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

This appeal is from an order of His Honour Judge Hacon, sitting as a judge of the High Court, dated 11 November 2016, by which he dismissed the Claimants’ application to join as additional Defendants two companies in the Sandoz group, Aeropharm GmbH and Hexal AG (“Aeropharm” and “Hexal”). He himself gave permission to appeal.

Glaxo has an extremely successful product for the treatment of asthma, marketed in the UK under the name Seretide. It is sold as an inhaler in two different formats, one of which is called the Accuhaler. It has been on the market for some 15 years. Sandoz has launched a competing product which is sold under the name AirFluSal. This product was first sold in the UK market in November 2015; it is sold here by the First Defendant, Sandoz Ltd, which I will call Sandoz UK. Glaxo’s case is that Aeropharm and Hexal were involved in earlier stages of the preparations by the Sandoz group to launch AirFluSal, and in particular in contributing to the get-up and packaging with which it is sold, including its colour which is similar to that of Seretide.

In the proceedings Glaxo claims remedies for trade mark infringement and for passing off. The trade mark claim is in suspense pending the determination of Glaxo’s appeal against an earlier order of Judge Hacon, and it is not relevant to the present appeal.

The basis of the passing off claim is that the sale or promotion of AirFluSal in the UK in the colour, get-up and packaging used amounts to passing that product off either as being equivalent to Seretide, or as being a product of Glaxo or connected in the course of trade with Glaxo.

Originally, as issued on 7 December 2015, the proceedings were brought only against Sandoz UK. In May 2016 Glaxo applied to join Sandoz International GmbH (“International”), Aeropharm and Hexal as additional defendants. Eventually there was no issue about joining International, and that company is now a defendant. However, joinder of the other companies was resisted, and Judge Hacon refused the application in respect of them.

The Glaxo appellants were represented before us by Mr Malynicz Q.C. and Ms Newnes, and the Sandoz respondents by Mr Martin Howe Q.C. and Ms Berkeley. I am grateful to Counsel for their written and oral submissions. Having considered and reflected on them, and for the reasons set out below, I take a different view from that of the judge on the two grounds on which he decided the case against the Claimants and which are challenged on appeal. I would therefore allow the appeal.

Judge Hacon refused to join Aeropharm or Hexal as parties for two reasons.

I will deal with each of those points in turn.

Glaxo’s claim is in passing off, and is based primarily on acts committed by Sandoz UK, which sells and promotes AirFluSal in the UK. In order to extend its claim to International, Aeropharm and Hexal it alleges that each of those companies is a joint tortfeasor with Sandoz UK, not because any of them has done anything which in itself involves an act of passing off in the UK, but on the basis that what Sandoz UK has done and is doing is done pursuant to a common design on the part of all four defendants, or some of them, that acts should be done in the UK which amount to the tort of passing off. It is therefore necessary to consider both the constituents of the tort of passing off and the factors necessary to give rise to joint tortfeasorship of this kind.

Lord Oliver summarised what a claimant must show for a claim in passing off in the Jif Lemon case, Reckitt & Colman Products Ltd v Borden [1990] RPC 341 at 406, as follows:

“First, he must establish a goodwill or reputation attached to the goods or services which he supplies in the mind of the purchasing public by association with the identifying "get-up" (whether it consists simply of a brand name or a trade description, or the individual features of labelling or packaging) under which his particular goods or services are offered to the public, such that the get-up is recognised by the public as distinctive specifically of the plaintiff's goods or services. Secondly, he must demonstrate a misrepresentation by the defendant to the public (whether or not intentional) leading or likely to lead the public to believe that goods or services offered by him are the goods or services of the plaintiff. … Thirdly, he must demonstrate that he suffers or, in a quia timet action, that he is likely to suffer damage by reason of the erroneous belief engendered by the defendant's misrepresentation that the source of the defendant's goods or services is the same as the source of those offered by the plaintiff.”

It is not a necessary ingredient of the cause of action to show that the defendant intended to mislead consumers, but claimants sometimes seek to establish that the defendant has acted deliberately, if only because, as Lindley LJ said in Slazenger & Sons v. Feltham & Co (1889) 6 RPC 130 at 538, the court will not “be astute to say that he cannot succeed in doing that which he is straining every nerve to do”.

Liability on the basis of joint tortfeasance may be established in a variety of cases. Some common examples are irrelevant to the present case: joint acts by two or more persons as primary tortfeasors, liability for inducing, inciting or persuading another to commit a tort, and vicarious joint liability for torts committed by an agent or an employee.

The present case is said to be an example of joint liability on the basis that the primary acts (of Sandoz UK) were committed pursuant to a combination or common design on the part of all or some of the four companies in question. The law in this respect has recently been considered in the Supreme Court in Fish & Fish Ltd v Sea Shepherd UK [2015] UKSC 10, [2015] AC 1229. Although the court was divided as to the result, the difference of view was on the facts, not as to the principles of liability. In summary, the defendant sought to be made liable jointly with a principal tortfeasor must be shown to have acted in a way which furthered the commission of the tort by the principal tortfeasor, and must have done so in pursuance of a common design to do or to secure the doing of the acts which constitute the tort: see Lord Toulson at paragraph 21 (which I set out at paragraph 21 below). An allegation of joint or shared intention is therefore of the essence of liability on this basis. I will come back to the judgments in Fish & Fish v Sea Shepherd later, but first I will summarise Glaxo’s allegations.

Glaxo’s claim or intended claim against the several Sandoz parties was set out in revised draft Amended Particulars of Claim served shortly before the hearing of the application by the judge below. The detailed allegations are set out in paragraphs 53A and 53B of the draft. He quoted these in paragraph 23 of his judgment. The essence is this.

In paragraph 53B it is alleged that, “in the premises”, which I take to mean in reliance on the facts and matters alleged in paragraph 53A, each of the acts of passing off complained of was committed pursuant to a common design between two or more of Sandoz UK, International, Aeropharm and Hexal. On that basis each is alleged to be liable jointly and severally as joint tortfeasors for Sandoz UK’s acts of passing off.

As regards those acts, at paragraph 61 Glaxo alleges that the Defendants have adopted packaging and get-up for AirFluSal with, it is to be inferred, the deliberate aim of deceiving or creating confusion in the mind of the relevant public so as to benefit from the goodwill, distinctiveness and reputation in Seretide. Particulars are given in paragraphs 61.1 to 61.6 of matters to be relied on. Passing off is then alleged in paragraphs 62 and 62A. It is alleged (in 62) that the acts of the Defendants in selling or promoting AirFluSal in the colour, get-up and packaging complained of will amount to a misrepresentation to the relevant public and have led or will lead to members of the relevant public assuming, contrary to the fact, that AirFluSal is equivalent to Seretide or that AirFluSal is a product of Glaxo or is connected in the course of trade with Glaxo.

In paragraph 62A the allegation is that International, Aeropharm and Hexal have knowingly brought into existence goods which are inherently likely to deceive ultimate purchasers or consumers in the UK into believing that AirFluSal is equivalent to Seretide or is a product of Glaxo or connected with Glaxo in the course of trade. The judge explained at paragraph 26 that this allegation was intended to convey that Aeropharm or Hexal or both of them provided the inhalers to Sandoz and thereby supplied instruments of deception. To supply such products outside the UK would not in itself amount to a tort in the UK, but the allegation is intended to show that Aeropharm and Hexal were involved in the process whereby, it is alleged, Sandoz committed the tort of passing off.

The judge approached the application to join the two companies as additional defendants on the basis that the court needed to be satisfied that the proposed pleaded allegations against the parties to be added disclose a sufficiently arguable case. It was not suggested that he was in error in this respect.

After examining the allegations in the proposed amended pleading, he rejected two aspects of the case as inadequate, of which Glaxo does not complain. He found that there was a sufficiently arguable case for saying that the design and of AirFluSal inhaler, and of its packaging, was done by Aeropharm, Hexal and a third party company called Vectura, or one or more of them, between 2004 and 2009. He said (at paragraph 61) that he assumed for the purposes of the application that Aeropharm and Hexal did significantly contribute to the creation of the get-up in issue and that they expected that all AirFluSal inhalers sold (at least in the EU) would bear that get-up. He also accepted it as sufficiently arguable (see paragraph 62) both that Aeropharm collected data for the purposes of obtaining marketing authorisation on an EU-wide basis (so as to include authorisation for the UK), and was thus involved in obtaining marketing authorisation for the placing of AirFluSal on the UK market, and also that Hexal conducted clinical trials of AirFluSal, which would also have been part of the process of getting the necessary authorisation.

However, he held that the part played by Aeropharm and Hexal in the design process did no more than facilitate the sale and promotion of AirFluSal on the UK market, and it did not amount to active co-operation in that sale or promotion (paragraph 61). In turn at paragraph 63 he said that the involvement of Aeropharm and Hexal in obtaining authorisation in the UK did not even arguably constitute part of a common design with Sandoz UK to sell or promote AirFluSal in the UK.

As mentioned above, the law in this respect can now be taken, for present purposes, from Fish & Fish v Sea Shepherd. I have already referred to what Lord Toulson said at his paragraph 21. For convenience I set it out here:

“To establish accessory liability in tort it is not enough to show that D did acts which facilitated P’s commission of the tort. D will be jointly liable with P if they combined to do or secure the doing of acts which constituted a tort. This requires proof of two elements. D must have acted in a way which furthered the commission of the tort by P, and D must have done so in pursuance of a common design to do or secure the doing of the acts which constituted the tort.”

At his paragraph 25 he went on to say, of the question whether a given defendant had combined to secure the doing of acts which proved to be tortious, that “there is no formula for determining that question and it would be unwise to attempt to produce one”. Each case depends on its own circumstances.

Lord Sumption said, at paragraph 37, that “the defendant will be liable as a joint tortfeasor if (i) he has assisted the commission of a tort by another person, (ii) pursuant to a common design with that person, (iii) to do an act which is or turns out to be tortious”. He also pointed out at paragraph 38 that if these requirements are satisfied the accessory’s liability is not for the assistance, but for the tortious act of the primary actor, because the law treats him as a party to that act by virtue of the assistance. But he need not have joined in doing the act which constitutes the tort. Later Lord Sumption noted that the principal concern of the law in this area is to recognise a liability for assisting the commission by the primary actor of a tort, while ensuring that the mere facilitation of the tort will not give rise to such a liability, even when combined with knowledge of the primary actor’s intention: paragraph 39. He referred to CBS Songs Ltd v Amstrad Consumer Electronics plc [1988] AC 1013, where CBS complained of Amstrad selling to ordinary customers a machine which enabled the purchaser to record material from one tape to another. That material might well be the subject of copyright, so that the copying would be an infringement of copyright, but it might be material not covered by any copyright, or not of any third party, in which case the copying would be entirely innocent. The machine was therefore capable of being used both for lawful and for unlawful purposes. As the House of Lords held in that case, and Lord Sumption observed at paragraph 41, the mere supply of equipment which is known to be capable of being used to commit a tort does not suggest intent that it shall be so used, whereas other circumstances may do so.

Lord Neuberger encapsulated the requirements for liability as joint tortfeasor at paragraph 55:

“First the defendants must have assisted the commission of an act by the primary tortfeasor; secondly the assistance must have been pursuant to a common design on the part of the defendant and the primary tortfeasor that the act be committed; and thirdly the act must constitute a tort as against the claimant.”

I find these several formulations helpful in determining the correct approach to the present case.

On Glaxo’s allegations, Sandoz UK is the company within the Sandoz group which distributes, markets and sells products including AirFluSal in the UK. The strategy of the group as regards products, at any rate respiratory products, is the responsibility of International, which took decisions about AirFluSal, including its launch and marketing in particular countries. International, Aeropharm and Hexal were responsible for the development of AirFluSal, and for its design, including the colour, shape, technical design and overall get-up of the inhaler and its packaging. That design and development was carried out, so it is alleged, knowing and intending that AirFluSal would be marketed and sold throughout the EU, including in the UK, pursuant to the chosen design. Aeropharm manufactures the product, according to the chosen design and in accordance with the marketing authorisation obtained for it, and supplies it to Sandoz UK. For the purposes of obtaining marketing authorisation, testing and patient studies were carried out, with the involvement of International, Aeropharm and Hexal, and all four companies are alleged to have collected or collated data including the results of such studies, and provided information for the marketing authorisation dossier.

If the promotion, marketing and sale of AirFluSal in the UK is tortious on the part of Sandoz UK, then it is clear that the commission of that tort has (on these allegations) been assisted by each of International, Aeropharm and Hexal. It is also clearly alleged that International, Aeropharm and Hexal shared a common intention and design that the product should be sold in the UK (as well as in other markets) with the chosen design and get-up, subject to obtaining the necessary authorisation. The allegation in paragraph 61 is that each of the four companies adopted the particular packaging and get-up with the deliberate intention of deceiving or creating confusion in the mind of the public. In practice, it seems that that allegation is directed against International, Aeropharm and Hexal, rather than against Sandoz UK, which does not seem to have been involved in the decisions about the design and get-up. Nevertheless it fortifies Glaxo’s allegation against International, Aeropharm and Hexal of a common design and intention on the part of those three companies, and of a combination between them, to do or to procure the doing of acts, namely the promotion, marketing and sale of AirFluSal in the UK, which on Glaxo’s allegations constitutes a tort.

Sandoz UK came into the picture at a later date, after the design decisions had been taken and, no doubt, implemented. It was involved, so Glaxo alleges, in the process of obtaining marketing authorisation, and once that had been obtained it is involved in importing and selling the product in the UK. That is the act in respect of which the other three companies are alleged to have combined with a view to its being done.

For the Sandoz parties, Mr Howe argued that the judge had been right to hold that the acts alleged on the part of Aeropharm and Hexal had been no more than facilitation, without the necessary additional element of common design and intention that the acts should be done, namely marketing in the UK, which on Glaxo’s case amounts to passing off. He submitted that the work carried out by Aeropharm and Hexal would have been, indeed that it was, undertaken on a general basis without any specific intention as to where the product was to be sold. He argued that it was done without any view to any specific market, and that the question of which markets the product would be sold on was for a later decision by another entity, namely International. However, Glaxo’s allegation, against Aeropharm and Hexal as well as against International, is that the design work was carried out with the intention that the product be sold in the EU including in the UK. There may turn out to be an issue of fact on that, which would have to be resolved at trial on the evidence, but Glaxo’s allegation seems to me to be sufficient to make out an arguable case that all three companies were party to a common design and a combination with a view to the resulting product being sold in the UK, as well as in other countries.

At the stage of design and planning, Sandoz UK will not have been involved in the process; at any rate Glaxo does not allege that it was so involved. However, it was the entity through which the act was carried out which, so it is alleged, was the subject (or part of the subject) of the combination and common design by International, Aeropharm and Hexal, namely marketing in the UK. It was the member of the Sandoz group which was relevant for that purpose. Can it be that because Sandoz UK was only involved at the later stage, once all or most of the relevant work to be carried out by Aeropharm and Hexal was complete, the latter companies are not to be regarded as having been in a combination with Sandoz UK intending that the acts should be done in the UK which, on Glaxo’s case, amount to passing off? If that were so, it seems that the careful use of a fragmented corporate structure might enable a group to limit the exposure of some relevant member entities to liability on the basis of joint tortfeasance.

It is clear from authority that if the common design is shared between several parties to a combination, it matters not that some relevant acts are done only by one or some parties and other relevant acts are done by others: see Lord Neuberger in Vestergaard Frandsen A/S v Bestnet Europe Ltd [2013] 1 WLR 1556, at paragraph 34, cited by Lord Sumption in Fish & Fish v Sea Shepherd at paragraph 38. Therefore the fact that Sandoz UK was not involved at the design stage is not in itself a sufficient answer to the allegation of joint liability as regards the other companies. And it seems to me that it is not likely to be a convincing answer to that allegation to say that Sandoz UK was not only not involved at that stage, but it knew nothing about the exercise then (as it may not have done) and only became involved once the decision had been take to move towards marketing the product in the UK and to obtain the necessary authorisation for that purpose. Before that date it may be difficult to speak of Sandoz UK as having combined with the other companies to do or to secure the doing of the relevant acts: see Lord Toulson at paragraph 21 of Fish & Fish v Sea Shepherd. But if Glaxo is right to allege a combination between International, Aeropharm and Hexal at the stage of design, one of whose purposes was that the product should be marketed in the UK, it is not likely to be a sufficient answer to the claim based on joint liability to say that everything relevant done by Aeropharm and Hexal was in the past so they cannot be treated as having combined with Sandoz UK at that point with a view to Sandoz UK carrying out what was always part of the intention of the combination, namely selling the product in the UK. At any rate, Glaxo seems to me to have made out a sufficiently arguable case of liability on this basis on the part of not only International (which is no longer in issue) but also of Aeropharm and Hexal, jointly with Sandoz UK for its primary acts of passing off.

Mr Howe showed us Napp Pharmaceutical Group Ltd v Asta Medica Ltd [1999] FSR 370, a decision of Laddie J in a patent infringement case, in which he had to consider whether there was any substance in allegations of joint tortfeasance against two connected companies, one of which (D1) was alleged to be the primary infringer. The basis of the allegation of common design was, first, that the other company (D2) was the parent of D1, and secondly that D2 had supplied information to enable D1 to apply to the UK Medicines Control Agency for UK marketing authorisation, or to support D1’s application. Laddie J held that those matters were altogether insufficient to make out a case of joint liability for the patent infringement. No doubt, if all Glaxo could rely on in the present case was (a) the corporate relationship between the various parties and (b) the supply of information relevant to the application for marketing authorisation, then Napp would provide a neat answer to Glaxo’s case. Likewise, if the only connection were that D2 manufactures goods and supplies them to D1, even if they are members of the same corporate group, Glaxo might not be able to make out the necessary elements of common design and combination. But there is much more to Glaxo’s case, as I have indicated by reference to its pleading.

Mr Howe pointed to a contention in Glaxo’s skeleton argument on the appeal that AirFluSal is incapable of unobjectionable use. That is not a point made in terms in Glaxo’s draft Amended Particulars of Claim, although if Glaxo can make good what is alleged in paragraphs 61 and 62 that conclusion may follow as regards the UK market. Mr Howe pointed to the fact that in at least one market (South Korea) Glaxo’s attempt to prevent the sale of the rival Sandoz product has been defeated in the local courts. So, he submitted, its use must be taken to be unobjectionable in that market at least, and it is therefore not a product which is inherently incapable of unobjectionable use. It seems to me that this attaches too much significance to a point made in the skeleton argument, which risks diverting attention from what really matters which is the pleaded case.

Accordingly, I accept Mr Malynicz’s submission that the judge fell into error in not finding that there was an adequate allegation of combination and common design, pursuant to which acts have been committed by Sandoz UK which, if Glaxo is right, amount to passing off. In my judgment, Glaxo’s pleaded case sufficiently makes out a case that International, Aeropharm and Hexal did combine together to do acts (as regards the design of the inhaler, and its get-up and packaging) intending that acts should be done in the UK which, on Glaxo’s case, amount to passing off.

I must therefore also consider the judge’s conclusion on limitation, namely that any claim by Glaxo against Aeropharm and Hexal would be statute-barred because the acts relied on were done more than six years before the commencement of the proceedings.

It is true and clear that Glaxo’s case against Aeropharm and Hexal is based at least in part on acts done more than six years before the commencement of these proceedings. As regards the design process, it seems to have been substantially complete by 2009. On this basis, the Defendants argued that a claim against these companies would be barred by the lapse of six years, under section 2 of the Limitation Act 1980: “An action founded on tort shall not be brought after the expiration of six years from the date on which the cause of action accrued”. The judge accepted that, in this context, a claim against Aeropharm or Hexal would be time barred because it would be based on their acts done more than six years before the issue of the proceedings.

It is difficult to see from the judge’s judgment quite how the case was argued in this respect. For Glaxo, Mr Malynicz submitted that the cause of action could not accrue until AirFluSal was marketed in the UK. Aeropharm and Hexal are sought to be made liable jointly with Sandoz UK, and therefore, necessarily, for the same cause of action as is asserted against Sandoz UK. That cause of action first accrued late in 2015 when AirFluSal was first promoted and sold in the UK. That Aeropharm’s and Hexal’s part in the process had been completed long since (if it be the case) did not give Glaxo any cause of action against either of them absent acts within this jurisdiction which could amount to passing off. As I mentioned in paragraph 23 above, Lord Sumption noted in paragraph 38 of Fish & Fish v Sea Shepherd that the accessory is liable not for his acts of assistance but for the primary actor’s tortious act. This shows that no cause of action accrued against Aeropharm or Hexal, on Glaxo’s case, until Sandoz UK started placing the product on the UK market.

Mr Howe argued before us that Glaxo would have had a cause of action before the placing of AirFluSal on the UK market, even if only on a quia timet basis for an injunction. This was a novel point, but it is clearly wrong. A pre-emptive claim for a quia timet injunction, to prevent the commission of a wrong, can sometimes be brought before a cause of action in law has accrued, but it is an invocation of what used to be the jurisdiction of equity. Section 2 is excluded from application to such a claim by virtue of section 36(1)(a) of the 1980 Act. Such a claim is left to be subject to the equitable jurisdiction to refuse relief on the grounds of acquiescence or otherwise: section 36(2).

In my judgment, Mr Malynicz was right to submit that the same limitation period applies to the claim against Aeropharm and Hexal as to the claim against Sandoz UK. It follows that limitation provides no justification for refusing to join those companies as additional defendants.

Of course, if a very long time elapsed between the acts alleged against the parties sought to be made liable as joint tortfeasors and the acts of the principal tortfeasor, there might well be issues of causation as to whether the one was really part of, or done pursuant to, a combination and a common design to do the other. And there might be a case in which there was at one stage a common design, but before it was carried into effect some of the parties withdrew from it, and took steps to cancel the effect of their own preparatory acts. In such a case it might be impossible to establish the necessary continuing common design and combination. But it is well known that in the pharmaceutical world processes of moving towards marketing and sale of a new product can take a very long time, and the passage of such a period of time is not in itself a reason for holding that liability cannot be established, if otherwise the requirements of the law are satisfied. Nor was it suggested that the issues raised against Aeropharm or Hexal cannot properly be tried, despite the lapse of time. Accordingly, as regards limitation too I respectfully disagree with the judge below.

In conclusion, therefore, I would allow the appeal and order that Aeropharm and Hexal be added as defendants to the claim. The case should be remitted to the High Court for consequential case management directions.

I agree.

I also agree.