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Glaxo pauses for breath – purple inhaler does not infringe

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United Kingdom

Mr Justice Arnold has recently handed down a lengthy judgment (Glaxo Wellcome UK Limited and Anor v Sandoz Limited and Ors [2019] EWHC 2545 in which he dismisses Glaxo's claims of passing off in relation to its purple inhaler.

Mr Justice Arnold has recently handed down a lengthy judgment (Glaxo Wellcome UK Limited and Anor v Sandoz Limited and Ors [2019] EWHC 2545 in which he dismisses Glaxo's claims of passing off in relation to its purple inhaler.  

Background

Glaxo marketed a combination of salmeterol and fluticasone for the treatment of asthma and chronic obstructive pulmonary disease ("COPD") through two inhalers: a dry powder inhaler branded Acuhaler and a metered dose inhaler branded Evohaler. Both are coloured shades of purple and sold in purple packaging.

From 1999 to 2015, Glaxo's inhalers were the only inhalers on the UK market that were coloured purple and sold in purple packaging. In 2015, Sandoz launched a branded generic competitor to the Acuhaler, coloured a shade of purple and sold in purple packaging. Other pharmaceutical manufacturers also launched competing inhalers which contained shades of pink and purple.

In December 2015, Glaxo sued for passing off, alleging: (1) Sandoz had passed off its inhaler as connected in the course of trade to Glaxo's; and (2) Sandoz had passed off its inhaler as equivalent to Glaxo's through the get-up and packaging.

The respective inhalers were prescription-only medicines, meaning they could not lawfully be advertised directly to patients or without a prescription. A prescription may refer to a proprietary brand or the generic name. For inhalers, it is necessary to distinguish between the name of the medication and the name of the inhaler that delivers it. Glaxo and Sandoz agreed that inhalers should be prescribed by brand, even where the active ingredients are generic. Where the prescription is written generically, a pharmacist may sell either a branded or generic product. However, medical advice and guidelines for prescribing inhalers state that generic prescribing should be avoided because patients may get an unfamiliar device they can't use properly.

The case reached trial in 2019, having been delayed due to various interlocutory applications on both sides. By the end of the trial, the only get-up Glaxo relied on in this claim was the colour purple.

The Judgment

Arnold J stated that November 2015 was the important date, being the date on which Sandoz's inhaler was launched and, therefore, the date for assessing whether the elements of a claim for passing off were made out. At that time, patients understood that different colours signified inhalers containing differing types of medication for different purposes (e.g. blue and brown).

Having cited the relevant authorities, Arnold J emphasised that passing off requires deception, rather than mere wondering and that a substantial number of members of the public must be misled. He also made clear that passing off does not require the misrepresentation to be deliberate, but any intention or recklessness may have evidential relevance.

For its passing off claims to succeed, Glaxo had to demonstrate that, in November 2015, the colour purple was distinctive of: (1) trade origin and (2) the characteristics of its inhaler. The evidence showed that the colour purple was not distinctive of Glaxo's products

Of the 4 surveys submitted by Glaxo to evidence distinctiveness, 2 failed to comply with the Whitford Guidelines (as laid down in the Court of Appeal case of Imperial Group Plc v Philip Morris [1984] RPC 293) and the remaining 2 failed to comply in part. Glaxo's inhaler could not be marketed directly to patients, with the evidence showing that patients simply knew that one of the inhalers they used was purple. There was no evidence that patients saw the colour purple as distinctive of trade origin or the characteristics of the inhaler.

Regarding misrepresentation, Arnold J noted that, despite putting a great deal of effort and resource into searching for evidence, there was no factual evidence of confusion of patients. Indeed, he noted that "the cupboard was entirely bare". Similarly, given the length of time that had passed, there was no likelihood of confusion arising in the future. The evidence showed that inhalers are often prescribed by brand and there was nothing to show misrepresentation as to the inhaler's equivalence.

Regarding the alleged intention to deceive, at trial the case advanced by Glaxo was that Sandoz had been reckless as to whether the relevant public would be deceived into believing that their inhaler was connected with Glaxo. Arnold J accepted Sandoz's evidence that the colour purple was chosen because it was the signal colour for the substance combination, and that the colour purple was the only similarity in the packaging. Arnold J noted that developing a product which assists in switching from a branded product to a generic, without deception, is not passing off. Deception does not occur by reassuring patients that a product has the same active ingredients as another product. Therefore, he concluded that there was never any proper basis for the allegation of recklessness.

In summary, all of Glaxo's claims failed.

Comment

Pharmaceutical companies are no strangers to long, complex intellectual property litigation. However, such proceedings often involve infringement and invalidity claims relating to patents which, by their very nature, are technical and require expert evidence. Passing off proceedings do not, ordinarily, involve the same amount of time and resources. However, these proceedings involved an 11 day trial, 45 witnesses, substantial disclosure, 4 surveys, 16 experts reports from 6 experts, 9 barristers and 3 firms of solicitors.

Arnold J provides a clear account of the law of passing off before dealing clearly and pragmatically with the factual issues he had to determine. Therefore, it will be interesting to see what grounds are put forward should Glaxo seek to appeal. In any event, by the time any appeal is heard, Arnold J will be sitting as a Lord Justice.

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