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August 18, 2010


A Brave Italian Farmer; French Have It All Wrong; Gene Theft by a Plant; Turkey Braces for GM; Patents in Europe


* Italian Farmer Pushes Genetically Modified Crops
* French Foes of Genetic Engineering Have It All Wrong
* Gene Theft by a Parasitic Plant
* India: Biotech Regulatory Authority Bill for Safety and Efficacy: Ramesh
* Turkey to Enact New GMO Regulations
* The Future of Biotechnology Patents In The European Union
* Two Excellent Additions to the AgBioTech Bookshelf

Italian Farmer Pushes Genetically Modified Crops

- Colleen Barry, Associated Press, August 18, 2010

PORDENONE, Italy — Giorgio Fidenato has made a habit of carrying a raw ear of yellow corn and taking a hearty bite whenever a camera is in sight.

It's a provocation. The Italian farmer's corn is genetically modified, grown surreptitiously in fields in the northeast not far from the Austrian and Slovene borders. "Our biggest goal is to show consumers that it is safe to eat," said the 49-year-old advocate of what's known as genetically modified organisms, or GMOs.

More activist than farmer, Fidenato's cultivation of nearly 5 hectares, or 12 acres, of genetically modified corn is a rogue act aimed at forcing the legalization of genetically engineered crops in Italy. He waxes on about their benefits: They require fewer chemicals and produce higher yields and greater profits.

Fidenato faces formidable opposition in Italy. His opponents are angry, organized and, in some cases, equally prepared to take the law into their own hands. Unlike Americans, the vast majority of Europeans are staunchly against the marketing of genetically modified foods.

Arrayed against Fidenato are agriculture officials, who put a moratorium on genetically modified seeds in March, the country's main farm lobby, consumer groups, environmentalists and anti-globalization protesters. "Violating the law to get the debate going is a very dangerous precedent," said Roberto Burdese, president of Slow Food Italy, one of 20 organizations that have banded together to keep genetically modified food out of the country.

The European Commission announced in July a proposal that would allow the 27 member states to have the final word on whether to allow cultivation of genetically altered food within their own borders. That would likely lead to more bans because countries would no longer be required to back up their rulings with new scientific data. The announcement was bad news for Fidenato, though by then his corn was knee-high.

The genetically modified corn, produced by St. Louis-based Monsanto, was the only genetically modified seed authorized for commercial cultivation in Europe until March, when a potato seed sold by the German company BASF was approved. Besides the moratorium in Italy, the seed has been banned in at least six countries, including France, Germany and Austria.

Tired of legal battles, Fidenato planted the corn on April 25, Italy's national Liberation day. He posted a video on YouTube showing him planting six seeds, but he didn't disclose that he had in fact planted two fields. That only came out when anonymous letters containing pieces of the plants reached prosecutors in July, raising opponents' suspicions that there could still be others. He won't say where he got the seeds.

Word spread about the crop, and on Aug. 9 about 70 anti-GMO activists wearing chemical protection suits trampled nearly an acre of corn to the ground. "The pity is they should have waited 10 days, and it would have been ready to make polenta," Fidenato said, referring to the corn meal that is a dietary mainstay in northern Italy.

The leader of the corn bandits, astrophysicist Luca Tornatore, argued there is enough uncertainty surrounding the health and environmental risks posed by GMOs to make them undesirable. Tornatore said his group grew frustrated that prosecutors, who have sequestered the fields, had not destroyed the crops despite a 2001 Italian law that forbids their cultivation.

The protesters also would like to destroy the 4 1/2 hectares Fidenato has planted in another town, but "we don't know where it is," Tornatore acknowledged. Fidenato responded that genetically modified corn has been legal in Italy since it was added to the European Union's catalog of authorized crops 12 years ago. And he pointed to a decision by an administrative court in Rome, which ruled that the agriculture ministry cannot decline to authorize the seeds out of caution.

The ruling resulted from a three-year court battle waged by Silvano Dalla Libera, a neighboring farmer in the northeastern region of Friuli, where Fidenato's fields are located. The former agriculture minister, Luca Zaia, along with the health and environment ministers, responded to the administrative decision by putting a moratorium on GMOs in March. There was a risk nearby fields could be contaminated, they said.

"To stop me, one poor farmer, three ministries mobilized," Dalla Libera said with a hint of pride.
Fidenato began farming when he was 12 and now has about 70 acres. He became persuaded of the merits of genetically altered crops during a trip to the United States in the 1990s and helped found Futuragra, a group of farmers fighting for GMOs.

By planting the corn, he risks up to three years in jail and a fine of euro50,000. Fidenato said he's not bothered by the threat of prosecution. Futuragra has been in touch with farmers in Spain, which has the highest concentration of genetically modified corn in Europe, and France, where it has been banned, to press the battle.

"If they don't understand it is an EU right, that we don't need authorization, then I have farmers in the entire Po River valley, from Piedmont to Veneto, who will plant GMO corn," Fidenato said.


French Foes of Genetic Engineering Have It All Wrong

- The 300 News Daily, August 18, 2010 http://news300.info/

Last Sunday French opponents of genetic engineering destroyed 70 genetically modified vines belonging to the national institute for agricultural research near the city of Colmar.

The business paper Les Echos writes that the activists are missing their target:

“Just like the environmentalists, the proponents of organic foods would have us believe that defending their convictions necessarily involves attacking all genetically modified organisms. However by systematically casting – for reasons far more ideological than scientific – genetic engineering in the role of the enemy, the anti-innovation fundamentalists completely miss their target. When put to good use, genetic technology is not their enemy.

--- Organic products, which are not necessarily any better for the environment than conventional products, would do well to forge an alliance with the GMOs. By making organic products more efficient, such organisms could make organic farming far more competitive.”


Gene Theft by a Parasitic Plant

- R&D magazine, August 6, 2010 http://www.rdmag.com

'Plant genome evolution requires reassessment with the discovery that parasitic plants can ‘steal’ nuclear genes .'

The exchange of genes between non-mating species—a process known as horizontal gene transfer (HGT)—is common in bacteria but seemed confined to mitochondrial genes in plants. HGT between plants and microbes has also been documented.

Now, a team led by Ken Shirasu of the RIKEN Plant Science Center, Yokohama, has published evidence for nuclear gene transfer between host and parasite plant species1. Mitochondrial genes are those of cellular organ-like structures, whereas nuclear genes belong to the cell’s nucleus and are therefore part of the plant’s main genome.

The findings mean that, in principle, parasitic plants could adapt rapidly by acquiring useful genes from their hosts rather than having to evolve new functions de novo—just as today’s plant breeders genetically modify crop plants by introducing into them genes for desirable traits, such as disease resistance, from other species.

As a model system, the researchers focused on the flowering plant known as purple witchweed (Striga hermonthica); it is a root parasite of sorghum (Sorghum bicolor), rice (Oryza sativa) and other cereals. The species is a major agricultural menace responsible for devastating crop infestations in subtropical Africa.

Sorghum and rice are members of the grass family. Like all other witchweed hosts, they are monocots, meaning that their seedlings have just one embryonic leaf, or cotyledon. In contrast, the seedlings of witchweed have two cotyledons, making it a dicot. “We reasoned that the discovery of monocot-specific genes in witchweed would provide compelling evidence for the existence of nuclear HGT between host and parasite plant species,” says Shirasu.

By screening 17,000 witchweed genes, the researchers identified one gene, ShContig9483, similar to genes in sorghum and rice, but not present in parasitic or non-parasitic relatives (eudicots) of witchweed. An evolutionary ‘gene tree’ built by the researchers, using DNA sequences of ShContig9483 and related protein-coding genes, revealed that the position of ShContig9483 in the tree is not consonant with witchweed evolutionary relationships.

“Our analyses indicate that S. hermonthica most likely acquired ShContig9483 from sorghum or a related grass species, and that the transfer event was relatively recent,” Shirasu notes. “Although we do not, as yet, know the function of the protein encoded by ShContig9483, ours is the first clear evidence of nuclear HGT between host and parasite plant species,” he adds.

The researchers believe that other similar cases of nuclear HGT await discovery and that HGT may be a powerful force in plant genome evolution, facilitating rapid adaption through the acquisition of new genes.
1. Yoshida, S., Maruyama, S., Nozaki, H. & Shirasu, K. Horizontal gene transfer by the parasitic plant Striga hermonthica. Science 328, 1128 (2010)


India: Biotech Regulatory Authority Bill for Safety and Efficacy: Ramesh

- Economic Times (India), Aug, 18 2010, http://economictimes.indiatimes.com

The Biotechnology Regulatory Authority bill, scheduled to be introduced in Parliament imminently, will not open the floodgates to genetically modified (GM) food. Infact, it has maintained the integrity of both the environmental assessment process and the public consultation process, environment and forests minister Jairam Ramesh said today.

Addressing a meeting of the Association of Biotechnology-led Enterprises (Agricultural Group) or ABLE-AG here, the minister stressed that the prime objective of setting up the Authority was to ensure a professional and independent regulator whose core concern would be the safety and efficacy of biotech use in agriculture and not commercialisation.

There will be other fora, other platforms for commercialisation, the BTRA will not be that, Mr Ramesh said adding After 6 years of prolonged incubation, the bill has been able to craft a compromise and address, among other, the concerns of civil society.

After introduction in Parliament, the bill will head to the relevant parliamentary standing committee and then be thrown open for public debate, he said. Mr Ramesh held that all the concerns of the environment and forest ministry were also incorporated in the bill.

Notwithstanding that, Industry would welcome the bill, he said. Infact, except for those who are not congenitally opposed to biotechnology will accept the bill, he quipped.

Emphasizing the need for biotech research application especially in agriculture, the minister said that there was need for strong public sector involvement in the sector. Apart from an independent regulatory authority, there was also need for very strong public sector presence in research in order that the undoubtable potential in the technology could be harnessed.

However, he said, all of this had to function with sufficient safeguards in place. GM is not a magic bullet for resolving all the problems of food security. GM is a crucial route to food security but we must retain a sense of perspective and be realistic on what we can accomplish, the minister said. Having said that, the minister pointed out that despite having had an early start in hybrid rice some 20 years ago, China was way ahead of India since
our system was not geared towards higher production.


India: GEAC Becomes Redundant; Whither Biotechnology?

- Business Standard (India), August 18, 2010 http://www.fnbnews.com/article/detnews.asp?articleid=28133§ionid=1

The union government, in a surprise move, divested the Genetic Engineering Approval Committee (GEAC) of its job of approving the genetically modified (GM) products and converted it into merely a GM appraisal body. The gazette notification to this effect replaces the word “approval” in the committee’s nomenclature with “appraisal,” thus making it the Genetic Engineering Appraisal Committee.

One obvious reason for doing so could be to justify, with retrospective effect, the environment ministry’s controversial action in February last to over-rule the GEAC’s decision to clear the launch of the country’s first GM edible product, Bt brinjal. Even if it is so, the usurping of authority of clearing products of a sophisticated science like molecular biotechnology by the political bosses is bound to raise questions.

Misgivings over the motive behind this move arise also because it has come at a time when the Biotechnology Regulatory Authority of India (BRAI) Bill, 2010, is awaiting introduction in parliament. Once the BRAI comes into being as the country’s apex and scientifically competent biotechnology regulator, the GEAC would automatically become redundant.

Besides, unlike the GEAC, whose competence to regulate GM products has been widely challenged for being inappropriately controlled by the ministry of environment, rather than that of agriculture, health or science and technology, and for being headed by a bureaucrat, instead of a scientist, the proposed BRAI may have better acceptability. For, the proposed Bill envisages the BRAI to be a three-member body, all scientists, assisted by three divisions looking after issues related to agriculture and allied fields, human and animal health, and industry and environment. Reservations expressed by some activists about the BRAL Bill on the ground of likely political interference have been addressed.

The immediate concern really is the uncertainty this move has created over the fate of a large number of gene-altered products evolved at substantial cost and scientific effort which are either awaiting clearance or are in advanced stages of trials. While the GEAC has been virtually debarred from approving new GM products, the new regulator, the BRAI, is unlikely to start functioning in the near future as enactment of the statute and framing of rules under it may take years, as in the case of the Food Safety & Standards Authority of India. At stake also is the future of the Indian biotechnology industry, which is presently estimated over Rs 5,000 crore. Besides, large investments have also been made in the public sector biotech research centres by the Indian Council of Agricultural Research (ICAR), state agricultural universities, the Department of Biotechnology and other publicly funded bodies.

Over a dozen of transgenic and non-transgenic but gene-altered seeds are said to be in advanced stages of evaluation and may be ready to seek approval soon. India is already way behind many other countries in gainfully harnessing the limitless potential of the amazing science and biotechnology in vital sectors like agriculture, pharmaceuticals and others. An ill-timed policy and needless administrative interventions can push the country further back in this field. India needs a competent and professionally independent regulator for this sector.


Turkey to Enact New GMO Regulations

- Anatolia News Agency, August 15, 2010 http://www.hurriyetdailynews.com

A new regulation concerning the commercial use of genetically modified organisms, or GMOs, prepared under the law for biosafety, was announced in the Official Gazette on Friday. According to the announcement, the regulation will become effective as of Sept. 26.

The regulation by the Agriculture Ministry involves adjustments on a legal basis about applications for GMO sales, imports and exports, the evaluation of applications, decisions after the evaluation process, legal monitoring and control of the products launched in the market, the process of marketing to prevent consequences stemming from GMO use, as well as protecting human, animal and plant health in addition to environmental and biological variety.

The regulation also determines the rules to maintain well-controlled research for developmental or experimental purposes on GMOs to prevent the risks to the environment and organisms.

The enduring legal framework until the new regulation and the law for biosafety, which was prepared by the Agriculture Ministry in September 2009 in line with the comestibles law and which triggered a lasting controversy in public opinion, has been abolished with the ratification of the new regulation.

According to the previous regulation the Scientific Committee decided positively on imports of genetically modified bacteria to be used as an additive for animal food and ferment. Until the new regulation becomes effective, the old framework will apply to the use of GMOs in veterinary services, plant health and comestibles and animal food.

According to the new regulation, the import of GMOs necessitates an official document prepared by the authorities of the source country or a chemical analysis from an internationally accredited laboratory. The regulation enables the ministry to carry our analyses aiming for control or supervision as only the products yielding positive results will be granted import permit.

The ministry will keep a record of these products as well as the firms importing them. This practice will also apply to the products imported without payment and used for public consumption.

The passage of GMOs through customs will be regulated by Customs Undersecretary. The import of GMOs used other than for comestibles and animal food production purposes will be carried out collaboratively by the related ministry and institutions. The import of products containing GMOs or GMO compounds will necessitate a prior authorization of the GMO content.

For exports, on the other hand, the procedure will go in line with the demands of the purchasing country and the ministry will keep record of the GMOs permitted to be exported. The transit passages will be carried out according to the terms and conditions of the ministry’s written permit and to Customs Law and passages will necessitate measures be taken to prevent GMO contamination in the environment, like sealing the transportation vehicles. The ministry will control and supervise whether the measures are taken and keep a record of the results.

GMOs will be produced and stored according to indoor conditions and standards determined by the Scientific Committee and considering the risk classifications.

Provided that a products containing GMO or GMO compound is to be launched in the market after the authorization of the ministry, it will have to fulfill the necessities of the Turkish Food Codex and also the package of the product will visibly bear the inscription that the product contains GMO or is produced out of GMO compound.

In the event of violation of the terms of the regulation, or if new scientific data emerges about the potential risks of using GMOs and products with GMO content, the decision concerning the products may be canceled by the Scientific Committee and the products will be withdrawn from the market.

The regulation will be effective as of Sept. 26. In the event that the application process regarding the GMOs is not finished by then will be finalized according to the new regulation.


The Future of Biotechnology Patents In The European Union

'The Potential Impact of Monsanto Technology LLC v. Cefetra et al. on Patent Infringement'

- Richard Peet, Vid Mohan-Ram, and Philippe Vlaemminck, IP Watch, August 17, 2010 http://www.ip-watch.org/weblog/2010/08/17/the-future-of-biotechnology-patents-in-the-european-union/

A recent Court of Justice of the European Union opinion in Monsanto Technology LLC v. Cefetra BV et al.1 may unintentionally inflict serious economic harm on the European biotechnology industry. In its ruling, the European Court of Justice (ECJ) interpreted Directive 98/44/EC (the “Directive”) in the context of patent infringement as requiring functionality for there to be infringement of important types of claims. The ECJ reasoned that patent claims covering isolated DNA or transgenic products that contain the patented DNA cannot be infringed if the DNA is not functional at the time of alleged infringement.

As a result of the ECJ decision, there is a significant risk that countless biotechnology products are not protected by enforceable patent claims. An accused infringer, for example, could deny infringement by simply asserting that the patented polynucleotide or gene does not perform its function at the time of alleged infringement. Because many genes are only temporarily functional, or functional only in some tissues or organs, or have many functions, this defense may have merit. Furthermore, the opinion’s impact may extend far beyond a narrow conception of the biotechnology industry. For example, the viability of patents claiming isolated DNA or RNA sequences used as reagents – including reagents used in diagnostic methods such as gene tests and DNA chips – are now in jeopardy.

The ECJ decision is surprising because Article 9 of the Directive, which was an important basis for the ECJ’s ruling, was intended to define what constitutes patentable subject matter when the claims in question cover living and replicating organisms. Article 9 was not intended to define the scope of enforceable rights in the context of alleged patent infringement. We believe that, in the context of patent infringement, so long as the patented genetic information is present in the commercial product, its activity at the time of commercialization is immaterial. We propose steps the biotechnology industry in Europe and the U.S. might take to remedy the serious consequences of the ECJ ruling including legislation and World Trade Organization litigation.

In the meantime, intellectual property owners should immediately review their portfolios with an eye toward obtaining additional protection that is not affected by the ECJ’s decision. Utility patent claims, for example, covering products with unique characteristics, have always been important but now have increased significance in view of the opinion, as do method claims. Plant biotechnology companies also should obtain Plant Breeder’s Rights for important plant varieties to protect harvested material and products made from harvested material.

The Future of DNA Patents in Europe
Biotechnology companies should immediately undertake a careful review of their options and intellectual property protection strategies.

Plant biotechnology companies should give careful attention to obtaining Plant Breeder’s Rights protection pursuant to the International Convention for the Protection of New Varieties of Plants (UPOV). Some countries have adopted UPOV provisions which extend the plant breeder’s rights to harvested material and products made from harvested material. Article 14.2 of the 1991 UPOV Convention extends the plant breeder’s rights to harvested material obtained from the protected variety, and Article 14.3 extends the rights to ”products made directly from harvested material of the protected variety ---, unless the breeder has had a reasonable opportunity to exercise his right in relation to the said harvested material.” Soybeans and soybean meal would fall within the protection provided by Articles 14.2 and 14.3, respectively.

Biotechnology companies also should review utility patent claim strategies. The ECJ’s opinion increases the importance of claims directed to methods of making a product. For example, a method of making soybean meal comprising the steps of harvesting seed from a glyphosate tolerant plant transformed with the EPSPS gene, extracting oil from said seed and recovering the soybean meal, would have been very useful in Monsanto’s effort to prevent import of soybean meal made from seed produced by glyphosate tolerant plants in Argentina. Furthermore, special attention should be given to how the function(s) of any claimed polynucleotides are described in a patent application to increase the likelihood of enforcement.

The ECJ’s ruling increases the importance of claims directed to a product that recites the product’s unique characteristics without reference to the genetic material that confers those characteristics. A conventional transgenic product claim might recite a tomato fruit transformed with a gene X which confers trait Y. If gene X is not expressed in the fruit, import of the fruit into an EU member state would not constitute and infringing act according to the ECJ. If a claim to a tomato fruit comprising trait Y is patentable, import of tomato fruit comprising trait Y would constitute an infringing act, even if the gene which controls the trait is not expressed in the fruit.

The enforceability of patent claims directed to isolated nucleotides used as reagents, such as reagents in diagnostic methods, are put at significant risk by the ECJ’s opinion. These nucleotides do not perform their function in a reagent vial or kit. Thus, patent claims directed to this subject matter may not be enforceable in view of the ECJ’s judgment. Method claims such as claims to use of a nucleotide in a diagnostic method, have increased importance in view of the opinion.

Furthermore, the biotechnology industry should consider seeking political and legislative reversal of the ECJ’s opinion. The US biotechnology industry may want to urge the US government to take action at the WTO because the Directive, as interpreted by the ECJ, now makes it very difficult to effectively enforce patent claims for biotechnology inventions in the EU. We believe this undermines the intent of the Directive’s drafters and, more importantly, violates Article 27 and/or 30 of the TRIPS Agreement.

The European biotechnology industry should therefore consider initiating discussions with various EU institutions including the EU Commission and the European Parliament, as well as the member states, to amend the Directive to clarify that for biotechnology inventions, patent infringement can occur regardless of whether the patented genetic information is performing its function at the time of alleged infringement.

Full article at http://www.ip-watch.org/weblog/2010/08/17/the-future-of-biotechnology-patents-in-the-european-union/


Two Excellent Additions to the AgBioTech Bookshelf

Thomas P. Redick, Stuart Smyth, Drew Kershen and Bryan Endres, “Innovation and Liability in Biotechnology: Transnational and Comparative Perspectives”. (Edward Elgar press) (2010)

Thomas P. Redick, Gary Marchant Ph.D and Guy Cardineau, Ph.D “Thwarting Consumer Choice: The Case against Mandatory Labeling for Genetically Modified Foods” (American Enterprise Institute). (2010)