England and Wales Patents County Court

IN THE PATENTS COUNTY COURT

		Rolls Building 7 Rolls Buildings London EC4A 1NL
		29/11/2011

His Honour Judge Birss QC :

1. In this action the claimant (Mr Liversidge) brings proceedings for patent infringement against the defendants (Owen Mumford and Abbott). The patent is EP (UK) 2 067 496 entitled Medical Injector. It was granted on 27^th April 2011. The original parent application was filed on 23^rd June 2003 claiming priority from a filing on 3^rd February 2003. The product alleged to infringe is an auto-injector device containing a pre-filled syringe of Humira ("the Humira Pen"). Humira comprises a recombinant human monoclonal antibody used in the treatment of various autoimmune diseases including rheumatoid arthritis. In a witness statement dated 13^th May 2011, Abbott's solicitor explained that Humira is the Abbott group's largest selling product with global sales in excess of $6Bn in all delivery formats. The precise level of sales in the UK is confidential but they are plainly very substantial.
2. On the day the patent was granted, Mr Liversidge commenced proceedings for patent infringement in the Patents County Court against both defendants. On the same day Abbott started proceedings in the High Court (Patents Court) for revocation. The parties agreed the case should be heard in one court but could not agree which court was the appropriate forum for it.
3. On the issue of forum Mr Liversidge explained that he is an individual inventor with some but limited financial resources and a comparatively simple (but effective) invention. He explained that from his point of view the PCC procedures provided an individual like himself with access to justice because in the worst case, if he lost, he would have to pay his own costs plus at most £50,000 to the defendants. He said that that would be difficult but was a risk he was able to take. He could not take the risk of losing in the High Court where his own costs would be higher and the defendants' costs would be uncapped. He estimated the defendants' costs in the High Court might well exceed £500,000 and if he was ordered to pay sums of that magnitude it would "wipe him out".
4. The defendants explained the importance of the dispute from their perspective. Rheumatoid arthritis is a particularly unpleasant and painful disease and affects between 0.5% and 1% of the population of England and Wales (some 400,000 people). Humira has been approved in the UK for rheumatoid arthritis and other diseases. It is available in a conventional pre-filled syringe (launched in 2003) and via the Humira Pen (launched in 2006). Most patients who use the Humira Pen self-administer once every two weeks. It is a popular delivery format that facilitates compliance as it is convenient for use by patients in their own homes. The defendants stated that the permanent injunction sought by the claimant would prevent Abbott from supplying existing and new patients with Humira in the existing Humira Pen format. Changing the delivery system for such an important product in one of Abbott's largest markets would be time consuming, very expensive and potentially very disruptive to patients. A new delivery system would require approval by the regulator which would take several years to achieve.
5. Shortly before the matter came before the court to be decided, the parties agreed terms on which the matter would be decided in the Patents County Court. Mr Liversidge would seek damages for infringement on the basis of a notional royalty to be assessed in respect of the device (and components), not the drug contained in the device; and Mr Liversidge would not seek a final injunction but instead would seek damages in lieu of an injunction on the same basis as above. The undertakings include a proviso that the claimant may ask the court to include in its final order a provision giving him permission to apply for an injunction against a defendant in the event that that defendant refuses to pay the damages ordered to be paid in lieu of an injunction.
6. An order on that basis was made by consent, with the proceedings to continue in the Patents County Court. In summary, the action is proceeding in the Patents County Court because the dispute concerns the auto-injector device and not its contents.
7. The parties then pleaded out their cases in accordance with CPR Part 63 r 63.20 and the matter came on for a case management conference (CMC) today (16^th November 2011). The CMC dealt with a number of more or less minor matters and a few issues of substance. I gave my decisions on the various matters arising but informed the parties that, for those decisions which required reasons, the reasons would be given in a reserved judgment. This is that judgment.
8. At the CMC, James Abrahams appeared for Mr Liversidge instructed by Field Fisher Waterhouse and Charlotte May appeared for both defendants instructed by Manches for Owen Mumford and Herbert Smith for Abbott.
9. The major matter arising related to experiments and I will address that issue below. Before doing so however it is worth recording how certain other issues were addressed.
10. The parties prepared a list of the issues arising. This has proved to be a useful expedient for CMCs conducted under the PCC procedures. It raised a number of points which were worth addressing. On Mr Liversidge's behalf it was submitted that I should rule that obviousness was not in issue because the matter had not been properly pleaded in accordance with CPR Pt 63 r63.20. On analysis it turned out that what had happened was as follows. The defendants' case is that the relevant claims (1 and 3) lack novelty as a result of two items of prior art: US 3,742,948 ("Post") and US 3,797,489 ("Sarnoff"). They then stated that if these references did not anticipate the claims then their case was that, whatever the differences were, they did not give rise to an inventive step. However since the defendants did not accept there were any differences, they did not elaborate. The pleading could not elaborate until the defendants knew what the differences were which the claimant contended existed. In some cases this position might not be a genuine one but in many cases it is a legitimate position to adopt. So here. In response Mr Liversidge's Reply and Defence to Counterclaim set out his case as to what integers of the claims were missing from the prior art and articulated his case that there was a long felt want in this art for a solution to a problem described as the "Sequencing Problem". (This is the problem of ensuring that first the needle is inserted to the correct depth in the patient's body, second the medicament is expelled and in doing this ensuring that no medicament is expelled in the first step.) The defendants articulated their answers to this and set out further details of their obviousness case in their Replies to the Defence to Counterclaim.
11. It is fair to say that with the matter pleaded out as it was, the defendants' case was not as clear as it might have been. However it seems to me that no criticism could be levelled at the defendants for taking the approach they had in this case. In my judgment they were not in breach of r63.20 and the argument about compliance with the rules risked obscuring the issue. The defendants offered to submit a single consolidated document dealing with their case on obviousness ("voluntary particulars") and I directed that that should be done. The claimant was concerned that this should not be a blank cheque to the defendants to create a whole new case on obviousness and submitted that there should be an element of judicial oversight. I agree. Thus I directed that the document should be filed and the claimant will have the opportunity to raise any problems with it in writing. I will determine any dispute which arises in writing.
12. The direction for expert evidence correctly provided that the evidence would address a subset of the issues on the list. So for example added matter is an issue on the list but is one which (rightly in my view) the parties saw no need to call expert evidence. Added matter was not in the subset to be addressed by the experts. However the subset did included the four anticipation issues (two claims and two citations) as well as a reference to evidence on "technical terms referred to in the patent in suit and the prior art". Evidence as to technical terms is admissible if there are such terms in the documents and there are cases in which evidence in relation to novelty is highly material, but often there is no need for such evidence. I informed the parties that so far in the PCC the practice has been not to permit experts to address any of those questions unless the parties explain a specific point which needs to be dealt with. A specific point can then be considered. Neither side had a specific point in mind and they agreed not to include those issues in the list of points to be covered by the experts. Obviousness will be included in the list. In addressing obviousness one obviously cannot avoid referring to the teaching of the prior art and the differences between it and the claim but that is not the same as permitting open ended evidence directed to a case of lack of novelty.

The Experiments

13. The major issue in contention at the CMC was experiments. The issue was about how the Humira Pen works. The point arose as follows. Claim 1 is an apparatus claim to a mechanism for performing an injection. It includes a syringe, a plunger and a sleeve. The claim refers to protuberances on the plunger. Mr Liversidge contends that there is infringement because the Humira Pen has the required protuberances. The defendants contend that the claimed protuberances have a functional requirement defining a temporary stop position for the plunger on being moved into the syringe bore. Mr Liversidge contends that in the Humira Pen, the protuberances engage the rear end of the syringe and thereby push the syringe forward causing the needle to project from the forward end of the sleeve. So his case is that the claim is satisfied. The defendants do not agree. They contend that the protuberances do not push the syringe, rather the syringe housing only moves forward when the plunger impacts a piston inside the syringe. So they contend the Humira Pen does not satisfy the functional requirements in the claim. Mr Liversidge does not agree that the Humira Pen behaves in the manner the defendants contend for and relies on two Abbott patent applications which he says describe how the device operates. He also contends in the alternative that even if the Humira Pen works in the manner the defendants say, it infringes anyway on the true construction of the claim, as a claim to a product and not a process.
14. The foregoing is a brief summary of the parties' positions and is not intended to be a full treatment of either party's cases. It is sufficient for the purposes of addressing the experiments.
15. In their Defence and Counterclaim the defendants referred to three short videos which they say show how the Humira Pen actually works and which they contend support their case. They say the tests show that the Humira Pen works in such a way that it does not infringe. In response Mr Liversidge's Reply and Defence to Counterclaim denied that the defendants were entitled to rely on the videos since they were experiments and needed permission to be adduced in evidence, and also criticised the experiments themselves in various respects. Mr Liversidge also put forward a short video of his own which he stated he wished to rely on if the defendants were entitled to rely on theirs. The defendants then served a draft Notice of Experiments with further short videos showing (they say) how the Humira Pen works and (they say) answering the criticisms levelled by the claimant. The Notice of Experiments was objected to and the matter fell to be considered at the CMC.
16. Mr Abrahams submitted that Mr Liversidge, having given up the right to an injunction as a price for the action remaining in the Patents County Court, should not then be forced to litigate as if the case was being conducted in the High Court. He said that the experiments were very costly and complex and should not be admitted. Although Mr Liversidge was protected by the PCC costs cap in relation to sums spent by the defendants on the experiments, if the experiments were admitted, he would still have to spend time and money on his own side to deal with them. A number of further criticisms of the experiments were raised by Mr Abrahams, these included issues about the way the test rig grips the pen, the orientation of the pen having regard to how it will be used in practice, and the cutting away which has been done to allow sight of the operation of the Pen in practice. In general terms Mr Abrahams submitted that the sorts of experiments admissible in the PCC are of a simple sort such as a pH test and not elaborate complex experiments of the kind here.
17. Ms May submitted that preventing the defendants from deploying the experiments in evidence would deprive her clients of the right to tell the truth about how the Humira Pen works. She submitted that the importance of access to justice was not just a matter of cost but that a party should be entitled to prove its case in the best way it can so long as it is reasonable and proportionate in the context of the case as a whole. I was shown one of the video clips to seek to demonstrate how straightforward and simple the matter was. Ms May also submitted that the criticisms of the experiments levelled by claimant were, in reality, small points which were being exaggerated for the claimant's forensic purposes. As regards giving up the injunction, Ms May submitted that Mr Liversidge had not done so since he had already sought a running royalty from the defendants.
18. CPR Part 63 r 63.23 governs case management in the Patents County Court and paragraph 29 of Practice Direction 63 deals with orders at the CMC. Paragraph 29.1(3) provides that the PCC may order experiments. Like all other such orders at the CMC (and see also Temple Island v New English Teas [2011] EWPCC 19) they are subject to the cost benefit test (PD 63 para 29.2(2)). Also in paragraph 1.3 of the Guide to the Patents County Court in considering whether a case is suitable for the Patents County Court, there is the following statement:

Experiments in a patent case may be admitted in the Patents County Court but a case which will involve substantial complex experimental evidence will be unsuitable for the Patents County Court.

19. In my judgment the experiments are not highly complex, viewed in the context of these proceedings as a whole. The case is about an auto-injector, the dispute is about how the defendants' auto-injector works and the experiments are tests designed to show how the auto-injector works. One cannot view directly how the pens work, first because the workings are inside the opaque barrel and second, because in use the process happens very quickly. So the defendants have cut away the barrel to try and show what is going on inside and used a high speed camera to take the pictures so that one can slow things down and see what happens.
20. There is a written description in Abbott's patent applications which the claimant says is a description of how the pen works (and the claimant says it assists the claimant's case) but Abbott contends that the applications were filed before any tests were made to determine the way in which the "elbows" were in fact operating. ("Elbows" is the name Abbott use for the feature Mr Liversidge contends are "protuberances" within the claims.) The defendants' case is that the elbows in the Humira Pen do not operate in the way that is described in the paragraphs of the patent applications Mr Liversidge relies on. Whether the defendants will succeed in this aspect of their case cannot be determined at this stage but without tests of some kind it is hard to see how else the matter could be resolved.
21. I cannot say whether the criticisms of the experiments are valid or not. It is not part of the process at this stage to decide whether they are right or wrong, but it is possible to say at this stage that the criticisms do not raise complex or difficult questions. In my judgment there is no risk of these proceedings being derailed by having to deal with the experiments. Mr Abrahams in his skeleton argument suggested that the experiments might add a day to the length of these proceedings. I do not agree but in any event the time allotted to this case will be sufficient to deal with all the issues (including this one).
22. In the course of dealing with the CMC I ruled that the proceedings would take no more than 2 days to try (the defendants had contended that 2 ½ days were needed) and fixed the trial on that basis. This case is about a simple mechanical patent and two items of prior art which are also simple mechanical patents. Mechanical patents can be conceptually tricky to understand at first but once they have been understood as a result of the pre-trial reading process, the issues to be decided are not complex or lengthy in nature. Ordinarily I would expect a case like this could be readily accommodated in one day in the PCC. I permitted the case to occupy two days mainly in order to ensure that the issue of how the Pen works can be addressed properly. Another factor which may lengthen the hearing a little is that the two defendants are separately represented. This will not lead to a doubling of the time to be taken by the defendants but it may lead to a modest increase in the time required.
23. A further factor in the balance is that Mr Liversidge has a video to deploy in support of his case. Mr Abrahams described it as a "dagger". His metaphor may or may not be appropriate but the existence of the video means that Mr Liversidge already has the means to show the protuberances operating (he says) as described in the patent in suit.
24. The defendants used the independent consultants Cambridge Consultants to conduct the experiments and their evidence is that the costs incurred in doing so amounted to £20,000. Mr Abrahams submitted that this was out of scale with the costs cap for experiments (£2,500). I do not agree that comparing the actual costs incurred with the costs cap is a useful exercise in these circumstances. The important factor is that it is inherent in the PCC procedure that Mr Liversidge is protected by the costs cap from exposure to undue costs expended by the defendants on the issue. On the other hand the cost and time spent by Mr Liversidge on the issue is something he and his advisers can control. It is obviously the case that admitting the experiments will cause the claimant to incur some costs in dealing with them but those costs do not seem to me to be likely to be disproportionate to the issues in the case. Admitting these experiments does not mean that Mr Liversidge is being forced to litigate as if this case was being conducted in the High Court.
25. The decisive factor to my mind is that the experiments go directly to the question of how the product alleged to infringe actually works. It may be that the correct construction of the claim means that the product infringes either way, regardless of the dispute about how it works. However when I raised the question of whether I should direct a preliminary issue on the question of construction there was no enthusiasm for that course from either side. In my judgment the functioning of the Humira Pen is likely to be a crucial issue in this case.
26. Ms May submitted that a party is entitled to prove its case in the best way it can so long as it is reasonable and proportionate in the context of the case as a whole. In my judgment that formulation is capable of leading to trouble in relation to the Patents County Court procedure. To say that a party is entitled to prove its case the best way it can subject to caveats puts the matter the wrong way round. The purpose of the Patents County Court procedure is to facilitate access to justice, in part by streamlining and controlling what is admitted into the proceedings. Experiments are capable of becoming an expensive distraction in patent litigation unless they are kept under control. What is reasonable and proportionate is always important. Seeking to justify potentially complex evidence on the basis that it is the best evidence is a path which leads to increases in cost and time. In my judgment in this case the experiments are not complex at all. The claimant may succeed in showing they are entirely worthless but that is different from saying that they are complex or costly. They will be admitted because they satisfy the cost-benefit test.
27. I will not make an order at this stage permitting the defendant to attend repeats. They may be entirely unnecessary. In the course of the hearing I indicated that it seemed to me to be sensible for the defendants to allow the claimant's advisers (if they wished) to have a look at the actual cut away Humira Pens which were used in the tests. If a dispute arises about a need for repeats I will resolve it on paper.
28. Mr Abrahams submitted that if I allowed the experiments in I should strike out the earlier videos deployed by the defendants from their Defence and Counterclaim. Ms May objected to that. I decided not to strike out the references to the earlier videos since apart from anything else it will just create further cost and complication. However I ruled that no further evidence may be given in relation to those earlier videos.

Conclusion

29. For the reasons given I will allow the defendants to rely on the Notice of Experiments. There will be no repeats without further permission of the court.