Pfizer Ltd v F. Hoffmann-La Roche AG
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss |
| Judgment Date | 20 June 2019 |
| Neutral Citation | [2019] EWHC 1520 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2017-000064 |
| Date | 20 June 2019 |
[2019] EWHC 1520 (Pat)
Mr Justice Birss
Case No: HP-2017-000064
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Royal Courts of Justice
The Rolls Building
7 Rolls Buildings
Fetter Lane
London EC4A 1NL
Richard Meade QC, Thomas Raphael QC and Thomas Jones (instructed by Taylor Wessing) for the Claimant
Andrew Lykiardopoulos QC and Mark Chacksfield QC (instructed by Herbert Smith Freehills) for the Defendants
Hearing dates: 1st, 2nd, 4th April 2019
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
| Topic | Paragraphs |
| Introduction | 1 |
| The witnesses | 14 |
| Background | 24 |
| The law | 60 |
| Declarations | 61 |
| Belgian law | 89 |
| Useful purpose | 108 |
| Prima facie merits of technical case | 109 |
| Roche's conduct and shielding | 110 |
| Real commercial value | 115 |
| Useful purpose overall | 118 |
| Conclusion | 123 |
Introduction
This is a claim by Pfizer for Arrow declarations in relation to its proposed launch in Europe, including the UK, of a biosimilar monoclonal antibody drug called bevacizumab, for the treatment of various cancers in combination with other drugs. Bevacizumab is an antibody against VEGF, a molecule in the signalling pathway that leads to the formation of blood vessels. The Defendants (Roche) already market a bevacizumab product under the brand name Avastin. Avastin is a successful product with a huge market. Roche's European sales of Avastin in 2018 were over £1 billion. Pfizer's biosimilar product will be branded Zirabev.
Genentech Inc (a member of the Roche group) held a patent for bevacizumab itself. As a result of a Supplementary Protection Certificate, including a paediatric extension, the protection conferred by the basic patent continues until June 2020. I refer to that date as SPC expiry. Pfizer wants to launch immediately after that. However Roche has what Pfizer calls a thicket of second-line patents and patent applications which hinder Pfizer in various ways and are causing uncertainty generally. Pfizer contends that causing this uncertainty is a deliberate policy of Roche.
The patents and patent applications all relate to combinations of bevacizumab with other known cancer drugs for use treating various types of cancers. The relevant types of cancer are the ones found in the Summary of Product Characteristics in the Marketing Authorisation for Avastin. The relevant types of cancer fall into three classes. The first class is a group consisting of colon, lung, renal and cervical cancers. These are free of patents and applications. Pfizer can obtain a marketing authorisation for its biosimilar bevacizumab product for those indications and can market the product after expiry of the SPC without fear of Roche patents. The other two classes are breast cancer and ovarian cancer. The patents and applications in this case relate to these two forms of cancer.
Roche's group of patents and applications include material (text and data) which would support claims to the use of bevacizumab in combination with certain other cancer drugs, for the treatment of particular instances of these two forms of cancer. One of the uncertainties which afflicts Pfizer is that a currently pending application might lead to a patent being granted either before or after June 2020 and Roche might try to obtain an interlocutory injunction against Pfizer.
Pfizer's case is that given the state of the art at the earliest claimed priority date for a given patent or application, bevacizumab in combination with the relevant other cancer drugs for the treatment of the relevant indication lacked novelty and/or was obvious. To prove it Pfizer has put in evidence the relevant prior art, provided reports from experienced experts in breast cancer and ovarian cancer and set out cogent arguments in favour of its case. Assuming that fact is true then Pfizer would have a complete Gillette defence to any patent claim should Roche sue at any time after launch. The defence would be a good one regardless of when such a patent might be granted. An application for an Arrow declaration would allow the parties to resolve this dispute now and remove the uncertainty. If the declaration was granted it would be binding as between the parties in this jurisdiction. In addition says Pfizer, the declaration, along with a reasoned judgment on the issues would have a strong persuasive effect in other European contracting states to the EPC. One such state is Belgium. Pfizer plans to supply the UK market from Belgium and so a preliminary injunction application in Belgium would not only have effect in that country but would disrupt the UK market as well. Under Belgian law the courts apply a presumption of validity of patents at the preliminary stage but Pfizer contends that following a decision of the Belgian Cour de Cassation ( Syral v Roquette Cass 12 Sept 2014, Pas., 516 1861 IRDI 2014, 634) the judgment of a court of another contracting state of the EPC such as the UK must be at least taken into account, and when that happens it may be given weight and serve to help rebut the presumption of validity.
Roche disagrees with some important parts of this analysis. Roche does not accept that it has deliberately created uncertainty or that its conduct can be fairly characterised as “shielding” in the manner that term is used in the cases on Arrow declarations. Roche has led evidence to seek to show that its prosecution of this portfolio of patents and applications is commonplace in the field. Both sides called experienced patent attorneys as expert witnesses to comment on Roche's approach to patent prosecution. Roche also does not agree with Pfizer's analysis of Belgian law. Both sides called experienced Belgian lawyers as expert witnesses about that and I will need to consider this evidence further below.
Most importantly of all, today Roche has no relevant UK patent and furthermore Roche has now abandoned any prospect of obtaining such a UK patent in future. That “de-designation” of the UK from all relevant pending EP patent applications was complete in November 2017, a few weeks after this action for an Arrow declaration was commenced. There never will be a Roche UK patent for these indications arising from any of the relevant patent families. Roche contends that this means that the UK court ought not to grant an Arrow declaration in this case. The declarations would serve no legal purpose.
Roche has, save in one respect about priority, studiously avoided engaging with Pfizer's case on the question of the lack of novelty or obviousness of bevacizumab combinations for the relevant cancer indications. This refusal to engage is despite every opportunity to do so.
Pfizer contends as follows. The de-designation of the UK is a deliberate and transparent act of shielding by Roche. The UK is and will be in future a valuable market for bevacizumab and the only rational reason for doing this must be to prolong the commercial uncertainty. Roche's case on novelty or obviousness is very weak and so this is all part of Roche's strategy to shield its patent applications from the scrutiny of the Patents Court. In some cases there can be rational reasons to de-designate a state like the UK, but none of them apply here. So, Pfizer argues, these submissions support the idea that the court should go ahead and consider the merits of an Arrow declaration and should grant one in this case despite the absence of UK rights. The real reason Roche says nothing about the merits in this case is because it has nothing to say which would withstand scrutiny.
Roche does not agree. While it does not engage with the issues of novelty or obviousness nor does it advance a positive case about its motives, Roche does take issue with one factual element of the reasoning in the previous paragraph. That is the significance of the UK market. Roche contends its future value is not so significant. Both sides called witnesses from their business teams to address that matter.
Finally Roche argues that if it is right that no Arrow declaration should be granted, then in this case it would be wrong and unfair for the court to conduct a fully reasoned analysis of the merits of the novelty and obviousness issues since that would be tantamount to giving Pfizer the relief which should not be given. At one stage there was a suggestion that the reasoned analysis could be part of a confidential annex in case the matter went on appeal, but Pfizer objected to that and Roche did not advance it in closing.
So this is a curious case to be tried in the Patents Court. The evidence about novelty and obviousness has not been cross-examined, because the patentee Roche chose not to do so. Nevertheless Roche has played a full part in these proceedings. Despite what seemed to be a suggestion to the contrary, these proceedings have been fully contested by Roche. No party who fully contests a case is obliged to disagree with every point raised by their opponent or to call evidence on every point. The fact a party has not done those things does not mean they have not fully contested the case. Roche has taken the opportunity to call detailed evidence on the topics it wishes to and to challenge the evidence from its opponent. Roche has had every opportunity to make submissions on the issues of novelty or obviousness, to call whatever evidence it wishes about them or to test the evidence before the court. At trial I asked Roche's representatives specifically if Roche would like the opportunity to have the case adjourned...
To continue reading
Request your trial
- Teva UK Ltd and another v Novartis AG
-
ISG Construction Ltd v English Architectural Glazing Ltd
...Ltd v ABC Electrification Ltd [2019] EWHC 1769 (TCC); [2019] BLR 522 at [10–11] and Pfizer Ltd v F. Hoffman-La Roche AG [2019] EWHC 1520 (Pat) at [61–67].” 21 In the particular context of Part 8 claims in the context of adjudication business in the TCC the relevant considerations and case......
-
Teva UK Ltd v Novartis AG
...are a couple of judgments in the Fujifilm litigation and the decision of Birss J (as he then was), in Pfizer v Hoffman-La Roche [2019] EWHC 1520 (Pat). I think caution is required in considering that those litigations represent what is typical to Arrow declarations or that they represent, ......
-
Vestel Elektronik Sanayi Ve Ticaret A.S. v Access Advance LLC (formerly HEVC Advance LLC)
...nevertheless be a proper exercise of the court's jurisdiction based essentially on something I said in Pfizer v Hoffmann La Roche [2019] EWHC 1520 (Pat). I can see that if what Vestel seeks would be a proper exercise of the court's jurisdiction then it might be a “claim” within gateway 11 ......
-
Court Of Appeal Dismisses Appeal In Relation To Service Out Of Jurisdiction In Proceedings For FRAND Declaration, Finding That The Court Did Not Have Jurisdiction
...a FRAND declaration, despite the absence of any assertion of a right to such a licence. Vestel argued that Pfizer v Hoffmann La Roche [2019] EWHC 1520 (Pat) showed that "useful purpose" was the only criterion that had to be satisfied for the court's declaratory jurisdiction to be engaged an......