Trademark Registration & the Pharmaceutical Industry: Lawyers Advice
Pharmaceutical Industries are one of the sensitive sector in the world. The major issue with these industries is protection of their rights and its usage. There are two sides to this. One, to secure them from being misused and the other, to get benefits out of their inventions. Now, it has become a general practice to get a Trademark on a drug either by its principal component or by the name of the disease for which it is used. For safeguarding the rights of these industries, Section 13 of the Trademarks Act, 1999 strictly prohibits the use of ‘Generic names’ and ‘Chemical names’ as a Trademark. It is the paramount duty of pharmaceutical industries that customers should easily differentiate between the products on the basis of the name. Therefore, it is required of them to invest more in the Trademarks which they usually tend to ignore. Obtaining brand registration and/or brand name registration and/or company logo registration is a complex and challenging task and should not be dealt in a callous manner. Applying for a trademark in India is an online process, however, the same involves the successful execution of a ot of steps which are discussed in detain herein below.
Classification for Trademark Registration
The three classes under which the Pharmaceutical Industries can apply for registration of a Trademark are as follows:
• Class 5: It majorly deals with Pharmaceutical preparations; sanitary preparations for medical purposes; dietetic substances adapted for medical use including Nutritional supplements, tonics [medicines], sulphonamides [medicines], serotherapeutic medicines, medicines for human purposes, medicines for alleviating constipation, capsules for medicines, drugs for medical purposes, chyawanprash (ayurvedic medicine), shilajeet (ayurvedic medicine), yeast for pharmaceutical purposes, turpentine for pharmaceutical purposes, tissues impregnated with pharmaceutical lotions, thymol for pharmaceutical purposes, tartar for pharmaceutical purposes, syrups for pharmaceutical purposes, sunburn preparations for pharmaceutical purposes, stick liquorice for pharmaceutical purposes, starch for dietetic or pharmaceutical purposes, pharmaceutical preparations for skin care, royal jelly for pharmaceutical purposes, rhubarb roots for pharmaceutical purposes and so on.
• Class 10: It provides registration for Surgical, medical, dental and veterinary apparatus and instruments, artificial limbs, eyes and teeth; orthopedic articles; suture materials including syringes for injections, syringes for medical purposes, receptacles for applying medicines etc.
• Class 35: It includes services of retail or wholesale for pharmaceutical and sanitary preparations and medical supplies.
Filing of Application for Trademark Registration
The Trademark Application can be filed by a person who claims to be the proprietor of the goods or services in respect of which the registration is sought. The Application should be made in TM-A as per Rule 23 of Trade Marks Rule, 2017. Along with the Application, the statement of use (Rule 25 of Trade Marks Rule, 2017) i.e. duration since when the mark has been used should be clearly specified. The goods or services in which the proprietor deals should be specific enough to not to confuse the Registrar (Rule 26 of Trade Marks Rule, 2017).
The Application can be made either online or offline but the former is efficient and faster. Once you receive the acknowledgement you can use the symbol (TM) beside the Trademark. When we have completed all the procedural formalities accurately then Application status is seen as formalities check pass but if the documentation and formalities are incomplete then the status is seen as formalities check fail which further requires compliances of the Trademark. Next, the Application is sent for examination to check the reliability of registration. Under this status examiner checks the compliances of the Application with the provisions of Trademark. If the Application is accepted, it gets registered under the Trademark Registry. In case the examiner raises objections against the registration of your Trademark, then a reply must be filed within one month from the date of receipt of the hard copy of the notice. But if the party fails to do so, the Application stands abandoned.
The following documents are required for the registration of of a Trademark by a Pharmaceutical Company:
• Authority Letter or the Power of Attorney along with Board Resolution in favour of the Trademark Agent or Attorney;
• Details about the Company;
• Principal or Registered Place of Business;
• Mobile No. & Email address of an Authorized Person of the Company;
• Copy of Identity Proof & Address Proof;
• User Affidavit is required by Trademark authorities for confirming the use of Trademark by the applicant;
• Certificate of operating as a small enterprise (if applicable);
• Certificate registered for Start-up (if applicable)
Objections raised under Section 9 of the Trademarks Act, 1999
Trademark Applications are rejected in whole or in part in accordance with Sections 9 and 11. First, it is clear that Section 9 has been added to the Trademarks Act to prevent monopoly of the traders that other traders would legally want to use.
Section 9(1)(a) prohibits Trademark registration, which are devoid of any distinctive character. Words or words that actually describe one person’s goods should not apply to another person’s goods. There are two types of distinctiveness: Inherent and Acquired. To be distinctive or capable of distinguishing the goods, a Trademark may have unique characteristics that can distinguish one person’s product from another.
Section 9(1)(b) prohibits registration of Trademarks, which consist solely of marks or indications, subject to the kind, quality, quantity, intended purpose, value, geographical origin or the time of production of the goods or other characteristics of the goods or services. This provision applies to both descriptive and non-distinctive marks in relation to the goods or services for which the protection is sought. While analyzing a mark, the word should not be viewed in its strict grammatical significance, but as it would represent to the public at large and form an opinion of what it connotes.
Finally, Section 9(1)(c) constitutes an exception to marks or indications which have become customary in the current language or in the bona fide and established practices of trade from being registered under the Act. Clause (c) to Section 9(1) is included primarily to protect the free use of indications or marks already in use in the trade, from being monopolized as a Trademark.
In many cases, the Indian Courts are aware of the risks associated with similar/ deceptively similar pharmaceutical Trademarks. In Bio-Chem Pharmaceutical v. Astron Pharmaceuticals, 2003 (26) PTC 200 (Delhi), the Delhi High Court enumerated potential adverse consequences that may occur due to confusion in the pharmaceutical space. The Court in this case observed that trade mark/name disputes in the pharmaceutical sector must be seen through the prism of public interest where the correct manufacturer is held accountable 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.
The Delhi High Court in Bharat Biotech International Ltd. v. Optival Health Solutions (P) Ltd., CS (COMM) 1248/2018 & IAs. 16073/2018, 16074/2018 and 1997/2019 ,the plaintiff had Trademarked the terms ‘TCV’ and ‘Typbar–TCV’ in 2012 in relation to a Typhoid vaccine for children and that the defendants at the end of 2018 started promoting a similar Typhoid vaccine, named ‘ZYVAC-TCV’ which was similar in composition to their product. As a result, the plaintiff filed for permanent injunction. The previous judgements of the Delhi High Court had repeatedly held that the first use of a descriptive word as a brand mark, the users cannot register it as a mere Trademark. Regarding the similarities between the two competing product names, the Courts have put forth that the words “TYPBAR” and “ZYVAC” after excluding ‘TCV’ as a Trademark, have no deceptive similarity or confusion between the words either phonetically or visually. Similarly, there was found to be no deceptive similarities in the packaging of the two products. The defendant’s contention that they were not the first ones to adopt the words ‘TCV,’ was not denied by the plaintiffs and thus, the Court found the earlier entity responsible for coining the term in 2009 and used the existence of third parties selling medicinal products with the term ‘TCV’ as a sign that different products with this term can coexist in the market without confusion. The Court rejected the plaintiff’s Application on insufficient grounds to issue an interim relief.
Objections raised under Section 11 of the Trademarks Act, 1999
Section 11 includes relative grounds of refusal that a mark shall not be registered:
• If the mark causes likelihood of confusion on part of the public i.e. likelihood of association with the earlier Trademark;
• If the mark is identical to a well-known Trademark in India and subsequent use may affect the distinctive character of the well-known Trademark;
• If the mark’s use in India is liable to be prevented by law of passing off or copyright law;
The provision further envisages that if the description of goods are different then refusal will not be justified. However, if the mark is likely to be deceptive or cause confusion registration may be refused. In other words, where there is an existing similar Trademark in the Trademark register the Trademark shall not be registered.
In a recent appeal filed in Sharmilee Kapur & Anr. v. Kiran Bharekar, trading as TanMan, Civil Appeal No. 1238 of 2019, before the Bombay High Court, the Court upheld the decision of the lower Court and refused to grant an ad-interim injunction against the respondent. The respondent was using the mark TANMAN in relation to ayurvedic treatment and research services. The appellants alleged that the respondent’s mark was similar to their registered mark, ATMANTAN – BE TRANSFORMED, which was in use in relation to human health, hygiene, beauty care and hospitality services. Referring to the settled position of law of comparing marks as a whole, the Court held that the rival marks did not bear any resemblance to one another in any manner – phonetically, structurally or visually – and, therefore, there would not be any confusion in the minds of the consumers. Further, the Court held that the rival services (ayurvedic treatment and research services vs. wellness resort services) under the parties’ respective marks were dissimilar. Thus, the Court held that no case for interference with the order of the lower Court was made out and dismissed the appeal.
In the case of Yogi Ayurvedic Products Pvt. Ltd v. The Yogi & Ors. IP SUIT (L) No. 1604 of 2021, the Bombay High Court passed an ex-parte ad-interim injunction in favour of the Plaintiff, inter alia, restraining the Defendants from using the mark “THE YOGI” and the website www.theyogi.store. The Plaintiff claimed that they came across the Defendant’s Trademark Applications for the mark “THE YOGI” in relation to similar ayurvedic products and herbal preparations on a ‘proposed-to-be-used’ basis. Upon investigation, they discovered the Defendant’s online presence through their website www.theyogi.store. It was found that the two marks were structurally, visually and conceptually similar. The range of products between both the parties were also observed to be exactly the same and the Court held that, “The range itself tells us that if any competitor introduce any similar product, the average consumer is bound to (i) mistake one for the other; and (ii) be led to believe that the new product actually emanates from the Plaintiff.” The Court held that the similarity between the domain names of the parties, was another reason to grant the Plaintiff relief.
Filing of Trademark Oppositions & Counter Statements
Opposition with respect to registration of a Trademark is mentioned in Section 21 of the Trademarks Act, 1999. The Application of opposition can be filed by any person, not necessarily the person who has the personal/commercial interest in the matter. The notice of opposition should be filed in the form TM-5 within 4 months from the date of publication of the Trademark journal in which the Application for registration of the Trademark was advertised or re advertised and as per the requirements mentioned under Rule 43 of the Trade Marks Rules, 2017. There are no specific grounds of opposition but the Applications are majorly filed on:
• The mark is a generic term for the associated wares or services (in any language);
• The mark is primarily merely a surname;
• The mark is confusing with another trademark, official mark, an Olympic mark or a geographical indication registered in India;
• The trademark is prohibited under the Emblem and Names Act, 1950;
• The mark is scandalous, obscene or immoral;
• The mark is customary in the current language or in the established practices of business;
• The mark is contrary to the law or is prevented by law;
• The mark contains matters that are likely to hurt the religious feelings of any class or section of people;
• Another party had prior use of the mark or a confusingly similar mark in India;
• The applicant used the mark only as a licensee of another party;
• The mark is devoid of distinctive character;
• The mark is descriptive in nature;
• Application for the trademark is made with bad faith;
• The trademark is likely to deceive the public or cause confusion.
A counter-statement is a reply to the notice of opposition which is required to be filed in TM-6 form within two (02) months. There is no extension provided by the TM Registry to file a counter-statement. So, if a Trademark applicant fails to submit a counter-statement within two (02) months of issuance of the Notice of opposition, the mark will be then deemed to be abandoned. This duration of two (02) months may be further extendable by one (01) month of getting the counter-statement, the opponent is required to provide evidences in affidavit form in support of the Notice of Opposition. Opponent may also opt to waive filing an Affidavit if it wants to rely on the facts stated in the Notice of Opposition. Regardless of the option chosen by the opponent, the opponent need to inform the TM Registry and the applicant at the specified time. In case the opponent fails to inform the same, the opposition proceedings would be treated as abandoned. Within two months of receiving evidence or information relating to the waiver from the other party, the applicant must provide evidence in support of its submitted counter-statement/Application. In this case, the applicant also has the option to waive the right to submit evidence.
Infringement of Trademarks
Trademark registration is not mandatory in India. However, registration only gives the right to sue the owner for “Trademark infringement”, “fraud” or any unauthorized use of a Trademark similar to the owner’s Trademark by any person not being the proprietor himself or a permitted user, in such a way as to cause confusion in the minds of the public with regards to the ownership and quality of the goods. It is a ‘Statutory Right’.
The Section 29 of the Trade Marks Act of 1999 provides for Trademark infringement. If in any way the rights of the Trademark owner are violated, legal action can usually be taken against the Trademark infringement. A civil action for infringement of a registered Trademark may be initiated alongside a criminal action for effective deterrence. In civil proceedings, rights holders may be entitled to compensation in the form of an injunction, seizure and destruction of infringing stock and damages (since no compensation is provided in criminal proceedings).
The grounds for proving a Trademark infringement are the intention to create confusion to mislead, and dishonest intentions. While infringements in other sectors might only lead to financial losses, infringements in the pharmaceutical sector often have serious and dangerous consequences on the health of consumers, sometimes fatal. Following are few cases showing the unprejudiced stand taken by the judiciary in dealing with drug related infringement cases.
In a recent suit of Sun Pharmaceutical Industries Lltd. v. Nukind Healthcare P. Ltd. & Anr., CS (COMM) 209/2021, order dt. 28.04.2021, based on its REVITAL mark and packaging, the Delhi High Court restrained the defendants, Nukind Healthcare P. Ltd. & Anr., from using the NUVITAL mark and its label/packaging/trade dress on/in relation to medicinal preparations/health supplements. The plaintiff contended that the defendants’ use of the deceptively similar mark NUVITAL and a similar color combination, get up, placement of features and trade dress of the NUVITAL product amounts to infringement of its REVITAL mark and copyright infringement and passing-off of the trade dress of the REVITAL label/ carton packaging. Based on the plaintiff’s arguments and documents on record and the nature of goods involved, the Court granted an ex parte ad interim injunction in the plaintiff’s favour. It also directed the defendants to file an affidavit indicating the steps taken by them to implement the order by issuing necessary directions to the chemist/stockists for recall of the products in question from the market and also disclosing the quantities and the last batch number of the products manufactured by them bearing the mark NUVITAL.
The Delhi High Court in Mankind Pharma Limited v. Novakind Bio Sciences Private Limited, CS (COMM) 188/2021, Order dt. 20.04.2021, restrained the defendant from using marks containing the word KIND on/in relation to medicinal and pharmaceutical preparations, based on Mankind Pharma Ltd.’s prior rights in the well-known mark MANKIND and other marks containing the suffix KIND as an essential or dominant feature of its family of marks. The plaintiff also alleged that, besides trade mark infringement and passing-off, the defendant was defrauding the public by using the ® symbol next to the mark NOVAKIND BIOSCIENCES, which was pending before the Registry, and the ™ symbol next to the mark DEFZAKIND, which was abandoned. The Court noted that, prima facie, the suffix KIND, being common to all the products of the plaintiff, has attained distinctiveness, and the defendant’s use of KIND as the suffix for its pharmaceutical products has the possibility of confusing the public into believing the products of the defendant to be those of the plaintiff. Given the nature of the products involved, the Court granted an ex-parte ad-interim injunction restraining the defendant from using marks identical/deceptively similar to the plaintiff’s marks.
In the case of Arudra Engineers Pvt. Ltd. v. Pathanjali Ayurved Ltd. & Anr. O.A. No. 258 of 2020 in C.S. No. 163 of 2020, the defendant, Patanjali, was restrained from using the word “Coronil” while marketing its product i.e., immunity booster tablets. The defendant contended that it had passed the test of clinical trials to cure coronavirus. Since the Plaintiff acquired registration of the Trademark ‘CORONIL- 92 B’ in 1993 in relation to Acid inhibitor for industrial cleaning, the Court held that the Defendant’s action amounted to infringement under Section 29(4) of Trademarks Act, 1999. The Court also opined that Patanjali’s use of the word ‘Coronil’ could mislead the consumers about treating the coronavirus through tablets. Thus, the Court forbade plaintiff from marketing its products under “Coronil” taking into consideration the reputation of the Plaintiff’s registered Trademark and the larger public interest.
Trademarks & Passing-Off
Passing-Off is a ‘Common Law Right’. This right is open to unregistered Trademark owners in the form of an action of ‘Passing-Off’. If a Trademark is not registered in India, a civil action for the tort can only be brought provided that the mark carries substantial goodwill and reputation in the relevant markets could cause real or potential damage to the Trademark owner as a result of the misrepresentation.
Thus, ‘Passing-Off’ is a form of common law tort, used to enforce unregistered Trademarks. The law prohibits a person from ‘Passing-Off’ or misrepresenting the goods or services of another as if they were their own. This term has not been defined anywhere in the Act but it finds the mention in Sections (27)(2), 134(c) and 135 of the Trademarks Act, 1999. It is based on the basic foundation of the law: ‘No one should reap the benefits of the labour of the other’. Unlike in an action for infringement, one cannot succeed simply by proving similarity or identity of marks. It must be shown that the use of a Trademark can lead to deception or confusion.
The Supreme Court in Satyam Infoway Ltd. case (2004 (6) SCC 145), established the following three elements for an action of Passing-Off: (a) The first element in an action for Passing-Off, as the phrase “Passing-Off” itself implies, that is to restrain the defendant from passing off its goods or services to the public as that of the plaintiff’s. This is not only an act to preserve the reputation of the plaintiff, but also an act to safeguard the public interest. The defendant must have sold the goods or provided services in a way that misled or may mislead the public, believing that the goods or services belong to the plaintiff. (b)The second element to be determined by the plaintiff is the defendant’s misrepresentation to the public and what must be determined is that the goods or services provided by the defendant may be mistaken in the eyes of the public as the plaintiff’s goods or services. In assessing the possibility of such confusion the Courts must take into account imperfect recollection of a person of ordinary memory. (c) The third element of a Passing-Off action is loss or the probability of it.
In Cadila Healthcare Ltd. v. Cadila Pharmaceuticals Ltd. (JT 2001 (4) SC 243), the Supreme Court identified several factors for determining an action of Passing-Off on the basis of unregistered Trademark. It held that factors like characteristics of the marks i.e. whether the marks are word marks or label marks, the extent to which they resemble between the marks phonetically similar and hence similar in idea, the nature of the goods in respect of which they are used as Trademarks, the similarity in the nature, character and performance of the goods of the rival traders, the class of buyers who are likely to buy the goods bearing the marks they require, the mode of purchasing the goods or placing orders for the goods and any other surrounding circumstances which may be relevant in the extent of dissimilarity between the competing marks are to be considered.
In M/s ITC Limited v. Nestle India Limited (C.S.No.231 of 2013), ITC introduced two varieties of Sunfeast Yippie Noodles i.e. one of which was “Magic Masala”. The defendant, Nestle adopted the name “Magical Masala” for one of their instant noodle product. As the term “Magic Masala” was not registered as a Trademark by the Plaintiff, it filed a Passing-Off suit against Defendant. The defendants confirmed that they were using the term “Magical Masala” as a flavour descriptor. The defendants further argued that “Magic” and “Masala” are the two most used terms in the culinary industry and therefore cannot be monopolized. The Madras High Court held that the terms “Magic” and “Masala” are terms commonly used in the Indian food industry and Indian culinary, therefore the same could not be monopolized by the Plaintiff or the Defendant. The Court further opined that even Plaintiff used the term “Magic Masala” as a flavour instead of a Trademark or sub-brand. Therefore, the Court inferred that ITC had used the term “Magic Masala” in an exaggerated way and could not monopolize it.
The gist of the concept of Passing-Off is that the goods are in effect telling a falsehood about themselves, which is calculated to mislead. The law in this area aims to protect traders from that form of unfair competition, including the use of false or deceptive means to obtain the benefits of the reputation that competing traders have already acquired.
Generic Medicines & their Trademarks
In the pharmaceutical sectors, it is seen that most of the medicinal/pharmaceutical products are named after their generic ingredients. However, such marks are generally considered weak or non-distinctive, because the affected component can be easily traced and it leads to customer confusion. These marks also run the risk of being adopted by other manufacturers whose medicines contain the same generic ingredient.
However, when the name of a Trademark is derived from its generic ingredient, an injunction won’t always be refused. Courts will compensate a party’s inventiveness in brilliantly begetting a mark from the name of its generic ingredient. In Wyeth Holdings Corporation v Burnet Pharmaceutical (Pvt) Ltd (AIR 2008 Bom 100), involving the marks FOLVITE and FLOV, the defendant claimed that:
• a combination of ‘Fol-’, representing ‘folic acid’, and ‘-vit’, representing ‘vitamin’; is included in the plaintiff’s mark FOLVITE
• just by the adding ‘-e’ to an abbreviation of the two words, the plaintiff cannot assert a monopoly over ‘folic acid’ and ‘vitamin’
The Bombay High Court dismisses the plaintiff’s contention and held that the plaintiff’s Trademark constituted a composite invented word, and that it was not open to the defendant to claim that the combination of common elements was done by breaking down the mark.
The Supreme Court in the recent case of Neon Laboratories Limited v Medical Technologies Limited ((2016) 2 SCC 672), while adjudging the plaintiff’s claim over the mark PROFOL – derived from the compound Propofol – commented that:
• a mark should normally involve a new creation; and
• if there is an existing word mark, it should not contain descriptive features of the product it should not bear descriptive characteristics relating to the product and should not be praised.
While recognizing the truth that in the pharmaceutical industry marks usually repeat and reflect the constituent composition, the Supreme Court held that, though this aspect may be good grounds for declining registration of the mark, it may nevertheless remain a favourable determinant in a passing-off action.
Trademark Registration of Nutraceuticals & Food Supplements
The current trend of healthy eating, healthy living and active lifestyle is increasing, and new products are constantly appearing in the market. This provides a dizzying array of options for eager consumers, but it also means that this is an excellent opportunity for the company to innovate in the field of nutrition. Investing in protecting innovation and developing brand recognition, while carefully avoiding liability for infringement, requires resources, but this investment is invaluable in protecting the right products with the right intellectual property rights.
In Sun Pharma Laboratories Ltd. v. Ajanta Pharma Ltd., CS (COMM) 622/2018, the Delhi High Court, rendered judgment on May 10, 2019, determining that the test methods to infringement and passing-off for nutraceutical products is the same as those applicable for pharmaceuticals, and granted an interim injunction against the Defendant’s use of the trademark GLOTAB. The Plaintiff filed a suit before the Delhi High Court for passing-off and infringement of its registered trademark GLOEYE, under which it sells a nutraceutical product used for age-related dimness of vision and diabetic retinopathy. The Plaintiff’s main contention was that the Defendant’s trademark is deceptively similar to GLOTAB, also being a nutraceutical product consumed for the same ailment, which may be confused for the trademark GLOEYE. It was further submitted that nutraceuticals are to be treated on par with pharmaceuticals and hence, a stricter test for determining trademark infringement and passing-off must be applied to nutraceuticals as laid down in Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd. (2001) 5 SCC 73 for pharmaceuticals. After carefully considering the law and the facts, the Court noted that nutraceuticals, like pharmaceuticals, are highly regulated products which cannot be manufactured without a license. The Court perused various factors (viz. licences, physical and physiological factors, diseases and disorders) and concluded that the nutritional food supplements and nutraceuticals are akin to medicines and pharmaceutical preparations. Accordingly, the Court held that the mere fact that these products are nutritional food supplements or nutraceuticals and are not pharmaceuticals in the strict sense is not convincing enough for adoption of a less stringent test. Pharmaceuticals and nutraceuticals are to cure diseases and disorders. They are both meant to address specific ailments. and to improve the health of patients. The mere fact that nutraceuticals contain ingredients derived from plants are termed so, , does not mean that a lenient test needs to be adopted in respect of these products. The effectiveness of the product and the consumer of the product are all the same, and the tests that apply to pharmaceuticals also apply to nutraceuticals.
Trademark Registration & the Challenges faced by the Pharmaceutical Industry in India
- Online Issues
a) E-Pharmacies & Online Medical Portals
With the advent of electronic pharmacies, online sales of counterfeit drugs have increased. In case of infringement or passing off, the owner not only has the right to claim damages against the seller or manufacturer of the counterfeit drugs, but may also sue the electronic pharmacy under the internet intermediary liability. Notice can be sent to these e-pharmacies to remove product-related infringing content. If e-pharmacies does not comply then a cause of action based on internet intermediary liability is available.
b) Domain Names
As in other industries, pharmaceutical companies can dispute and complain about domain names. In these cases, complaint can be registered on the National Internet Exchange of India. Because domain names are similar to Trademarks, similar remedies can be used for Trademark infringement and passing off relating to domain names.
- Research & Development Hurdles
The production of drugs that cannot be met by potential safety standards is risky, and drug research and development can fail after years of investment. It takes about 8-10 years from the date when the compound was first synthesized, even if those medicines clear development hurdles. As patented products emerge as important tool for intellectual property protection, pharmaceutical companies will have to shift their focus of R&D from development of new processes for producing known drugs towards development of a new drug/new chemical.
- Access & Availability Issues
Intellectual Property Rights IPRs have an important effect on health and consumer welfare by promoting more rapid diffusion of new drugs across countries. Studies of the timing of new drug launches across countries show that there can be long delays before newly approved drugs become available outside the country in which they are first approved. Indeed in many instances, new drugs are never launched in a country. Countries with weak IPRs and aggressive price regulation new drugs become available for sale (if at all) only with substantial delays.
However, identification of these temporal and geographic “gaps” in availability of new drugs is not straightforward. Because a single new active ingredient may be sold in a variety of chemically distinct yet clinically highly similar variations, or sold in combination with other drugs, or sold under different names, simply establishing whether or not a new drug is being marketed in a given country can be formidably difficult. Neither is it clear how to establish the timing of when a drug becomes available: historical records on regulatory approval are difficult to access, and regulatory approval may not correspond to the drug actually being distributed.
- Pricing & Consumption
It is very important to identify aspects of the regulatory and policy environments which influence pricing and consumption. These include price controls or other forms of price regulation which can take a wide range of forms, such as direct price controls or regulation of margins at various points in the distribution chain, regulation of rates of return, price controls based on benchmarking of manufacturer prices against comparator countries etc. Other important aspects of domestic pharmaceutical policy or market institutions include limits on access or consumption of drugs via formularies or other constraints on prescribing under government health plans or private insurance, utilization caps or reimbursement limits placed on specific drugs and operating on prescribers or patients, legal or regulatory frameworks that permit or encourage therapeutic substitution among drugs or brand-generic substitution within drugs by dispensing pharmacists.
It is a generally accepted fact that “every coin has two sides.” Meanwhile, with the increasing usefulness of intellectual property as a Trademark; misuse, abuse, and illegal activities are also increasing, which cannot be completely ignored, but there is a wise duty to establish legal and statutory principles for this. As mentioned above, infringement and passing off in the pharmaceutical industry have a devastating effect on human life and cannot be taken lightly. The Court is taking a similar position, which is evident from the discussion above. It clearly reflects the judiciary’s impartiality, careful analysis, and rigorous approaches to pharmaceutical brands involving public health and welfare. The entire process of trademark and logo registration is a lengthy and time taking process which involves a lot of steps which have been explained. In order to register your trademark online one has to complete the entire process and cross all the hurdles therein.
Authored By: Adv. Anant Sharma & Aashita Khandelwal