Teva UK Ltd v Novartis AG
| Jurisdiction | England & Wales |
| Judge | Mrs. Justice Bacon |
| Judgment Date | 19 October 2022 |
| Neutral Citation | [2022] EWHC 2779 (Ch) |
| Court | Chancery Division |
| Docket Number | Case No: HP-2022-000005 |
[2022] EWHC 2779 (Ch)
Mrs. Justice Bacon
Case No: HP-2022-000005
HP-2022-000006
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
7 Rolls Building
Fetter Lane, London
EC4A 1NL
Dr Justin Turner KC and Ms Katherine Moggridge (instructed by Pinsent Masons LLP) on behalf of Teva
Mr Andrew Waugh KC and Mr Geoffrey Pritchard (instructed by Bristows LLP) appeared on behalf of Novartis
Approved Judgment
Introduction
This is the hearing of an application by Teva for what is referred to as an Arrow declaration, that its proposed acts of importing and selling generic fingolimod to treat relapsing-remitting multiple sclerosis ( RRMS) at a daily dose of 0.5 mg p.o. was obvious at the priority date of European Patent EP 2 959 894 ( EP 894), for which Novartis AG is the registered proprietor.
The application is what is left of two separate sets of proceedings between Teva and Novartis concerning Teva's right to launch a generic version of fingolimod in the UK, in competition with Novartis' branded product Gilenya.
Gilenya was launched in the UK in 2011, and has been protected by an extensive patent portfolio. These proceedings relate to the patent EP 894, claiming a daily 0.5 mg dose of fingolimod for treating RRMS. EP 894 was the second divisional patent application following Novartis' parent application, which was originally filed in June 2007, but withdrawn in 2015.
The EP 894 patent application was initially refused by the Examining Division of the European Patent Office in November 2020 for lacking novelty. Novartis then filed an appeal to the Technical Board of Appeal of the EPO, which allowed the appeal on 8th February 2022, and decided that the patent would proceed to grant.
Regulatory marketing exclusivity for Gilenya expired on 22nd March 2022. A month before that occurred, on 25 February 2022, Teva commenced its claim seeking an Arrow declaration in order to clear EP 894 out of the way and allow the launch of generic fingolimod. On 2 March 2022 Novartis in turn commenced proceedings against Teva and other manufacturers or suppliers of generic drugs, claiming interim injunctive relief to prevent the sale of generic fingolimod in the UK. Teva and three of the other defendants then counterclaimed for Arrow declaratory relief.
Roth J refused Novartis' application for an injunction ( [2022] EWHC 959 (Ch)), and on 25 May 2022 Birss LJ refused permission to appeal ( [2022] EWCA Civ 775). Roth J did, however, order an expedited trial of the two sets of proceedings to be heard together, commencing on or around 3 October 2022. There was a brief skirmish about specific disclosure in June, leading Novartis to apply to adjourn the trial. That was resolved by agreement and Novartis withdrew its application.
Thereafter, trial preparation proceeded on both sides until 10 August 2022, when Novartis informed Teva that it was de-designating the UK from EP 894 so that it would not proceed to grant in the UK. Novartis also, at the same time, removed the UK designation from a third divisional patent application that had been sought for the same family. The next day, Novartis applied to discontinue its infringement action against all of the defendants.
The effect of that was that when EP 894 was eventually granted by the EPO on 12 October 2022, it did not apply in the UK and the UK is therefore now a generic market. Novartis has subsequently either settled or reached agreement in principle with all of the defendants to its infringement action, other than Teva.
Teva, however, maintains its application for an Arrow declaration on the basis that it will continue to serve a useful purpose. In order to do so, Teva applied to amend its pleadings in both actions. Novartis resisted that application. On 16 September 2022 Meade J allowed the amendments, subject to further particularisation of the pleading and amplification of Teva's evidence ( [2022] EWHC 2366 (Pat)). Meade J also directed that the trial of Teva's application for an Arrow declaration should be confined to the issue of whether, as a matter of discretion, a declaration should be granted in circumstances where Novartis does not have patent protection for its 0.5 mg dose in the UK.
As regards the technical question of whether the subject-matter of the claim is obvious, Novartis has not put in any evidence on that point and has said that it will not be cross-examining Teva's technical witnesses or making submissions to defend the inventiveness of what is claimed in EP 894. Meade J, therefore, directed that the present trial of the discretionary issue would proceed on the assumption that Teva is correct that the relevant subject-matter is in fact obvious. If I find following this hearing that on the basis of that assumption it is appropriate to grant the declaration that Teva seeks, then there will be a subsequent hearing of the technical issue of obviousness. Given Novartis' position on that, however, the hearing is likely to be rather short.
The sole issue for this hearing is, therefore, whether, as a matter of discretion, the court should grant the declaration sought by Teva.
Witnesses
Teva's witnesses
Teva relied upon the evidence of two factual witnesses. Mr Christopher Sharp, a solicitor at Pinsent Masons, representing Teva in these proceedings, gave evidence regarding the history of these proceedings and the status of proceedings to enforce EP 894 in various other countries. Following objection by Novartis to some of the passages of his witness statement, those passages were withdrawn. The remainder of his evidence is not controversial and Novartis did not seek to cross-examine him.
Secondly, Teva relied upon the evidence of Ms Claudia Kulla, a commercial portfolio manager at Teva. She gave evidence as to the logistics of supplying Teva's fingolimod product to the UK, and said that it would be highly disruptive to the supply of that product if the supply chain had to be changed because Teva's supply into a particular transit country were to be injuncted because of EP 894's patent protection outside the UK. The identity of that transit country is confidential and has been referred to in the redacted versions of the materials before me as Country A.
At the PTR before me on 11 October 2022 Novartis applied, rather belatedly, to cross-examine Ms Kulla. I granted that application on condition that she would give evidence remotely from Germany, where she is currently resident. Following the hearing, however, it transpired that the necessary authorisations for Ms Kulla to do so would not be able to be obtained in time from the German authorities. On that basis, Novartis agreed that it would not cross-examine Ms Kulla, but would confine itself to making submissions as to the reliability and weight to be attached to her evidence.
Finally, Teva relied on an expert report, supplementary report and reply report from Dr Anna Wolters-Höhne, a German attorney and patent litigator. The sole issue addressed in her evidence was the weight that the German courts would give to a decision of the UK courts granting an Arrow declaration on the terms sought by Teva. Novartis did not seek to cross-examine Ms Wolters-Höhne. Indeed, Novartis said that her evidence was put in such limited terms that it was ultimately supportive of Novartis' case.
Novartis' witnesses
Novartis, for its part, relied on factual evidence from Dr Gregory Bacon, a solicitor at Bristows, representing Novartis in these proceedings. He responded to Mr Sharp's evidence by providing further details on a limited number of points, including the status of the proceedings in other countries. As with Mr Sharp, his evidence was not disputed and he was not cross-examined.
Novartis' second factual witness was Mr Alexander Denoon, also a solicitor at Bristows, who gave evidence on the regulatory position concerning the supply of Teva's fingolimod product into the UK. His position was that from a regulatory perspective, appointing a new importer from another country should be relatively straightforward and not materially disruptive. In light of Novartis' confirmation that it was content not to cross-examine Ms Kulla, Teva agreed that it would likewise not cross-examine Mr Denoon.
Novartis' German-law expert was Professor Christopher Ann, the Chair of Intellectual Property Law at the Technical University of Munich. He responded to the evidence of Dr Wolters-Höhne as to the status of foreign case-law in the German courts. Teva did not seek to cross-examine Professor Ann, but made some submissions about the scope of some of his evidence.
Legal framework
An Arrow declaration is a particular type of negative declaration which takes its name from the judgment of Kitchin J in Arrow Generics v Merck [2007] EWHC 1900 (Pat). Arrow had sought (among other things) declarations that its own product was obvious at the priority date of pending divisional patent applications in circumstances where Merck had threatened patent infringement proceedings on the basis of those...
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