Nabil Asaad

Glaxo v Sandoz: ‘evergreening’ the colour purple

by Dr Nabil Asaad

 
 

Mid-December saw a further court ruling in the ongoing litigation between Glaxo and Sandoz on the use of the colour purple in Sandoz’s generic version of Seretide, which is Glaxo’s combination therapy for asthma. This was the sixth court ruling in litigation that is being watched with interest by both Active Pharmaceutical Ingredients (API) rights holders and generic manufacturers owing to its possible implications for market entry by generic competitors.

What the litigation is about

Glaxo claims that it owns goodwill in the purple colours used on the packaging and the inhaler itself. The company contends that Sandoz’s use of the same colouring on its generic combination therapy amounts to passing off.

Glaxo had also applied for trade mark protection for the two shades of purple used. In parallel litigation between Glaxo and Sandoz, Glaxo’s trade mark was held to be invalid.

The latest ruling, handed down on 15 December 2017, was on the procedural issue of whether or not Glaxo could use survey results as evidence of the distinctiveness of the purple colours in question. In particular the Claimant’s case for passing off relies on the darker shade of purple which is claimed to be the ”main purple colour”.

What is at stake?

The Glaxo-Sandoz litigation is important for the wider implications that it may have for generic competition. As between the parties, if Glaxo wins, it would be likely that Glaxo would be awarded financial compensation and Sandoz would be obliged to change the colour of its competing product. The wider significance of that result would be that, despite the patents covering the combination therapy and Glaxo’s ‘Diskus’ inhaler having lapsed, Glaxo would effectively be given a further monopoly in relation to the product’s purple colouring.

One facet of the law of passing off is that it protects the goodwill associated with products, or elements of products, including get-up, appearance and packaging that are distinctive of a particular trader. This can be particularly useful if those elements are not protected by other intellectual property rights or where the link in the minds of the public between the product and the trader has built up over time. In this case, the link between purple and Seretide (or specifically Glaxo) will have built up during the period of patent monopoly. If Glaxo’s claim for passing off succeeds, then we would expect to see other patent holders seeking to identify and incorporate distinctive elements in their products, with a view to retaining monopoly protection for those elements once the period of patent protection expires. That monopoly could last indefinitely and could serve to diminish the impact of generic competition, particularly if it further strengthens patients’ natural disinclination to move away from their existing medication.

The latest ruling

The survey evidence in question was collected for Glaxo for the parallel trade mark litigation. The claimant’s case for passing off is (or at least involves) an allegation that the colour purple per se is distinctive. All surveys involved putting a blank rectangle of the relevant purple shade to the interviewees and asking questions. Glaxo contended that the survey results (as demonstrated by the answers given to those questions), indicated strong recognition by pharmacists and general practitioners that the purple colouring is associated with Glaxo’s Seretide. Sandoz attacked the survey evidence on several fronts asserting that the surveys were inherently flawed, not relevant to whether or not Sandoz’s product would be confused with Glaxo’s and not sufficiently useful to justify their consideration at trial. Those arguments proved unsuccessful, handing a victory to Glaxo.

Next steps

The case is set to move on to a full trial of Glaxo’s claim for passing off. There will doubtless be further arguments at trial as to the value of the survey evidence and whether this assists Glaxo’s case. Even if Glaxo shows that its purple colouring is distinctive of Seretide, it still has significant hurdles to overcome in order to show that it has goodwill in the colour purple used and that Sandoz’s use of the same colouring is unlawful.

 
 
 

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