Hospira UK Ltd v Genentech, Inc

This is an application by Genentech (the patentee) relating to the confidentiality of certain documents which were disclosed during these proceedings and which played at least some part in them. It arises under CPR 31.22 following my judgment in this case, which was handed down on 10th April 2014, [2014] EWHC 1094. At the hearing to decide on the consequential orders, it was not possible on that occasion to deal with this matter. The matter was adjourned, the parties exchanged evidence and it has come before me this morning.

Essentially, the position is as follows. The patentee disclosed a number of documents which it had designated as confidential and which were then covered by a pro tem CPR 31.22 order. In the course of preparing for this application, the solicitors for Genentech reviewed those documents with their clients and narrowed down from thirteen to six the ones they submit should remain confidential after trial. The hearing is therefore focused on these six documents.

CPR Rule 31.22 states:

"(1)

A party to whom a document has been disclosed may use the document only for the purpose of the proceedings in which it is disclosed, except where –

"(a)

the document has been read to or by the court, or referred to, at a hearing which has been held in public;

"(b)

the court gives permission; or

"(c)

the party who disclosed the document and the person to whom the document belongs agree.

"(2)

The court may make an order restricting or prohibiting the use of a document which has been disclosed, even where the document has been read to or by the court, or referred to, at a hearing which has been held in public.

"(3)

An application for such an order may be made –

"(a)

by a party; or

"(b)

by any person to whom the document belongs.

"(4)

For the purpose of this rule, an Electronic Documents Questionnaire which has been completed and served by another party pursuant to Practice Direction 31B is to be treated as if it is a document which has been disclosed."

The principles which should guide the court in deciding whether to make such an order were set out by Buxton LJ in Lilly Icos v Pfizer (No 2) [2002] EWCA Civ 2 at paragraph 25 and were helpfully set out by Mr. Mitcheson in paragraph 4 of his skeleton. They are:

"(i)

The court should start from the principle that very good reasons are required for departing from the normal rule of publicity. That is the normal rule because, as Lord Diplock put it in Home Office v Harman [1983] AC 280 at p303C, citing both Jeremy Bentham and Lord Shaw of Dunfermline in Scott v Scott,

"'Publicity is the very soul of justice. It is the keenest spur to exertion, and the surest of all guards against improbity. It keeps the judge himself, while trying, under trial

"The already very strong English jurisprudence to this effect has only been reinforced by the addition to it of this country’s obligations under articles 6 and 10 of the European Convention.

"(ii)

When considering an application in respect of a particular document, the court should take into account the role that the document has played or will play in the trial, and thus its relevance to the process of scrutiny referred to by Lord Diplock. The court should start from the assumption that all documents in the case are necessary and relevant for that purpose, and should not accede to general arguments that it would be possible, or substantially possible, to understand the trial and judge the judge without access to a particular document. However, in particular cases the centrality of the document to the trial is a factor to be placed in the balance.

"(iii)

In dealing with issues of confidentiality between the parties, the court must have in mind any “chilling” effect of an order upon the interests of third parties: See paragraph 5 above.

"(iv)

Simple assertions of confidentiality and of the damage that will be done by publication, even if supported by both parties, should not prevail. The court will require specific reasons why a party would be damaged by the publication of a document. Those reasons will in appropriate cases be weighed in the light of the considerations referred to in sub-paragraph (ii) above.

"(v)

It is highly desirable, both in the general public interest and for simple convenience, to avoid the holding of trials in private, or partially in private. In the present case, the manner in which the documents were handled, together with the confidentiality agreement during trial, enabled the whole of the trial to be held in public, even though the judge regarded it as justified to retain confidentiality in respect of a significant number of those documents after the trial was over. The court should bear in mind that if too demanding a standard is imposed under CPR 31.22(2) in respect of documents that have been referred to inferentially or in short at the trial, it may be necessary, in order to protect genuine interests of the parties, for more trials or parts of trials to be held in private, or for instance for parts of witness statements or skeletons to be in closed form.

"(vi)

Patent cases are subject to the same general rules as any other cases, but they do present some particular problems and are subject to some particular considerations. As this court pointed out in Connaught, patent litigation is of peculiar public importance, as the present case itself shows. That means that the public must be properly informed; but it means at the same time that the issues must be properly explored, in the sense that parties should not feel constrained to hold back from relevant or potentially relevant issues because of (legitimate) fears of the effect of publicity. We venture in that connexion to repeat some words of one of our number in Bonzel v Intervention Ltd [1991] RPC 231 at p234.27:

"'The duty placed upon the patentee to make full disclosure of all relevant documents (which is required in amendment proceedings) is one which should not be fettered by any action of the courts. Reluctance of this court to go into camera to hear evidence in relation to documents which are privileged which could be used in other jurisdictions, would tend to make patentees reluctant to disclose the full position. That of course would not be in the interest of the public.'

"In our view, the same considerations can legitimately be in the court’s mind when deciding whether to withdraw confidentiality from documents that are regarded by a party as damaging to his interests if used outside the confines of the litigation in which they were disclosed."

A matter which was also debated before me was the judgment of Laddie J in the Dendron case (Dendron GmbH v The Regents of the University of California [2004] EWCH 589). There, Mr. Tappin relied on the considerations of the law set out by Laddie J in paragraph 42 and his application of it to the facts before him in paragraphs 43-47. That case was an application during the course of proceedings by a party for permission to use documents for a collateral purpose, permission for which is required based on the rules of court and the authorities, such as Halcon v Shell[1979] RPC 97; Crest Homes v Marks[1987] AC 829; and so on.

Mr. Mitcheson submitted that the principles applicable in Dendron are not relevant directly to the matter before me. I accept his submission. Dendron was a case in which a party was seeking an order lifting the obligation not to use documents disclosed during the proceedings for a collateral purpose. The position before me is a different one. Here, the party who disclosed the documents is seeking an order maintaining these documents as confidential on a permanent basis following their use during trial. Prima facie, a document which was read or referred to during the case -- and all the documents the subject of this application satisfy that criterion -- would ordinarily expect to be made public. However, as Lilly Icos explains nevertheless there can be good reasons why documents which would ordinarily be made public should not be made public and should be confidential. That is a different question from the question arising in Dendron.

Nevertheless, I can understand why Mr. Tappin referred to the Dendron case. That is because one of the reasons advanced by Hospira in favour of disclosure, is that his clients, and his clients's associates, wish to use some of these documents, or parts of them, in parallel proceedings in the European Patent Office. Therefore, one can see that the points raised in Dendron may have some bearing on the issues I have to decide.

In summary, the evidence before me comes to this. Mr. Gilbert, the solicitor for Genentech, having spoken to his clients, explains why the various documents should remain confidential. Essentially the reason comes down to saying that there are real commercial risks and there would be real commercial prejudice to Genentech if this material was made public. It is confidential and it might be of assistance to Genentech's competitors. In particular, it might be of assistance to a competitor seeking to bring to market a bioequivalent product to the trastuzumab antibody with which this case is concerned.

Mr. Cohen, the solicitor for Hospira, replies to Mr. Gilbert's evidence and challenges the assertion in Mr. Gilbert's evidence that these documents are confidential. He explains particularly, in some cases, why a competitor who was seeking to make a bioequivalent product would not find any of the information that Mr. Gilbert refers to as being of any real use.

Mr. Balme, who is another solicitor at the defendant's solicitors, replies again to Mr. Cohen and, if I may say so, without any disrespect to Mr. Balme, essentially repeats what Mr. Gilbert says and explains why they are good reasons why the confidentiality should be maintained.

In general, it seems to me that the following points should be kept in mind. First, as explained in Lilly Icos, cogent reasons are required from a party seeking to maintain a claim to confidentiality as to why that should be done. The onus is on the party seeking to maintain that confidentiality.

On the other hand, as the Court of Appeal recognised in Lilly Icos, it is important to bear in mind the potential chilling effect of undue disclosure of materials which a party regards as confidential. As point (vi) of the cited passage from Buxton LJ’s judgment explains, parties should not feel constrained to hold back from relevant, or potentially relevant, disclosure because of legitimate fears of the effect of publicity.

Another important matter is that one should not allow this debate under 31.22 to turn into major satellite litigation but, on the other hand, if a court does not maintain proper scrutiny over this process, there is a risk that parties will maintain claims to confidentiality which are not justified. A balance has to be struck.

As I explained in my recent judgment in Smith & Nephew v Convatec, it is highly inconvenient to resolve these disputes in the middle of a trial and the best course, as has happened in this case, is to make orders pro tem and then decide the matter here and now.

Another general matter I will mention at this stage is this. At least for some documents, Mr. Gilbert states on behalf of his clients that they are in danger of revealing what he calls regulatory know how. In other words, they are documents which have been filed by the pharmaceutical company with the relevant regulator and it is said that the disclosure of a document will reveal some know how which the pharmaceutical company possessed about how to conduct its dealings with regulators.

I accept that it is possible that such know how is a genuine form of confidential information and that there are cases in which that sort of thing can be legitimate. However, I cannot help but observe is that the assertion that a document will reveal pharmaceutical regulatory know-how appears to be a catch all point used when the party cannot think of another reason why the contents of a document itself are truly confidential. This is an example of that practice. I am far from convinced that the detail in Mr. Gilbert's evidence relating to the assertion of the revelation of regulatory know how is sufficient to justify that claim.

A further point is the following. Genentech accepts that full copies of the experts’ reports, which refer to the six of the documents in question, will be in the public domain. So on a number of occasions the expert in question, usually Dr. Earhart, quotes sections of a document. Genentech submits that allowing the report to enter the public domain is enough and the underlying document can remain confidential. I accept that in many cases such an approach may be an appropriate course to take, balancing the requirements of open justice with confidentiality but there are potential difficulties with this approach. It recognises that a claim to the confidentiality of the information in the expert's report cannot be maintained and therefore the report could be used elsewhere (e.g. in the EPO). However using the report without the exhibit may create the opportunity for an argument by the party against whom the report is deployed to contend that expert's report amounts to cherry picking and to contend that other parts of the underlying document, which the EPO cannot see, are contrary to the expert’s view. There is a difference between the impression created simply by reading a quotation of a document in an expert's report and seeing that the underlying document itself bears out and corroborates what the expert is saying. As Mr. Mitcheson submitted, access to the exhibit prevents any unwarranted suggestion being made later that there is other material, not quoted, which contradicts what the expert has said.

I turn to consider the particular documents in this case. The first document I will consider is RCFL-8, which is clinical study protocol no. B 015935, dated 4th May 1999. It was referred to in Prof. Leonard's report. It is a document which contains full details of a clinical study from that timeframe.

Hospira submit that the document contains, essentially, one sentence which gives a rationale for embarking on a particular course of action relevant to this case. This is explained in Prof. Leonard's report. It suggests that that is a matter which could, and should, be in the public domain and that the claim to confidentiality is not made out.

I do not accept that. Mr. Gilbert's evidence amply explains why this full document, which runs to 30-35 pages, can be characterised as a blueprint for a clinical trial. It is exactly the kind of material which a pharmaceutical company such as Genentech would legitimately regard as confidential. It seems to me that the one-line reference to the rationale is not a sufficient reason why this document needs to be made public. Anyone wishing to scrutinise the process of the trial before me in the Patents Court will be able to read what Prof. Leonard said. Bearing in mind the fears expressed by Mr Mitcheson I will say now that what Prof Leonard said is a perfectly fair quote from the document. There is no reason why the rest of the document needs to be made public. I therefore accept Genentech's application in relation to document RCF-8.

I also reach the same conclusion in relation to pages 10-54 of document RHE-10. That is another version of the clinical protocol study of the same document and the same reasons apply in relation to it. In fact, it was referred to by Dr. Earhart rather than Prof. Leonard, but the point is the same, about the rationale. It is another blueprint for a clinical trial. I am satisfied that it contents should fairly be kept confidential.

The next documents I will deal with are Exhibits HE-6 and HE-7. I believe they are extracts from the same biologics licence application dated 1st May 1998. These together come to about 35 pages for RHE-6 and a further 20 pages or so for RHE-7, coming to about 50 pages. They contain a mass of clinical data, pharmacokinetic data, pharmacodynamic data and other clinical data generated by Genentech.

It is suggested by Mr. Mitcheson that a number of pages contain matters which justify the refusal of the order sought by Genentech. He referred me to pages which contained observations which can be seen, sitting here today, as being relevant to the issues in the case. In particular the references on pages 5, 6, 9 and 12 of RHE-6. They are all examples which, to the best of my knowledge and recollection, did not play any part in the trial. That is not to say that Mr. Mitcheson is wrong that what is said on these pages is not capable of having a bearing on the issue of obviousness. But there are no markings on my copies of these documents which indicate that those particular pages played any role. I am not satisfied that the fact that they could be said now after trial to have some relevance to inventive step is a good reason why the documents should be made public.

On the other hand, there are particular pages which were referred to and indeed quoted by Dr. Earhart. There is one particular page, page 14, which contains text which was quoted by Dr. Earhart and also a figure which was not quoted by Dr. Earhart but which was referred to me in closing by Mr. Meade QC, the leading counsel handling this case for Hospira. That was referred to in the context of a debate about the quality of the fit between predicted data and measured data and how good a fit one might or might not want before being prepared to act in a particular way. That figure played a part in this case. It is right, as Mr. Tappin submitted in relation to all of this but in particular in relation to this figure, that the figure itself is not quoted in the judgment. However, if the document had been public and if a person had been sitting in court, in order to have understood the submissions of counsel during the closing, that member of the public would naturally have wanted to see what the figure looked like. Indeed, looking at the picture is a critical part of understanding why it is that the court was being told something about the quality of the fit between the actual and the predicted data.

That is a good reason why page 14 as a page should be public and should not be made confidential.

However, I am not satisfied that the remaining parts of Exhibits 6 and 7 satisfy that test. They again contain a mass of technical information which is of no relevance to this case. Mr. Mitcheson submitted that Genentech should have proposed redactions to these documents in order to enable the public bits to be kept public and not made confidential. There is some force in Mr. Mitcheson's submission, but in the end, it seems to me that Genentech should not be criticised for not producing redactions. It is possible to understand the trial process by reading Dr. Earhart's reports with the addition of the extract on page 14.

For all those reasons, subject to making page 14 public, I will accept Genentech's submission in relation to the rest of RHE-6 and 7.

I now turn to deal with RHE-10, pages 1-9. This consists of a letter from Genentech to the FDA on 20th February 2001 (pages 1 and 2) with some further pages which explain what is in the letter and support it, going up to page 9. They provide a summary of the results of pharmacokinetic studies and explain an increase in half-life estimate by Genentech. They contain far less detail than the contents of Exhibits RHE-6 and 7, which I have already mentioned. Also, I bear in mind that a substantial amount of what is in the letter is not confidential and, indeed, large chunks (but not the whole of this letter) have already been quoted by Dr. Earhart.

I did not find the reasons Mr. Gilbert gives why these particular pages are confidential convincing. They were generalised and not specific. The pages are not a blueprint of a clinical trial and I am not satisfied that the information in pages 1-9 would cause real harm to Genentech if it was made public. I am also satisfied that these are documents which a person observing the trial would wish to see in order to understand the way the trial had gone. I will therefore not accede to Genentech's application in relation to pages 1-9.

The other point made by Mr. Gilbert is that what one is apparently supposed to be able to tell from pages 1-9 is what combination of choices regarding the strategies which Genentech were going to adopt were in fact adopted by Genentech. That does not convince me as being a good reason why this data should be kept secret. It is unspecific.

In relation to this document I also bear in mind the debate which is going on in the European Patent Office relating to the plausibility of the patent. I have seen both the Opposition Division's decision and the submission for Genentech by its patent attorneys. This debate involves an argument about when exactly Genentech's view of the half-life of trastuzumab changed and on what basis. The question of the half-life of trastuzumab and the analysis leading up to these issues is something that was discussed extensively at trial. It seems to me that this is a matter which the EPO have a real interest in, as I can see from the documents already. Since the EPO will inevitably be shown my judgment or, for that matter, any judgment in the Court of Appeal in this case if there is one, it seems to me that it is proper that they should be able to see documents such as pages 1-9 in order to fully understand what took place in the United Kingdom. For all those reasons, I will not accede to Genentech's application relating to pages 1-9.

That leaves RHE-4 and 5. These are dosage regimen analyses relating to the 4+2 regimen which ultimately led, I believe, to the data in the Cobleigh paper. They were relied on by Dr. Earhart and referred to by Hospira in the case as showing that the patentee was prepared to use a one-compartment and two-compartment model. The reason these documents are said to be confidential is because they contain underlying data arising from the study in question, which was a 50 patient study.

I am not satisfied they should keep these documents confidential. Mr. Tappin is right that it would not be realistic to expect them to be redacted and, therefore, making these documents public will put into the public domain the underlying data which they contain. The submission was that this would assist a competitor who was seeking to conduct a bioequivalence study of trastuzumab but, if that is the basis for the claim to confidentiality, the idea that this data would give any significant assistance to such a competitor is not sufficiently explained in Genentech’s evidence. This data led to a published paper. The issue of whether a one or two-compartment model was used was certainly something which was live at the trial. It is something a reasonable observer would wish to understand when understanding these proceedings. As Mr. Mitcheson pointed out, this case is not concerned primarily with a product which is on the market on a 4+2 regimen. It is concerned with a three-weekly dosage regimen. For all these reasons, I do not accept the claim to confidentiality in relation to Exhibits 4 and 5.

I believe I have covered all the documents and that is my judgment on those.