Maarg Manthan · Topic 10.13

Protection of Biotechnological Inventions: Patents, Trade Secrets, Plant Breeders’ Rights

Science & Technology › Biotechnology – Principles and Techniques · Topic 10.13

Biotechnological inventions are protected through three main systems of intellectual property: patents, trade secrets and plant breeders rights. A patent gives the inventor an exclusive right for 20 years in return for disclosure of the invention, and under the Patents Act, 1970 an invention must be new, involve an inventive step and be capable of industrial application. A trade secret protects confidential know-how, such as a culture medium recipe, for as long as it stays secret. Plant breeders rights protect new plant varieties under the Protection of Plant Varieties and Farmers Rights Act, 2001, which also recognises the rights of farmers. The Budapest Treaty of 1977 provides for international deposit of microorganisms for patent purposes.

5 min read · UPSC Prelims · Science & Technology · Biotechnology – Principles and Techniques

At a Glance

Patent term 20 years
Indian patent law Patents Act, 1970
Plant varieties law PPVFR Act, 2001
Microbe deposit Budapest Treaty, 1977
Global rule TRIPS Agreement
Exam link UPSC Prelims, Science & Technology: Biotechnology – Principles and Techniques

Where Does It Fit?

This topic follows embryo transfer technology. After learning the techniques, the student turns to the legal tools that protect the products of those techniques. Previous topic: Embryo Transfer Technology. Next topic: Industrial Genetics and Microbial Ecology.

How Are Biotech Inventions Protected?

Tool	Key features
Patent	Exclusive right for 20 years from filing. The invention must be novel, non-obvious and industrially useful. The details are published
Process patent	Protects a method, for example a method of making a recombinant protein
Product patent	Protects the product itself, such as a genetically modified microbe, subject to the law of the country
Trade secret	No registration or time limit. Protection lasts while the information stays confidential and valuable
Plant breeders rights	Exclusive right to produce, sell and export the seed of a registered variety. In India the term is 15 years for annual crops and 18 years for trees and vines
Geographical indication	Protects names linked to a place, such as Darjeeling tea
Biological Diversity Act, 2002	Requires permission and benefit sharing for use of Indian biological resources

What Does Indian Law Allow and Exclude?

Section 3 of the Patents Act: lists what is not an invention, such as discovery of a natural substance and plants and animals in whole or in part, including seeds, varieties and species
Microorganisms: are patentable in India if they are modified and not merely found in nature
Methods of treatment: of humans and animals are not patentable
Essentially biological processes: for the production of plants and animals are excluded
Disclosure of source: the applicant must name the source of biological material used, which supports the Biological Diversity Act
PPVFR Authority: the Protection of Plant Varieties and Farmers Rights Authority registers varieties and farmers varieties, and is located in New Delhi
Farmers rights: farmers can save, use, sow, exchange and sell farm saved seed, except branded seed of a registered variety
Gene Fund: the National Gene Fund supports conservation and rewards communities that conserve plant genetic resources

What Else Should You Remember?

TRIPS Agreement: the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization, in force from 1995, requires patents for microorganisms and non-biological processes and protection of plant varieties by patents or a special system
Sui generis system: India chose its own system for plant varieties, which is allowed under TRIPS
Diamond versus Chakrabarty: a 1980 United States Supreme Court ruling that allowed a patent on a genetically modified bacterium
Basmati and neem: Indian challenges to patents on basmati rice lines and on neem products in other countries are well known cases of alleged biopiracy
Turmeric: a United States patent on the wound healing use of turmeric was revoked in 1997 after India showed prior knowledge
Traditional Knowledge Digital Library: an Indian database of traditional knowledge that helps patent offices check prior art
Compulsory licence: the Government can allow others to make a patented product in certain conditions, as with the 2012 licence for a cancer drug
Evergreening: Section 3(d) of the Patents Act blocks patents on new forms of known substances without improved efficacy
Seed concerns: critics argue that strong patents raise seed prices and reduce farmer choice
Bt cotton: licensing of the Bt gene and trait fees has been a subject of dispute between the seed industry and the Government
Farmers variety: a variety that farmers have traditionally cultivated and evolved can be registered, with the community able to claim benefit sharing

Why Does It Matter for the Exam?

Terms: patent period and criteria
Laws: Patents Act, PPVFR Act and Biological Diversity Act
Exclusions: plants, animals and methods of treatment
Current affairs link: biopiracy cases and seed disputes
Common errors: saying that seeds can be patented in India, or that trade secrets need registration

As an analytical point, India tries to balance reward for innovation with farmers rights and public access. A strong system for traditional knowledge and benefit sharing protects national interest while allowing private research.

Why Is This Topic Important?

Laws Three Indian Acts
Exclusions Plants and animals
Cases Neem, turmeric, basmati

What Came Next?

The next topic covers industrial genetics and microbial ecology. Next topic: Industrial Genetics and Microbial Ecology.

Key People and Terms

Patent Time limited exclusive right
Trade secret Confidential know-how
Biopiracy Unfair use of bio resources
Prior art Earlier public knowledge
Sui generis Special system
Benefit sharing Sharing gains with providers

Exam Corner

Points to Remember

Patent term: 20 years.
PPVFR Act: 2001.
Budapest Treaty: 1977.
Plants and animals are excluded from patents in India.
Turmeric patent revoked: 1997.

Do Not Confuse With

Patent and plant breeders right Invention right versus variety right
Trade secret and patent Secret versus disclosed
Biopiracy and bioprospecting Unfair taking versus lawful exploration

Memory Hook

Patent twenty and published, secret stays hidden, breeders get the seed.

Mains Angle

Questions ask about the laws and their balance. These points help.

Laws Three tools
Balance Innovation and farmers
Cases Biopiracy

A Question You May Face

An original practice question, not a past paper question.

“Discuss the legal framework for protecting biotechnological inventions in India and how it balances innovation with farmers rights.”

How to Answer

Tools Patent, secret, PPVFR.
Limits Plants excluded.
Balance Farmers rights, benefit sharing.
Way Clear rules and TKDL.

GS Relevance

Prelims: patent conditions, exclusions, PPVFR Act, Budapest Treaty, TRIPS. GS Paper 3: science and technology, intellectual property rights, biotechnology.

Frequently Asked Questions

What can be patented in biotechnology in India?

In India, modified microorganisms, recombinant processes, and products such as new vaccines can be patented if they are new, inventive and industrially useful. Plants, animals, seeds, varieties and essentially biological processes, and methods of treating humans and animals, are excluded from patent protection under Section 3 of the Patents Act, 1970.

What is the Protection of Plant Varieties and Farmers Rights Act, 2001?

The Protection of Plant Varieties and Farmers Rights Act, 2001 is the Indian law that protects new plant varieties and the rights of breeders and farmers. It gives breeders exclusive rights for 15 years for annual crops and 18 years for trees, and lets farmers save, use and exchange farm saved seed.

What is the Budapest Treaty?

The Budapest Treaty of 1977 is an international treaty that lets a patent applicant deposit a microorganism at a recognised depository for the purpose of patent procedure. This removes the need to file the culture in every country where a patent is sought. India joined the treaty in 2001.

What is a trade secret?

A trade secret is confidential business information, such as a method of making a product, that has commercial value and is kept secret by its owner. It needs no registration and has no fixed term, but protection ends if the secret becomes public through legal means such as independent discovery.

What is biopiracy?

Biopiracy is the unauthorised or unfair use of biological resources or traditional knowledge of a country or community without permission or benefit sharing. Patents granted abroad on neem uses and on turmeric for wound healing were challenged by India, and the turmeric patent was revoked in 1997.

PYQ Practice — Statement Analysis

1 Under the Patents Act, 1970, plants and animals in whole or in part are not patentable.

True

They are excluded under Section 3.

2 A patent lasts for 50 years from the date of filing.

False

It lasts for 20 years.

3 A trade secret needs to be registered to get protection.