Novartis AG and another v Teva UK Ltd and Others
| Jurisdiction | England & Wales |
| Neutral Citation | [2022] EWHC 959 (Ch) |
| Year | 2022 |
| Court | Chancery Division |
2022 March 17, 18; April 26
Patent - Infringement - Injunction - Infringement of rights conferred by publication of patent application - Applicant’s dosage patent delayed pending completion of administrative procedures - Applicant seeking interim injunction to prevent defendants from launching generic drug - Whether prohibition against prospective patentee from bringing damages claim before grant of patent also applying to injunctive relief - Whether injunction to be granted -
The first claimant was the parent company of a pharmaceutical group and the second claimant distributed the group’s products in the United Kingdom. The first claimant filed an application before the European Patent Office for a divisional patent covering the use of a drug for the treatment of multiple sclerosis. The Technical Board of Appeal ordered that the patent be granted, but because various formal procedures had to be gone through it was expected that the claimants would not be granted the patent for several months. The claimants, relying on their pending patent, applied for an interim injunction pursuant to section 37 of the Senior Courts Act 1981F1 to prevent five of the six defendants from launching a generic drug. Two of the defendants contended that section 69(2) of the Patents Act 1977F2, which prohibited a prospective patentee from bringing a claim for damages for pre-grant acts of infringement until after the patent had been granted, also barred proceedings for an injunction being brought pre-grant.
On the application—
Held, refusing the application, that section 69 of the Patents Act 1977 only explicitly referred to claims for damages, but if the prohibition in subsection (2) also applied to pre-grant proceedings for an injunction, it was only a procedural bar that did not preclude the court’s jurisdiction to grant interim relief; that although a claim falling within section 69(2) was liable to be struck out for abuse of process, where, as in the present case, the parties all knew that the patent would be granted and it was only because of administrative procedures that it had not been, it was not an abuse of process for the applicant for a patent to seek interim relief to restrain acts that would otherwise give rise to loss; but that, in the circumstances, damages would be an adequate remedy to the claimants, therefore no interim injunction would be granted (post, paras 28–38, 71, 81).
The following cases are referred to in the judgment:
Actavis Group PTC EHF v ICOS Corpn
American Cyanamid Co v Ethicon Ltd [
Arrow Generics Ltd v Merck & Co Inc
Convoy Collateral Ltd v Broad Idea International Ltd
Fujifilm Kyowa Kirin Biologics Co Ltd v Abbvie Biotechnology Ltd
Johnson v Gore Wood & Co (a firm) [
National Commercial Bank Jamaica Ltd v Olint Corp Ltd
Neurim Pharmaceuticals (1991) Ltd v Generics UK Ltd
Novartis AG v Hospira UK Ltd (Practice Note)
Sevcon Ltd v Lucas CAV Ltd [
Spring Form Inc v Toy Brokers Ltd
The following additional cases were cited in argument or were referred to in the skeleton arguments:
Actavis UK Ltd v Merck & Co Inc
Amalgamated Metal Trading Ltd v City of London Police Financial Investigation Unit
British Air Line Pilots Association v British Airways Cityflyer Ltd
Catnic Components Ltd v Stressline Ltd [
Cephalon v Orchid
Eng Mee Yong v Letchumanan s/o Velayutham [
Evalve Inc v Edwards Lifesciences Ltd
Gore (W L) & Associates GmgH v Geox Spa
Guardian Media Group Plc v Associated Newspapers Ltd (unreported) 20 January 2000,
Hallen Co v Brabantia (UK) Ltd (No 1) [
N v Royal Bank of Scotland plc
Neurim Pharmaceuticals (1991) Ltd v Generics UK Ltd
Petter v EMC Europe Ltd
Smithkline Beecham Plc v Apotex Europe Ltd
Warner-Lambert Co LLC v Actavis Group PTC EHF
APPLICATION
The first claimant, Novartis Pharmaceuticals AG, filed an application before the European Patent Office for a divisional patent covering the daily dose of fingolimod in the treatment of relapsing-remitting multiple sclerosis. By an order dated 11 February 2022, the Technical Board of Appeal of the EPO reversed a decision of the Examining Division that the patent was invalid. Pending the grant of the patent, which was expected in June 2022, the first claimant and the second claimant, Novartis Pharmaceuticals UK Ltd, who was the first claimant’s distributor, commenced proceedings against the defendants, Teva UK Ltd, Dr Reddy’s Laboratories (UK) Ltd, Glenmark Pharmaceuticals Europe Ltd, Tillomed Laboratories Ltd, Zentiva Pharma UK Ltd, and Aristo Pharma GmbH, who had in 2020 and 2021 all received authorisation to market their generic version of fingolimod in the UK. By an application notice dated 2 March 2022 the claimants applied for an interim injunction restraining the first to fifth defendants from introducing the generic products to the market.
Charlotte May QC, Lindsay Lane QC and Henry Edwards (instructed by
Thomas Hinchliffe QC and Adam Gamsa (instructed by
Christopher Hall (instructed by
Tom Mitcheson QC (instructed by
William Duncan (instructed by
The fourth and sixth defendants did not appear and were not represented.
The court took time for consideration.
26 April 2022. ROTH J handed down the following judgment.
Introduction1 The first claimant is the parent company of a well-known pharmaceutical group based in Switzerland and the second claimant is its wholly owned English subsidiary which distributes the group’s products in the UK. I shall refer to them together as “Novartis”.
2 These proceedings were commenced on 2 March 2022 and Novartis applied for an interim injunction as a matter of urgency, for reasons which I explain below.
3 There are six defendants named on the claim form but the sixth defendant has not been served and no relief is sought against it. The five defendants against whom relief is sought are all manufacturers or suppliers of generic drugs and I shall refer to them together, except where it is necessary to distinguish between them, as “the generic Defendants” or simply “the generics”. Novartis and the fourth defendant have agreed that the application as against the fourth defendant will stand or fall with the application against the other four active defendants, and on that basis that fourth defendant took no part in the hearing of the application.
4 The application came on for hearing just over two weeks after it was issued. Following the hearing, some further information was received from the parties in writing, and I then informed them that the application for interim relief is refused for reasons to follow. This judgment sets out my reasons.
Background5 The application concerns a prescription-only pharmaceutical drug called fingolimod. It is used very beneficially as a disease modifying treatment (“DMT”) for relapse remitting multiple sclerosis (“RRMS”), which is one of the three main types of MS. It is supplied in the UK by Novartis under the brand name “Gilenya”.
6 Gilenya was launched in the UK in 2011. The regulatory and market exclusivity for Gilenya expired on 22 March 2022, i e five days after the application was heard.
7 The generic Defendants have all received marketing authorisation for their generic version of fingolimod in 2020 or 2021, and it appears that some if not all of them are in a position to seek to enter the market. By this application, Novartis seeks an injunction to prevent that from happening.
8 The reason the application was not made earlier is the somewhat unusual situation regarding the patent on which Novartis seeks to rely. In summary, the relevant patent application is EP 2 959 894 (“EP894”). That is an application for a divisional patent which was filed before the European Patent Office (“EPO”) on 16 July 2015 and published on 30 December 2015. It claims a priority date from 27 July 2006. On 29 June 2016, the application was amended to introduce a claim at a once daily dosage of 0.5 mg.
9 In early November 2019, the EPO examiner raised an objection to the application in response to which Novartis filed an amended claim, relying on a single main request, incorporating the 0.5 mg dosage. That is the form which was ultimately approved.
10 An oral hearing before the Examining Division of the EPO was scheduled to take place on 29 May 2020. However, due to the COVID-19 pandemic, it became clear that the hearing could only take place virtually. Novartis considered that an in-person hearing would...
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