What is a Biotechnology Patent? Meaning, Scope, and Importance

It is always a curiosity among the learner that how can be a biotechnological work can be patented. How do patent work in biotechnology? Is genes and living organ can be patented? Such questions are nowadays very in discussion especially among students.

It all started after arrival of Bt Cotton, especially in India the arrival of Bt cotton opened the door to a rich discussion — because biotech patents are among the most debated and fascinating areas in Intellectual Property Law today.

Synopsis

What Is a Biotechnology Patent?

Let’s begin with the basics.

Biotechnology means creating useful products by involving living organisms or parts of them. Some examples are genetically modified seeds, vaccines, enzymes, insulin, and even DNA sequences.

Similar to other scientific inventions, a biotechnology patent is a legal right granted to an inventor or company that creates something new, useful, and not obvious in the field of biotechnology.

In short, it gives the right to stop others from making, using, or selling the invention without permission — usually for 20 years.

Best Examples of Biotech Patents

Some familiar examples of biotech inventions that have been patented include:

Human insulin produced by genetically modified bacteria (a game changer for diabetes patients).
Bt cotton, a genetically modified crop resistant to pests.
DNA-based testing kits used during COVID-19.
Gene therapy techniques used in treating inherited diseases.

Now let’s explore how courts have viewed this complex field.

Important Case Laws That Shaped Biotech Patents and Importance of biotechnology patents

1. Diamond v. Chakrabarty (U.S. Supreme Court, 1980)

Fact: An Indian-American scientist, Ananda Chakrabarty, created a genetically modified bacterium. That bacterium could break down crude oil, which helps clean up oil spills.

He applied for a patent in the U.S., but the Patent Office refused, saying living things can’t be patented.

Court’s Verdict: The U.S. Supreme Court disagreed. It ruled in favor of Chakrabarty, saying:

“Anything under the sun that is made by man is patentable.”

Impact: This landmark decision opened the doors for patenting genetically modified organisms (GMOs) worldwide.

2. Association for Molecular Pathology v. Myriad Genetics (U.S. Supreme Court, 2013)

Fact: Myriad Genetics discovered the BRCA1 and BRCA2 genes, linked to breast and ovarian cancer risk. They isolated these gene sequences and patented them.

Problem: Scientists and patient groups challenged the patents, arguing that you can’t patent something that exists in nature, like genes.

Court’s Verdict: The U.S. Supreme Court ruled that naturally occurring DNA sequences cannot be patented. But they allowed patents for synthetic DNA (cDNA) created in labs.

Impact: Struck a balance — discovery of natural substances is not patentable, but lab-modified biotech is.

3. Novartis v. Union of India (Indian Supreme Court, 2013)

Fact: Novartis wanted a patent in India for its cancer drug Glivec. The drug was already known abroad, but Novartis made some changes to its form and tried to patent it.

India’s Stand: The Patent Office said the new version was not significantly more effective than the old one. They rejected the patent under Section 3(d) of the Indian Patents Act , which prevents patents for minor changes that don’t improve efficacy.

Supreme Court’s Verdict: It upheld the rejection. The court said:

“Evergreening of patents” should not be allowed if it affects public access to life-saving drugs.

Impact: Protected affordable access to medicines in India, and clarified biotech patent standards.

What Can Be Patented in Biotechnology?

Here’s what generally qualifies:

Genetically modified microorganisms
Biotech processes (like producing insulin)
Lab-created DNA or RNA (cDNA, mRNA)
Vaccines and therapeutic proteins
Diagnostic kits

But only if they are:

New
Involve an inventive step
Capable of industrial application

What Cannot Be Patented?

Under Indian law (Section 3 of the Patents Act), certain biotech innovations are NOT patentable, such as:

Natural living organisms (plants, animals, or humans)
Naturally occurring DNA/RNA
Agricultural or horticultural methods
Mere discoveries of new forms of known substances
Traditional knowledge (like neem or turmeric)

Why Are Biotech Patents So Important?

Biotech patents are very important. Because biotech inventions save lives. It helps farmers to improve farming. And help us deal with future challenges like pandemics or climate change.

View: 10 landmarks IP cases every law student should know

Patents in biotechnology:

Encourage innovation and investment
Give exclusive rights to inventors for a limited time
Help recover high R&D costs (especially in drug development)
Promote collaboration between science and industry

But patents have a flip side too, when patents become too broad or too powerful. They can block access to essential medicines or food and especially in developing countries where still large percentage of the population is poor and cannot afford the monopolized patent products. Therefore, it is the responsibility of the government of the day to ensure such a monopolized scenario does not arise where it becomes difficult for the poor to buy essential bio products.

So the law should be made to balance incentives for inventors with public interest.

India’s Unique Approach to Biotech Patents

India follows a balanced model. It allows biotech patents but with strict filters. Section 3(d), 3(j), and 3(i) are safeguards that:

Prevent misuse of patents
Protect traditional knowledge
Keep life-saving drugs affordable

India has also played a leading role at the World Trade Organization (WTO) in fighting for TRIPS flexibilities allowing developing countries to prioritize health over patents.

Conclusion: The Law Is Still Evolving

Biotechnology patents sit at the intersection of law, science, ethics, and economics.

Should life be patented? Can we own a gene? World are in search of answer to questions like what is the line between discovery and invention?

These are not just legal questions they are moral debates of our time.

As a student of law, knowing these basics and understanding the real-life impact of landmark cases will help you become a lawyer who can navigate the legal frontiers of tomorrow.

Whether it’s a village farmer or a global pharma company, biotech law touches everyone.

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