Alcon Research LLC v Actavis Group Ptc EHF
| Jurisdiction | England & Wales |
| Judge | Mr Justice Meade |
| Judgment Date | 23 April 2021 |
| Neutral Citation | [2021] EWHC 1026 (Pat) |
| Date | 23 April 2021 |
| Docket Number | Case No. HP-2015-000003 and HP-2020-000014 |
| Court | Chancery Division (Patents Court) |
[2021] EWHC 1026 (Pat)
Mr Justice Meade
Case No. HP-2015-000003 and HP-2020-000014
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Rolls Building
Fetter Lane
London, EC4A 1NL
Andrew Waugh QC and Anna Edwards-Stuart (instructed by Bristows LLP) for the Claimants
Justin Turner QC and Daniel Selmi (instructed by Innovate Legal) for the Defendants
Hearing dates: 16–18 and 22 March 2021
Approved Judgment
I direct that pursuant no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
| Introduction | 3 |
| Conduct of the trial | 3 |
| The issues | 4 |
| The witnesses | 4 |
| The skilled team | 6 |
| The skilled team – applicable law | 7 |
| The facts, application of the law | 10 |
| The common general knowledge | 13 |
| Agreed common general knowledge | 13 |
| General pharmacological principles | 13 |
| Prodrugs | 14 |
| The anatomy of the eye | 14 |
| Glaucoma | 15 |
| Treatment for glaucoma | 15 |
| Prostaglandins | 16 |
| Prostaglandins and the treatment of glaucoma | 17 |
| Animal models | 17 |
| Prostaglandin drugs in 1993 | 17 |
| Disputed common general knowledge. . | 18 |
| Prostaglandins as therapeutic agents to treat glaucoma | 19 |
| Prostaglandins, prostanoid receptors, and their classification | 19 |
| Fluprostenol | 21 |
| The Patent | 21 |
| Example 5 | 23 |
| Example 6 | 24 |
| Claims in issue | 24 |
| Technical contribution of the Patent | 26 |
| An Issue of claim interpretation | 27 |
| Validity | 27 |
| Anticipation – the law | 27 |
| The allegations of anticipation in this case | 27 |
| Obviousness over Stjernschantz | 29 |
| Legal principles | 29 |
| Teaching of Stjernschantz | 29 |
| Pozzoli analysis | 33 |
| The Defendants' case | 34 |
| Evidence relied on by the Defendants | 37 |
| Conclusion on obviousness | 38 |
| Obviousness/insufficiency squeeze | 38 |
| Conclusions | 38 |
INTRODUCTION
These actions concern European Patent (UK) No. EP 1 920 764 (the “Patent”) which protected the drug travoprost until its expiry on 3 August 2014. Thereafter, an SPC based on the Patent, SPC/GB12/038, (the “SPC”) was in force until 28 May 2017.
The Patent was opposed in the European Patent Office (“EPO”) and upheld in amended form by a decision of the TBA of 21 April 2016 (T1872/14 Travoprost/ALCON), to which I will refer below.
The TBA's decision was on the basis of different prior art, different evidence, and different arguments, so in many respects it is of only limited relevance.
The Patent relates to the use of travoprost (fluprostenol isopropyl ester (“ FIE”), a prostaglandin F2α analogue) for the treatment of glaucoma and ocular hypertension (in this judgment I will generally, for brevity, just refer to glaucoma as the condition to be treated, and not refer repeatedly to ocular hypertension; the relationship between them is explained below). Its priority date is 3 August 1993.
Although the Patent and the SPC have both expired, this trial has been necessary because interim injunctions were obtained on the basis of them in respect of which cross-undertakings in damages were given. If the Patent is invalid then those cross-undertakings will come into force.
It is unnecessary to go any further into the procedural history in this judgment, or to refer in any detail to the different Defendants and their relationships. All I need say is that the only active Defendants remaining are the second Defendant in each action. I will refer to them together as “ the Defendants”.
There was quite a lengthy period when the proceedings were paused, and that had the result that the expert witnesses started work on their reports several years ago, so their recollection of the process of their preparation has faded.
Infringement (in the event that the Patent is valid) by the Defendants' generic products is admitted. So in essence this is now a revocation action. The only attack on the SPC is that it is invalid if the Patent is invalid, so I do not need to say anything further about it.
Andrew Waugh QC appeared for the Claimants, to whom I will refer as “ Alcon”, with Anna Edwards-Stuart, and Justin Turner QC and Daniel Selmi appeared for the Defendants.
CONDUCT OF THE TRIAL
The trial was conducted fully remotely, supported by a third-party IT provider retained by the parties, and worked well. Dr Krauss, Alcon's pharmacology expert, gave evidence from the USA, and to accommodate this, and to allow him to watch the proceedings during the evidence of his opposite number, Dr Wilson, the Court sat some time-shifted hours, outside the normal Court day.
I thank the Court staff and the shorthand writers for their assistance with these extended hours, and the parties for providing electronic bundles.
THE ISSUES
The issues narrowed in the run up to trial, and during trial. The remaining issues are:
i) The nature of the skilled team.
ii) The scope of the common general knowledge.
iii) Novelty over a patent application referred to as “ EP 800” (European Patent Application No. 0 603 800). This was prior art for novelty only. Novelty has to be assessed for the claims upheld by the EPO and, if those are anticipated, in respect of amended claims put forward by way of a conditional application to amend.
iv) Obviousness over a prior art publication referred to as “ Stjernschantz” (“ Phenyl substituted prostaglandin analogs for glaucoma” by Stjernschantz and Resul published in Drugs of the Future, 1992 Vol 17(8): 691–704 published in October 1992).
v) An obviousness/insufficiency squeeze.
One of the issues that fell away during trial was an allegation that the Patent was obvious over another prior art document referred to as “ Karlsson” (Abstract No. 55 entitled “ Receptor profile of PhXA41, a new phenyl substituted prostaglandin ester” by Maritha Karlsson et al. published in Experimental Eye Research Vol 55, Supplement 1 in or around September 1992), either alone or in combination with Stjernschantz. Karlsson was referred to in Stjernschantz and the attack over it was closely related to that over Stjernschantz. It was a pragmatic decision by the Defendants to drop it in the light of the way the evidence had gone; it was reasonable to run it up until then.
I will refer below to a point about the interpretation of the claims (the meaning of “for use”), but nothing turned on it and in the end I do not think there was a dispute about it.
THE WITNESSES
Each side called two expert witnesses: a pharmacologist and a medicinal chemist. It was common ground that the skilled addressee in this case would be a team of that kind. Each medicinal chemist gave some evidence (in particular on receptor binding profiles) which I would normally have expected to come from the pharmacologist member of the team, but this was done about equally on each side, and no objection was taken. It did not represent a significant duplication, and it may, as Counsel for the Defendants submitted, just have been a symptom of a team whose members would need to cooperate particularly closely.
Alcon's pharmacologist was Dr Achim Krauss. He was working in industry at Allergan at the priority date and has (and had then) direct knowledge of prostaglandins in the context of glaucoma.
Although clearly knowledgeable and good at explaining things, I found Dr Krauss to be a frustrating witness because he often gave long and non-responsive answers, repeatedly seeking to get across points he thought were important. Counsel for the Defendants showed great patience in dealing with this and did not submit that it was a symptom of a lack of independence, so I need say no more about it.
Dr Krauss also took an approach in his first report which I found odd, in that although his own expertise included, as I have said, prostaglandins, he gave evidence on the basis that the notional skilled pharmacologist was a generalist in glaucoma and would not know anything about them. He then dealt with the approach of a pharmacologist knowing of prostaglandins only in reply. I was assured (in post-trial written submissions) by Counsel for Alcon that this was not a tactical move, and accept that, and so I do not see any need to discount Dr Krauss' evidence for this.
It was submitted by Counsel for the Defendants that Dr Krauss ought to have acknowledged in his written evidence that he was working with fluprostenol before the priority date. I agree that he should have but in itself it was a minor matter and probably just a facet of the way he addressed the skilled team, to which I have already referred.
Overall, the presentation of Dr Krauss' evidence could have been better and more efficient, but was valuable to me and I have factored it into my analysis.
Alcon's medicinal chemist was Dr David Cavalla. He has been a medicinal chemist in industry for many years. His evidence was extremely clear and cogent. He had no experience in prostaglandins or glaucoma at the priority date, but that expertise would come from the pharmacologist in the team and the skills of the medicinal chemist are largely transportable from one target to another.
The Defendants' pharmacologist was Dr William Wilson. He was an academic at the priority date, with a research interest in the treatment of glaucoma, but with no experience in relation to the possible...
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