Recently Lupin Atlantis Holdings SA secured trademark registrations for three colour combinations for its inhalers. Highlighting some interesting bits from the prosecution of these applications and explaining the implications of these registrations on the larger access to medicines issues, we are pleased to bring to you this post by Md. Sabeeh Ahmad. Sabeeh is a recent law graduate from AMU, Aligarh. His previous posts can be accessed here.
What’s in a Colour? Taking a Look at Lupin’s Colour TM Application for its Inhalers
Md. Sabeeh Ahmad
Lupin Atlantis Holdings SA, the Switzerland based pharmaceutical product developer has registered three colour combinations for its inhalers under trademark classification – Class 5 (Inhalers filled with pharmaceutical preparations for the treatment of respiratory ailments) and Class 10 (Inhalers used for the treatment of respiratory ailments). The colours are grey for the actuator combined with either pink, brown, olive green for the cap of the inhaler. Documents available on the Trade Marks Registry’s website show applications for the grey-olive green (see here) and grey-pink (see here) combination were made in December, 2019. Application for the grey-brown combination was made twice – first in May, 2021 (see here) and with certain “interesting” changes (discussed below) again in January, 2022 (see here).
Before we jump into analysing the how’s of it, we will first discuss the why(s)? Patents and access to medicines remains a raging debate already. However, the grant of non-traditional trademarks (such as the Lupin one – of colour/colour combinations) create another set of access barriers for pharmaceuticals, not much talked about. Prof Scaria and Kavya Mammen have discussed it here that branded drugs already enjoy patent protection which is furthered by extensive marketing of trade dress. Inhalers, for example, are used for a variety of respiratory ailments including asthma. The total burden of asthma in India is estimated to be 34.3 million, accounting for 12.9 % of the global burden as of 2022. But India shockingly also contributed to a disproportionate 42.4% of deaths by asthma globally. Another interesting study showed that the heavy underuse of Inhaled Corticosteroids (ICS) for Asthma in India may be contributing to deaths globally. This study suggests that there is over 90% of under-use of ICS by asthmatic patients in India. (For readers, a heads up, there is a traditional colour coding of inhalers, with brown being the prevalent one for ICS – more on this below) With monopoly over colours (and combinations) having begun by virtue of trademarks, can we predict a future where these already low-in-use inhalers may face further access barriers?
In this blog post, we will first analyse Lupin’s application, their arguments in favour of the trademark to their supposedly “innovative” colour combinations, and general concerns regarding the grant of trademark to colours with a focus on pharmaceuticals.
The Lupin Case – Analysis Of Examination Report And Reply
In the application number 4392876 for the pink-grey combination, the Registrar of Trademarks in its Examination Report raised objections u/s 9(1)(a) and (b) of the Act as being non-distinctive in nature (The report here) Section 9 of the Indian Trade Marks Act deals with absolute grounds for refusal of registration. Section 9(1)(a) gives for a Trade mark which is not unique or different, then this can be a ground for Trade mark refusal. Section 9(1)(b) says that Trade marks that only describe the kind, quality, quantity, and geographical origin of the goods or services cannot be registered. The examination report is not detailed in its content and does not specifically point to concerns, consequent to which applicants are left to their own wisdom to reply in detail against the objections. This may both be beneficial or detrimental to their applications because it leaves little room for accountability or scrutiny against the Trade Marks Registry.
The Applicant in its reply (here) had argued that the colour coding had been put forth in an innovative manner so as to produce a net impression of distinctiveness. They further argued that the positioning of the colour coding (grey for the actuator and pink for the cap of the inhaler) is the “brainchild” of the applicant and gives an unique impression. The applicant had replied that ‘the products for which the said colour mark is applied for are used in a very niche market and for a very specific class of consumers.’ Lupin had cited Pfizer, Colgate, and Deere in support of its arguments. However, it is noteworthy that all the cited precedents had a distinctive niche in the market and they were well-known, a requirement under trademark law. The objections and reply for the olive green and brown cap trademark applications were almost similar.
Interestingly (or oddly) though, the Registrar in its Examination Report for the ‘brown cap’ inhaler raised an objection under Section 9(3)(a) in addition to 9(1)(b). S. 9(3)(a) concerns itself exclusively with the shape of goods. The application was made specifically with respect to the brown-grey colour combination. The applicant has also clarified the same in its reply that the application is not concerned with the shape of the product. (Lupin did in fact make a separate application for its unique 3D shape inhaler, the report of which is here)
Another fact that captures our attention is that the brown-grey combination also seems to have two different registrations by Lupin (both linked above). The first (Application no. 4970711) made in 2021, and published on 15/01/2024. The second (Application no. 5293298) made in 2022 and published on 12/02/2024. There seems to be no difference with respect to their examination report as well as the reply but the latter excludes a condition that featured in the former. Here:
1st Application:
2nd Application:
The second application seems to have let go of the “limited to the colours as shown in the representation on the form of the application” condition. Does this create a situation where even if the colours in the representation do not precisely match the one trademarked for, the applicant can claim infringement? Remember the reference to “brown” in the introduction? It seems there is an indirect relationship between the high requirement/use of ICS inhalers and this amendment in the second application. This may be intended at maximising the ambit of their trademark. As noted earlier, traditionally preventer inhalers (ICS) are predominantly brown in colour.
General Concerns
Colour Combinations and Notions in Pharmaceuticals
Normally, with respect to inhalers, each colour is identified with the purpose it is expected to serve. Although there exists no universal standard, the importance of colour-coded asthma treatment in patient education is well accepted. For example, a) Blue for beta-agonists. b) Brown for inhaled corticosteroids (ICS). c) Green for long-acting beta-agonists. d) Yellow for anticholinergics. e) Blue and Brown for beta-agonists and ICS combination. f) Green and Brown for long-acting beta-agonists and ICS combinations, and so on. If this is the case, then, without doubt any colour coding would convey a reference to the character of the goods in question. Colour, as we know it, is an asset to target market niche, and in the immediate case, with colour being known to specifically direct towards a particular type of treatment, this becomes a bigger issue. In 2019, GlaxoSmithKline claimed passing-off against Sandoz stating that it was aiming to confuse consumers by using the same (purple-white) combination for its generic inhaler. This has been discussed in more detail here. The European Court of Justice had ruled in favour of Sandoz accepting their argument that purple was chosen to indicate active ingredients in line with established practice of colour coding inhalers.
Patient Preferences, Quality, and Monopoly in Pharmaceutical Trade Marks
With respect to pharmaceuticals in general, the general patient tendency leans towards products they have been identifying with for a long time. Colour, of course, being a huge indicator for it. The problem with colour trademarks seems to be extending an unintended (or maybe intended?) monopoly indefinitely. As argued before here, monopoly over a colour may become an issue of anti-competitiveness in the future. The identification of a colour attached to a particular type of inhaler, in this case, would mean patients may be reluctant to switch to another equally effective available alternative. The difference in colour of similar inhalers would mean that quality concerns may arise amongst patients. Any physical difference may create a perception that generics which do not have the same colour coding as the inhaler they are using, may not be at par. The dangers of this perception was pointed out here. Pharmaceutical trademarks are not to discharge a quality control function but they may inadvertently do so.
Trade Marks of Colours and the Larger Questions
What Lupin seems to have trickily done is – combined a grey element with the main indicative colour, thus escaping the deeper scrutiny of trademark. This may seem a different or distinct identity, but the focus from the primary indicative colours does not escape our thoughts. Another problem with a colour trademark seems to be the subjective nature of it. Precluding any other entity from carrying a colour combination does not make much sense and refers us to a larger question – Can colour/colour combination be owned entirely? As Lupin has argued in its reply to the examination report that the colour combination is an output of innovative pursuit – can we really zero it down to an innovation or distinctiveness? This argument is of course, without being prejudicial to the fact that protecting colour by trademark seems more desirable for entities who are pre-established and therefore it becomes a tool for reputation protection. In that case, it carries a distinctiveness by use.
The Process of a Colour Trademark: Evidence and Lupin’s Case
In the case at hand, Lupin seemed to have had it easier than what is prescribed. It is timely to make a reference to Chapter II of the Draft Manual of Trade Marks. The Section 3.2.4 clearly emphasises that – “it will be necessary to consider how unusual the colour combination is in relation to the goods and whether, prima facie, the combination is likely to strike the relevant consumer as an indication of trade source.” In addition to this, wherever exclusive right to colour is sought, “weighty evidence should be necessary to overcome objection under Section 9(1)(a) of the Act. (12.2.5)“
For Lupin, lack of evidence that consumers associate and recognise the colour combination to its own inhalers is the first roadblock. In its reply, Lupin has emphasised that the usage of the colours in an usual position mark appeals to the eye as an independent feature. However, a simple search on available inhalers in India – one can see that there seems to be nothing unusual about the colour positioning, it is a common colour scheme for inhalers (See here). Another problem with Lupin’s argument seems to be the absence of any persuasive evidence that would point to whether the way colour is used forms an essential part of the subject matter of their trade mark, as required under 3.2.4.
Conclusion
At the beginning of the post we had emphasised on the impact that this might have. The concern that this might create a barrier is well founded. The grant of colour combination trademarks will open doors for more such applications irrespective of distinctiveness by use. To sum up, we are curious (read sceptical) on two fronts. First, in addressing the larger questions of whether colours should, at all, be considered for trademarks without pressing evidence that they are distinct by use? Second, whether the consequent public impact is even a consideration for the Trademarks Registry in granting such a trademark? Shouldn’t questions on monopoly, anti-competitiveness, and access be deliberated upon in detail?