intent to start sales after 1 April, including sales of tablets for once-daily administration.

At the trial I heard six joined claims for revocation of EP 961 which were brought by most of the respondents before the court today. There was a counterclaim for infringement by Bayer, plus a claim of infringement against four third parties. Infringement was not disputed, at least for the purposes of the proceedings. The trial was solely about the validity of EP 961, turning on inventive step and other grounds.

I told the parties at the hearing that judgment will be handed down in the first week of next term, probably on 9 April 2024, a little under 7 weeks from the end of the trial. Argument on the form of the order will be heard on 11 or 12 April 2024. There will therefore be a window of 9–10 days after the compound patent expires before there is a possibility of a permanent injunction against the respondents restraining sales of once-daily rivaroxaban in the event that EP 961 is held valid. The purpose of Bayer's application is to keep the window shut.

Come what may, from 2 April 2024 the respondents will be able to sell rivaroxaban in forms suitable for administration twice or more daily, if they wish.

Representation of the parties was as shown at the head of the judgment. The ninth respondent was not represented and did not appear.

Aspire Pharma

The second to eleventh respondents were all parties at the trial and are liable to be enjoined by a permanent injunction if EP 961 is held valid.

The first respondent, Aspire Pharma Limited, was not a party to the trial. On 7 February 2024 Aspire brought a claim against Bayer for a declaration for non-infringement of EP 961, raising a point of construction that was not in issue at the trial. Aspire seeks a listing of the trial in July. At the present hearing I gave directions dealing with the listing. In the meantime Aspire consents to an interim injunction. Aspire says that if another generic company launches a generic rivaroxaban product while the interim injunction is in force, that will constitute a material change of circumstances so that Aspire will be entitled to lift the injunction. Bayer dispute this but argument on the point will be dealt with if and when it arises.

Other applications

There were three other applications. One was by Bayer for permission to amend its Part 20 Counterclaim to add Bayer AG and Bayer plc as additional Part 20 Claimants. The reason for the application was to include Bayer companies which are said to suffer potential harm if the interim injunction is not granted. This was resisted only by the fourth, fifth and sixth respondents (collectively “STADA”) which argued that it was not clear from the documents so far provided by Bayer that any damage suffered were there to be no interim injunction would fall on the proposed new applicants. The point was also made that liability for damage appeared to depend, in part, on a licence recently made exclusive and which is terminable by Bayer AG at any time.

It seemed to me that these are all points that can be raised at an inquiry as to damages, should there be one. I gave permission to join the two further Bayer companies as second and third applicants.

Secondly there was an application by the second and third respondents (collectively “Teva”) for permission to rely on evidence from Dr Avantika Chowdhury in the application for an interim injunction. Dr Chowdhury is a professional economist who gives evidence about the uncertainties or otherwise which are liable to surround an assessment of damages – to Bayer if there is no interim injunction and to Teva if there is one. Admission of this evidence was resisted by Bayer on the ground that it was served less than 2 working days before hearing. Bayer and the respondents took me through their respective accounts of the history of exchanges leading to the hearing of the interim injunction and why, in each case, the opposing side was culpable of delay. I have not sought to work through the detail of the correspondence and sequence of events. Service of Dr Chowdhury's evidence was not as timely as it should have been but I have the impression that there has been a degree of delay on each side. Bayer had two working days and a weekend to digest and work out their response to Dr Chowdhury's report. I took the view that it would be just to have its contents debated and gave permission for Teva to rely on the report. Leading counsel for Bayer seemed well able to deal with it at the hearing.

Thirdly, STADA filed an application notice on the day of the hearing seeking permission to rely on expert evidence from another economist, Richard Williams. I did not give permission, partly because the application was so late and party because, having looked through the report in court (it had not reached me before then), it seemed to me that the report mostly or possibly entirely consisted of argument which Stada's leading counsel could advance in any event. He did.

Communication with the court

In October 2021 the Technical Board of Appeal of the European Patent Office allowed an appeal from the Opposition Division and upheld the validity of EP 961. From that time all the companies with ambitions to market rivaroxaban tablets for once-daily administration knew that they had two and a half years to challenge the validity of EP 961 in any EPC State in which they intended to sell. In this jurisdiction, the first claim form seeking revocation of the patent was filed by the seventh and eighth respondents (“Sandoz”) and the ninth respondent (“Accord”) a full year later in October 2022. Other claim forms followed later still. The claims were joined and so far as I can tell, until the question of a trial date was in view they progressed without unusual haste. A consequence was that the trial was fixed for hearing dates that ended about five and a half weeks before 1 April 2024.

On the first day of argument at the trial, counsel for the claimants (the parties seeking to revoke EP 961) said that the claims had been case managed so as to try to ensure that judgment could be handed down before 1 April 2024. To the best of my recollection no more was said about it. I was of course aware of the significance of the date and aimed to meet the proposed deadline, though other commitments also had to be dealt with. What I did not know about was the consequence of overrunning 1 April by 9–10 days. On the working day before the hearing of the present application I was taken aback by the scale of it, particularly the number of counsel and solicitors involved and presumably the huge cost incurred. It may be that the parties' legal advisors, being steeped in their exchanges from early in the year about a possible application for an interim injunction, assumed that everyone realised the scale of the likely consequence of judgment not being handed down in time for argument on the form of order by 1 April....