Mains Paper 3 Science and Technology| Bio-technology and issues relating to intellectual property rights.
From UPSC perspective, the following things are important:
Prelims level: Basics of IPR, GM, GEAC.
Mains level: The newscard discusses impact of SC ruling on IPR environment, in a brief manner.
- The Supreme Court restored Monsanto Co.’s patent claim on genetically modified (GM) Bt cotton until its validity is decided by a single judge of the Delhi high court.
- It ought to reassure biotech companies that had held back on introducing new technologies in India after the controversy over genetically modified (GM) cotton erupted.
- The ruling is the result legal battles between Monsanto and domestic seed companies, led by Nuziveedu Seeds Ltd.
- In 2004 Monsanto entered into a sub-license agreement with domestic company Nuziveedu for an initial period of 10 years.
- The agreement had entitled the Indian firms to commercially exploit genetically modified hybrid cotton planting seeds with help of Monsanto’s technology within the limits of the agreement on the payment of a license fee.
- Local seed firms, which get licenses from Monsanto to sell genetically-modified seeds, used to pay a “trait fee” fixed by the government.
- Recently Nuziveedu Seeds was arguing that the U.S. company was not entitled to get any more money from them and had petitioned in the court to cancel Monsanto’s patent
- Soon after, Monsanto had lodged counter cases for patent infringements by Indian companies.
- The agreement was terminated in November 2015, giving rise to the patent suit.
- The Single Judge, in March 2017, restored the agreement and ordered the parties (Monsanto and companies like Nuziveedu) to adhere to their obligations under it.
Why did the Delhi HC reject patent?
- The judge reasoned that Monsanto’s Bt gene was useless to farmers unless inserted into a cotton hybrid, which farmers could then grow to repel pests.
- This insertion is carried out by seed companies, who cross a Bt gene-containing plant (from Monsanto’s donor seeds) with their proprietary cotton varieties.
- The judge argued that this crossing of plants was a natural and biological process.
- This argument undermined Monsanto’s patent, because under Section 3(j) of India’s Patents Act, a seed or a plant, or a biological process to create a seed or plant cannot be patented.
- If this argument is correct, few plant biotechnology innovations would be patentable in India.
- This is a dangerous conclusion because the lack of patent protection would discourage crucial research by the agri-biotech industry.
Significance of SC ruling
- SC order validates that patents are integral to innovation and reinforces faith in the Indian judiciary and the Indian patent system.
- Technology developers will now be encouraged to invest more money into bringing new technologies to the market.
- The court has recognised that products of biotechnological processes such as man-made DNA constructs are patentable in India.
- The ruling may prompt some biotech companies to revive expansion plans that were placed on hold amid restrictions imposed by the government and local courts in recent years.
- SC ruling will bring certainty in the policy environment and looking to improve Indian cotton farmer’s competitiveness.
- IPR issue-
- Protecting intellectual property rights is vital to improving the competitiveness of the Indian farmer.
- The Supreme Court’s suggestion to the Delhi high court—a division bench of which had ruled that life forms cannot be patented—that all aspects related to Monsanto’s patents on genetically modified seeds can be considered could allay apprehensions among technology developers over losing pricing freedom in India.
- Reduced Royalty
- The government has capped royalty payments to Monsanto and asked it to grant licences to more seed companies for using Bt cotton. Indian seed companies pay a government-mandated trait fee, as such royalty is called, on genetically modified seeds.
- Multinational biotechnology companies like Monsanto which has held back other Bt cotton varieties from India and Bayer has gone slow in introducing a hybrid rice seed that can withstand flooding for two weeks.
- Maze over field trials
- Regulatory clarity over field trials for genetically modified seeds is overdue. A moratorium on field trials for Bt brinjal, for instance, is in its ninth year and the government wants more research done for GM mustard, which involves more field trials that, in turn, await permissions from state governments.
- Transgenic technologies such as Bt cotton are an important part of India’s cotton production arsenal. They are not infallible.
- But this is true of all technologies, like antibiotics, that fail when used improperly, as was the case with Bollgard-2.
- The important thing for India is to keep incentivizing the development of such technologies and to use them properly. Strong patent protection is a crucial part of this process.
GM Crops in India
- India has the world’s 5th largest GM crop acreage. The world order is – USA, Brazil, Argentina, Canada, India.
- If that’s not interesting enough, then let me add another fact on this – this rank is largely on the strength of Bt cotton, the only genetically modified crop allowed in the country.
- At present, 96% of India’s cotton cultivation area is under Bt cotton crops.
Genetic Engineering Appraisal Committee (GEAC)
- GEAC is apex body under Ministry of Environment, Forests and Climate Change for regulating manufacturing, use, import, export and storage of hazardous micro-organisms or genetically engineered organisms (GMOs) and cells in the country.
- It is also responsible for giving technical approval of proposals relating to release of GMOs and products including experimental field trials.
- However, Environment Minister gives final approval for GMOs.
What is Bt (Bacillus Thuringiensis)?
- Bacillus thuringiensis (Bt) is a bacterium that occurs naturally in the soil and produces proteins that kill certain insects.
- Through biotechnology, scientists can use these naturally occurring Bt proteins to develop insect-protected crops that protect against insect damage and destruction.
- When targeted insects eat the plant containing the protein, they ultimately die; but impact of Bt on humans and other animals is still being questioned.