H. Lundbeck A/S (Claimant/Part 20 Defendant) v (1) Norpharma Spa (2) Infosint S/A (Defendants/Part 20 Claimants) (3) Lundbeck Ltd and Others (Third, Fourth and Fifth Parties/ Part 20 Defendants)

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeMr Justice Floyd
Judgment Date14 April 2011
Neutral Citation[2011] EWHC 907 (Pat)
Docket NumberCase No: HC10C0883

[2011] EWHC 907 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Royal Courts of Justice

Strand, London, WC2A 2LL

Before:

The Hon Mr Justice Floyd

Case No: HC10C0883

Between:
H. Lundbeck A/S
Claimant/Part 20 Defendant
and
(1) Norpharma Spa (2) Infosint S/A
Defendants/Part 20 Claimants

and

(3) Lundbeck Limited
(4) Lundbeck Pharmaceuticals Limited
(5) Lundbeck Group Limited
Third, Fourth and Fifth Parties/ Part 20 Defendants

Justin Turner QC and Dominic Hughes (instructed by Wragge & Co LLP) for the Claimant and Part 20 Defendants

Andrew Lykiardopoulos (instructed by Cumberland Ellis) for the Second Defendant

Hearing dates: 16 th–18 th; 21 st and 23 rd–24 th March 2011

Mr Justice Floyd

Introduction

Paragraph numbers

Introduction

1–2

Issues

3–7

Expert witnesses

8–11

Fact witnesses

12–15

The skilled addressee or team

16–19

The common general knowledge

20–24

The 614 patent

25–34

The claims in issue

35–36

Construction

37–55

The prior art

56–82

Lack of novelty

83–94

Obviousness

95–122

Claim 22

123–135

Insufficiency

136–145

Infringement

146–162

Section 64

163–173

Section 68 — Limitation of remedy

174–201

Conclusion

202–203

1

The claimant H. Lundbeck A/S ("Lundbeck") brings this action to revoke European Patent (UK) 1 118 614 ("the 614 patent"). The 614 patent now belongs to Infosint A/S, the second defendant, ("Infosint"), as a result of an assignment in 2002 from Norpharma SpA, the first defendant ("Norpharma"). By counterclaim, Infosint alleges infringement of the 614 patent by Lundbeck and the third, fourth and fifth parties, all wholly owned subsidiaries of Lundbeck. No arguments were advanced which made it necessary for me to distinguish between the various Lundbeck companies, so I will refer to them collectively and individually as "Lundbeck".

2

The 614 patent relates to a method of making 5-carboxyphthalide (5-cbx). 5-cbx is an intermediate compound used in the manufacture of Lundbeck's anti-depressant drug citalopram.

Issues

3

Lundbeck assert that the 614 patent is invalid for lack of novelty over two papers by a Mobil scientist called Forney and a Danish patent application. However, by the end of the trial, the lack of novelty objection was limited to the Danish application. Lundbeck also contend that the 614 patent is invalid for obviousness over the Forney papers, and that claim 22 is invalid for insufficiency.

4

There are further issues relating to infringement by current and past processes operated by Lundbeck. Lundbeck also contend that they have a defence under section 64 of the Patents Act 1977 ("the Act") arising out of acts performed before the priority date which they maintain give them a right to continue to do acts which would otherwise infringe.

5

Next there is an issue about the consequences, having regard to section 68 of the Act, of the delayed registration of the assignment from Norpharma to Infosint at the UKIPO.

6

It was agreed that a further group of issues concerning a limitation defence can be dealt with on the hearing of the enquiry as to damages or account of profits, should they arise.

7

As, by the time of the counterclaim, the issues were those of a conventional infringement action, Infosint opened the case and called its evidence first. Mr Andrew Lykiardopoulos appeared for Infosint; Mr Justin Turner QC and Mr Dominic Hughes appeared for Lundbeck.

Expert witnesses

8

Infosint called Dr John Scott and Dr John Moses. Dr Scott is a process chemist. He was the Vice President of Research and Development at Hoffmann La-Roche from 1990–1997 and was then Executive Director of Process Research & Development at Bristol Myers-Squibb from 1998–2003. Since 2003 he has acted as a consultant. He is a highly experienced industrial process chemist, and gave his evidence fairly and impressively. He was called primarily to deal with issues of infringement, but his expertise was such that he could have given all the expert evidence which it was necessary for Infosint to call in this case. He was a little hesitant about areas of the case from which he had been insulated: but when he was unsure he made this plain to the court.

9

Dr Moses is an Associate Professor in Organic Chemistry at the University of Nottingham. Prior to this he was at the School of Pharmacy in London. He has been a member of the Royal Society of Chemistry since 2005. Although he has also worked as an industry consultant, his industrial experience was far less than that of Dr Scott and Mr Ward. I found his approach to the issues a little adversarial, appearing at some points in his evidence to be arguing a legal case on behalf of Infosint, rather than giving technical reasons to support a point of view. It was, in any event, not clear to me why Infosint needed to call two experts in a case involving process chemistry which was entirely within the expertise of Dr Scott. In the end, Lundbeck chose to put nearly all aspects of their validity case to Dr Scott, as they were fully entitled to do. Nevertheless, I have taken account of Dr Moses' points when reaching my conclusions.

10

Lundbeck called Mr Neal Ward and Professor Stephen Davies. Mr Ward is an industrial chemist, currently an independent consultant. Prior to April 2002 he was employed by GlaxoSmithKline as a project manager in Chemical Development, both developing new molecules and improving production processes. Infosint criticised his evidence as "didactic and without compromise" and submitted that he had difficulty seeing things in any way other than his own. I do not think this is fair. He did express confident views. However, he was equally capable of seeing a fair point made against him and agreeing with it. I found his evidence overall to be balanced.

11

Professor Davies is the Waynflete Professor of Chemistry at the University of Oxford and Chairman of the Department of Chemistry. He also founded Oxford Assymetry Company which specialised in preparing compounds with high stereochemical purity. He is an acknowledged expert on stereochemistry. His evidence was originally directed to a narrow point about the technical background to the construction of claim 22. On the pretext that one of Professor Davies' papers had been mentioned by Dr Moses, Lundbeck also asked him to give some evidence in relation to Forney. No criticism was made of Professor Davies as a witness.

Fact Witnesses

12

Infosint called Mr Luigi Zanetti, a former director of Norpharma and Infosint and now a consultant to Infosint. He gave evidence directed to the issue of registration of the assignment of the 614 patent. Mr Zanetti found the process of giving evidence through an interpreter very difficult. It is not possible to say how much this was his fault and how much was the fault of the interpreter, who was provided by Infosint – I suspect it was a little of each. Despite this I was able to understand the gist of his evidence. His credibility was attacked to a degree by Lundbeck, but I make no criticism of him, given the difficulties he was labouring under. The facts on this part of the case were not really in dispute.

13

Lundbeck called Mr Poul Nielsen and Mr Peter Trickett. Mr Nielsen gave evidence of the processes used by Lundbeck, including those adopted before the priority date. His cross-examination had to be interrupted because it transpired that Lundbeck had given inadequate disclosure of documents relating to the work he carried out before the priority date. The work Mr Nielsen had described turned out not to be the first work he had performed on the relevant reaction. Moreover he had not himself been back to his original notebooks. Given that the work was carried out more than 30 years ago, and he had little actual recollection of the details of the work, this was not an adequate way of ensuring that the court was put in possession of an accurate history.

14

Infosint did not go as far as to suggest that Mr Nielsen was setting out to mislead the court, and I do not think he was. However, the manner which he and Lundbeck set about putting this evidence before the court was, in my judgment, wholly unacceptable. If parties decide to rely on secondary evidence of this kind, they must make sure that the evidence is fairly and accurately put before the court. As a result of these failures by Lundbeck, I am left with no confidence in this Lundbeck story at all.

15

Mr Trickett gave evidence of the history of citalopram production in the UK both before and after the priority date. He was an entirely fair witness.

The skilled addressee or team

16

The patents are addressed to an industrial process chemist. Such a person will have a degree in chemistry or chemical engineering and some years of practical experience.

17

There was some debate about whether the skilled person was someone having an interest in citalopram, which is discussed in the introduction of the patent and claimed as an end product in claim 22. The argument was that, as the patent mentions the use of 5-cbx as an intermediate for making, amongst other things, citalopram, it follows that the skilled person was to be deemed to be interested in making citalopram.

18

In Schlumberger Holdings Limited v Electromagnetic Geoservices AS [2010] EWCA Civ 819; [2010] RPC 33 at [30] to [70] the Court of Appeal explained that the skilled team required to implement the patent and to understand its teaching was not necessarily the same as the team used to interpret the prior art and as the touchstone for the question of inventive step. This might be so in cases where the invention changed the art or married two unrelated arts together.

19

A similar but not identical point arises in the present case because claim 22 claims the use of 5-cbx made by the claim 1 process in the...

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