The Indian Pharmaceutical industry has been on a steady rise over the previous few years. As per the publication of India Brand Equity Foundation (IBEF) in July 2020, the Indian pharmaceutical sector contributes over 50 percent of worldwide demand for various vaccines, 40 percent of generic demand within the US and 25 percent of all medicine within the UK. The publication also reports that India’s domestic pharmaceutical market turnover reached Rs 1.4 lakh crore (USD 20.03 billion) in 2019 and the pharmaceuticals export from India stood at USD 20.70 billion in FY20. Further, as per an analysis conducted by Mckinsey, the Indian pharmaceuticals market was expected to grow to USD 55 billion by 2020. Owing to the dominant role played by the pharmaceutical sector within the economy, it is evident that its impact would cause ripples in all the fields, including intellectual property. The pharmaceutical industry is one of the forerunners in trademark filings worldwide owing to the consistent progresses in this sector. GlaxoSmithKline has approximately 110,000 registered trademarks and spends about £1.5 million (US$2.8 million) annually on renewals. Trademarks play a vital role for healthcare professionals, pharmacists and patients in the pharmaceutical industry owing to their impact on the health and safety of a patient by avoiding name related medication errors and as a marketing instrument for companies. Any margin for error in the nomenclature of a drug, like similar sounding or looking names or any similarity in packaging, trade dress etc. can sway the purchasing decision of a patient, wherein purchase of a wrong drug may prove to be fatal. Thus, Courts are stringent in this regard and exert extra caution while adjudicating matters pertaining to the pharmaceutical industry, keeping the general public welfare and public health in highest regard. In this article, we aim to cover the legislation and jurisprudence surrounding trademark protection in the pharmaceutical industry in India.
Nomenclature of a pharmaceutical product:
All pharmaceutical products have multiple names: a chemical or scientific name, a generic or non-proprietary name and a brand name, which is commonly known and used by the public. For example, the chemical name of the common antidepressant Prozac is N-methyl-3-phenyl-3[4-(trifluoromethyl) phenoxy]propan-1-amine, which is naturally difficult to market, and its generic name is fluoxetine. As per the WHO Guidance on International Nonproprietary Names (INN), each INN is a unique name that is globally recognized and is public property and trademarks cannot be derived from INN and, in particular, must not include their common stems. To concur with this, Section 13 of the Indian Trade Marks Act, 1999 mandates that words that are commonly used for a single chemical element or compound or INNs are not registrable as trademarks. However, brand names or common names are registrable, and a stricter approach needs to be adapted for safeguarding the same to prevent any likelihood of confusion or deception. Pharmaceutical companies incessantly derive brand names for their products from the prime ingredient or the principal component, the disease or ailment the medicine seeks to cure, the related organ, name common to the product or a part of the generic name to circumnavigate the bar under Section 13. However, chances of confusion arise owing to this practice since several companies end up incorporating similar parts of names, which thereby give rise to deceptive similarity or identity of marks.
Non-conventional protection of pharmaceutical products:
Pharmaceutical companies also rely on non-conventional trademark protection for their products besides the name of the product itself. The most renowned in this regard is the protection of Nexium, the heartburn medicine, as the “purple pill” by AstraZeneca. The distinctive purple and gold colour of the medicine has been registered and has also prevented other manufacturers from launching purple coloured medicines for heartburns in the United States of America. Another known example is of the distinctive blue colour and the diamond shape of the Viagra tablet by Pfizer, on the basis of which, the Court had ordered a Defendant to change the blue colour of its packing and tablet, which was similar to that of Viagra’s. However, in another case, the Court has held that distinctiveness of a medicine is owing to the name and not owing to the shape or colour since consumers purchase on the basis of advice of doctors or on prescription and on the basis of the name and not colour or shape.
Position taken by Courts:
The issues of trademark infringement and passing off are very important in the pharmaceutical industry owing to the impact on the health and life of an individual and the hazardous effect in case of confusion or deception. In a developing country like India, possibility of confusion is high and thus, stricter approach and stringent rules are applied for comparison of pharmaceutical trademarks, as compared to other sectors, since any confusion may result in harmful consequences to the health of consumers. The Courts consider even minute chances of confusion or deception associated with the use of deceptively similar marks and rely on the principle of judging similarity from the viewpoint of a common man with average intelligence, and imperfect memory, who will not go for splitting the names and analysing their individual meaning before purchasing, but would rather depend upon his memory, or what he has learnt from someone about the product. Some of the key takeaways from judgements in the pharmaceutical industry of various Courts have been enumerated below:
The Supreme Court Cadila case is the leading authority on adjudicating similarity or identity of pharmaceutical trademarks which has given a conclusiveness to the position that lesser degree of proof is desirable to prove confusion in respect of medicinal products in public interest. The Court observed that confusion between medicinal products can be life threatening, and also emphasized the necessity for stricter standards in matters involving pharmaceutical products.
The Court also made the important observations in this regard that physicians and pharmacists are trained people, yet they are not infallible, and doctors are under tremendous pressure placed by society and thus, there should be clear indicators for distinguishing medical products. Moreover, purchasers of goods may not have knowledge of English or the language in which the trademark is written, and slight differences in spellings of different words may sound phonetically the same.
The Court further observed that adjudicating authorities should consider requiring the applicant to furnish an official search report from the Trade Mark office pertaining to the trade mark in question which will enable the drug authority to reach a correct conclusion.
The Court penned down certain factors for determining deceptive similarity between pharmaceutical trademarks, which include:
- The nature of the marks i.e. whether the marks are word marks, label marks or composite marks;
- The degree of resemblances between the marks, i.e. similarity of idea or sound;
- The nature of products;
- The class of purchasers, their education and intelligence and the degree of care they are likely to exercise in purchasing and/or using the goods;
- The mode of buying the products or placing orders for the products; and
- Any other surrounding circumstances which can be relevant in the extent of dissimilarity between the competing marks.
The Delhi High Court has also given some important rulings in this regard and in one of the cases has observed that trademark/name disputes in the pharmaceutical sector must be seen through the prism of public interest where the correct manufacturer is held responsible in case there is any problem with its pharmaceutical product and conversely no innocent manufacturer is made to suffer an injury because of the same name. Further, the Court has placed reliance on aural similarity between medicinal products and while examining the similarity between GENTAC and ZANTAC/ZINETAC marks has observed that a large percentage of Indian population is unfamiliar with nuances of the English language and may be confused. Moreover, in one of the cases, the Court has applied the principle of ‘likelihood of confusion’ on the basis of deceptive similarity of ‘Bectodine – M’ and ‘Betadine’ marks, trade dress and packaging as well as identity of colour scheme, get-up and layout. The Court has also observed that although medicines are used to treat the same ailment, this does not negate the possibility of side effects and in a recent case, while reiterating that marks have to be compared as a whole, has observed that even though the marks are used on products designed to treat different ailments and the ways in which the products are administered are significantly different, drugs may be sold through common channels and the consumer base is also to be considered. Further, relying on the Cadila judgement, the Delhi Court has also necessitated the need for drug authorities to consider requiring the applicant to furnish a search report from the Trade Marks Office for the brand name sought to be approved for the drug in question.
The Bombay High Court has observed that in case of pharmaceutical products, the test is of possibility of confusion and not probability of confusion and in a case regarding the marks ‘PACITANE’ and ‘PARKITANE’ for pharmaceutical preparations for treatment of Parkinson’s disease, the Court held that the goods were similar, the customers buying these goods as well as the trade channels are also the same. Further, the Bombay Judicature has also come down heavily on ‘habitual’ infringers and in a recent case, imposed exemplary costs of INR 1.5 crores (approximately USD 200,000) against the defendant, who was ‘habitually’ committing trademark infringement of pharmaceutical products. The Court gave a grave observation in the matter – “Drugs are not sweets. Pharmaceutical companies which provide medicines for health of the consumers have a special duty of care towards them. These companies, in fact, have a greater responsibility towards the general public. However, nowadays, the corporate and financial goals of such companies cloud the decision of its executives whose decisions are incentivized by profits, more often than not, at the cost of public health. This case is a perfect example of just that.” .
Current situation owing to the Pandemic:
There have been a plethora of filings for “CORONA” or “COVID” comprising trademarks during the pandemic, such as “COVID RELIEF”, “COVID SANJEEVANI”, “CARE CORONA”, “GO CORONA”, “CORONA SANITISER”, “ANTI-CORONA”, etc, which have resulted in unprecedented business opportunity within the pharmaceutical and allied industries. The judgement of the Supreme Court in Hamdard Dawakhana (Wakf) Lal Kuan gains importance in this regard wherein it was observed, “object of the Act, as shown by the scheme of the Act, is the prevention of self-medication and self-treatment and a curb on such advertisements is a means to achieve that end.” In view of this judgement, Examiners need to adopt an additional cautious approach while examining such applications since owing to the rampant fear and the lack of knowledge, consumers may purchase products, which may have nothing to do with the treatment of the virus and may cause more harm than the pandemic itself. Presently, most of these marks are at the Examination stage and the stance taken by the IPO is keenly awaited.
Post Cadila judgement, the settled position is that the decision of the adjudicating authority should vary from case to case owing to the overall facts and circumstances of the case. The Courts should take a broader view while deciding cases pertaining to pharmaceutical products and also pay attention to other factors such as medical abbreviations, use of handwritten or oral prescriptions, drug in question is prescription only or available over the counter etc. Summarily, owing to the impact on human life, Indian courts are adopting a stricter approach to adjudicate likelihood of confusion in pharmaceutical trademarks. Thus, relying on the stance taken by various Courts, the following things should be kept in mind while choosing a brand name for pharmaceutical products:
1. Avoid terms or words which have become common to trade or are descriptive, as they might not serve as indicators of source but as merely indicative of the ingredients or ailments;
2. Avoid suggestive words or terms;
3. Conduct a search on the Trade Marks Registry website for prior registrations or applications to avoid the risk of infringement or passing off action;
4. Conduct a Google search to ascertain prior drugs in the market and avoid similar looking or sounding names or taglines, similar trade dress or packaging as earlier products; and
7. Avoid terms or marks which contain inert or inactive ingredients which may be misleading.