Glaxo Wellcome UK Ltd (t/a Allen & Hanburys) & Anor v Sandoz Ltd & Ors

At the hearing of the case management conference on 14^th June 2017 the Defendants applied for permission pursuant to CPR Part 35 to rely upon expert evidence from three experts covering three interrelated subject areas. Having heard full argument on that application, which was opposed by the Claimants, I refused to grant permission for expert evidence and indicated I would give my reasons for that decision in writing. I directed that the Defendants’ time for applying for permission to appeal was extended to 21 days after the handing down of my judgment.

The Claimants are responsible for the sale of the Seretide Accuhaler and Seretide Evohaler inhalers for asthma and chronic obstructive pulmonary disease (“COPD”) in the United Kingdom. Seretide is the fourth biggest selling pharmaceutical product of all time and on the Claimants’ case it has been sold in the United Kingdom in the same get-up since 1999. The First Defendant is responsible for the sale in the United Kingdom since November 2015 of the generic AirFluSal Forspiro inhaler. The Claimants’ Seretide and the First Defendant’s AirFluSal products contain the same active ingredient, salmeterol/fluticasone propionate, the patent for which expired some years ago.

The original claim was brought against only the First Defendant and included a claim for trade mark infringement. The First Defendant counterclaimed for invalidity of the relevant mark and its application for summary judgment in respect of that issue was successful both at first instance and in the Court of Appeal. On 10^th May 2017 the Court of Appeal refused permission to appeal to the Supreme Court and subsequently the Claimants have filed an application for permission to appeal to the Supreme Court itself. The current position is that the claim for infringement and counterclaim for invalidity are stayed pending the determination of the Claimants’ application for permission to appeal.

The balance of the claim is for passing off. The Claimants’ case is that the First Defendant’s AirFluSal Forspiro inhaler and packaging mimics the distinctive get-up, indicia and livery of the Claimants’ Seretide inhalers. These indicia include the use of purple colours and the rounded shape of the Seretide Accuhaler. The Claimants’ case is based upon a misrepresentation both as to trade origin and that the AirFluSal Forspiro inhaler is allegedly equivalent to the Seretide inhalers. It is alleged that the mimicry was deliberate and that the product and get-up were deliberately designed so as to cause deception and confusion and thereby to benefit from the goodwill, distinctiveness and reputation of Seretide.

The Claimants’ case is denied by the Defendants and, in particular, it is denied that the alleged indicia relied upon by the Claimants are either calculated to be or are in fact distinctive of the Claimants. Furthermore, the Defendants deny that the Seretide get-up and indicia have any significant role in influencing prescribing and dispensing decisions. Their principal case is that:

The progress of the claim to date has been slow but not solely on account of the Defendants’ application for summary judgment in respect of the validity of the relevant mark. In May 2016 the Claimants issued an application to join what are now the Second, Third and Fourth Defendants. Joinder of the Third and Fourth Defendants was contested. The application was refused at first instance, but successful on appeal to the Court of Appeal.

The scope of the permission sought from the Court has developed from the way it was put forward initially in correspondence by the Defendants providing a revision to the draft order for directions. The application is supported and explained by two witness statements; one from Dr Christopher Goode who is the Medical Director of the First Defendant and the second from Dr Anke Nordemann-Schiffel who is a partner in the law firm Boehmert & Boehmert of Berlin, Germany. The Claimants have provided a short witness statement in reply from Mr Eifion Wyn Morris who is a partner with Stephenson Harwood LLP.

The application as it is expressed in the draft order is:

“16.

That each party has permission to adduce expert evidence in the fields of:

16.1

The medical conditions treatable by the use of inhalers, including the types of inhalers and the active ingredients which they contain which are employed for the treatment of such conditions.

16.2

The practice of healthcare professionals, including general practitioners, in relation to prescribing inhalers.

16.3

The practice of healthcare professionals, including general practitioners, in relation to dispensing prescriptions relating to inhalers.

17.

The Claimants together have permission to adduce the same expert evidence from up to three experts and the Defendants together have permission to adduce the same expert evidence from up to three experts.”

It is proposed that experts’ reports should be exchanged by 28^th February 2018 which is the same date for exchange of witness statements and that each party should be permitted to serve supplemental reports by 30^th April 2018. No further directions are proposed concerning either prior engagement of the experts before reports are served or engagement after exchange for the purposes of narrowing issues and agreeing a joint statement.

Dr Goode explains in his witness statement that although he worked as a speciality registrar in respiratory and general medicine before moving into the pharmaceutical industry, it has been about 4½ years since he practised medicine on patients. Furthermore, neither he nor any other Defendant has in-house expertise of a GP who has practised in the United Kingdom, a currently practising pharmacist in the United Kingdom, or the expertise of a consultant who has practised in the respiratory field in the United Kingdom. It will therefore be necessary, he says, for the Defendants to seek assistance “… from independent and appropriately qualified experts in order to give evidence to the Court about the relevant practices followed in prescribing and dispensing inhaler products of the kinds in issue in the proceedings, and about the conditions which are treated and how they are treated using these products.”. He says that COPD and asthma are not treated in every case through just one type of medication and such medications are prescription-only medicines. As such, they cannot be supplied without prescription, nor can they be advertised to the general public.

The application as it is put forward by Dr Goode is for “… permission to submit evidence from one or more experts covering …” the three areas of evidence described in the draft order. The words underlined are my emphasis. The draft order puts the request slightly differently by asking for permission to adduce expert evidence in the three areas that are identified from up to three experts.

The witness statement goes on to provide a more detailed explanation of the basis upon which expert evidence is required:

“13.

…The clinical decision as to which individual or combination treatment is to be prescribed is complex and relies to a significant extent on practice experience. Doctors involved in this process may be specialist respiratory doctors such as consultants, general practitioners or specialist nurse practitioners.

14.

Once the appropriate medication has been ascertained, the correct inhaler device must be assessed and applied to the patient’s needs. Not all designs of inhaler operate in the same manner. Different kinds also have different functionality and handling requirements. One fundamental difference between designs is whether an inhaler is a metered dose inhaler or a dry powder inhaler. There are advantages and disadvantages to both. If a patient is, say, partially sighted or has arthritis, one design may be easier to use than another. Such things have to be assessed by the prescriber. The selection of a prescribed inhaler will, should therapeutic needs present a choice, often be influenced by cost. The decision making process may also be made using computerised prescription tools which may further guide the decision making process.

15.

Prescription of inhalers occurs not only by GPs but also hospital respiratory specialists and specialist nurse practitioners. Appropriately qualified experts could give insight into all these different practices.

16.

Once prescribed, an inhaler will then need to be dispensed. The nature of pharmacies can range from hospital dispensaries, to high street pharmacists (whether national chains or independent local businesses) to pharmacies at a GP practice. Some will be run in a traditional manner, others may be highly automated with robotised stock and delivery systems. The practice of each may vary considerably.

18.

…Independent knowledge about how pharmacists go about dispensing is essential in a case where it is suggested that trade dress or claimed indicia are alleged to play a role in causing confusion and/or misrepresentation.

19.

Pharmacists play a particularly important part in repeat prescriptions or resupplying lost inhalers when a patient is perhaps away from home. Pharmacies will also tend to stock what is frequently prescribed by local GPs and hospitals. It would be useful for the Court to understand what happens in such differing situations from an independent and appropriately qualified expert fully familiar with the different current dispensing practices.

20.

In conclusion, there are many factors involved in assessing the medical needs of patients, deciding upon their treatment and providing the treatment to them. There is no standard model for how the process works in every case from diagnosis to dispensing and many variables need consideration. Inhalers are complex, prescription-only medical devices for treatment of various conditions in differing types of patient with varying therapeutic needs which themselves change over time. In order to understand the details and specific practices behind the facts claimed and allegations made in this case, I consider input from appropriately qualified and experienced experts in the three fields identified … above to be of very great assistance to the Court.” [my emphasis]

The witness statement made by Dr Anke Nordemann-Schiffel comments upon the suggestion made by the Claimants’ solicitors that the Claimants and First Defendant have already agreed in other jurisdictions, for the purposes of associated litigation, what the different types of inhalers are and their functions. This is said to be incorrect and there has been no such agreement except at a very rudimentary level.

In response to that statement, Mr Eifion Wyn Morris sets out a number of undisputed submissions about the different types of inhalers in claims taking place in Belgium, The Netherlands, Estonia, Portugal, Norway and Latvia and also refers to other material. His witness statement provides cogent support for the proposition that there is very little if anything between the parties concerning the first area in respect of which expert evidence is sought.

Under Section 3(1) of the Civil Evidence Act 1972 subject to any rules of Court, “… where a person is called as a witness in any civil proceedings, his opinion on any relevant matter of which he is qualified to give expert evidence shall be admissible in evidence.”

Under CPR 35.1, the Court is under a duty to restrict expert evidence to that which is reasonably required to resolve the proceedings. In British Airways Plc v Spencer [2015] EWHC 2477 (Ch) Warren J (at [68]) proposed a three stage test based upon the sliding scale that is implicit in CPR 35.1.

“(a)

The first question is whether, looking at each issue, it is

necessary for there to be expert evidence before that issue can

be resolved. If it is necessary, rather than merely helpful, it

seems to me that it must be admitted.

(b)

If the evidence is not necessary, the second question is

whether it would be of assistance to the court in resolving that

issue. If it would be of assistance, but not necessary, then the

court would be able to determine the issue without it (just as in

Mitchell the court would have been able to resolve even the

central issue without the expert evidence).

(c)

Since, under the scenario in (b) above, the court will be

able to resolve the issue without the evidence, the third

question is whether, in the context of the proceedings as a

whole, expert evidence on that issue is reasonably required to

resolve the proceedings. In that case, the sort of questions I

have identified in paragraph 63 above will fall to be taken into

account. In addition, in the present case, there is the

complication that a particular piece of expert evidence may go

to more than one pleaded issue, or evidence necessary for one

issue may need only slight expansion to cover another issue

where it would be of assistance but not necessary.

Further, although CPR 35.1 does not refer to issues, but only to

proceedings, if evidence is not reasonably required for

resolving any particular issue, it is difficult to see how it could

ever be reasonably required for resolving the proceedings. I

therefore see a test directed at issues as a filter. That, at least, is an approach which can usefully be adopted.”

CPR 35.4 provides the Court’s powers with which it is to fulfil the duty to restrict expert evidence. In addition to the requirement for permission in rule 35.4(1) the rule provides:

“(2)

When the parties apply for permission they must provide an estimate of the costs of the proposed expert evidence and identify –

(a)

the field in which expert evidence is required and the issues which the expert evidence will address; and

(b)

where practicable, the name of the proposed expert.

(3)

If permission is granted it shall be in relation only to the expert named or the field identified under paragraph (2). The order granting permission may specify the issues which the expert evidence should address.”

I was referred to a passage in the notes to the current edition of the White Book at 35.2.2 where it is said:

“The functions of an expert witness may include giving assistance to the Court on, for example, a technical or scientific matter, or specialist practice or procedure, and giving their opinion on specific matters in the dispute within their expertise. However, it is not the function of an expert witness to give their opinion on the issues of law or fact which the judge or jury has to decide.” [my emphasis]

I was also referred to the judgment of Birss J in Fenty v The Arcadia Group Brands Ltd (1) [2013] EWHC 1945 (Ch) where he deals in detail with what can be described by way of shorthand as “trade evidence” in trade mark and passing off claims. In that case, neither party had obtained permission to rely on expert evidence and witness statements had been exchanged only a matter of weeks before the trial was due to commence. Objections were raised by the defendants concerning the admissibility of some of the witness statements served by the claimants, these being witness statements from members of the relevant trade. Having undertaken a review of the law concerning expert evidence as it relates to trade mark and passing off cases, Birss J agreed with the observation of Lewison J (as he then was) in O2 Holdings Ltd v Hutchinson 3G Ltd [2006] EWHC 601 at [9] that the formulation of an overall test concerning expert evidence is an impossibility. Birss J sets out a series of conclusions in the following passage:

“31.

First, the category identified by Maurice Kay LJ [in esure Insurance Ltd v Direct Line Insurance Plc [2008] EWCA (Civ) 842 is not the only kind of expert witness evidence covered by CPR Part 35. For example, in patent cases expert evidence is routinely called from persons who are not professional experts and do not necessarily belong to bodies with recognised standards and rules of conduct.

32.

Secondly, independence is not what takes such evidence into the relevant category. There are numerous examples of evidence from experts who are not in fact independent at all. That may be fine, as long as the nature of any link with either side is identified and taken into account.

33.

Thirdly, it seems to me that the nature of the proceedings and the role the evidence is to play in those proceedings is an important element in characterising the evidence in question.

34.

Fourthly, sometimes parties do call an expert report identified as such in trademark and passing off cases. It is important to note that there is no issue in esure… or Samuel Smith [2012] FSR 7 that Mr Blackett’s evidence was expert evidence. As I say, it was identified as such. So the difficulty before me did not arise in those cases. I should say that in this judgment I am not expressing a word of disagreement with the decisions I have referred to above, which emphasises the lack of utility of anyone – trade witness or a self-identified expert in ‘branding’ – giving an opinion on the likelihood of confusion in a case about a market that the Court is likely to be familiar with.

35.

Fifthly, for years trademark and passing off case have routinely included evidence from persons in the relevant trade describing the circumstances of the trade, the nature of customers and so on. Such evidence would always have explained the experience of the witness in order to justify their evidence and add credibility to it. That evidence will always consist of factual statements about the trade. Although it is primarily factual, it will sometimes include statements which are, properly analysed, expressions of opinion. They are not necessarily opinions simply on likelihood of confusion but are expressions of opinion about how customers behave. However, it is clear, and I refer, for example, to Hasbro [2011] FSR 21, that such evidence has not always been treated as expert evidence as such and has not hitherto been regarded necessarily as subject to the regime in CPR Part 35. Hasbro is also an example showing that as long as it is kept in its proper place, not characterising it as expert evidence within CPR Part 35 does not matter.

36.

Moreover, to impose the further burden of the duties and responsibilities of expert witnesses on such witnesses is capable of having a chilling effect in trademark and passing off cases.”

The judge went on later in the judgment [39] to say:

“But, in my judgment, in a trademark and passing off case, evidence of the factual circumstances of a trade by a person in that trade, even when they deploy their experience in that trade to bolster what they are saying, is not necessarily “expert evidence” within CPR Part 35. Apart from anything else, there is no reason to treat it as such. However, the fact that evidence is not labelled as an expert’s report does not mean it is not in truth expert evidence.”

In support of the application, Mr Howe QC took Dr Goode’s evidence as his starting point and pointed to the fact that the Defendants do not have access to witnesses who can deal with the three topics in-house. The Defendants therefore have to rely upon evidence from external professional witnesses.

In the course of his submissions, he confirmed that the Defendants wish to call evidence from a respiratory specialist, a GP and a pharmacist and that the evidence from each of them, particularly the respiratory specialist and the GP, is likely to traverse more than one of the three areas in relation to which permission is sought. Thus the application moved from “one or more expert witnesses” and up to three experts to a definite request for three experts. He clarified in the course of submissions that there is some overlap between the issues and the experts he wishes to call so that, for example, the respiratory specialist would give expert evidence in categories (1) and (2) (paragraphs 16.1 and 16.2 in the draft order) and the GP would give evidence covering the same issues and possibly issue (3) (16.3 in the draft order). The pharmacist would deal with issue (3) because that issue relates to dispensing prescriptions for inhalers.

Furthermore, he says this case is quite unlike the circumstances in esure in which all three members of the Court of Appeal expressed the view that Mr Blackett’s evidence as an expert in branding about the risk of confusion was not properly characterised as expert evidence. He submits that this case is not about, for example, consumer goods selected on supermarket shelves where the Court can be expected to apply its own knowledge of the behaviour of consumers. This case is different because the field in which confusion may occur is outside the public domain. It is the perceptions of medical professionals about what (if anything) is conveyed by the purple colour and other claimed indicia, and the likelihood of confusion, that matters and the judge at the trial cannot be expected to deal with those issues from his own knowledge and experience.

Mr Howe QC also says this is not a usual passing off case. It is a very high value case involving products which are prescription only and therefore subject to purchasing processes which normally involve a doctor and a pharmacist as well as the patient. He submits that the Court will be assisted by independent experts in the three areas of specialisation and it is not appropriate, as the Claimants suggest, for evidence about the three subject areas to be given as evidence of fact.

Mr Malynicz QC, who appears for the Claimants, accepts that the Court will need evidence from witnesses dealing with the three subject areas proposed by the Defendants. In contrast with the Defendants, however, he submits that such evidence is neither necessary nor is it reasonably required to resolve the proceedings. He submits that it is perfectly satisfactory for evidence to be given by witnesses of fact on the relevant points without the evidence artificially being treated as expert evidence. He says expert evidence is very rare in passing off cases and he draws support from the judgment of Birss J in Fenty v Arcadia.

He drew attention to paragraph 20 of Dr Goode’s statement in which he positively asserts that there was no standard model for how the process of assessing the medical needs of patients, deciding upon their treatment and providing treatment to them works in every case. This, he submits, makes it either impossible, or at least inappropriate, for evidence of practices to be treated as expert evidence because there is no accepted standard which can form the basis for an expert opinion.

He submits that the Court should refuse to grant permission particularly in the light of the lack of certainty at this stage about precisely who the expert witnesses will be and what, if any, opinion evidence they intend to provide.

During the course of submissions, I was referred to a number of statements from doctors and pharmacists that had been produced by the Claimants in the IPO proceedings. I have not found it helpful to consider those statements in detail given that they were provided in very different circumstances.

In Fenty v Arcadia, the judge had the benefit of being able to read the relevant statements and to form a view about whether they were properly to be characterised as expert evidence in relation to which they would not be admissible without permission and in relation to which the provisions of CPR Part 35 would apply. In this case, the Court is asked to give permission to the parties (if permission is given to the Defendants the Claimants also wish to have permission) in advance without knowing the identity of the proposed expert witnesses, their qualifications (other than in the most general terms), their relevant professional experience and what evidence they are able to give. Importantly, the Court does not know at this stage what elements of their evidence, if any, may properly be characterised as expert evidence as opposed to the evidence of fact (that is non-expert fact) they may be able to give without the need for permission under CPR Part 35.

Furthermore, unhelpfully the parties were unable to come near to agreeing a list of issues prior to the CMC. The Claimants provided a draft list of issues to the Defendants but instead of commenting and amending that draft, the Defendants drafted their own list of issues in an entirely different style. At the hearing the Court was asked to provide guidance on the right approach in the hope that the parties will be able to reach agreement. In a case of any complexity it is essential when considering whether to grant permission to adduce expert evidence for the Court to be able to relate the proposed expert evidence to specific issues. Furthermore, CPR Part 35.4(3) permits the grant of permission to be limited to identified issues and in my view this is generally desirable.

It is incumbent upon the Defendants to satisfy the Court that permission to rely upon expert evidence should be granted and that onus must be seen in the light of the Court’s duty under CPR 35.1 to restrict expert evidence to that which is reasonably required to resolve proceedings. It is not the Defendants’ case the expert evidence is necessary in the sense that the Court could not try the case without it. The application is put forward relying on the second and third limbs of the approach adopted by Warren J in British Airways v Spencer. I find that approach to be a helpful one but it is necessary in this case to consider as an anterior issue whether CPR Part 35 is engaged at all. In other words, is it expert evidence the Defendants wish to adduce?

It is common ground between the parties that the Court will need evidence within the three areas proposed by the Defendants. The circumstances of this case are such that the Court cannot be expected to have knowledge of the relevant trade practices (more strictly described as professional practices of respiratory specialists, GPs and pharmacists). The Court will need to understand what commonly happens when products of the relevant type are prescribed and dispensed.

There is, however, a distinction between the first area of expert evidence and the remaining two areas. The first area seeks to provide the Court with factual information about the medical conditions treatable by the use of inhalers and the types of inhalers and the active ingredients which are employed for the treatment of such conditions. I accept there may be instances in which didactic evidence may properly be described as expert evidence because it is in a field in which the Court cannot be expected to obtain an understanding without evidence from an expert that goes beyond a mere description of facts and includes explanation and illustration. However, in this case there is cogent evidence provided by the Claimants in the statement of Mr Eifon Wyn Morris that the parties have not found the sort of information in category (1) to be contentious. Even if it goes too far to say the evidence has been agreed, evidence of the type the Defendants now say requires the involvement of experts has been provided in a number of related proceedings in the EU.

It is not in doubt that this evidence will be of assistance to the Court. I am not convinced, however, that it is properly characterised as expert evidence because it is not a matter of opinion and is not didactic evidence that neither need be contentious nor require explanation from an expert. If I am wrong about its nature, I am not satisfied that evidence from an expert is reasonably required. The starting point should be that instead of seeking permission to adduce expert evidence, the parties should engage with each other and establish whether there are genuine fault lines between them. As it seems to me, with reasonable efforts it should be possible to agree relevant facts. If that does not prove to be possible, based on the evidence before me, the differences are unlikely to be such as to require expert evidence even taking into account the financial value of the claim to the parties.

I would add that I can see no possible basis for expert evidence dealing with the first area to be required from both a respiratory specialist and a GP.

Turning to the second and third areas, one of the difficulties for the Defendants is that their own evidence accepts there is no relevant standard model for how the process of assessing the medical needs of patients, deciding upon their treatment, providing treatment to them and prescribing and dispensing works. The Defendants say, in the evidence of Mr Goode, that there are many variables that need consideration. I find it difficult to understand, therefore, how it can be suggested that the three medical professionals upon whom the Defendants seek to rely can be expected to provide a reliable opinion based upon a body of knowledge. There is an overwhelming likelihood that such witnesses will, in reality, be providing evidence about what they would do in any given circumstance, and about what Dr Goode describes as their experience of the “many variables”, rather than providing what is properly regarded as expert evidence based upon an assumed set of facts. As it appears to me, the Defendant wishes to adduce evidence of fact in relation to the second and third areas. There is no requirement for permission to be obtained from the Court for that purpose.

In any event, the Court faces particular difficulty in seeking to characterise with any degree of accuracy the type of evidence the Defendants wish to introduce based on the very limited description of it which has been provided so far. Had the application been supported with evidence about the identity of the likely individuals who will be introduced as experts, their own experience and the sort of evidence that they might give it would have been better founded because it would have been possible to identify evidence that might properly be characterised as expert evidence.

It follows that I am not satisfied that the Defendants are seeking permission to introduce evidence which is properly characterised as expert evidence.

I also have in mind the observations made by Birss J in Fenty v Arcadia about descriptive evidence of trade or professional practices commonly being introduced in trade mark and passing off cases without being regarded as expert evidence. It is one thing for a witness to give evidence about his or her experience in a particular area from which the Court itself is able to extrapolate and quite another for a witness to give evidence which is founded in a body of expertise rather than the witness’ own experience. And in case I am misunderstood on this point, of course I accept that the medical professionals of the types referred to by the Defendants have a high degree of training and are regulated. I am not convinced, however, that the evidence they might give is necessarily rooted in that training but rather is simply evidence of what they do as a matter of practice and believe others to do.

It is therefore unnecessary for me to go further in the analysis indicated above. In the most general terms, the evidence in the three categories is necessary and I accept that evidence of trade practices is an area which expert evidence may sometimes properly cover. However, the Defendants have not made out their case with sufficient particularity and in my judgment it would be wrong to grant the sort of open ended permission they seek when it appears the evidence they wish to introduce can be made available to the Court from non-expert witnesses. To my mind there is some force in Mr Malynicz QC’s submission that the Defendants’ application is an attempt to brand evidence from the three medical professionals as “expert” to enhance its value whereas, in reality, it should properly be seen as ordinary evidence of the type normally introduced in claims of this sort. I recognise, of course, that CPR Part 35 brings with it the benefits of control by the Court and that the form of the evidence, with a special statement of truth, may have greater value. There are perhaps some disadvantages in leaving this area of evidence for the trial unregulated. On balance, however, the Defendants have not discharged the onus that is upon them and for the reasons given above, their application is refused.

Although it should not be seen as encouragement to re-apply in the same terms, the parties have permission to apply in respect of expert evidence in the event that in light of a more focussed consideration of the evidence that will be needed at the trial of the claim, limited expert evidence can be shown to be likely to be of real assistance to the Court.