Eli Lilly & Company and Others v Genentech Inc.
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss |
| Judgment Date | 06 December 2017 |
| Neutral Citation | [2017] EWHC 3104 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 06 December 2017 |
| Docket Number | Case No: HP-2017-000041 |
[2017] EWHC 3104 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST
PATENTS COURT
Royal Courts of Justice
Rolls Building, Fetter Lane, London, EC4A 1NL
THE HON. Mr Justice Birss
Case No: HP-2017-000041
Alexander Layton QC, Thomas HinchliffeQC and Oliver Caplin (instructed by Allen & Overy LLP) for the Claimants
David Lewis QC, Michael AshcroftQC and William Duncan (instructed by Marks & Clerk Solicitors LLP) for the Defendant
Hearing dates: 6th and 7th November 2017
This is a jurisdiction application. The action concerns various national designations of European patent EP 1 641 822, entitled " IL-17A/F Heterologous Polypeptides and Therapeutic Uses Thereof". Recognising that there is no such thing as a European patent but rather a bundle of national patents I will refer to the whole bundle as EP 822. The claimants are all members of the Eli Lilly group of companies. The group is a major international pharmaceutical company. I will refer to the claimants as Lilly. The defendant, Genentech, is another major international pharmaceutical company. The patent belongs to Genentech and that company, which is a US corporation and therefore domiciled outside the area of the Brussels 1 (recast) Regulation or Lugano conventions, is the proprietor of all the relevant national designations of EP 822.
Lilly makes and sells a medicinal product marketed under the brand name Taltz with the non-proprietary name ixekizumab. The product is a monoclonal antibody and has a centralised European marketing authorisation to treat a form of the disease psoriasis. It is available on the NHS in England and NICE has recommended it. Lilly describes the product as an anti-IL17 antibody. IL17 or interleukin 17 is a human cytokine. Cytokines such as the interleukins are proteins which play important roles in the immune system. IL17 may play a role in stimulating the production of IL6 and IL8 in certain circumstances. The interleukins can exist in the form of a homodimer in which two identical molecules are bonded together.
EP 822 refers to IL17 as IL17A and acknowledges that it is a known cytokine. It also acknowledges that there are a number of known cytokines in the IL17 family (IL17A, IL17B, IL17C etc.). The invention described in EP 822 is based on the discovery of a new cytokine which the patent calls IL17A/F. The patent refers to this as a heterodimer, because it consists of an IL17A molecule bound to an IL17F molecule. Using this notation one could refer to the IL17 homodimer as IL17A/A.
There are opposition proceedings before the EPO in which a number of companies have challenged the validity of EP 822. Lilly is not a party to those proceedings. The Opposition Division has decided that EP 822 is invalid because the main request and three auxiliary requests involve added matter contrary to Art 123(2) EPC. The decision is now under appeal to the Technical Board of Appeal of the EPO. Stripped of its verbiage, claim 1 of the main request essentially claims an antibody which "specifically binds" to IL17A/F.
According to Lilly, Genentech does not have an IL17 product on the market or any product for psoriasis on the market or under development. Nevertheless Genentech has applied for a supplementary protection certificate under Regulation 469/2009 in various EU states (the UK, France, Germany, Spain, Italy and Ireland). The SPC application is based on Genentech's patent EP 822 and on Lilly's marketing authorisation for Taltz. Necessarily therefore Genentech's position must be that Taltz is a product protected by EP 822. Lilly disputes that Genentech can acquire such an SPC in that way but that is not germane to the issues I have to decide on this application.
Lilly does not accept that Taltz infringes EP 822 and so has brought these proceedings in the Patents Court in London. The claims are in these proceedings can be seen in two parts. First Lilly brings claims relating to the UK designation of EP 822. These are a claim for a declaration of non-infringement (a "DNI") in relation to the Taltz product, as well as a claim for revocation of that UK patent on various grounds. The DNI actually seeks two declarations, one is in conventional form drafted as a declaration that committing various acts such as making or selling the Taltz product does not infringe EP (UK) 1 641 822, the other is in a different form – a declaration that the product is not within the scope of the claims of the patent. This first part of the proceedings does not cause any difficulty. The English court's jurisdiction to hear and determine these claims is not in dispute.
The second part of the proceedings consists of claims for declarations of non-infringement (and scope) in relation to the five national designations of EP 822 in France, Germany, Spain, Italy and Ireland. These have been referred to as the "Related Claims". No claim for revocation or invalidity is made about those five foreign designations.
Leave to serve the proceedings out of the jurisdiction was given by Master Price on an ex parte application by Lilly. On this application Genentech applies to set aside service of the proceedings insofar as they include the Related Claims or for a stay on jurisdiction grounds. Three grounds are advanced by Genentech. The parties advanced them in argument in the opposite order, no doubt because, as good advocates, each side wanted to start with its best point. The three grounds are as follows. The first is that the Related Claims cannot be brought within one of the gateways for service out of the jurisdiction and so service should be set aside under CPR r6.36/6.37. The gateways are specified in CPR PD6B. The only relevant gateway is that in paragraph 3.1 (4A) of PD6B and Genentech submit the Related Claims are not within that gateway. The second is that the proceedings are " concerned with" the validity of the non-UK patents and thereby engage Art 24(4) of the Brussels I (recast) Regulation 1215/2012 and so, since under that provision the courts of the Member State in which the patent is registered (France, Germany, Spain, Italy and Ireland) have exclusive jurisdiction over validity, this court must decline jurisdiction over this aspect of these proceedings under Art 27 of the regulation. The third ground is forum non-conveniens. The argument is that England is not the proper forum for these claims. I have ranked the claims in this way because the gateway point is entirely distinct from the other two and because there is an overlap between the arguments on Art 24(4) and forum non-conveniens and it is convenient to resolve the former before dealing with the latter. Although it does not matter, I believe Art 24(4) is Genentech's best point, as was indicated by their approach to arguing the issues.
There was no dispute that on all three grounds the burden is on Lilly. It is not on Genentech.
There was also no dispute that where, as here, the defendant is domiciled outside the Brussels-Lugano area the jurisdiction over that defendant is determined by national law save for certain exceptions. The exceptions do matter in this case because one of them is Art 24 of the Regulation.
The CPR Gateway in PD 6B para 3.1(4A)
The basic principles are common ground. Lilly must show that it has a properly arguable case on the merits of the relevant claim and it must also show that it has much the better argument that the gateway is applicable. "Much the better argument" is a higher hurdle than "properly arguable".
Genentech submitted that where there is a doubt about the construction of the gateway provision, that doubt should be resolved in favour of the foreign defendant, i.e. Genentech. Lilly did not agree and submitted that the decision of the Supreme Court in Abela v Baadarani [2013] UKSC 44 in which Lord Sumption held (at paragraph 53) that the traditional characterisation of service out of the jurisdiction using "muscular presumptions" and language such as "exorbitant" was no longer correct because the introduction into English law of the distinct forum non-conveniens doctrine in Spiliada v Cansulex [1987] AC 460 provided a proper and pragmatic safeguard for foreign defendants. Therefore Lilly argues that the previous line of authority starting from In re Hagen [1908] P 189, which is the basis for Genentech's submission, is no longer good law. I must say I see the force in Lilly's submission however in Cruz City 1 Mauritius Holdings v Unitech Ltd and Ors [2014] EWHC 3704 (Comm) Males J recently rejected that very same submission at paragraph 16 and since I am not convinced the point is central to the issues I have to decide I will not get into it any further.
Turning to the merits of the cause of action itself, the point is this. Lilly contends that the debate turns on the true construction of the claim and in particular the words "specifically binds". Lilly's case is that as a matter of fact Lilly's antibody has a binding affinity to the IL17A/A homodimer of less than 3 pMol (pico moles) and also has a binding affinity of less than 3 pMol (pico moles) to IL 17A/F.
Lilly contends that the patent explains what "specifically binds" means and in summary the point is that the claimed antibody must not only bind to the target but must do so specifically, in other words it must not bind to other things. Put another way the claimed antibody must not cross-react with other proteins. Some small degree of cross-reactivity would be acceptable but it must be low, for example a figure of 10% of the level of target...
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