Both Monsanto and Syngenta shares slipped today in the US - Monsanto's by 23 cents - on news of the broadening legal feud between the 2 gene giants as Syngenta, stymied in Europe, moves aggressively against the Monsanto-dominated GM corn market in the US.

They may be at each other's throats in the US, but in India their desperation for markets means a shared agenda. Industry pressure for fast-tracking of GMOs is building all the time with industry demanding "changes in the rules relating to production, use, import, export, storage of genetically modified organisms (GMOs)" (item 2)

The industry is holding up the US as the perfect regulatory model for India to follow. If they succeed, they will then hold up India to the rest of the developing world.

For more on what's happening in India, see:
Ushering in the Second Green Revolution
http://www.lobbywatch.org/archive2.asp?arcid=4179
Clipping the wings of India's regulators
http://www.lobbywatch.org/archive2.asp?arcid=4183

1.Monsanto again sues rival Syngenta
2.Biotech Industry For Specialised Regulator
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1.Monsanto again sues rival Syngenta
By Jim Suhr
Associated Press, 07/28/2004
http://www.stltoday.com/stltoday/business/stories.nsf/0/94209BA289AA529A86256EDF0059A856?OpenDocument&Headline=Monsanto+again+sues+rival+Syngenta

ST. LOUIS (AP) -- Broadening its legal feud with Syngenta AG, Monsanto Co. has filed two new lawsuits accusing its Swiss agribusiness rival of breach of contract and patent infringement -- its third such action in less than three months.

The St. Louis-based company on Tuesday asked a federal court in Rockford, Ill., to block Syngenta from developing, using and selling Roundup Ready corn seed, including Monsanto's GA21 Roundup Ready variety. The filing in U.S. District Court in Rockford, Ill., alleges Syngenta infringed patents held by Monsanto's DeKalb Genetics Corp.

The breach-of-contract lawsuit, filed under seal Tuesday in a St. Louis County court, concerns a soybean license granted to Syngenta predecessor Ciba-Geigy Corp. Monsanto wants the court to end a license that allows Syngenta to sell soybeans genetically made resistant to Monsanto's Roundup herbicide.

"There are obligations that all parties must respect in order to properly license these value-added biotechnology products," said Carl Casale, Monsanto's executive vice president. "Unfortunately, Syngenta has chosen not to live up to these obligations, so we must act to protect our rights and those of our other licensees."

Syngenta spokeswoman Sarah Hull said Wednesday that the company will vigorously defend itself against the lawsuits.

"We are very confident about our position and that we are operating within the rights" of our agreements with Monsanto, she said.

In May, Monsanto sued Syngenta in Delaware, asking a federal judge to permanently bar Syngenta from marketing so-called GA21 corn, arguing that Syngenta's doing so would violate a Monsanto patent.

Syngenta has said it had bought rights to some parts of the GA21 technology from Bayer CropScience -- a unit of drug-making Bayer AG -- and planned to use and market that commodity in the United States. Monsanto said those rights were never part of its deal with Bayer, so Syngenta has no claim to them.

Syngenta has called the Delaware lawsuit groundless and suggested it would press ahead in using GA21 technology.

"Our position then and still is that we're confident we have the rights we need to commercialize the product," Syngenta's Hull said.

In late morning trading Wednesday on the New York Stock Exchange, Monsanto shares slipped 23 cents to $35.97, while Syngenta's U.S.-traded shares were down 12 cents to $16.30.
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2.Biotech Industry For Specialised Regulator
ASHOK B SHARMA
Wednesday, July 07, 2004
http://www.financialexpress.com/fe_full_story.php?content_id=62956

NEW DELHI: Not satisfied with the model of National Biotechnology Regulatory Authority recommended by Dr MS Swaminathan panel, the industry has proposed its own single window regulatory authority with three specialised wings. The model is presented before the taskforce on recombinant pharma sector - headed by Dr RA Mashelkar.

The industry has also demanded changes in the rules relating to production, use, import, export, storage of genetically modified organisms (GMOs), micro-organisms and cells and easy import of plant tissue cultures. The Mashelkar panel is expected to submit its report shortly.

The Federation of Indian Chambers of Commerce and Industry (Ficci) has suggested that the proposed Biotechnology Regulatory Authority should have three wings incorporating the existing bodies like the Genetic Engineering Approval Committee (GEAC), the Indian Council of Agricultural Research (ICAR) and the Drugs Controller General of India (DCGI).

The role of DCGI should be redifined and reconstituted into Biotech Controller General of India (BCGI).

There is no single regulatory authority for transgenic technology in the US. In the US, approval and regulations are done by three different bodies like the Environmental Protection Agency (US-EPA), the United States Department of Agriculture (USDA) and the Food and Drug Agency (US-FDA). In this context, Ficci has suggested that the three wings of the proposed Biotechnology Regulatory Authority in India should be based on the US model.

According to Ficci, the GEAC in India should oversee not only testing of genetically modified (GM) organisms but also the related containment, hygiene and environmental protection. Like USDA, the ICAR in India should oversee GM crop and animals. A nominee each from the Indian Council of Medical Research (ICMR) and GEAC should be deputed to ICAR to monitor and assess the impact of consumption of GM crops on humans. The GEAC nominee should also assess the impact on environment and also determine the pesticide levels in plants safe for human consumption.

Like the US-FDA, the existing DCGI in India should play the role of a regulator for drugs, chemicals, intermediaries and bulk drugs. The industry feels that the several provisions under the "Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Modified Organisms or Cell 1989 (Rules-1989)" are deterent to the growth of the transgenic technology and, therefore, should be amended.

Also the "Plant Quarantine (Regulation of Import into India) Order 2004" should be amended.

Ficci has also proposed that recombinant protiens (antigens) used by the medical diagnostic industry should be exempted from the purview of the GEAC as these are only synthetic dead protiens and not living modified organisms or cells.

There should be harmonisation of recombinant pharma guidelines involving the department of biotechnology (DBT), DCGI and GEAC.

Also, clinical trials and basic R&D should not come under the purview of GEAC.