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Pharmaceutical Trademarks 2020/2021 India LexOrbis Dheeraj Kapoor and Aprajita Nigam Pharmaceutical Trademarks 2020/2021 A Global Guide India LexOrbis Authors Dheeraj Kapoor and Aprajita Nigam Selection, clearance and registration devoid of distinctiveness, except where the The Ministry of Health and Family Welfare mark has acquired distinctiveness or secondary and the Ministry of Chemicals and Fertilisers significance on account of its use, publicity play a major role in regulating the healthcare and popularity. However, a feature peculiar and pharmaceutical sectors. The agencies to pharmaceutical trademarks is that these primarily responsible for regulating the import, marks are often derived from the name of manufacture, distribution and sale of drugs in the concerned ailment, organ or chemical India include: compound contained in the relevant drug, • the Central Drug Standard Control and may thus lack inherent distinctiveness. Organisation; Therefore, the deciding factor is the brand • the State Drug Standard Control owner’s evidence of secondary meaning. Organisations; and Section 13 of the Trademarks Act 1999 • the Drug Controller General of India (DCGI), prohibits registration of the names of chemical established under the Drugs and Cosmetics elements, compounds and international non- Act 1940. proprietary names (INNs) (which have been declared by the World Health Organisation Further, the Drugs and Cosmetics Rules and notified by the registrar of trademarks in 1945 framed under the Drugs and Cosmetics 2012), or which are deceptively similar to such Act set (among other things) the prescribed names. If an INN is erroneously registered standards and procedural guidelines for as a trademark, it is liable to be cancelled. its operation. Since INNs are generic names of active The pharmaceutical industry notably pharmaceutical ingredients, they can be used accounts for the most trademark registration by all drug manufacturers. The existence of a applications of any sector in India. large number of trademarks similar to INNs Indian trademark law prohibits registration highlights the need for greater scrutiny of of marks which are descriptive in nature or pharmaceutical trademark applications. www.WorldTrademarkReview.com Pharmaceutical Trademarks: A Global Guide 2020/2021 | 29 INDIA LEXORBIS LEXORBIS INDIA In order to increase their competitive edge, Parallel importation may sometimes be brand owners are developing more advanced followed by repackaging. At this stage, Section and innovative ways to distinguish their 30(4) of the Trademarks Act comes into effect. products. Conventional marks include those This section mandates that a brand owner consisting of letters, numerals, words, logos, may oppose further dealings in the goods images or combinations of these elements. where the condition of the goods has been Notable non-conventional marks in the changed or impaired after having been put on pharmaceutical field include shape marks, the market. Therefore, if the repackaging of colour marks and holograms. Certain shapes pharmaceuticals causes any material change and sounds have already been registered as or impairment, the brand owner may object to pharmaceutical trademarks in India. Although such repackaging; otherwise, the repackaging the concept of sound marks is not new, they must duly conform to the relevant packaging have been granted explicit recognition under and labelling requirements. the Trademarks Rules 2017 (as notified on 6 In early 2019 the Department of Industrial March 2017); as such, businesses would be wise Policy and Promotion released a draft to seek exclusivity for their musical or other e-commerce policy to strengthen enforcement auditory branding and marketing methods in mechanisms for IP owners. Although the steps order to appeal to consumers in today’s highly taken are generally welcome, there are some disruptive market. One such sound mark clauses which require further contemplation. registered in India for pharmaceuticals is the Clause 3.12 allows a trademark owner to ask sound of ‘HI’ ‘SA’ ‘MI’ ‘TSU’ sung over certain the e-commerce platform not to list any of its musical notations and applied on a ‘proposed products without prior concurrence, while to be used’ basis by Hisamitsu Pharmaceutical Clause 3.13 requires online marketplaces to seek Co Inc of Japan. The protection of colour trademark owners’ authorisation before listing combinations is recognised in India, but the any products which will have an impact on possibility of claiming exclusivity over a single public health. These clauses could conflict with colour remains a grey area. the principle of ‘exhaustion of rights’, which allows traders to sell genuine products freely. Parallel imports and repackaging Where a person lawfully acquires goods bearing Anti-counterfeiting and enforcement a registered trademark, the sale of or other Prevention dealings in those goods by that person or its Brand owners may consider the following agent will not amount to infringement in India. points for effective prevention: The concept of parallel imports is inextricably • Ensure that inherently distinctive marks are linked to the principle of exhaustion of rights. adopted and protected for the purpose of In respect of trademarks, India follows the effective deterrence. principle of international exhaustion of • Use the mark in such a manner that its rights as observed by the Division Bench genericide is avoided at all costs. of the Delhi High Court in Kapil Wadhwa v • Collect and preserve all documentary Samsung Electronics. evidence of use and publicity of a For the import of any drug, an import pharmaceutical trademark in order to build a licence is required from the DCGI, which winnable case in future. is valid for three years. No drug which is • Maintain a clear record of all such prohibited in the country of origin can be documents for each brand and accumulate imported into India, except for the purpose of them to show continuity. examination, tests or analysis. The import of a drug is prohibited where it: The available remedies against falsification • is not of standard quality; and false application of trademarks (including • is misbranded, adulterated or spurious; counterfeiting) are imprisonment for a term • may involve any risk to human beings or of six months to three years and a fine of animals; or Rs50,000 to Rs200,000 (approximately $725 to • does not hold the claimed therapeutic value. $2,885). These offences are cognisable under 30 | Pharmaceutical Trademarks: A Global Guide 2020/2021 www.WorldTrademarkReview.com LEXORBIS INDIA The import of spurious drugs entails a punishment of imprisonment for up to three years and a fine of up to Rs5,000 Indian criminal law procedure, which enables stricter. The import of spurious drugs entails a a police officer of a rank not below the deputy punishment of imprisonment for up to three superintendent of police to search and seize years and a fine of up to Rs5,000 ($73). Further, counterfeit stocks and arrest accused persons Section 11(2) of the Drugs and Cosmetics Act in possession of such stocks without a warrant provides that the commissioner of Customs or or prior court permission. However, the officer an authorised officer may detain any imported must obtain an opinion from the registrar of package suspected to contain any drug whose trademarks before any action is taken on a import is prohibited. complaint filed by the rights holder. The manufacture, sale or distribution of any spurious drug which is likely to cause a person’s Enforcement death or grievous harm on consumption will For the purpose of enforcement, a civil action entail imprisonment of 10 years to life, along for infringement of a registered trademark with a fine of no less than the greater of Rs1 may be initiated alongside a criminal action million ($14,410) or three times the value for effective deterrence. Through a civil action of the drugs confiscated. In all other cases the rights holder can also obtain remedies involving spurious drugs, the penalty will in the form of an injunction, seizure and be imprisonment of seven years to life and a destruction of infringing stock and damages (as fine of no less than the greater of Rs300,000 the remedy of damages is not available under a ($4,325) or three times the value of the criminal action). drugs confiscated. If the mark is not registered in India, a On 10 May 2019, the Delhi High Court in civil action for the tort of passing off can Sun Pharma Laboratories Ltd v Ajanta Pharma be initiated, provided that the mark carries Ltd ruled that the test for infringement substantial goodwill and reputation in the and passing off for nutraceutical products relevant markets and actual or potential injury is the same and as strict as that applicable will or is likely to be caused to the trademark for pharmaceuticals. owner as a result of the misrepresentation. On 6 February 2019, in Curewell Drugs & In respect of pharmaceutical trademarks, Pharmaceuticals Pvt Ltd v Ridley Life Science specific actions are also available under the Private Ltd, the Delhi High Court not only Drugs and Cosmetics Act, read with the Drugs awarded appropriate damages and costs and Cosmetics Rules. As one of the main against the defendant along with permanent objectives of this legislation is to ensure that injunction against manufacture and sale of publicly available drugs are safe and efficacious, infringing pharmaceutical products bearing it also stipulates criminal penalties for offences identical trademarks and packaging, but relating to
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