Can someone own a human gene? Scientists can now isolate DNA segments and synthetically recreate them — feats that look like inventions. But patenting genes is deeply contested. Here’s where the US and India stand.
The question
Genes — the basic units of heredity, made of DNA — can now be isolated from cells, and synthetically created by extracting particular strands and omitting the rest. Such breakthroughs look like inventions — so are they patentable, and can someone own these genes?
The US position — Myriad Genetics
In Association for Molecular Pathology v. Myriad Genetics, the US Supreme Court considered whether isolated natural DNA and synthetic cDNA are patent-eligible. Myriad had located the BRCA1/BRCA2 genes (mutations raising breast/ovarian cancer risk) and claimed patents. The Court held:
- Naturally occurring DNA is NOT patentable — it’s a product of nature, even once isolated; but
- synthetic cDNA IS patentable — because, although it retains natural exons, its nucleotide sequence is dictated by man, not nature, so it isn’t a “product of nature.”
The ruling was tentative — leaving ambiguity over the test for whether synthesised DNA is inventive enough to patent.
The Indian position — Section 3(c)
Section 3(c) of the Patents Act bars patents on “the mere discovery of a scientific principle… or discovery of any living thing or non-living substance occurring in nature.” So naturally occurring genes can’t be patented in India.
But isolated synthesised DNA is less clear — and the Patent Office has been inconsistent:
- JEV cDNA (Patent No. 243799) — a cDNA sequence was granted protection, though a mere derivative of a natural sequence.
- Filarial parasite polypeptide vector (Patent No. 246865) — the Office objected that the cDNA came from nature, but the objections were withdrawn and the patent granted.
Practice varied due to lack of guidance in the manual/Act — with naturally occurring isolated sequences sometimes granted despite Section 3(c).
The 2013 biotech guidelines
To address this, the Guidelines for Examination of Biotechnology Applications for Patent (2013) were issued — a welcome step toward consistency. They explicitly state that an isolated gene sequence occurring in nature is a discovery of a living thing and not patentable under Section 3(c). For cDNA (exon-only, introns removed by man), guidance is thinner — but an illustrative example suggests an isolated sequence wouldn’t fall under Section 3(c) if the claims show modification, alteration or deletion — though no guidance on the extent of modification required.
An unsettled criterion
Clearly, merely identifying a gene’s location as it exists in nature isn’t patentable under Section 3(c). What’s vague is whether isolated synthesised cDNA falls within the exclusion. The 2013 Guidelines are an optimistic start, but many questions remain — and with genetic technology advancing, expect continued litigation unless a uniform practice emerges. The Patent Office must be cautious — patents wrongly granted hinder development.
The takeaways
- Natural genes aren’t patentable — Section 3(c) (India) and Myriad (US) agree.
- Synthetic cDNA is patentable in the US — its sequence is man-made, not a product of nature.
- India’s practice has been inconsistent — some natural sequences were wrongly granted.
- The 2013 biotech guidelines help, but the cDNA question and the “extent of modification” remain unsettled.
Frequently asked questions
Can a naturally occurring human gene be patented in India? No — Section 3(c) bars patents on discoveries of living things or substances occurring in nature, so natural genes aren’t patentable.
Is synthetic cDNA patentable? In the US, yes (Myriad) — its sequence is man-made. In India, guidance is thinner, but modified/altered sequences may fall outside Section 3(c), though the required extent of modification is unclear.
Why has the Indian Patent Office been inconsistent on gene patents? Because of a lack of guidance in the Act and manual, some naturally occurring isolated sequences were granted despite Section 3(c) — which the 2013 biotech guidelines sought to correct.
What do the 2013 biotech guidelines say? That an isolated gene sequence occurring in nature is a non-patentable discovery under Section 3(c), while modified/altered sequences may be eligible — without specifying how much modification is enough.
Useful official resources
- The Patents Act, 1970
- Indian Patent Office — patents