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England and Wales High Court (Chancery Division) Decisions |
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You are here: BAILII >> Databases >> England and Wales High Court (Chancery Division) Decisions >> Glaxo Wellcome UK Ltd (t/a Allen & Hanburys) & Anor v Sandoz Ltd & Ors [2017] EWHC 1524 (Ch) (28 June 2017) URL: http://www.bailii.org/ew/cases/EWHC/Ch/2017/1524.html Cite as: [2017] EWHC 1524 (Ch) |
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CHANCERY DIVISION
INTELLECTUAL PROPERTY
Strand, London, WC2A 2LL |
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B e f o r e :
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(1) GLAXO WELLCOME UK LIMITED (T/A ALLEN & HANBURYS) (2) GLAXO GROUP LIMITED |
Claimants |
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- and - |
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(1) SANDOZ LIMITED (2) SANDOZ INTERNATIONAL GMBH (3) AEROPHARM GMBH (4) HEXAL AG |
Defendants |
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Mr Martin Howe QC and Ms Iona Berkeley
(instructed by White & Case LLP) for the Defendants
Hearing date: 14th June 2017
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Crown Copyright ©
Chief Master Marsh :
The claim
i) Seretide is not a "consumer brand" but dispensed only on prescription by doctors and pharmacists who are not influenced by the get-up of the product or its packaging;
ii) It is the words "Seretide" and/or "Accuhaler"/"Evohaler" that serve to identify the Claimants' products;
iii) There are colour conventions in respect of inhalers so that professionals and patients are not surprised by the adoption of a similar colour by a generic product of the same kind as an existing product; and
iv) The Claimants having regard to existing colour conventions, adopted in two tones, a colour for Seretide inhalers different from those used in the then existing colour conventions but in order to indicate the function of the combination of active ingredients.
The application
"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."
"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 law
"(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."
"(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."
"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]
"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."
"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."
The parties' submissions
Discussion