Human Genome Sciences Inc. v Eli Lilly and Company
| Jurisdiction | England & Wales |
| Judge | Lord Justice Jacob,Lady Justice Hallett,Mr Justice Lewison |
| Judgment Date | 09 February 2010 |
| Neutral Citation | [2010] EWCA Civ 33 |
| Docket Number | Case No: A3/2008/2673 |
| Court | Court of Appeal (Civil Division) |
| Date | 09 February 2010 |
[2010] EWCA Civ 33
IN THE HIGH COURT OF JUSTICE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE CHANCERY DIVISION
(PATENTS COURT)
Royal Courts of Justice
Strand, London, WC2A 2LL
The Hon Mr Justice Kitchin
Before: The Rt Hon Lord Justice Jacob
The Rt Hon Lady Justice Hallett
The Hon Mr Justice Lewison
Case No: A3/2008/2673
HC 06 C02687
Henry Carr QC and Michael Tappin QC (instructed by Messrs Powell Gilbert LLP) for the Appellant/Defendant
Andrew Waugh QC and Colin Birss QC (instructed by Messrs Howrey LLP) for the Respondent/Claimant
Hearing dates: 8, 9, 11 and14 December 2009
Lord Justice Jacob:
1. Kitchin J held ( [2008] EWHC 1903 (Pat), 31 st July 2008) that HGS's EP (UK) 0,939,804 was invalid and could not be saved by some proffered amendments. HGS appeals. At the time of his decision the Opposition Division (“OD”) of the European Patent Office (“EPO”) had also held the Patent invalid.
2. Since the Judge's decision things have moved on. In particular on 21 st October 2009, the Technical Board of Appeal (“TBA”) of the EPO allowed HGS's appeal based on some more restricted claims. It gave its reasons on 1 st December 2009, doing so as part of an accelerated proceeding in co-operative effort with this court (see [1–4] of its reasons).
3. This appeal has accordingly been conducted on the basis of the claims allowed by the TBA. It is not necessary to consider any points about the allowability of the amendments or the associated issue of construction considered by the Judge.
4. Mr Henry Carr QC and Mr Michael Tappin QC argued the case for HGS, Mr Andrew Waugh QC and Mr Colin Birss QC for Lilly.
5. The case is basically about the patentability or otherwise of a protein called by HGS Neutrokine-a, antibodies to it and the polynucleotide sequence encoding for it. HGS were the first to discover its existence, doing so by “bioinformatics” (see more below). Others independently made the same discovery shortly thereafter, each discoverer giving it a different name. That is not very surprising given the very fast accumulation of genetic code information coupled with improvements in computing power and other techniques.
Co-operation between the EPO and National Courts
6. Co-operation between national courts and the EPO of the sort which happened between this court and the TBA in this case is mightily to be welcomed. It should, as far as possible, extend to all the stages of procedure in both national courts and in the OD and Boards of Appeal of the EPO.
7. I should enlarge upon that. Far from all oppositions (and appeals) in the EPO are of immediate commercial concern to the parties. Many, perhaps most (it would be valuable to find out), oppositions are started on a precautionary basis only: a potential competitor of the patentee takes the view that although the patent is of no immediate concern to him, it might have an impact on his business at some time in the future. If that is so, unless he is to lose all possibility of a central attack, he must start an opposition before the nine month period from grant expires. So he does.
8. Of course there are cases where the patent may have an immediate and obvious important commercial impact. It is in that class of case, and perhaps only that class, that parallel litigation in the EPO and one or more national courts occurs. Such cases are actually rare considering the total number of patents under opposition in the EPO at any one time. And it is in those cases that the sort of co-operation there has been in this case can be most valuable.
9. Actually it would have been better if the co-operation had started earlier. That probably would have happened if either of the parties has asked for it: neither the OD nor the TBA nor a national court can know that a case needs speeding up unless someone tells them and asks for it.
10. The more the overall opposition procedure can be expedited in the relatively small class of cases of immediate commercial concern, the more significant uncertainty (which is inherently damaging) is likely to be reduced for European industry and business. That needs co-operation from the outset not only between the TBA and the national court (as happened here) but co-operation between the national court(s) on the one hand and the EPO (both the OD and the TBA) on the other. And the parties should actively co-operate too. Commercially urgent and important cases need a fast track.
The Issues on the Appeal
11. The Judge held that all the claims of the Patent were invalid on three grounds: they were not susceptible of industrial application, they were insufficient and they were obvious because of a lack of technical contribution. There was also a further distinct finding of insufficiency as regards claims 18 and 19. HGS challenges all these findings.
12. The Judge rejected Lilly's obviousness attack based on two pieces of prior art called “Image clone” and Fujisawa EST. Only obviousness over Image clone was pursued on Lilly's respondent's notice. The point was raised contingently, that is to say Lilly only intended to pursue it if HGS could overcome the Judge's findings of invalidity. On the same contingent basis Lilly challenged the Judge's rejection of its insufficiency attacks on claims 1 and 13 and its claim that the amendment has impermissibly extended the protection of claim 13.
13. After we had heard full argument on HGS's appeal, we concluded that it failed. We accordingly informed the parties it was not necessary to hear argument on the points raised by Lilly – points which, incidentally, we note were decided adversely to Lilly by Kitchin J and the TBA. Of course by so indicating we were also indicating the result of the appeal. So what follows are my reasons for its dismissal.
The nature of a first instance decision in England and Wales
14. Because we are differing from the TBA I should point out some basic matters of procedure and approach which help explain why.
15. A key rule of civil procedure in England and Wales (and indeed in most if not all common law countries as well as some civil law countries) is that each side must marshal all its evidence (expert and factual) and arguments for the trial court – the court of first instance.
16. The process at a trial in England involves an intensive investigation and testing of the evidence. Each party's witness statements and expert reports must be provided in advance of the hearing. The expert witnesses are generally people who have been closely engaged with the very technical subject matter of the case. Each party's internal documents relevant to the issues in the case (and most particularly the documents adverse to its case) have to be disclosed in advance by the process called by most common lawyers “discovery” but now in England “disclosure”.
17. At the hearing the evidence, both factual and expert, is severely tested by the process of cross-examination – the asking of questions by a lawyer from the other side who will have been educated deeply in the art by his own party's expert. An expert's opinion, as such, is treated by the court as of little value. His reasons for that opinion are what matter. Those reasons are apt to be probed without remorse before a tribunal which itself will have developed a good understanding of the technical subject-matter. Because that is likely to happen, expert witnesses in English are less apt to “stretch” things in favour of the party relying on them. They know their reputation is “on the line.”
18. Moreover the Judge himself will generally not only have an expertise in patent law but also some considerable general technical expertise. Many (but not all) English patent judges have a science degree and many years experience of the practice of patent law. The trial Judge here, Kitchin J, is no exception.
19. Finally in cases of particularly complex subject-matter it is possible for a scientific advisor to be appointed to the court. Sometimes that is done both at first instance and on appeal, sometimes only on appeal. The function of such an advisor is merely to assist the court in its technical understanding. He or she is not there to provide an opinion on the merits. Experience shows that such advisors are well capable of keeping within their proper function.
20. In this very case we have had the benefit of a scientific advisor, Dr John Murphy of Kings College London. He is a Senior Lecturer of the Immunology, Infection and Immunity Research Group within the Division of Life Sciences of that University. His particular experience includes work on autoimmune diseases and immune regulation.
21. Prior to the hearing Dr Murphy gave us some “teach-ins” about the background technology. At the hearing he sat with us and provided valuable further explanation of the technology. At all times he meticulously refrained (as he had been asked) from commenting on the parties’ respective cases and he played no part in our decision making process. I would like to go on record to express the court's thanks to him.
22. The English trial procedure has the very considerable advantage that all parties know that they have to make their best efforts for the first instance decision. Each side has to put its cards on the table. That in itself causes quite a few cases to settle: if the other side has aces and kings and you have only low value cards and you each know broadly what the other has, you had better settle on as best terms as you can get.
23. The system has its problems –...
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