📌 Challenging broad spectrum patents!

(from the archives)

The European Patent Office at Munich recently ran into opposition to a broad spectrum patent granted on all GM soyabean varieties to a Monsanto owned company.

On 5th May, an international group of civil society organisations in Munich, Germany challenged a patent granted to Agracetus (now a Monsanto company). The patent is for a particle bombardment (biolistic) method of transforming soybeans and importantly it was granted to cover all soybean varieties by the European Patent Office. This is a very broad spectrum patent awarded on all existing GM soybean varieties (and all other plants using the same GM technology used by the soyabean work). Greenpeace-Germany is coordinating this challenge.

Dr. Suman Sahai, president of the Delhi based non-government organization Gene Campaign was invited to Munich to depose as an expert to challenge the soybean patent before the Opposition Bench. The bench is a group of experts from the European Patent Office who sit to hear oppositions to a patent and decide on it. Others in the opposition coalition were Greenpeace Germany and civil society organizations from Canada, Germany as well as a scientific community member from China.

Interestingly, joining cause in opposition to this patent were the corporations Syngenta and De Kalb in Munich. Syngenta and De Kalb are in opposition because such a broad patent prevents them from entering the market with soyabean varieties of their own. They are obviously reluctant to accept that Monsanto will hold a monopoly on all GM soy varieties. Not surprisingly, before acquiring Agracetus Monsanto had opposed this patent. What is surprising though is the soy patent has been upheld in the EU which has so far had more liberal patent laws and greater reservations about plant patents. The grant seems to indicate an apparent shift in official EU policy. Ironically, a similar broad spectrum patent held by Agracetus on all GM cotton varieties, was struck down in the US.

A public meeting was organized by Greenpeace-Germany on May 6, to explain the negative consequences of such sweeping patents on the researchers and farmers of developing countries. Dr. Sahai said it is important to bring the attention of the west to the grave implications of such patent mediated monopolies on the food and livelihood security of developing countries since access to new technologies will be denied. In her deposition before the European Patent Office in Munich, Germany, Dr. Sahai argued for the canceling of the patent granted to Agracetus for transforming soybeans, covering all soybean varieties.

The philosophy and rationale of the patent system, which was to balance public and private interest. Now, with broad patents, monopolies are sought to be established in a way that private interest outstrips the public interest.

While some of the reasons cited for opposing the patent were technical, there were several arguments submitted that generic and question the very premise of granting any broad spectrum patent, soyabean included. According to those opposing this patent, if upheld it would effectively restrict access to this technology for anyone with new or novel ideas to further improve soybean. Any further research on soybean by any person or agency, without royalty payments to Agracetus would not be possible. This would create a situation that establishes monopoly, is anti-competitive and will stifle innovation and development in the field of agricultural research and crop development. In the present day of functional genomics, with its potential to discover new and novel genes that can be used for crop improvement, this broad spectrum patent will deter research to improve soybeans and other plants.

The impact of such a broad patent extending to all plants will become a grave impediment to the ability of developing country researchers to access new crop improvement technologies to breed new crops for their regions. Patents per se and such broad patents particularly have grave implications for farmers in developing countries. Restricting access to seed can strike at food and livelihood security by limiting the ability to access new seeds that can help to cope with biotic and abiotic stress situations that occur from time to time in agriculture. Patents of the kind being claimed and granted on biological materials and seeds are in essence faulty and cannot be defended since variability is a central feature of biology and the innovation is not reproducible. Every plant in a field of any crop variety will be different to the others.

Any patent on crop varieties and certainly one with such a broad scope is in essence inequitable and unjust since it appropriates the several innovative contributions made by other parties, specially farmers, who have created the land races and farmer varieties on the basis of which further breeding takes place. If it took a hundred steps to create a new crop variety, it would be safe to assume that farming communities have contributed at least the first 80 to 90 steps and the scientists such as the ones claiming this patent have contributed the last few steps. They cannot be allowed to appropriate the innovations and contributions of farming communities and other scientists by claiming a patent and that too one with such broad application.

In acknowledgement of the deeply critical nature of vital sectors like food and medicine for the survival and well being of communities in today’s developing countries, patent laws have granted a special status to these sectors. IPR regimes have been soft and flexible so that monopolies in the form of strong and exclusive patents do not become serious barriers to communities who have vulnerabilities with respect to food and health security. Broad spectrum patents go directly against the philosophy and rationale of the patent system, which was to balance public and private interest. The innovator was rewarded with a temporary monopoly on the invented product so that he/ she continued to benefit society by inventing new and useful products. This was the reason for ‘utility’ being such an important feature of a patent claim. Now, with broad patents, monopolies are sought to be established in a way that private interest outstrips the public interest. This attitude cannot be in the larger interest of most people and this patent must be opposed on that ground alone.

Later this month, the Opposition Bench ruled to uphold Monsanto’s broad patent. While the official decision will come out later, the civil society coalition that opposed the patent will go into appeal.

This article appeared in India Together on 01 May 2003 - https://indiatogether.org/brodpatnt-agriculture/ 

📍GM, agriculture, and food security

(from the archives)

India's position is opaque, based on incomplete research, and unresponsive to public health and food security issues. Dr. Suman Sahai lists recommendations from a national symposium.

A two day national symposium on “Relevance of GM Technology to Indian Agriculture and Food Security was organised by Gene Campaign on Nov. 26 and 27, in Delhi, to celebrate its 10th Anniversary. The Multistakeholder symposium brought together speakers and participants from across the entire range of views held on the subject of GM crops. Speakers ranged from strong supporters of GM technology to those equally strongly opposed to it and those with measured views. Participants included scientists, academics, social scientists, farmers, members of parliament, lawyers and judges, representatives of government, including the regulating agencies, various policy makers, the National Academy of Agricultural Sciences (NAAS), the seed industry, food processing and retailing industries, environmentalists, consumer organisations, organic farmers (IFOAM) and civil society organisations.

The two-day event witnessed a series of high quality presentations and strong, focussed discussions. One thing that all speakers pointed out was the appalling state of the Regulatory Framework in India and the urgent need to change it. Members of the Genetic Engineering Approval Committee (GEAC), India’s apex regulatory body explained the process of regulation and in the face of vociferous demand, agreed to put more data on the GEAC website.

Members of the Genetic Engineering Approval Committee explained the process of regulation, and were met with vociferous demands for better information.

A series of recommendations emerged from the two-day consultations. These are being forwarded to the Government’s Task Force on Biotechnology, the GEAC, the Department of Biotechnology, the Minister of Science and Technology, the Indian Council of Agricultural Research and the Ministry of Agriculture, the Ministry of Environment as well as the Prime Minister’s Office.

Recommendations

1. A distinct law should be enacted to oversee Genetic Modification Technology and its implementation. This law must harmonise with other laws and national and international agreements.
2. A comprehensive biotechnology policy should be developed in consultation with all stakeholders.
3. A statutory National Bioethics Commission must be set up.
4. There should be a consultative and participatory process to prioritise crops and traits for genetic improvement through biotechnology with the goal of addressing the needs of small farmers and Indian agriculture.
5. Investment in public sector research should be increased and strengthened. Novel gene discovery in crops of relevance to India should get highest priority.
6. India must develop a policy for transgenic varieties of crops for which it is a Centre of Origin and Diversity. Commercial cultivation of GM rice should not be allowed until the nature of gene flow and its impact is understood.
7. The Herbicide Tolerance trait should be subject to rigorous cost and risk benefit analysis before being considered for adoption.
8. Alternatives to the GM approach must be carefully evaluated in each case before deciding on the GM route. A cost and risk benefit analysis must be conducted before deciding on a GM product.
9. Protocol for food safety tests must be vastly improved and mechanisms for long term monitoring of human health (post GM food release) be put in place.
10. Develop a stringent protocol to assess environmental and ecological impact.
11. There should be provisions for post-market surveillance and monitoring of GM products.
12. Have a policy to deal with bio terrorism urgently.
13. India must exercise caution in the IPR regime that it adopts. The current PPV-FR should be retained since it balances Breeders and Farmers? Rights.
14. A new statutory, independent National Biotechnology Regulatory Authority must be established.
15. Make GEAC more competent, transparent and accountable. Post data on research and development of GM crops and products on websites and local newspapers.
16. An annual review of all decisions on GM products must be presented to Parliament.
17. Conduct a scientifically sound study to assess attitudes and perceptions about GM technology among stakeholders in India.
18. Undertake a program of awareness about GM technology to educate the public.
19. Organize a series of public debates across the country to elicit the views of the people, to channel it into policy making. The government should fund this exercise.
20. There should be a moratorium on commercial cultivation of GM crops until the regulatory system is demonstrably improved. Research on GM crops, however, should continue.

This article appeared in India Together on 01 Dec 2003: https://indiatogether.org/gmconf-agriculture/

 📍Svalbard: The Gene Bank near the North Pole

One of the most precious structures located in the Arctic is the Svalbard Gene Bank built into a mountain on Spitsbergen Island, just outside the town of Longyearbyen in the remote Arctic Svalbard archipelago of Norway. This international Gene Bank is located roughly 120 meters deep inside the frozen permafrost, at a latitude of 78 degrees North, well inside the Arctic Circle, close to the North Pole.

The Gene Bank in Svalbard is often referred to as the Svalbard Global Seed Vault or the Doomsday Vault. This name embodies the intent of the Gene/ Seed collection in Svalbard, that if the Earth were to suffer catastrophic damage, if doomsday, so to speak, were to arrive, then seeds of the crops grown across the world would be found stored safely here. These seeds could be used to replant the ravaged Earth and help the remnants of the surviving humanity to stay alive and re-people the Earth again.

Svalbard is to be seen as a secure backup facility for seeds. It is like a safe deposit box where the seeds remain the property of the depositors. The bank holds over 1.4 million samples from countries across the globe. The vault physically holds backup seed samples from over 220 countries /territories which means practically the whole world. It preserves the genetic diversity of crop plants, especially food crops against climate change, wars, disasters, and other catastrophes that the human race could dream up.

India is among the leading contributors to the Svalbard Bank. The largest number of samples have come from the National Gene Banks of India, the United States, Germany, and Canada. These countries maintain some of the biggest volumes of backup crates inside the vault. 

I visited the Svalbard Seed Vault in 2009 at the invitation of the Norwegian Government. The invitation came because of Gene Campaign’s work on conserving crop genetic diversity and setting up community managed Zero Energy Gene–Seed Banks in villages in Jharkhand. Different kind of banks to the Arctic vault but same goals.

 

THE ROLE OF WOMEN IN CONSERVING GENETIC DIVERSITY

Women have traditionally played an important role in managing the genetic diversity in their regions, harvesting carefully, and allowing regeneration so that the resource base is sustained over generations. In many Asian societies, field operations like ploughing and marketing are done by men, and the selection and storage of seed, planting and weeding in fields, by women. Women generally use their knowledge of natural and biological resources to satisfy multiple household needs. They breed well-adapted varieties and develop sophisticated farming systems using a range of crop varieties, to ensure food and nutrition for the family. Their access to and use of genetic resources is unhindered and they succeed in making effective use of them for food, fodder, medicine and other essential products.

The transformation of agriculture to meet the needs of a globalizing market economy is contributing to the steady erosion of the biological resources and knowledge systems controlled by women. The trend towards monocultures and cash crops in a high input, intensive agriculture system, to produce crops on contract or for urban and export markets, is impacting negatively on women’s role in domestic and local arenas. 

Communities often have well-defined gender roles in plant and seed selection and storage. Traditionally women in Asia often use a variety of indigenous plants, trees and animals, and they have a direct stake in conservation. The Neem tree, for example, is used as a bactericidal agent in agriculture, in the household for storing food and to prevent infections. Women tend to take a lead role in preserving and conserving croplands, forests and other natural resources for perpetual use. Men are more likely to be involved in converting these resources into cash. Women are also often the traditional caretakers of genetic and species diversity in agriculture. Their knowledge of growing conditions and nutritional characteristics of various species trains them in seed selection and plant breeding. In many societies, it is women who are mainly responsible for this, as well as for seed exchange and preservation of local bio diversity, often gathering fruits and medicinal plants from forests for immediate use or for sale at local markets.

The ‘Convention of Biological Diversity’ (CBD), which affirms the sovereign rights of nations over their bio resources, calls for conservation of bio diversity, sustainable use of its components, and fair and equitable sharing of benefits arising from the utilisation of genetic resources. The CBD makes reference in the Preamble to the central role of women in conserving bio diversity and knowledge of plant properties: “Recognizing also the vital role that women play in the conservation and sustainable use of biological diversity and affirming the need for the full participation of women at all levels of policy-making and implementation for biological diversity conservation”. ‘Agenda 21’, adopted at the Earth Summit in Rio de Janeiro in 1992, also stresses the need to strengthen women’s involvement in national ecosystem management and control of environmental degradation. 

Other international plans of action have highlighted the critical role of gender in genetic resources conservation and sustainable utilisation. The Food and Agriculture Organization (FAO) publication, ‘Gender – Key to Sustainability and Food Security’, states: “Rural women in developing countries hold the key to many of the planet’s agriculture systems for food production, seed selection, and protection of agro-bio diversity. Women using diverse wild and indigenous species often use home gardens as experimental plots.”

 

📍ARE DESIGNER BABIES DANGEROUS ? 

Tampering with the genetics of producing babies began with Dolly the sheep who became a genetic sensation in 1996. She was cloned by a process called somatic cell nuclear transfer. In this, scientists took a cell from an adult sheep and transferred its DNA into another sheep egg cell from which the nucleus was removed. This embryo grew up to be Dolly, showing for the first time that specialized cells from an adult body could be reprogrammed to create an entirely new organism. Since then scientists have cloned over 20 other mammal species, including cattle, horses, pigs and mice and later, even monkeys.

 

We have come a long way since Dolly, via stem cell therapy and research on human embryos . The latter is governed by the globally accepted 14-Day Rule which prohibits researchers from culturing or researching live human embryos in the lab past 14 days of development. This convention was breached in 2018 by a Chinese scientist Dr. He Jiankui who secretly edited the DNA of twin embryos to make them resistant to HIV. There was an international furore when this was discovered and it led to Dr. Jiankui’s imprisonment for violating medical ethics and regulations. 

 

I have a sense that the earlier scientific outrage seems to be weakening as genetic technologies develop further and the appeal of designer babies refuses to abate. 

The new gene-editing technologies like CRISPR-Cas9 have made it even easier to alter the DNA of human embryos and produce genetically modified babies or ‘designer babies’. It is feared that this prohibited line of research is now being done covertly in more than one lab.

The main scientific goal of creating designer babies is to halt the transmission of heritable diseases but there are already whispered demands to create an infant with certain characteristics that parents consider desirable. This would be the start of the slippery slope.

Apart from grave ethical concerns, the reason why frivolous genetic alteration of the embryo is proscribed is because DNA editing of human embryos often leads to unintentional or “off-target" mutations. This will result in a “cellular mosaic”, meaning not all cells will get altered as intended. These defective changes will be passed down to all future generations, so all descendants of this “designer person” will carry the defect of the cellular mosaic. And we have no idea what impacts this will have.

 

If designer babies and designer adults become a reality in substantial numbers, we can easily imagine that the genetic and physical integrity of homo sapiens will change. How likely is it that this will happen? Hard to say. Covenants and regulations can be/ have been broken as we have seen. And there are plenty of mavericks out there wanting to go out and plant their flag on something outrageous…and forbidden.