IN THE UK OFFICE

Inhaler Colours Found Non-Distinctive

The pharmaceutical house Glaxo Wellcome (Glaxo) sells a range of products aimed at the prevention of asthma attacks. In each case, a particular set amount of the active ingredient (beclomethasone dipropionate) is delivered to the patient by pressing an aerosol can containing the drug into an inhaler, which in turn is held by the patient to his mouth. The product delivering the highest amount of active ingredient (250 micrograms) per actuation to the patient is sold in the UK under the trade mark Becloforte.

Each of the inhalers used to deliver the drug are coloured to distinguish one from the other. The Becloforte inhaler has a maroon coloured body and a pink coloured cap placed on the inhaler’s mouthpiece. This colour combination has been used since about 1988. Prior to that the whole inhaler, including the cap, was maroon.

Once the patent had expired on beclomethasone dipropionate, Glaxo began looking for ways to prevent competitors selling generic versions of the drug that employed a get-up similar to both Becloforte and the other products in the range. In January 1993 therefore, they filed a UK trade mark application for a mark which consisted of a diagram of an inhaler device together with the following wording,

"The trade mark consists of the colour pink applied to the cap of the mouthpiece of the inhaler device and colour maroon will apply to the remainder of the surface of the inhaler device, as shown in the representation on the form of application".

Once the application was only aimed at those generic competitors who might be tempted to mimic Glaxo’s range of products in a slavish fashion, the specification of goods was very narrowly drawn, namely

"Pharmaceutical preparations containing beclomethasone dipropionate or solvate thereof sold in a metered dose aerosol can which delivers 250 micrograms of active ingredient per actuation".

The application (UK1524601) was allowed to proceed to registration on the basis of the significant sales of the Becloforte inhaler in the UK up to the trade mark application date.

In March 1996, one of Glaxo’s competitors in the asthma market, Riker Laboratories, applied to cancel UK1524601 on the following grounds,

• The mark was in breach of Sections 3(1)(b), (c) and (d) of the Trade Marks Act 1994.

• The mark had not, as a consequence of any use which had been made of it either prior to or after the date of application, acquired a distinctive character.

• The mark was registered in breach of Section 3(3)(a) of the Act as contrary to public policy, since monopoly rights obtained through this registration put members of the public who suffer from asthma at risk.

 

In their evidence, Riker’s principal arguments were that the colours claimed by Glaxo were too non-specific and open to wide interpretation, that the use of the colour pink when applied to asthma inhalers indicated that the product was stronger than the usual dosage and that the colours of asthma inhalers should be used to indicate the nature of the active ingredient rather than the source of the drug.

In response to the argument that their mark was too non-specific, Glaxo applied to limit the colours claimed in their registration to Pantone 197C (pink) and Pantone 492C (maroon). As far as the other two arguments were concerned, Glaxo’s evidence pointed to 3M’s (Riker’s sister company’s) use of colours other than pink for their high strength asthma inhalers in the UK and also outlined their (Glaxo’s) share of the relevant asthma market. In 1992, the Becloforte inhaler accounted for around 20% of the relevant market, a share which, due to increased competition, had declined in the following years.

The Hearing Officer (Mr James) reviewed the various grounds raised by Riker in some detail and finally came to the following conclusions,

• The amendment to the wording of the colours made by Glaxo was accepted by the Registrar as a voluntary limitation to the infringement rights claimed under Section 9 of the Trade Marks Act. The limitation had little bearing on whether or not the particular colours had an inherently distinctive character.

• The opponent had not been able to identify any public policy relating to the use of colours on asthma inhaler devices. Their argument was more that there ought to be such a policy. Since a policy did not exist, however, the Section 3(3)(a) ground failed.

• The shape of Glaxo’s claimed asthma inhaler was typical of inhalers used in the industry, the trade mark should therefore be viewed as consisting essentially of the two colours.

• In a cancellation action, the onus is on the applicant to cancel to show that the trade mark registration is invalid. Since Riker had provided no evidence to show that by January 1993 (Glaxo’s application date), it had become customary for the pharmaceutical industry to use either the colour pink or the pink/maroon colour combination to indicate a high strength product, the objection raised under Section 3(1)(d) failed.

• A two colour combination that has not been used before in relation to a particular product is not necessarily inherently distinctive. The position will depend on the nature of the product. In the case of asthma inhalers, at the date of Glaxo’s application, the combination of pink and maroon was not inherently distinctive. The mark was therefore excluded from registration by Section 3(1)(b) of the Act. In view of this, there was no need to consider Section 3(1)(c).

• Use of a mark does not prove that the mark is distinctive. Increased use, of itself, does not do so either. The use and increased use must be in a distinctive sense to have materiality (quoting from Bach Flower Remedies Ltd v. Healing Herbs Ltd).

• Glaxo had provided no evidence that they had ever used the colour combination in an overtly trade mark manner, for example, promotional material containing a statement such as "look for the one in the maroon tube". Further, there was no consumer survey or trade evidence to show how the colours were viewed, either by the public or by Glaxo’s competitors. In the absence of such evidence, the Hearing Officer formed the view that the average consumer of the product would regard the colour combination as indicating an inhaler of a certain strength. Given this background, use alone was not sufficient to establish acquired distinctiveness, either prior to or after the application date.

• The registration was consequently declared invalid under Section 3(1)(b) of the Trade Marks Act 1994.

 

Comment

Once the patent on a successful drug expires, the market share enjoyed by that product will usually fall dramatically as generic competitors launch their own versions of the medicine. The research industry understands this and clearly has to accept it.

The aspect of the post-patent situation that they find difficult to digest, however, is the generic competitor’s use of product get-up and packaging that is either identical with or similar to that of the original medicine. For example, if the original anti-ulcer drug is sold in black and red coloured capsules, then so are the generic versions. Similarly, if the original asthma product employs a pink and maroon inhaler, then the generic asthma treatments will follow suit.

Glaxo’s trade mark application for the Becloforte inhaler colour combination was designed to thwart what the research industry sees as slavish imitation and unfair competition. The narrowness of the specification of goods illustrates that they were only concerned with the prevention of Becloforte inhaler look-alikes. This UK Office decision therefore deals a blow to the research industry and their fight to limit the damage that generic competition can do to drug products coming off patent.

In the writer’s view, however, some solutions to those problems lie in the industry’s own hands. Within the constraints placed upon them by health authorities, they should draw the trade mark nature of their products’ colours to the attention of the patients who use those products. They should employ novel shapes for tablets, inhalers, etc. and use registered designs and copyright to protect those shapes. Having done so, they should then tell their patients that the novel shapes indicate a product source rather than a product type. At the very least such actions should give a research company a fighting chance of registering their colours and shapes (or perhaps their colour/shape combinations) as trade marks prior to patent expiry.

If a pharmaceutical company does not like what it believes to be unfair competition once a drug’s patent expires, it should use more imagination, long term planning and resources to prevent it.