This article has been published by Sneha Mahawar.
Intellectual Property alludes to the manifestations of the human mind like developments, abstract and creative works and images, names, pictures, and plans utilised in business. This is a legal right that is given to every individual or creator to protect their invention or creation for a certain period.
The Indian Pharma Industry is growing at a very fast speed and had consistent growth over the past three decades, being the third largest in terms of volume and the thirteen largest in terms of value. The pharma organisations need to stay up with a development that makes a critical effect on many lives and is the primary concern of an organisation. Innovations play an important role in the development of the Pharma Industry for their growth, drug discovery, and higher returns on investment. This blog examines the intellectual rights in the pharmaceutical industry. As the market is expanding and industries also participate in the investment such that intellectual property rights are also becoming very important for businesses. This article mainly focuses on trademarks and patents in the pharma industry.
Relevance of intellectual property rights in the pharma industry
When the innovations are made these need to be protected through intellectual property rights. Patents give pharma organisations selective freedoms to advertise drugs and forestall others to fabricate, sell, and make these drugs for a time of 20 years. IPR is essential for pharma organisations for recognizable proof, arranging, commercialization, and security of innovation. It is likewise a significant apparatus to safeguard speculation, time, and exertion and supports healthy competition, consequently advancing the modern turn of events and monetary development.
The IPR assurance works in various ways:
- Gives fair and compelling motivating force to the development
- Safeguards pharma organisations against expected infringers
- Gives solid authorization instruments to guard encroached patents
Two principles affect the pharma industry in IPR;
- There is the issue of evaluating and access, where conversation centres around the connections between IPRs (especially patents), the rejection of contenders, and the accessibility and valuing of new drugs.
- There is the issue of R&D impetus – in other words, the job of IPRs in giving impetus to find, create and advertise new medications – and the impact of IPRs on R&D consumption and its allotment across sicknesses, nations, and associations.
Cipla Limited vs M.K. Pharmaceuticals, In this case, the plaintiff produced “NORFLOXACIN” tablets that were oval in shape and orange in colour in blister packing under the trademark “NORFLOX-400”. Defendant also used the same name, “NORFLOX-400”, but that was not the name for which the plaintiff sued, instead the plaintiff sued the defendant for imitating the shape, colour, and blister packing of pills, which confused the market. It was established that there cannot be a monopoly of colours as no consumer asks for medicine by its colour or shape or by packaging. Blister packaging is very common and tablets are fairly frequent round or oval in shape. Therefore, no injunction was granted. It was held that the name of the medicine should be distinctive and not the colour, shape, or packaging even if there is a deliberate imitation.
Neon Laboratories Ltd vs Medical Technologies Ltd & Ors, In this case, the appellant filed an application in 1992 for the registration of the trademark. In 2001 appellants were granted a trademark of ‘ROFOL’ but after the registration, the product was not introduced in the market until 2004. Then in 1998, the respondent introduced the drug ‘PROFOL’. As a result, it was clear that the respondent had a prior user date while the appellant had prior registration. The case was decided in the favour of the respondent as the Respondent had earned substantial goodwill with its manufacturing and marketing of the drug. Hence Injunction was placed under the trademark ‘ROFOL’. Both the factors of an interim injunction are a balance of convenience and irreparable damage factors of a temporary injunction were in favour of the respondent. The Supreme Court held that a mark should normally be innovation and if the mark is an existing word, it should not bear descriptive features relating to the product.
Trademark law in pharmaceutical industry
The registration of the trademark protects various drugs of pharmaceutical companies and helps in giving immense value to maintaining a brand name for the drug in the market. In India, the pharmaceutical industry is considered to have a majority of the trademark registration as compared to any other sector.
Section 9 (1)(a) of the Trademark Act, 1999, prohibits the registration of trademarks “which are devoid of any distinctive character, that is to say, not capable of distinguishing the goods or services of one person from those of another person” such that the person is incapable of distinguishing the goods or services of one origin to another and it is of such nature to deceive the public or create confusion in the market. Notwithstanding, when the brand name has obtained auxiliary importance or has acquired a particular person attributable to its drawn-out utilisation and acknowledgement among the purchasers.
Section 11 of the Trademark Act, 1999, states that a trademark shall not be registered if it has an identity with an earlier trademark and is providing similar goods and services such that it is creating confusion in the market among the public.
Goods or services which are not like those for which the prior trademark is enlisted for the sake of an alternate owner, will not be enrolled, if or to the degree, the previous trademark is a notable trademark in India and the utilisation of the later imprint without due cause would exploit or be adverse to the distinct person or repute of the previous trademark.
Section 13 of the Trademark, 1999 states the provisions related to the classification of Goods and Services and provides that the Registrar shall classify goods and services by the International Classification of Goods and Services for registration of Trademark.
Patents law in pharmaceuticals industry
India had an item patent system for all innovations under the Patents and Designs Act 1911. Notwithstanding, in 1970, the public authority presented the new Licences Act, which rejected drugs and agrochemical items from qualification for licences. This rejection was acquainted with splitting away India’s reliance on imports for mass medications and definitions and accommodating the improvement of the self-reliant native drug industry.
The Indian medication industry grew rapidly by making more affordable variations of different meds authorised for the local market and finally moved powerfully into the overall market with nonexclusive prescriptions once the worldwide licences ended. Similarly, the Patents Act gives different safeguards to hinder abuse of patent honours and give better induction to drugs.
Section 3 (d) of the Patents Act, 1970, states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation. -For this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties about efficacy”
Interpretation of Section 3 (d), of Patents Act, 1970
The basic discovery of a new form of a known substance does not result in the upliftment of the known efficacy of that substance is not patentable. This means that different forms of a known substance should differ significantly in the properties concerning efficacy.
The analyst makes the comparison between the known substance and the new form of known substance concerning their properties or upliftment of efficacy. When the new form is made it is then converted into another new form, and then the comparison between the two of them is made i.e. the already existing form and another new form yet not between the base compound and another new structure.
The efficacy of a substance need not be quantified in terms of a numerical value to examine whether the product is efficacious or not because it is impossible to have a standard numerical value for the efficacy of all products including pharmaceutical products.
In the case of Novartis AG vs Union of India and Ors, the true legislative intent of Section 3(d) of the Patent Act,1970 was emphasised and it stated that it deals with chemical substances and more particularly pharmaceutical products. The judgement given by the Hon’ble Supreme Court is to stop the everlasting patented products and give relief to those who can’t afford the lifeguarding drug as these pharmaceutical companies sell such lifeguarding drugs at a very high price hence it is overpriced for the common man to afford it. In this case, the Supreme Court made it clear that India is a developing country and the medicines should be available at a cheaper rate as it is necessary for the lives of 1 billion people. Section 3 (d) of the Patent Act, 1970 prevents pharmaceutical companies from obtaining secondary patents by introducing minor changes in existing innovations.
Section 3 (e) of the Patent Act, 1970, states that “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance.” It disallows the protection of substances that are acquired just by blending known fixings or parts, such substances involving properties that are the consequence of the conglomeration of such components.
Compulsory licences under the Patents Acts
According to Section 84, any individual, whether or not he is the holder of the permit of that Patent, can make an application to the Controller for grant of compulsory licence on expiry of three years, when any of the accompanying circumstances are satisfied;
- The sensible necessities of people in general concerning the licensed creation have not been fulfilled.
- The licensed innovation isn’t accessible to the general population at a reasonable cost.
- The licensed innovation doesn’t work in that frame of mind of India.
The pharmaceutical industry is unusually knowledge-intensive, and the financial matters of this area are broadly perceived to be strangely delicate to IPRs. The Indian Courts likewise give explanations to guaranteeing the security of licensed innovation freedoms, to advance insurance in each industry, including the drug business.
The drug item has not been conceded insurance, but rather it will be altered and be given security under the demonstration. The term will likewise be reconsidered except if the authority is persuaded by the condition of the country.
In any case, open doors flourish for creating and dissecting more far-reaching information on this complex and basic area, especially in non-industrial nations and nations with economies on the move.
- https://www.drugdiscoverytrends.com/intellectual-property-and-the-indian-pharmaceuticalindustry/#:~:text=Intellectual%20Property%20Rights, These%20innovations%20lead&text=Patents%20provide%20pharma%20companies%20exclusive,commercialization%2C%20and%20protection%20of%20invention
- Cipla Ltd Vs M.K. Pharmaceuticals MIPR 2007 (3) 170
- Neon Laboratories Ltd Vs Medical Technologies Ltd & Ors 2015 (64) PTC 225 (SC)
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