Intellectual Property Rights, Patents, Geographical Indications, Bioethics and Biosafety Notes for UPSC: TRIPS, TKDL, GEAC, Biological Diversity Act and Ethical Issues in Biotechnology

In the knowledge economy, ideas, inventions and designs are as valuable as land or machines. The legal rights that protect these creations are called Intellectual Property Rights (IPR). At the same time, advances in biotechnology and medicine raise hard moral questions in the field of bioethics, and the use of the genetically modified organisms needs the safeguards of biosafety. For UPSC, these topics appear in the Science and Technology paper of the Prelims (the types of IPR, GI tags, the TRIPS agreement, the Biological Diversity Act, the GEAC) and in the Mains (the patents and the access to the medicines, the biopiracy, the ethical issues of the surrogacy and the gene editing). These notes explain each concept, the Indian laws and institutions, the famous cases, the ethical principles and the way to write a balanced answer.

Why Study IPR and Bioethics?

IPR connects the science with the economy, the trade and the law, and the issues like the drug prices and the traditional knowledge are in the news. Bioethics links with the Ethics paper (GS IV) and the Mains questions on the biotechnology. Revise the base with our notes on Biotechnology and Genetic Engineering, Human Diseases and Vaccines and Environmental Laws and EIA.

Types of Intellectual Property Rights

Patents in Detail

• What can be patented: A product or a process which is new, non-obvious and useful. Discoveries, scientific principles, plant and animal varieties and the methods of the treatment are not patentable in India.
• Section 3(d) and evergreening: The Indian law does not allow a patent for a mere new form of a known substance unless it shows a significantly better efficacy. This limits the "evergreening", i.e., the extension of the monopoly through the small changes. In the Novartis v. Union of India (2013) case on the cancer drug Glivec, the Supreme Court upheld this provision.
• Compulsory licence (Section 84): The government can allow another company to make a patented product if the patent is not worked or the price is not affordable. India granted the first compulsory licence in 2012 to Natco Pharma for the cancer drug Nexavar.
• Patent Office: The Controller General of Patents, Designs and Trade Marks (head office at Mumbai) works under the DPIIT; the Patent offices are at Kolkata, Delhi, Mumbai and Chennai.
• Patent Cooperation Treaty (PCT): Allows an inventor to seek the patent protection in many countries with a single international application.

Geographical Indications (GI)

A GI tag tells the buyer that a product comes from a specific region and has the special quality, such as the Darjeeling Tea (the first GI-tagged product in India), the Basmati rice, the Kashmir Pashmina, the Banarasi sarees, the Mysore silk, the Tirupati laddu and the Alphonso mango. The GI registry is at Chennai. A GI helps the local producers to get a better price and protects them from the imitations, but it is a collective right and not owned by one person.

International Framework: TRIPS and WIPO

• TRIPS (Trade-Related Aspects of Intellectual Property Rights): The WTO agreement of 1995 that sets the minimum standards of the IPR protection for all the member countries. The Doha Declaration (2001) said that the TRIPS must be interpreted to protect the public health and the access to the medicines for all, and recognised the right of countries to use the compulsory licences.
• WIPO (World Intellectual Property Organization): The UN agency with the headquarters at Geneva (1967), which administers the international IP treaties. It publishes the Global Innovation Index every year; India has risen in the ranking.
• National IPR Policy, 2016: The aim is to create awareness, promote the creation of the IP, strengthen the legal framework and the enforcement; the Cell for IPR Promotion and Management (CIPAM) is the nodal body.

Traditional Knowledge and Biopiracy

Biopiracy means taking the biological resources or the traditional knowledge of a country, usually of the developing countries, and patenting them without permission or benefit sharing. Famous cases include the US patent on the wound-healing use of turmeric, which India got revoked in 1997, the European patent on the neem fungicide, which was revoked in 2005, and the dispute on the Basmati patent. To prevent this, India created the Traditional Knowledge Digital Library (TKDL), a database of the traditional medicine formulations (Ayurveda, Unani, Siddha and Yoga) in the international patent languages, which the patent examiners can check. The Biological Diversity Act, 2002 sets up the National Biodiversity Authority (Chennai), the State Biodiversity Boards and the Biodiversity Management Committees, and requires the approval for the use of the biological resources and the benefit sharing with the local communities (Access and Benefit Sharing, in line with the Nagoya Protocol).

Bioethics: Key Principles and Issues

Bioethics is the study of the moral issues raised by the biology and the medicine. Four basic principles guide it: autonomy (respect for the person's choice and the informed consent), beneficence (doing good), non-maleficence (doing no harm) and justice (fair distribution of the benefits and the burdens).

Biosafety and GM Organisms

The Genetic Engineering Appraisal Committee (GEAC), under the Ministry of Environment, Forest and Climate Change, is the apex body that approves the use of the genetically modified organisms and the products in the environment, under the Rules of 1989 made under the Environment (Protection) Act, 1986. The Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology checks the research. Bt cotton, approved in 2002, is the only GM crop grown commercially in India; the GM mustard has been the subject of the court cases and public debate. The international framework is the Cartagena Protocol on Biosafety (2000), under the Convention on Biological Diversity. The key concerns are the effects on the biodiversity and the health, the contamination of the non-GM crops, the control of the seeds by a few companies and the farmers' rights.

The Mains Angle

For the Mains, remember to present both sides. On IPR: patents encourage the innovation and the investment, but they can raise the prices of the medicines and the seeds, so India follows a balance with the Section 3(d), the compulsory licences and the TKDL. On bioethics: technology brings benefits, such as the cures and the better crops, but it needs the guardrails of the consent, the equity and the precaution. Suggest a way forward: a strong and transparent regulator, the public engagement, the support for the domestic innovators and start-ups, the protection of the traditional knowledge, the inclusion of the farmers and the communities in the benefit sharing and the international cooperation.

Previous-Year Style Practice

• Which was the first Indian product to get a GI tag? Answer: The Darjeeling Tea.
• What is the term of a patent in India? Answer: 20 years.
• Which body approves the GM crops in India? Answer: The Genetic Engineering Appraisal Committee (GEAC).
• What is the TKDL? Answer: The Traditional Knowledge Digital Library, a database to prevent the biopiracy.

Frequently Asked Questions (FAQ)

What is an IPR?

Intellectual Property Rights are the legal rights over the creations of the mind, such as the inventions, the works of art and the brand names.

How long does a patent last in India?

20 years from the date of the filing.

What is evergreening of a patent?

Extending the monopoly of a patent through the small changes in the existing drug or product.

What is Section 3(d) of the Patents Act?

The provision that does not allow a patent for the new form of a known substance unless it shows a significantly better efficacy.

What is a compulsory licence?

A permission by the government for a third party to make a patented product without the consent of the patent holder, in the public interest.

What is a GI tag?

A mark showing that a product comes from a specific place and has the quality linked with that place.

Which was the first GI-tagged product in India?

Darjeeling Tea.

What is the TRIPS agreement?

The WTO agreement that sets the minimum standards of the IPR protection.

What is biopiracy?

The use or patenting of the biological resources or the traditional knowledge without the permission or the benefit sharing.

What is the role of the GEAC?

It approves the use of the GM organisms in the environment in India.

What does the Biological Diversity Act, 2002 provide?

Conservation of the biodiversity, the sustainable use and the access and benefit sharing, through the NBA, the SBBs and the BMCs.

How is this topic asked in UPSC?

As the types of IPR, the laws and the institutions in the Prelims, and as the balance of the innovation and the access, and the ethical issues in the Mains.