Confusion reins on the GM front in India with even the iondustry saying it threatens a "bioi-disaster". See also the following recent items on India's GM chaos:

No end to woes of Bt cotton farmers in India
http://www.lobbywatch.org/archive2.asp?arcid=4600
Bt Cotton Fails Yet Again in India - farmers go on rampage
http://www.lobbywatch.org/archive2.asp?arcid=4557
Keep away, Anjammas tell GM pushers
http://www.lobbywatch.org/archive2.asp?arcid=4583

1.Illegal Seeds Overtake India's Cotton Fields
2.New patent regime may pose challenges to farm sector
-------

1.Illegal Seeds Overtake India's Cotton Fields

- K.S. Jayaraman, Nature Biotechnology 22, 1333 - 1334; Nov. 2004 [via AgBioview] www.nature.com/nbt

Indian agricultural minister Sharad Pawar admitted in parliament on August 16 that there is a flourishing illegal market in genetically modified (GM) cotton seeds, strengthening allegations by the industry that more than half of all the GM cotton now growing in the country is from unapproved varieties. Pawar, Indian scientists and seed companies want state governments to take action against the seed producers and traders to protect the industry and to prevent an impending 'biodisaster.'

India's Genetic Engineering Approval Committee (GEAC), the country's main agbiotech regulatory body, opened the door to genetically modified (GM) products in 2002 (Nat. Biotechnol. 20, 415, 2002) and now allows the sale of four varieties of insect-resistant GM cotton, all of which carry St. Louis-based Monsanto's proprietary cry1Ac gene from Bacillus thuringiensis (Bt). Now in its third year of use in India, Bt cotton--including illegal varieties--is estimated to cover more than three million acres in the country, which is about one-third of the total area of planted cotton.

But, because of poor monitoring by the government, "80% of all Bt cotton growing in India are nameless, unlicensed varieties," says Sateesh Kumar, managing director of Prabhat Agri-Biotech in Hyderabad. This year, farmers have planted unapproved GM cotton in more than half-a-million acres in the Gujarat state alone, say industry executives.

The problem started in 2001 when an unlicensed Bt cotton hybrid carrying the cry1Ac gene was found growing on over 10,000 acres in the western state of Gujarat (Nat. Biotechnol. 19, 1090, 2001). Failure by the government to enforce GEAC's order to destroy the crop or to punish Navbharat Seeds, the Ahmedabad-based company that sold the unapproved seeds, emboldened seed producers to covertly multiply and sell them. Two things created the demand for this illegal variety: its demonstrated ability to resist bollworm attack and the relatively low price (Rs.600 ($13) for 450 grams compared to Rs.1,600 ($35) for an approved variety marketed by Monsanto licensee Mahyco in Jalna).

Companies are becoming frustrated at the lack of accountability for the illicit behavior. "We spend millions of rupees in research and then wait for years for regulatory clearance," says Foujdar Singh, adviser to Syngenta India Limited in Hyderabad, whose insect-resistant cotton is undergoing field trials. "But here are unauthorized varieties openly sold in market for the past three years. If this is the situation, why should companies invest in R&D at all?"

Perhaps potentially more harmful for India's cotton industry is a looming environmental disaster if pests develop widespread resistance to the Bt crop. Such resistance is typically combated by planting refugia of non-Bt cotton, which dilutes the presence of Bt-resistant genes in pest populations through gene flow. But farmers planting illegal seeds are not obliged to provide such refugia for resistance management. Syngenta's Singh predicts, "Only when there is a major pest problem farmers will wake up" and stop planting the illegal varieties without refugia.

"The illegal proliferation of GM varieties must cease or else the biosafety regulations will be rendered meaningless," warns a government committee headed by M.S. Swaminathan, a noted agricultural scientist and chairman of his own Research Foundation in Chennai. But it is not going to be easy, because traders masquerading as farmers sell the illegal seeds in unmarked cloth bags, no bills or receipts issued, according to Singh. "Indian laws allow farmer-to-farmer sales, even of patented varieties, as long as they are not branded," explains Prabhat's Kumar.

"We have been running up and down the government corridors seeking a ban on illegal seeds, but the organized sector cannot do much unless the government is firm," says Singh. In response, government officials claim to have registered 18 complaints and to have conducted 40 raids, with arrests in four states and seizures of 62 kilograms of illegal seeds.

But industry officials doubt the sincerity of these efforts. "If the government really wanted to end the illegal trade, it could have raided the seed production centers," says Kumar. Industry sources say that illegal seeds produced in about 8,000 acres in Gujarat and 4,000 acres in Andhra Pradesh are enough to plant 2.5 million acres--about twice the quantity of legal seeds that Mahyco claims to have sold this year.

How long the illegal seeds will rule the Indian Bt market is unclear. The fight is expected to intensify in two years when 12 more varieties of Bt cotton hybrids developed by Raasi Seeds, Ankur Seeds and Mahyco are expected to reach the market.
------

2.New patent regime may pose challenges to farm sector
ASHOK B SHARMA
FARM FRONT Column
Financial Express, November 08, 2004
http://www.financialexpress.com/fe_full_story.php?content_id=73556

India is set to amend its Patent Act, 1970 for the third time with a view to meet its commitments to WTO by January 1, 2005. The amendments are proposed to be consistent to the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS - 1994).

Patent Act, 1970 was amended for the first time in 1999 and for the second time in 2002 which came into effect from May 20, 2003. The third amendment is slated to provide patent product regime in pharmaceuticals, food and chemicals, including agro-chemicals. Granting patent rights over micro-organisms, microbiological and non-biological processes for production of plants and animals are also likely to be covered under the third amendment.

Though India opted for sui generis system for protection of varieties and enacted a law for the purpose, it is likely that the transgenic seeds developed through human intervention may be covered under the new patent regime. The biotech industry in the country is eager to seek such a protection citing Article 27 of the TRIPS agreement. The TRIPS agreement has stipulated three criteria for patent rights namely novelty, inventive step and utility. In tune with Article 27, the second amendment to the Patent Act effected from May 20, 2003 has inserted a new definition of ‘invention’ which reads : "invention means new product or process involving an inventive step and capable of industrial applications." Though the second amendment has excluded plants from the patent regime, it says that biotechnological processes to develop unique plants can be covered under patents.

Keeping in view the past events and likely developments in the near future, the upcoming third amendment to the Patent Act may, therefore, pose new challenges before the farm sector. In this context, the policymakers has a duty to ensure that several protections given to farmers like for saving seeds for the next season under the Plant Varieties Protection & Farmers' Rights Act are not diluted. Similarly the community rights ensured under National Biodiversity Act should not be ignored. The challenge, therefore, before the government is to develop a holistic view of the entire intellectual property rights (IPR) regime in the country. The second amendment to the Patent Act has a provision for disclosure of the geographical origin of the biological material and notifying certain depositories for biological inventions.

The TRIPS agreement has not defined micro-organisms and microbiological processes. Here the question is whether the micro-organisms existing freely are patentable or their mere isolation in pure form are patentable or human intervention in establishing a level of novelty in the discovered micro-organism is needed for patenting. The USPTO verdict of the case Diamond vs Chakraborty in 1980 establishes that human intervention leading to a novelty in expression can be patented. It says : "respondent's mico-organism plainly qualifies as patentable subject matter. His claims is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter - a product of human ingenuity having a distinctive name, character and use... His discovery is not nature’s handiwork, but his own..."

Next question is whether a product produced by a micro-organism which is known can be patentable or the process is patentable. In absence of clear definition of micro-organism and micro-biological process in the TRIPS agreement, the country’s policymakers need to drawn a distinctive line between the the product of human intervention leading to novelty and those freely occurring in nature.

Claims in gene patent applications may pertain to genes or partial DNA sequences, proteins encoded by these genes, vectors used for transfer of genes, genetically modified micro-organisms, cells, plants and animals and the process of developing a transgenic product. These may lead to multiple rights owned by multiple actors called patent thickets over a final product. Hence there are problems of not only patent thickets, but also of royalty stacking and reach-trough claims. Reach-through claims are research tool patents such as patents on markers, assays, receptors, transgenic animals. Reach-trough claims results in royalty stacking. These complexities need to be resolved so that the farmers does not end up paying heavy sum in royalty.

The food sector in the country will also have to face new challenges in the new patent regime.

Different processes and products will become patentable. There is, therefore, a need to document all the traditional processes as well as products with a view to reduce the number of controversies over claims for patent rights.