INNdistinctiveness of Pharmaceutical Trade Marks: Contours and Evolving Landscape

Pharmaceutical companies have since long been devising brand names for their drugs/medicines from the names of the underlying active pharmaceutical ingredients (“API”), which are recognized by their International Non-Proprietary Names (“INN”) assigned to them for their global identification. Due to this naming practice however, friction between pharmaceutical companies over trademarks becomes inevitable, as all the companies are vying to devise new brands from the same pool of generic names, and it does not take long for these disputes to be converted into litigations.

Realizing the sheer volume of such cases filed in India and the severity of public health challenges involved, the Supreme Court laid down certain criteria which a court must be mindful of while deciding such matters in the celebrated case of Cadila Health Care v. Cadila Pharmaceuticals. The Apex Court, in this case, vouched for the application of stricter tests for adjudging similarity between marks pertaining to pharmaceutical products. The court also expressed a word of caution for future courts from placing too much trust on the prudence of doctors or pharmacists in such cases, observing that they could not be considered immune from confusion or mistakes, especially when marks are deceptively similar and relate to drugs and pharmaceutical products having, by-and-large, similar APIs.

However, somewhere down the line, the authority of these factors seems to have dwindled. Cases where the Cadila factors are not given their due deference have led to an undesirable situation where the possibility of confusion among consumers has increased, resulting in increased threat to public health.

One of the earlier and more prominent examples of such cases is a 2007 division bench decision of the Delhi High Court in Astrazeneca UK Ltd. & Anr. v. Orchid Chemicals & Pharmaceuticals Ltd., where the marks MEROMER and MERONEM were held to be dissimilar on the ground that neither party could lay claim to ownership over the word MERO, which was the only common element between the rival marks, since it emanated from the name of the API Meropenem, and since registration of such words/INNs is prohibited under Section 13 of the Trade Marks Act, 1999 (the “Act”). This ruling was followed and affirmed by another division bench of the Delhi High Court in Schering Corporation v. Alkem Laboratories, wherein the marks TEMODAL and TEMODAR were held to be dissimilar from TEMOKEM and TEMOGET on the ground that TEMO, which was common to both the marks had been derived from the name of underlying API Temozolomide, due to which, the comparison would be made only of the dissimilar part of the mark, i.e., DAL/DAR and KEM/GET, which were admittedly completely different.

The above cases inspired the August 2022 decision of another division bench of the Delhi High Court in Sun Pharmaceutical Laboratories v. Hetero Healthcare Ltd. (“Sun v. Hetero”), where the court held that Hetero’s use of the mark LETERO could not be injuncted on the basis of Sun Pharma’s prior use of the mark LETROZ since the purported similarity between both the marks was only on account of the first six letters of the INN Letrozole, which was publici juris and not open to anybody’s monopoly.

These three decisions have a lot in common. Firstly, being division bench decisions, they have significant authoritative value. Secondly, the marks involved in the facts of all the three matters were heavily inspired from the names of their underlying APIs, which played a crucial role in the courts’ decisions to decline injunctions. Thirdly, and interestingly, all three decisions are also subject to scrutiny on common grounds, i.e., the courts in all the three cases, in addition to placing reliance upon Section 13 of the Act, also placed reliance on extraneous factors to carve out distinctions between the marks, such as price points, specialized nature, prescribing instructions, presence of similar infringing marks on the Trade Marks Register containing common elements, etc., all of which were expressly discouraged by the Supreme Court in Cadila. In fact, the decisions in Astrazeneca and Sun v. Hetero also erringly took into account the defendants’ submissions of genericity of the plaintiffs’ marks, when the impugned marks were themselves evidently heavily inspired from the INN of the underlying APIs, thereby rendering them incapable of adverting to a Section 13 defence, on account of principles of estoppel and approbation and reprobation, which have been upheld in various decisions.

Despite the above grounds which make these decisions susceptible to reproach, various courts have since passed orders denying injunctions on the basis of these decisions, which have cumulatively diluted the Supreme Court’s ratio in Cadila (supra). Having been pronounced well over a decade ago, the decisions in Astrazeneca (supra) and Schering Corp. (supra) have formed the basis of numerous decisions such as Bharat Biotech v. Optival Health, Corona Remedies v. Franco-Indian Pharma, Sun Pharma v. Intas Pharma, Disposafe Health and Life Care v. Hindustan Syringes and Medical Devices, to name a few recent ones, where courts not only deemed the mark alleged to be infringed as generic, but they, without exception, also took into account the factors such as the products being scheduled drugs, price differences, difference in therapeutic indication, and so on for determining dissimilarity between the rival marks, contrary to the ratio in Cadila (supra).

A similar decision came from the Delhi High Court earlier this year in Modi-Mundipharma Pvt. Ltd. v. Preet International Pvt. Ltd. & Anr, where, pursuant to a full-fledged trial, the court, gathering from the observations in Schering Corporation (supra) and Sun v. Hetero (supra), concluded that the mark FEMICONTIN could not be injuncted for being similar to the mark FECONTIN-F, simply because the words FE and CONTIN, common to both medicines, were, in the court’s opinion, descriptive of Iron and the Continuous Drug Delivery System, both of which were the features of the rival products. Even the plaintiff’s prior registrations for its FECONTIN-F and CONTIN series of marks did not persuade the court to rule in favour of the plaintiff, and the suit was accordingly dismissed. Further, similar to the facts in Astrazeneca (supra) and Sun v. Hetero (supra), the court failed to give due weightage to the fact that the defendant couldn’t allege that the plaintiff’s mark was descriptive or generic as it had itself applied for registration of the FEMICONTIN mark.

This decision in Modi-Mundipharma is an example of why the general legal principle of foreclosure of a trademark from protection from infringement merely on the basis that it consists of an INN in some form should not be extracted from the decisions in Astrazeneca (supra), Schering (supra) and Sun v. Hetero (supra). Carving out general principles from these cases without duly appreciating the unique facts involved may lead to a situation where even apparently deceptively similar marks such as FECONTIN and FEMICONTIN, might be deemed dissimilar on some cavil or the other. The reasoning employed by the court, that since FE and CONTIN, which make up the Plaintiff’s mark, are both individually descriptive, a mark formed by combining them would also be descriptive, appears to not take into account the fundamental principle of trademark law that microscopic examination of marks by fragmenting them into components should be avoided, as enunciated in various Supreme Court decisions. In fact, a completely contrary law can be winnowed from the Bombay High Court decision in Sun Pharma Laboratories v. The Madras Pharmaceuticals & Anr., where, while holding the defendant’s METOSAN mark to be infringingly similar to the plaintiff’s METOSARTAN mark, notwithstanding the fact that METOSARTAN was, admittedly, coined by combining the INNs Metoprolol Succinate and Telmisartan, the court held that Section 13 of the Act could not be read to hold a combination of generic names as unregistrable, and such a reading would be overbroad and without statutory support. A somewhat similar opinion, though not in the context of pharmaceuticals, can also be extracted from a recent Single Bench decision of the Delhi High Court, where it has been pertinently observed that two ordinary words, though completely lacking in distinctiveness as being generic, can very well be distinctive when combined together.

While Section 13 of the Act undoubtedly places a statutory bar on registration of marks which consist of or resemble INNs, its applicability is limited to the issue of validity of the registration in question alone, and nothing forecloses a trademark owner’s right to seek protection by alleging passing off, or to allege that the mark, though generic at the time of adoption, has acquired secondary significance owing to substantial use.

The above decisions highlight yet another aspect, which may require improvement by courts in India. It is noticeable from all of the above cited decisions that while the courts, at a prima facie stage, do not hesitate in venturing into the inquiry of whether the marks are descriptive or generic, courts very rarely examine whether the plaintiff’s mark could have acquired distinctiveness by virtue of use. Courts, at times, also overlook the fact that even the remote possibility of deception as regards pharmaceutical products can adversely affect human health. Depending upon factors such as the rival products being scheduled drugs available only upon prescription, price differences, seriousness of the ailment, presence of similar marks on the Trade Marks Register, and the difference in therapeutic indication of both the products, all constitute an inherently flawed approach, ridden with pitfalls. Such approaches ignore the realities of the Indian market where most medicines are handed over the counter by pharmacists without requiring production of any prescription slips. Drugs are also, often, handed out to consumers against indecipherable prescriptions. Further, prescriptions are also, now-a-days, being handed over telephone and through online e-pharmacies, where purchasers are required to upload pictures of their prescriptions.

Thus, such factors, which constitute the reality of the Indian pharmaceutical markets, make it incumbent upon courts to factor in the risk of wrong administration of drugs earnestly, without allowing themselves to get entangled in statutory intricacies. Such a risk is accentuated by the peculiar nature of the Indian pharmaceutical industry where generic substitutes of branded drugs were not required to undergo bio-equivalence testing until very recently, making the threat of insufficient or over-administration of a drug, all the more plausible. Courts should be cautious to not place too much trust on the decisions of an ordinary chemist, anxious patient, or weary physician so as to credit them with too great a capability of invariably drawing careful distinctions between ostensibly deceptive similar marks.

Urfee Roomi is a Partner and Jaskaran Singh an Associate at Sujata Chaudhri IP Attorneys.