In a lengthy decision, the High Court has concluded that, through the get-up and packaging of its AirFluSal Forspiro inhaler, Sandoz has not passed its product off as being connected in the course of trade with Glaxo and/or as equivalent to Glaxo's Seretide Accuhaler (a combination of salmeterol and fluticasone for the treatment of asthma and COPD in a dry powder inhaler). Glaxo's Seretide Accuhaler product, on the market since 1999 is coloured two shades of purple and is sold in packaging featuring a shade of purple. Sandoz's generic product, launched in November 2015, is largely coloured a shade of purple and is sold in packaging featuring a shade of purple. Both are prescription only medicines (and so promotion to patients is highly restricted), with prescriptions normally being written using the brand name.
The parties agreed that a loose colour convention had developed in the UK in relation to certain types of inhaler (e.g., for blue and 'autumnal' colours), thereby promoting familiarity for patients. The evidence from healthcare professionals was that they would not assume that any purple inhaler was Seretide, but would regard the colour purple as denoting the combination of salmeterol and fluticasone. As for patients, the Court concluded that, whilst they would understand the different colours would signify an inhaler containing differing types of medication, most would have little idea as to what the different types of medication were.
Glaxo's passing off claim had two strands: (1) misrepresentation as to trade origin amongst patients, i.e., that the AirFluSal Forspiro inhaler was connected in the course of trade with Glaxo; and (2) misrepresentation as to equivalence of characteristics amongst healthcare professionals and patients.
The Court noted that it can be very difficult, although not impossible, for a claimant in passing off cases to establish that the shape or colour of a product or of its packaging is distinctive of them. Recognition and association will not be sufficient, in the same way as recently considered in relation to unconventional trade marks and acquired distinctiveness in Nestlé (discussed in our July 2018 bulletin). The Court further noted that consumers do not generally identify the origins of characteristics of a product by reference to its colour or that of its packaging and, as prescription only medicines, the products in this case cannot be directly marketed to consumers.
In order to seek to demonstrate goodwill in the colour purple, Glaxo relied upon a number of surveys that it had carried out amongst healthcare professionals - although its claim of passing off as to trade origin was limited to consumers. The Court identified a number of issues with the surveys, which underline the difficulties in producing a survey which complies with the relevant requirements. Further, there was no evidence of actual confusion amongst consumers – whilst absence of actual confusion evidence is not fatal to a claim of passing off, the Court saw this as confirmatory support for its conclusion that confusion as to trade origin amongst patients was unlikely to arise.
Glaxo also argued that there was an extended form of passing off, as the AirFluSal Forspiro was not equivalent to the Seretide Accuhaler in relation to certain characteristics. Whilst the Court accepted it was less likely that any actual confusion in the minds of patients on these grounds would come to light, it concluded that there was no evidence that - for either healthcare professionals or patients - purple would denote to them an inhaler with the characteristics and delivery mechanism of Seretide Accuhaler.
This has been a significant case, with a number of interesting interim decisions relating to evidence, and it is to be expected that Glaxo will seek permission to appeal.