Celltrion Inc v Biogen Idec Inc & Ors

This is an application by the Claimant “Celltrion” for an order that proceedings for revocation of three patents which were commenced on 30th November 2015 be listed as two separate trials within the twelve-month period contemplated by the Court's Practice Statement of 7th December 2015. Both trials will be heard as close as possible to 30th November 2015 if I grant this application.

The background to this application is as follows. The claim is for revocation of three patents covering dosage regimes for the monoclonal antibody rituximab. Two of the patents covered dosage regimes for the treatment of chronic lymphocytic leukemia which the parties term "CLL". The third covers dosage regimes for the treatment of rheumatoid arthritis which the parties term "RA".

The earliest of the CLL patents, the '572 Patent, has been revoked by the Opposition Division of the EPO and an appeal is currently pending. The later of the CLL patents, which is the '313 Patent, is still in the opposition period with one opposition already having been filed. The RA patent, which is the '304 Patent, is currently under opposition.

This action was served on the Defendants’ representatives, Mewburn Ellis, on 30th November 2015, and the Defendants' solicitors, Herbert Smith, were instructed on behalf of the Second and Third Defendants on 9th December 2015 and on behalf of the First Defendant on 15th December 2015. Herbert Smith acknowledged service and requested a 28 day extension for service of the Defence until 27th January 2016, which was granted by the Court.

Celltrion complains that the Defendants delayed in engaging with Bristows in order to list the trial. The Defendants' position was that they had instructed counsel who was not available until the second week of January because of the holiday period and other commitments.

I do not consider that it would be right to criticise the Defendants or their representatives for the course of conduct that they have taken. Obviously, parties from whom instructions needed to be taken were away over the Christmas period. Nor is it right to criticise the Defendants for obtaining an extension of time for their Defence, which the Court saw fit to grant.

I now turn to the substance of this application I refer to the Practice Statement of 7th December 2015 which states as follows:

"The Patents Court endeavours to bring patent cases on for trial where possible within 12 months of the claim being issued. To this end, the following procedure will be adopted.

1.

The parties will be expected (a) to start to consider potential trial dates as soon as is reasonably practicable after the service of the proceedings and (b) to discuss and attempt to agree trial dates with each other when seeking to agree directions for trial.

2.

The starting point for listing trials is the current applicable Trial Window advertised by the Chancery List Office. Patent cases will be listed on the basis that the Trial Windows are divided as follows: Estimated hearing time (excluding pre-reading and preparation of closing submissions) up to 5 days; estimated hearing time (excluding pre-reading and preparation of closing submissions) 6 to 10 days; and estimated hearing (excluding pre-reading and preparation of closing submissions) over 10 days.

3.

Where it will enable a case to be tried within 12 months, or shortly thereafter, the Court may list a trial up to one month earlier than the applicable Trial Window without the need for any application for expedition.

4.

The Court will use its case management powers in a more active manner than hitherto, with a view to dealing with cases justly and at proportionate cost in accordance with CPR rule 1.1. This may have the effect of setting limits on hearing times that enable cases to be listed promptly. For example, the Court may direct that a case estimated at 6 days will be heard in 5 days, and may allocate time between the parties in a manner which enables that to be achieved.

5.

Where it makes a significant difference to the time which cases must wait to be listed for trial and it will not cause significant prejudice to any party, cases may be listed without reference to the availability of counsel instructed by the parties."

The Practice Statement represents an important change to the management of patent cases. The change reflects the interests of court users and the wider public in the prompt resolution of disputes which are commercially important and have, in the case of pharmaceutical patents, a wider impact on the public interest. The reasons for this change in practice are set out in the Chancery Modernisation Review; Final Report by Lord Justice Briggs at Chapter 13.

“13.10

A European Patent granted pursuant to the European Patent Convention is a bundle of national patents. This gives claimants a broad international choice of forum, but means that the Patents Court now faces competition from a number of European courts. The responses to consultation suggest that the Patents Court is, comparatively, very highly regarded for the quality of its decision-making, and is indeed the forum of choice for those with large scale disputes meriting substantial trials within the EU, and from further afield.

13.11

There is nonetheless real concern that, because patent cases are listed for trial alongside the generality of chancery cases, with no built-in priority, the current waiting time of about fourteen months from setting down compares unfavourably with the time which the German patent court takes to reach a decision on infringement. The apprehended result is that the patent litigation industry in the UK faces stiff competition where the parties’ commercial priority is for a speedy outcome rather than perfect justice (as it often is)….”

Essentially, the UK Patents Court was falling behind certain other jurisdictions in the time that it took to resolve patent cases, and it needed to speed up. To that end, the Court will actively manage patent cases to bring them on, wherever possible, within twelve months and the parties need to cooperate to ensure that this happens.

I will now consider whether this is an appropriate case to be heard within the twelve month period and whether there should be a split trial. I should say that whether or not there is a split trial will make no difference to the date on which the matter is heard as the Court can currently accommodate, due to a settlement of a large patent claim, a trial of ten days or two trials of five days in late 2016.

The Defendants claim that this application is premature as, until pleadings have been closed, issues between the parties will remain uncertain. They oppose a split trial. Mr. Moore. who has given evidence on behalf of the Defendants, points out that there is no agreement between the parties as to the number and fields of expertise of technical experts, whether there will need to be evidence of foreign law, whether there will need to be factual evidence and as to the necessity and scope of any disclosure exercise.

I do not accept these submissions. In particular, the Defence is due on 27th January 2016, in three days. The Defendants must be well aware of the issues that need to be considered in the case. Furthermore, having considered the grounds of invalidity in this case, there is a very significant overlap between the grounds that are put forward to the UK Court and the grounds which have already been considered during opposition proceedings and, therefore, have been addressed in the EPO. I was told that the only difference is one additional piece of prior art.

I accept, for present purposes, Ms. Cohen’s estimate that if there are split trials they will be five days each, excluding pre-reading and preparation of closing submissions and if there is a single trial it will last for ten days, excluding pre-reading and closing submissions.

I shall now consider whether there ought to be a split trial. Mr Moody-Stuart, on behalf of the Defendants, referred to the decision of Hildyard J in Electrical Waste Recycling Group Limited v Philips Electronics Ltd and another v Philips Electronics UK Ltd and others [2012] EWHC 38 (Ch). This considered whether there should be a split trial of liability and quantum in a competition case. The judgment identifies the relevant principles which I will take into account, bearing in mind that the issue that I am deciding is very different to the question of splitting liability and quantum.

In the present case I consider that whilst there is a certain degree of overlap between the CLL patents and the RA patent, there are also significant differences. In particular, the priority date for the CLL patents is November 1998 and the earliest priority date for the RA patent is November 2005, seven years later. It therefore follows that the parties’ representatives, the Court and the witnesses will need to consider common general knowledge at very different dates. This, to my mind, shows a significant advantage in separating the trials. For example a witness during cross-examination may become confused as to which date is being discussed at any given time if the trial of all three patents is hear together.

I also recognise that, on the evidence before me, the indications covered by the respective patents are very different. In CLL B-cells proliferate to excess and symptoms are caused by their over-abundance, as Ms. Cohen explains in paragraph 30 of her second witness statement. By contrast, in RA B-cells proliferate normally but are thought to contribute to the disease process by expressing antigens and co-stimulatory molecules on their surface which activate T-cells and cause the immune system to attack tissues in the joints. Thus, Ms. Cohen says, and at the moment I have no reason to disagree, that while both involve B-cell function, the similarity exists only at a very general level. I also recognise, as the Defendants have submitted, that there is a degree of overlap between the cases. In particular it may well be that the same experts give evidence in both trials, for example a specialist in dosage regimes and a specialist in the mode of operation of rituximab may be one and the same individual in respect of all three patents.

Bearing these considerations in mind, in my judgment there should be a split trial. I believe that it would be convenient for the same judge to hear both trials. It would be of benefit to the judge and the parties if the second trial follows soon after the first trial, with a relatively short break between the two. I understand from listing that it will be possible, should I see fit, to order that successive trials take place as close as possible to 30th November 2016.

However, the Defendants have further objections to that course. It is said that until pleadings are closed it is unwise to make any order. It is pointed out that I do not know at the moment what disclosure will be ordered and if the burden of disclosure is particularly heavy on the Defendants then it may be that a trial date in November will be impractical. Furthermore, the Defendants rely on the fact that Hospira UK Limited have indicated that it wishes to be heard at the same time, having issued proceedings to revoke these patents, relying on the same objections as Celltrion.

I bear all these factors in mind but it does not alter my decision. It may well be that since the Claimant has sought a date within the twelve month period it will be more difficult for the Claimant to insist on wide-ranging disclosure at the CMC. Furthermore, I think it is unlikely, given that they are relying on exactly the same ground of objections, that Hospira will take a materially different position. If it did do so, then the Court might not consider that it was convenient to hear Hospira at the same time if it would substantially lengthen the trial.

I also bear in mind that there is, at the very least, a possibility that the priority date of the patent will be challenged, which may involve issues of US law. I do not think, even if that remains live at the trial, that it will materially lengthen the trial. Indeed, if it appears at the CMC that the either of the trials are going to be materially longer than five days, each of the parties will be under a duty to inform the Court of that fact. On present information from listing I do not believe that it will make any difference to the date when either of them are heard.

For those reasons I intend to order split trials to take place as close as possible to 30th November with a short break between them.

I should also add that there was an issue as to when the CMC should take place. The Claimant sought directions that it should be heard no later than the week commencing 2nd February 2016, in case I declined to fix a date for the trials at this hearing. I think it more convenient to have the CMC somewhat later, so that pleadings are closed, and I will hear counsel on the date. If for any reason the Court is persuaded that the trial dates that I have set are impractical, it can vacate themat the CMC. However, I am not encouraging Defendants to make such an application.