Glaxo Wellcome UK Ltd & Anor v Sandoz Ltd & Ors

A passing off claim based on the colour of a medicinal inhaler requires proof that the colour is distinctive of the claimant’s trade origin or relevant product characteristics, followed by a likelihood of material deception and damage. Recognition of, or association with, a product is insufficient. Colour conventions which help patients distinguish classes of medication, or facilitate lawful switching to a generic product, do not themselves establish passing off. A misrepresentation as to equivalence may be actionable, but the claimant must identify goodwill and show that the alleged representation is material and likely to damage it. The defendant’s awareness of litigation risk is not equivalent to recklessness as to deception.

Glaxo marketed Seretide salmeterol/fluticasone inhalers in purple packaging and devices. Sandoz launched AirFluSal Forspiro, a generic combination inhaler using purple colouring. Glaxo alleged that the colour conveyed misrepresentations that AirFluSal was connected with Glaxo and equivalent to Seretide, including as to licensing, strength, titration and delivery mechanism. Glaxo also alleged recklessness and joint liability by associated companies.

The trial concerned the position at the launch date in November 2015 and, for certain regulatory issues, the later variation of AirFluSal’s marketing authorisation. The central questions were whether purple had acquired the necessary distinctiveness, whether patients or healthcare professionals were likely to be materially deceived, and whether the associated companies shared a common design sufficient for joint liability.

1. Claims dismissed. Glaxo failed to establish any actionable misrepresentation or damage.
2. Colour may in principle acquire goodwill, but colour and product appearance ordinarily describe characteristics or assist recognition rather than denote trade origin. Evidence that healthcare professionals or patients recognised purple as associated with Seretide did not show that they relied on purple alone as a badge of origin. The evidence instead showed that colour helped distinguish inhalers by medication class and function.
3. The survey evidence was materially defective. The 2015 surveys were leading and inadequately documented and were of no value. The 2016 survey results concerning patients were unreliable. The usable parts showed recognition and association, not distinctiveness sufficient for passing off.
4. There was no likelihood of deception as to trade origin. Patients were familiar with the different devices, packaging, names and modes of operation. The absence of actual confusion after substantial sales and a lengthy period on the market reinforced that conclusion.
5. There was no misrepresentation as to equivalence. Healthcare professionals would consult licensing information and would understand that devices, strengths, indications and patient groups could differ despite identical active ingredients. The colour did not convey that AirFluSal had the same delivery mechanism, range of strengths or marketing authorisation as Seretide. The regulatory difference before February 2017 was not shown to damage Glaxo’s goodwill.
6. The use of purple to facilitate recognition of the same active-ingredient combination and lawful generic substitution was a legitimate commercial purpose. It did not become passing off merely because it assisted switching.
7. There was no recklessness. Awareness of a risk of proceedings, or of the commercial opportunity in generic prescribing, did not establish awareness of a risk of deception. The evidence supported the defendants’ explanation that purple signified the salmeterol/fluticasone combination.
8. Even if Sandoz had been liable, Aeropharm and Hexal would not have been jointly liable. They had assisted in development but were not shown to have participated in a common design to launch or market the product in the United Kingdom.