The majority of World Trade Organization members have amended their intellectual property (IP) regimes since the introduction of Trade-Related Aspects of Intellectual Property Rights (TRIPS). The vast term “intellectual property rights” refers to the domain of law that deals with securing ownership rights in works produced by the human mind and intellect. The exclusive rights granted to the creators of those works are known as intellectual property rights (IPR), and they enable them to profit commercially from their creative endeavours or reputation. It is identified as a crucial resource for every industry to improve the invention’s commercialisation, as well imitation and protection.
By 2023, it is anticipated that the Indian healthcare sector will be worth USD 132 billion, rising at a CAGR of 16-17%. The Indian healthcare market is predicted to grow at a 30.70% CAGR to reach 110 trillion rupees by 2027, with a 17.44% market share held by the digital healthcare sector. Equity has traditionally been at the heart of Indian health policy. It has recently been broadened to include the matter of universal healthcare, or the provision of accessible healthcare to all of a nation’s citizens. Following independence, the Indian government began to engage directly in the healthcare industry by offering medical facilities through a network of public medical centres and primary care clinics.
The advent of novel business strategies, unforeseen collaborations, and more rapid deliveries during the past couple of years have caused significant changes in the healthcare industry, necessitating active participation on the part of institutions in the growth, acceleration, and expansion of their innovation activities. However, in the interests of patients and society as a whole, the protection of ideas and discoveries by intellectual property rights (IPR) is essential for the continuous innovation in the creation of medicines.
What is Intellectual Property Rights?
The rights people are granted over their creative works are known as intellectual property rights. Generally, there is a grant of a time-limited, exclusive right to utilise their invention. Inventions, literary and creative works, designs, symbols, names, and pictures used in business are all examples of intellectual property (IP).
Patents, copyrights, and trademarks are some of the most used and famous examples of IP protection under the law. They allow people to benefit financially or gain a reputation from their inventions. The IP system seeks to provide an environment where creativity and innovation can prosper by striking an appropriate equilibrium between the interests of inventors and the larger public interest.
Intellectual property rights are also included in the Universal Declaration of Human Rights (UDHR) under Article 27, which reads that “Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.”[1]
There are different types of Intellectual property Acts present in India which help protect the various types of IP rights with legal backing; these acts include:
- The Copyright Act, 1957
- The Patents Act, 1970[1]
- The Trademarks Act 1999
- The Geographical Indications of Goods Act, 1999
- The Designs Act, 1999
- Semi-Conductor IC Layout Designs Act, 2000
- The Protection of Plant Varieties and Farmers’ Rights Act, 2001
- The Biological Diversity Act, 2002.
Importance of Intellectual Property Rights in the Indian Health Industry
The healthcare industry is undergoing significant changes, many of which are brought on by recent technological developments
Key components of the expanding healthcare breakthroughs include medical data, genetic engineering, biotechnology, and other fields that all rely on innovations. Additionally, healthcare costs are rising everywhere.
- The top pharmaceutical companies are combining resources in order to support ongoing research and development (R&D) costs.
- The legislation governing intellectual property (IP) is crucial to the healthcare industry’s R&D efforts.
- Leading pharmaceutical companies argued that fulfilling the requirements of Trade-Related Aspects of Intellectual Property Rights (TRIPS) would promote foreign direct investment, facilitate the transfer of knowledge, and enhance investment in research and development in developing countries like India.
- Effective intellectual property protections, like patents, are a crucial component of biotechnology and medical development and research that spurs inventors to create new, innovative products.
- This can support the development of a robust patented method in the healthcare industry.
- Healthcare-related inventions and patenting are becoming an expanding business globally as healthcare becomes increasingly integrated with daily living over time.
Patents and the Indian Health Industry
What are patents?
In simple terms, when in return for making the disclosure of the invention, which can be vital for the owner of the invention, the owner of the invention is granted a patent, which grants them the legal right to prevent others from creating, using, or selling a exact same or similar invention for a limited period of time, after that the rights of the invention are moved to the general public domain.
Patents in the Indian Health Industry
The Patent (Amendment) Act of 2005 successfully addressed issues relating to public interest and health in India. The Act has various provisions that protect the public health of the entire country. The pharmaceutical sector is one of the “intellect-driven” sectors of the economy. Testing for pharmaceuticals is quite costly and might be unforeseen. The study’s findings may take shape as an innovative, practical new product or approach. Given that India and its pharmaceutical businesses are substantial producers of affordable pharmaceutical goods in the form of generic medications, pharmaceutical patenting in India is particularly important in light of the present public health issues. One benefit of granting patents to pharmaceutical companies is that it encourages private businesses to invest on a larger scale in research and the development of the same to identify treatments for diseases that are common in poor nations.
Trademark and Indian Health Industry
What is a trademark?
A trademark is a symbol, word, design or phrase that signifies the origin of your goods and sets them apart from those made by other businesses. A trademark recognises the company that owns the brand for a particular service or product. A trademark, properly named, shows where products come from or serve as a flag of origin since it serves the only purpose of identifying the origin or source of goods or services. To put it another way, trademarks are used to designate a certain company as the provider of products or services. A trademark registration grants the owner of the trademark the sole right to use it.
This suggests that the trademarks can be used alone by its owner or may be licensed to a third party for usage in exchange for payment. In the event of a legal dispute, for instance, registration gives legal clarity and strengthens the position of the right holder.
Trademarks in the Indian Health Industry
Pharmaceutical enterprises have additional legal recourse and enforcement options owing to trademark protection against unauthorized utilization or infringement. Competent trademark protection helps ward off possible infringers, protect brand value, and keep the market competitive. The majority of authorized pharmaceutical products and services are the subjects of trademark applications. When a pharmaceutical trademark is used, the brand name or drug name is frequently derived from the medicine’s mode of action, salt content, or any other related medical term. It is common practice to name a medicine after the organ it treats (such as “Liv” for the liver), the ailment it treats, or the main constituent in the medication, notwithstanding Section 13 of the Trade Marks Act of 1999’s prohibition on using chemical names as trademarks.
The process of preserving a brand name or drug name becomes more challenging, and proof of acquired distinctiveness or secondary meaning is utilised to establish distinction. The resemblance in medicine names should be prevented since the risk of consumer misunderstanding puts their health in jeopardy.
Due to the usage of trademarks, businesses will be able to keep an eye on the security of their current medication. The trademark’s goal is to protect the mark’s originality and uniqueness. Many nurses, doctors, and other medical practitioners find it challenging to remember or spell common names due to the similarity of several generic names for drugs in the same category. Healthcare professionals use specific Trademarks associated with every pharmaceutical medicine to guarantee that the right treatment is given to patients.
Copyright and Indian Health Industry
What do you mean by copyrights?
A copyright is a legal privilege granted to the owner of intellectual property. It is the right to copy, as the name implies. The only people who have the sole right to reproduce a work are the original authors of that work and anybody to whom they grant permission. A work must be in physical form in order for copyright laws to protect it.
Copyright in the Indian health Industry
The Copyright Act of 1957 in India safeguards intellectual property. If clinical instructions and information are transmitted by any sort of medium, they could be covered by the Copyright Act. A basic collection of data is exempt from copyright laws. This is founded on the “sweat of the brow” argument, which holds that even though content like tables or databases lacks originality, copyright will only be protected if an individual undertakes to independently obtain the information. Software has a growing impact on medical innovation as technology develops.
Today, everything is controlled by software, from precise analytical and diagnostic tools to surgical devices that combine cutting-edge hardware with next-generation analytics and controls. Therefore, it is crucial that software used in the healthcare industry and other relevant industries be copyright-protected. The importance of databases to the healthcare sector is rising. An “informatics” tsunami is sweeping the sector as companies employ technology for data exchange to improve quality.
Trade secrets and the Indian Health Industry
What are trade secrets?
A valuable piece of knowledge that is kept private and offers a business a competitive edge is referred to as a trade secret. Generally speaking, any secret information about business that gives a company a competitive edge and that no one else is aware of can potentially be secured as a trade secret. It is considered an unfair practice and a breach of the trade secret protection when others obtain, utilize, or disclose such secret knowledge without authorization in a way that is inconsistent with honest business practices. The basic resources of the modern economy are information, knowledge, inventiveness, and innovation, and trade secrets are crucial for businesses of all sizes and in all economic sectors.
Trade secrets in the Indian Health Industry
Trade secrets have a potential market value in the hundreds or thousands of millions. Companies in the biotechnology and pharmaceutical industries should be able to fight against claims of trade secret theft and preserve their trade secrets. Trade secrets are not considered to be intellectual property rights in India; hence no legally recognised protection is provided. However, common civil law in India protects trade secrets.
The employer is under the impression that the execution of a Non-Disclosure Agreement (NDA) under the terms of the employment agreement will be adequate to safeguard their trade secrets against theft. Since the biological material that exhibits trade secrets is generally self-reproducing in nature, trade secret theft is a typical occurrence in the life science sectors. If a critical trade secret slips into the hands of its competitors due to a security breach, the organization would suffer grave financial consequences. Under the head of trade secrets the list containing the information about the patients can also be protected, as it is confidential information, and leaking this kind of information can cause loss to the patients as well as the medical organizations.
Case studies
As a treatment for cerebral malaria caused by the Falciparum organism, the “FALCIGO drug” used by Cadila Healthcare Ltd. won a trademark in the matter of Cadila Healthcare Ltd. v. Cadila Pharmaceutical Ltd[2]. The medicine used to treat the same ailment was given the name “Falcitab” by Cadila Pharmaceutical Ltd. a year later. In order to limit the use of the word “Falcitab,” the appellant filed a lawsuit in district court in Vadodara. Although both medications are sold with a prescription, the Supreme Court noted that this does not suffice to prevent misunderstanding. As a result, the court determined that the limitation in this instance is reasonably legitimate and that the confusing similarity test can be amended in the context of pharmaceuticals.
In the legal dispute between Cipla Limited and M.K. Pharmaceutical[3], the plaintiff manufactured oval, orange-colored “NORFLOXACIN” pills in blister packaging under the trade name “NORFLOX-400.” Plaintiff argued that although the defendant used the same name, “NORFLOX-400,” there was misunderstanding because of the defendant’s imitation of the colour, shape, and blister packaging of tablets. No one orders medicine based on its colour, shape, or packaging, hence there cannot be a colour monopoly, as is widely known. The form of tablets is frequently round or oval, and blister packaging is generally common. Therefore, there was no injunction issued. As a consequence of this ruling, it has been determined that the name of the drug, not its colour, form, or packaging, is what makes it distinctive, even when deliberate replication takes place.
Conclusion
India’s healthcare sector faces obstacles such patent disputes, a need for generic drugs at affordable prices, and the need to maintain traditional knowledge. The government’s initiatives are attempting to strike a balance in this regard. IPR and public health must be harmoniously integrated in order for India’s health industry to continue to grow and flourish.
Frequently Asked Questions
Because of the importance of the need to protect the health sector from negative aspects, IPR is important.
Some of the common used intellectual property rights for health are patents, trademarks, and copyright.
The seven types of IPR are copyright, patents, geographical indications, trademarks, plant varieties, semiconductor integrated circuit layout designs and industrial designs.
IP rights provide protection to all innovation in the health services, which is why it is important.
Patent and trademark are the most used intellectual property in the pharmaceutical industry.
IPR is a type of exclusive legal right given to the owners or the creator of the work. It can be an artistic work, literary work, an invention etc. It is important because it protects the individual or company from exploitation of the work by others.
Read Our Article: Basics Of Intellectual Property Rights: Explained
