The names of pharmaceutical products can be confusing for patients. International non-proprietary names (INNs) and even brand names may be difficult to remember. Patients may be taking several different medicines simultaneously, and many come to rely on product recognition in the form of shape and colouring. This presents both a challenge and an opportunity for innovative producers.
Protecting a brand name is relatively straightforward. Registration of brand names as trade marks offers clarity and strong protection. But if a producer can also establish rights in the appearance of the product, they may be able to strengthen a market position that will survive patent expiry.
Registration of the shapes and colours of products and their packaging as trade marks is difficult, but sometimes possible. A second option is to rely on unregistered rights built up through a period of use of the product. In the UK, you can take action to protect these kinds of unregistered rights through a “passing off” claim. If successful, this kind of protection can be very valuable, but establishing a claim of this kind is commonly difficult.
A recent example – GSK’s purple inhalers
GSK’s combination Seretide inhalers (Advair in the US) for the treatment of asthma and COPD are an important part of the company’s portfolio. Although down from their peak in 2013, global sales remained at around £2.4 bn in 2018. Patent protection on the drug combination has expired, making the product a tempting target for generic competition. Several other companies, including Mylan and Sandoz, have launched generic versions in recent years.
GSK’s Seretide inhalers (both the metered dose and dry powder versions) are presented in two shades of purple. Darker combinations of shades are used for the stronger formulations and paler shades for those of lower strength. The generic versions follow a similar theme, with at least some elements of pink or purple included on the packaging. Sandoz’s dry powder inhaler (AirFluSal) uses purple, again with shade variations for different strengths.
GSK tackled Sandoz’s use of this colour system through a passing off claim (ruling here).
In order to succeed, GSK had to prove three things: (i) that it had built up goodwill or a reputation based on the product colour scheme among either healthcare providers or patients, (ii) that there had been a misrepresentation to the relevant buying public and (iii) that there was resulting damage to its market. At first glance you might expect GSK to succeed, but the claim failed. Why?
Although patients relied on colour to distinguish between different kinds of inhalers, it was not clear that the purple colour scheme was seen as being specific to GSK’s product. For many, it simply indicated an inhaler containing a particular combination of two active ingredients, with their other inhalers coloured blue, orange, green etc. Things have evolved somewhat, but at the time of Sandoz’s inhaler launch there was a “loose convention” as to the colours of different types of inhaler.
GSK also argued that the purple colour scheme put forward the impression that the Sandoz product was equivalent to GSK’s dry powder inhaler product. There were differences between the marketing authorisations for the two products, and Sandoz’s AirFluSal worked in a different way. But the evidence did not show any deception. Healthcare professionals (HCPs) were all too aware that generic producers tended to present their products in similar colours and would not rely on colour to provide information about important aspects of the product. Indeed, the fact that GSK used the same colour scheme for both dry powder and metered dose inhalers undermined its argument.
An argument that Sandoz had been reckless as to the possibility of deceiving patients because they wanted them to switch to their product also failed. The product development team had considered dark blue colouring, but had gone for purple because it was “the signal colour for this substance combination”.
Points to note
This case shows how tempting it is to develop a “look” for a line of products and then hope to rely on this to bolster a market position in the face of generic competition. This can be effective if a colour combination or shape can be registered as a trade mark, but achieving this is challenging.
The ruling also shows the dangers of this approach. Despite extensive surveys, neither patients nor prescribers could be shown to rely on the packaging colours as indicating who the manufacturer was. HCPs certainly did not rely on this feature to give them information about licence scope or mode of use. In fact, all the colour scheme did was to help patients distinguish between broad classes of inhaler. If anything, it helped generic producers to enter the market.
James Fry and Isabel Teare