Synthon B.v v Teva Pharmaceutical Industries Ltd
| Jurisdiction | England & Wales |
| Judge | Mr. Justice Birss,Mr Justice Birss |
| Judgment Date | 21 May 2015 |
| Neutral Citation | [2015] EWHC 1395 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2014-000007 |
| Date | 21 May 2015 |
[2015] EWHC 1395 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice, Rolls Building
Fetter Lane, London, EC4A 1NL
Mr Justice Birss
Case No: HP-2014-000007
(formerly HP14 B02198)
Michael Silverleaf QC and Anna Edwards-Stuart (instructed by Bristows) for the Claimant
Andrew Waugh QC and Tom Hinchliffe (instructed by Bird & Bird) for the Defendant
Hearing dates: 5th, 6th,7th, 12th May 2015
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 | Paragraph |
| Introduction | 1 |
| The issues | 8 |
| The witnesses | 13 |
| The skilled person | 28 |
| Common general knowledge | 29 |
| The patents | 68 |
| Claim construction | 78 |
| Novelty: | 87 |
| Novelty – prior sales of Copaxone | 90 |
| Novelty – Lemmon | 96 |
| Inventive step | 104 |
| Inventive step – levels of bromine and use of a bromine scavenger | 106 |
| Inventive step – metal ion impurities | 128 |
| Insufficiency | 133 |
| Added matter | 140 |
| The Dutch decision | 161 |
| Conclusion | 165 |
| Annex 1 — the claims |
Introduction
This case concerns patents EP (UK) 2 177 528 and EP (UK) 2 361 924, both entitled "Process for the preparation of mixtures of trifluoroacetyl GA using purified hydrobromic acid". The patents are divisionals. They claim priority from a US filing on 9 th September 2004. The 528 patent was granted on 7 th December 2011 and the 924 patent on 11 th December 2013. The patents belong to the defendant, Teva. The claimant, Synthon contends they are invalid and applies to revoke them in this action.
The parent case (EP (UK) 1 799 703) was revoked by the EPO in opposition proceedings pursuant to Teva's withdrawal of it after a negative preliminary opinion. The 528 patent was upheld by the Opposition Division of the EPO in amended form (removing claim 13). That opposition is under appeal. The 924 patent has also been opposed in the EPO but that process has not yet reached the OD. Recently the Dutch designations of both the 528 and 924 patents have been revoked by the Hague District Court. Teva will appeal that decision. Teva contends that the reasons for the decision in the Netherlands are different from those in the pleadings and evidence here.
The patents relate to glatiramer acetate. Glatiramer acetate consists of a mixture of synthetic polypeptides made from four amino acids. A low molecular weight fraction of glatiramer acetate is sold as a pharmaceutical product under the trade mark Copaxone by Teva for the treatment for relapsing remitting multiple sclerosis. Copaxone is one of a limited number of drugs that have been found to be effective in the treatment of this debilitating disease of the nervous system.
Glatiramer acetate was first formulated in the late 1960s and was later tested in an experimental animal model for multiple sclerosis called autoimmune encephalomyelitis. Research showing its effectiveness which had been undertaken at the Weizmann Institute in Rehovot, Israel was published in 1971 and suggested the product as a potential treatment for multiple sclerosis. A US patent No. 3 849 550 was granted covering it. By 1987 it had been demonstrated to be a potentially effective treatment for exacerbating-remitting multiple sclerosis. The product's efficacy may derive from its composition as a synthetic analogue of a natural component in the myelin sheath. The myelin sheath surrounds and protects nerve fibres and is damaged in multiple sclerosis.
Both the 1971 paper and the 550 patent disclose the basic process for making glatiramer acetate. An international patent application (WO 95/ 31990) for an improved process was published on 30 th November 1995. The applicants were Lemmon Corporation and Yeda Research and Development Co. Ltd and the document has been referred to in this case as Lemmon. Lemmon was directed to producing the low molecular weight fraction of glatiramer acetate. This reduced toxicity while preserving efficacy. The subject matter of Lemmon came before the Patents Court. The Lemmon patent was found valid by Arnold J ( [2012] EWHC 1848 (Pat)) and that judgment was upheld on appeal ( [2013] EWCA 925 Civ).
Today Copaxone is responsible for $4.2 billion worth of annual sales worldwide, which represents 21% of the Teva's group's total revenue.
The two patents in this case relate to what are said to be improvements in the process for making glatiramer acetate.
The issues
Synthon challenges the validity of the patents on four grounds, as follows:
i) Each of the product claims of the 924 patent lack novelty in the light of pre-priority date sales of Copaxone;
ii) All of the claims of both the 924 and 528 patents lack novelty and/or lack inventive step over Lemmon;
iii) Both patents are insufficient;
iv) Certain claims in the 924 patent are invalid for added matter.
A large number of claims are alleged to be independently valid. For the 528 patent they are claims 1, 2, 3, 6 and 10. For the 924 patent they are claims 1, 8, 11–13, 16, 22, 23, 24, 25, 26, and 29. All the claims are set out in Annex 1. I will refer to allegedly independently valid claims as "i.v. claims".
There are four points of detail to note about the i.v. claims. First, claims 23 and 24 of 924 are only alleged to be independently valid for novelty. They are not said to be independently inventive. Second, some of the i.v. claims can only be understood having regard to other claims from which they depend but which are not themselves alleged to be independently valid. They are identified in Annex 1 as well. Third, although claim 22 depends ultimately on claims 19 or 20, Teva only relies upon claim 22 to the extent it depends on claim 20. Fourth Synthon's added matter arguments and Teva's defence of added matter covered more claims than the i.v. claims and can only be dealt with that way.
I am bound to say Teva's approach to the independent validity of the claims of these patents is unconvincing. I can quite see how there might be bare novelty of multiple claims with the cascading levels of bromine or metal ions but it is hard to credit the thought that there might be independent inventiveness in the large majority of the claims relied on.
There is an uncontroversial application to amend the 528 patent to bring it into line with the form of the claims allowed by the OD of the EPO by deleting claim 13. I will allow the amendment.
The witnesses
Synthon called Professor Alethea Tabor. Prof Tabor is Professor of Chemical Biology at University College London. She is a member of the Royal Society of Chemistry and, within the RSC, a member of the Protein and Peptides Science Group Committee. Her current research interest is in the field of solid-phase peptide synthesis. Prof Tabor produced a single expert's report.
Teva called Professor Ben Davis. Prof Davis is Professor of Chemistry at Oxford University. His election as a Fellow of the Royal Society was announced on 1 st May 2015. His research centres on biomolecular functions with an emphasis on proteins and carbohydrates. Of some 200 papers naming Prof Davis as an author, 110 are in the field of proteins/peptide science. Prof Davis produced an expert's report and a report in reply to Prof Tabor's report.
Teva accepted that Prof Tabor had given her oral evidence fairly but mounted a sustained attack on Prof Tabor's written evidence, submitting that it fell a long way short of complying with the obligations of an expert. A particular criticism was that there were important matters on which she agreed with points made by Prof Davis in his reply report which qualified evidence stated in her main report however, when Prof Tabor came to swear to the accuracy of her report, she did not correct those matters although they had already been pointed out. When this was put to Prof Tabor in cross-examination she was clearly embarrassed about it and explained that she had drafted various things in response but had been advised by the legal team acting for Synthon that there was no need for her to serve a reply report and the points were better raised in cross-examination. During closing speeches Mr Silverleaf took responsibility for this and submitted it did not and should not undermine Prof Tabor's credibility as an expert witness and her ability to help the court on the issues to be decided. He also submitted that the criticisms were grossly overstated.
This is the first occasion on which Prof Tabor has given evidence in a patent case. It is unfortunate that she was advised not to produce a reply report. Expert witnesses owe a duty to the court (CPR r35.3(1)). This duty overrides any duty they have to the party and its team of legal advisers and CPR r35.3(2) makes that expressly clear. Inevitably experts rely on what they are told by the legal team and this is particularly true in patent cases when the nature of the subject matter means that the experts are often not experts at being expert witnesses. Prof Tabor is at fault for swearing to a report which contains statements which, by the time she swore to it, she knew needed qualification in material ways.
The relevant instances are: Prof Tabor's evidence on benzyl cations (I will address the detail below), her unqualified statement that all halogen acids may contain traces of free halogen (an overgeneralisation), her unqualified statement that tyrosine is particularly susceptible to reaction with any electrophile (in fact it only reacts with certain electrophiles and conditions also matter), her statement that certain materials would be "free" of metal ions/...
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