Big Pharma is a multi-billion dollar industry that acts as one of the cornerstones to a successful healthcare paradigm, while simultaneously pushing the envelope when it comes to technical and scientific advancement through a strong intellectual property portfolio. Its greatest challenge is striking a balance between financially exploiting its own trademarks to the maximum in an exclusive manner, while dispensing medicare services without disadvantaging any segment of its target market. The situation is exacerbated, not only by the differential application of trademarks in the pharmaceutical sector as it requires a higher standard of care, but also the intervention by Healthcare Regulation Agencies to ensure trustworthy, safe, distinctive drugs with a minimal likelihood of confusion.
A trademark is not simply a mark or a visual symbol that denotes the proprietor or the quality of a product, but goes far as crystallizing customer loyalty even after the expiration of a patent term for a medicament. The law, thus, rewards registration of trademarks with statutory remedies in case of infringement under Section 29(1) of the Trademarks Act, 1999 in an effort to reduce the risk of confusion on the rational layman having imperfect memory. Since identicalness and deceptive similarity can have fatal implications in the pharmaceutical industry, the judiciary has gone beyond the bare provisions of Section 9(2)(a) and Section 11(1)(b) containing Absolute and Relative grounds for refusal of registration respectively by not only placing a differential burden of proof on the plaintiff1 but also by shifting the onus on the applicant when denouncing the deceptive nature of an applied trademark.2 The Likelihood of Confusion Doctrine has further been jurisprudentially developed from prior precedents and the imputation of foreign rulings to protect the interests of the proprietor, medical professionals and end-user consumers.
The contention arises from the intended two-fold amelioration of constitutionalized health and business rights enshrined in Article 19(1)(g) and Article 21 of the Indian Constitution respectively, as it is difficult to reconcile regulation emanating from consumer protection law and fundamentally different intellectual property rights.3 Creating a rigid criteria to gauge at the confusion arising from similarity in the drug industry falters when compared to circumstantial determining of the impact of a possible co-existence of opposing signs.4 Likelihood of confusion is influenced by phonetic, design, packaging or pattern similarity, or treatment of the same ailment with an even greater room for error when verbally or self- prescribing by the average individual. Deception, after all, flows from something contained in the mark, or from the nature of its use or resemblance to a senior mark.5
The application of Section 13 regarding the prohibition of the registration of generic and chemical names in the above sector also poses a unique challenge in the realization of their trademark rights– drug monikers are primarily either ailment based or on the principal components amalgamated with associative pre-fixes or suffixes. Thus, what is trademarked is different from the actual name of the drug that is bought by consumers and this can understandably have an adverse impact on all the parties involved. A consumer's loyalty and logical inadequacy, among other drawbacks, must not be allowed to be abused and, the courts have tackled different elements through many cases- Cadila Healthcare Ltd. vs Cadila Pharma Ltd.6 where a lesser burden of proof was required as medicines are life-threatening, Ranbaxy Laboratories Ltd. vs Anand Prasad & Ors.7 where deceptively similar suffixes in drug names were held to be against public health and welfare, and Win Medicare Pvt. Ltd vs. Galpha Laboratories Ltd. & Ors.8 where it was adjudged that there was a high risk of confusion due to the similarity in trade dress, colour and packaging.
The European Court of Justice has taken a step further by offering clarifications on the nature of confusion, that, when read with Section 11(1) classifies the likelihood of being deceived into direct confusion where the public confuses the sign and the mark in question, indirect confusion or association where the public makes a connection between the proprietor of the sign and those of the mark leading to confusion, and strict association where the similarity of the mark and the sign bring to mind the memorable mark even though the two aren't necessarily confused. Furthermore, it has also provided elements in Sabel vs Puma9 which builds on the Evershed Formula, without boxing in the discretion of the adjudicator or excluding extraneous circumstances. The basis for evaluation of the risk of confusion is dependent on whether the infringed and the infringer's drug treats the same disease, as the consumer base is different if the ailment is different; the amount of time consumed in ensuring correct administration of the drug by end-users and pharmacists; whether it is over-the-counter or a prescription based medication as, the former would require greater attention leading to a lower requirement of proving deceptive similarity while the inverse would be true for the latter; and who the actual consumer is, and the extent to which the doubtful impression is offset by knowledge and skill in the field.
The above cannot be considered in isolation, and couching the takeaways of the Smith Hayden Application10 within the Amritdhara Pharmacy case,11 which together forms the bedrock for testing confusion, produces a lesson where it is vitiated if: a substantial number of the senior mark's customers are not confused or deceived even if the applicant uses his mark in the fair and normal use of the registered goods, keeping in mind the relative circumstances of the case, the average intelligence and imperfect recollection of the layman and that deceptive resemblance can only be established by answering who the mark is intending to deceive and the rules of comparison to establish such similarity. The ruling in the Lipidrol12 case is a notable exception as it was a departure from the expectation of a low level of attention from the consumers as doctors were brought within its confines, but that doesn't take into account uninformed end-users, possibility of stress, and mistakes creeping into their considerations.
It is imperative that health should be of greater importance than intellectual property and, the lack of elaborative confusion/ association related provisos in contemporary Indian trademark law prevents the adequate reduction of risk of likelihood. Big Pharma, as well as end-users, are in urgent need of such clarifications to avoid a negative impact on goodwill, life and business. Now is a good time as any to look West for answers.
1 M/S S.M. Dyechem Ltd vs M/S Cadbury (India) Ltd on 9 May, 2000
2 National Sewing Thread Co. Ltd vs James Chadwick & Bros. Ltd. 1953 AIR 357
3 el Monaguillo SA v Province of Buenos Aires (Supreme Court, 1982)
4 Química Montpellier S.A. vs. Investi Farma S.A.", Case No. 440/2013, Setpember 9, 2016
5 Bass Ratcliff & Gretton Ltd. vs Nicholson & Sons Ltd. (1932) 49 RPC 88 p.107
6 Appeal (Civil) 2372 of 2001 and Special Leave Petition (Civil) 15994 of 1998
7 2004 (28) PTC 438 IPAB
8 I.A. Nos. 22711, 26365 of 2014 in CS(OS) No. 3507 of 2014
9 C-251/95 SABEL BV vs Puma AG, Rudolf Dassler Sport 11 November 1997
10 Smith Hayden & Co. Ltd.'s Application (1946) 63 RPC 97, p.101
11 Amritdhara Pharmacy vs Satya Dev Gupta AIR 1963 SC 449
12 Decision No. 2002/7864 E. 2003/64 K dated 13.01.2003 of the Supreme Court of Appeals (Turkey)
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