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June 14, 2005


EU Food Agency Says Illegal GMO Maize is Probably Safe; Comparing the Performance of Official and Unofficial Genetically Modified Cotton in India; A Cautionary Tale on Intellectual Property


Today in AgBioVoiew from www.agbioworld.org: June 14, 2005

* EU Food Agency Says Illegal GMO Maize is Probably Safe
* Chinese Minister of Sciences visits Ghent biotechnologists
* Comparing the Performance of Official and Unofficial Genetically Modified Cotton in India
* Evolution of Capacity for Institutionalized Management of Intellectual Property at International Agricultural Research Centers: A Strategic Case Study
* India invites investments in biotech sector
* A Cautionary Tale on Intellectual Property


EU Food Agency Says Illegal GMO Maize is Probably Safe

- Reuters, June 14, 2005

BRUSSELS - A genetically modified (GMO) maize that is illegal in Europe but found its way into EU countries probably does not pose a risk to either animals or humans, Europe's food safety agency said on Monday.

While data on the maize, known as Bt-10 and made by Swiss agrochemicals group Syngenta, was incomplete, it seemed that mixing of Bt-10 with a similar strain Bt-11 -- which is approved in the EU -- was probably harmless.
"...it is not considered likely that the inadvertent contamination of the imported maize grain with Bt-10 poses a safety concern to animals and consumers," the European Food Safety Authority (EFSA) said in a statement.

EFSA qualified its findings by saying it was impossible to reach a conclusion on the overall safety of Bt-10 maize since Syngenta had not given sufficiently comprehensive data for EFSA to conduct a full risk assessment.

This was because the company had not intended for its GMO maize to be further developed for commercial market purposes.

Last month, EU authorities blocked shipments of maize animal feed and grain from the United States unless it could be proved they were untainted by Bt-10 maize, engineered to resist the corn borer insect.

The EU measures will be reviewed at the end of October. US exporters send 3.5 million tonnes of corn gluten feed to Europe each year, a trade worth some 350 million euros ($449 million).

This followed Syngenta's confirmation in March that some of its maize seeds sent to the EU from the United States were mistakenly mixed with Bt-10 sometime between 2001 and 2004.

Small amounts of Bt-10 seed arrived in France and Spain for research purposes, and have since been destroyed. Some 1,000 tonnes of Bt-10 maize also entered the EU, mostly as animal feed, although it is still unclear to which countries.

Japan, the biggest buyer of US maize, recently found a shipment tainted with Bt-10 and will begin testing every US cargo. And last month, a US cargo of corn gluten feed found to contain Bt-10 was impounded on arrival in Ireland.


Chinese Minister of Sciences visits Ghent biotechnologists

Contact: Sooike Stoops

Ghent - The Chinese Minister of Sciences, Ma Songde, and Flemish Minister for Science and Innovation, Fientje Moerman, are today visiting the Flanders Interuniversity Institute for Biotechnology (VIB) in Ghent. With this initiative, Minister Moerman highlights the importance that the government attaches to this sector for the future of Flanders.

During the visit, Minister Moerman will explain to her Chinese colleague the prominent position occupied by the Flemish biotech industry. The encounter could also be an impulse for Flemish biotech to establish collaborative ties and to become acquainted with the Chinese market.

Biotechnology has become an important sector in China as well. Between 2000 and 2005, the Chinese government has injected some 500 million euro into the field. A thriving industry has sprung up - especially around Beijing, Shanghai, and Shenzhen - in vaccines, medical equipment, and immuno-diagnostics.

China and Flanders could collaborate, for example, in the area of genetically modified crops. Among other activities, the Chinese have developed a technology for producing rice and wheat with higher yields and better uptake of water and nutrients.


Comparing the Performance of Official and Unofficial Genetically Modified Cotton in India

- AgBioForum, By Stephen Morse, Richard Bennett, and Yousouf Ismael; The University of Reading, UK

Genetically modified (GM) cotton was approved for commercial cultivation in 2002. Hybrids to date have carried the Bt (Bacillus thuringiensis) gene, which confers resistance to Lepidoptera and certain Coleoptera. As well as "official" Bt hybrids (i.e., those that have gone through a formal approval process), there are "unofficial" Bt hybrids produced without such approval. The owners of the official hybrids, Monsanto-Mahyco, claim that the unofficial hybrids are not as good and could even damage the perception of Bt cotton amongst farmers. Anti-GM groups claim that neither type of Bt hybrid provides either yield or economic advantages over non-Bt hybrids. This paper reports the first study of official versus unofficial versus non-Bt hybrids in India (622 farmers in Gujarat State) with the specific aim of comparing one hypothesized ranking in terms of gross margin of (a) official Bt hybrids, (b) unofficial Bt hybrids, and (c) non-Bt hybrids. Results suggest that the official Bt varieties (MECH 12 and MECH 162) significantly outperform the unofficial varieties in terms of gross margin. However, unofficial, locally produced Bt hybrids can also perform significantly better than non-Bt hybrids, although second-generation (F2) Bt seed appears to have no yield advantage compared to non-Bt hybrids but can save on insecticide use. The paper explores some of the implications of this ranking.




Evolution of Capacity for Institutionalized Management of Intellectual Property at International Agricultural Research Centers: A Strategic Case Study

- AgBioForum, By Henrik Egelyng, Danish Institute for International Studies, Copenhagen

Intellectual property rights long remained a matter dealt with in vague terms of general policy at international agricultural research centers (IARCs). This situation changed at the turn of the century, when intellectual property (IP) became an object of a major institution-building process at three centers of the Consultative Group on International Agricultural Research (CGIAR). This article analyzes why and how policies were grounded and made operational in terms of new intellectual property structures and procedures. Focusing on initial developments at the International Rice Research Institute (IRRI), this analysis aims to make a strategic case and contribute towards an analytic framework for investigating institutional capacity for IP rights management by international organizations pursuing public missions.




India invites investments in biotech sector

- Silicon India, June 14, 2005

NEW DELHI: Asserting that India offers unprecedented opportunities for entrepreneurs in biotechnology industry, Minister of State for Science and Technology Kapil Sibal has invited venture capitalists, experts in the field and Indians staying abroad to invest their money and talent in this fast growing sector.

The Minister said the government to promote biotechnology in health, agriculture and environment, among other fields, is providing several incentives and encouragement.

It is for companies and individuals to take advantage of the opportunities, he told a select gathering of investor’s academics and professionals here, adding major pharmaceutical companies are already entering into partnership with their Indian counterparts, which provide world class manufacturing facilities.

He called on experts in the field and Indians staying abroad to invest their money and talent in the fast growing and potentially profitable sector.

India, he said, has an abundance of human capital and raw material available at far less the cost compared with the Western nations and new drugs and other products could be developed at less than one-third the money beings spent by major pharmaceutical outfits in the U.S.

Besides, India itself provided a huge market for new drugs with its growing older population and the drugs developed there could be sold at premium in the western nations, he told a meeting jointly organized by India-America Chamber of Commerce and Indian Consulate here.


A Cautionary Tale

Tech Central Station, By Sally Satel, 6/14/2005

GENEVA -- What do the national costumes of Yunan Province in China and the microbes of Panamanian rainforests have in common? Both are subjects of ongoing meetings of The World Intellectual Property Organization (WIPO) and the World Trade Organization/TRIPS. From June 6 to 15, delegates are gathering in Geneva to debate the best methods for protecting so-called traditional knowledge, cultural expressions and biological materials from misappropriation.

At issue are claims by indigenous and local communities that foreign interests are exploiting their cultural and biological bounties. These interlopers are accused of violations ranging from withholding commercial benefits that flow from products made from the communities' resources (or their traditions) to eroding their cultural identities.

Among those charging cultural infringement are the Indigenous Peoples of the Former Soviet Union. Nursing an historical grievance that dates to 1783, their delegate told of the Tsar's appropriation of sacred Crimean springs, medieval mountain monasteries and even the local herding dog (now called the Russian Shepherd Dog). The Crimean annexation tale evoked sympathy, but it was hard to know exactly what was at stake for the indigenous constituents today.

Contrast the Crimean plight -- more a symbolic bid for reparations, it seemed -- with the proposal to change international patent law to protect genetic resources. In that case, the implications are more palpable.

In fact, a new report released at the WIPO meeting last week says that weighting down the patent process with new mandates is bad for medical progress: it risks suppressing production of new drugs. Economists Timothy Wolfe and Benjamin Zycher, both with the Pacific Research Institute in San Francisco, have estimated that 150-200 new drugs would be lost over the next 20 years.

Before examining the results of the Wolfe-Zycher study, let's review recent history of intellectual property and genetic resources. The backdrop was set in 1992 with the introduction of modern efforts to protect biodiversity in the face of so-called biopiracy, the stealing of local genetic material. That year, the Convention on Biodiversity (CBD) was ratified, properly affirming the rights of countries over their biological resources in much the same way that they owned other natural resources such as timber or fishing rights.

At the most recent session of the CBD in February 2005 in Bangkok, a subgroup of 17 of the CBD countries calling themselves the Like-Minded Group of Mega-Diverse Countries -- mega because together they comprise almost three quarters of all plant and animal varieties on earth --proposed a mandatory amendment to international patent law whereby inventors would be required to list the place of origin of the genetic material used in products they make as well as any traditional knowledge held by native people that might have attracted interest in the material in the first place.

An alternative to undermining the patent system approach is a contractual one. There are numerous examples of private arrangements between drug companies and local communities that have worked well -- from the standpoint of benefiting the community, if not generating new drugs. The classic case is the relationship between Costa Rica and Merck. During the 1990's the drug company invested over $2 million in the country's National Institute for Biodiversity. Known as INBio, the project continues (though Merck's participation ended after a decade) and it is so successful that InBio scientists regularly engage with scientists elsewhere. Despite the success of the InBio-Merck project in terms of building local scientific infrastructure, none of the compounds studied by the institute went on to yield any profit.

Until now, bioprospecting has proceeded largely by private contractual arrangement. Starting three years ago, in 2002, the Convention introduced the idea of voluntary patent guidelines (the Bonn Guidelines) for what is known as Access and Benefit Sharing. The guidelines contained a provision for the "fair and equitable sharing of benefits arising out of the utilization of genetic resources." According to the CBD Secretariat, however, very few countries have implemented the voluntary regime. This may only increase the pressure for CBD members to vote for a mandatory Access and Benefit Sharing system at the next meeting of the CBD in 2006.

The prospect of alteration in patent law creates ambiguities that undermine the incentive of companies to pursue natural molecules and genetic resources. While the chilling effect on searching for new plants and molecules may not impose a major obstacle to drug development the implications for genetic information is likely to be meaningful. In particular, scientists are increasingly interested in gene sequencing information for use in medicine or crop enhancement.

But depending upon the nature of Access and Benefit Sharing (ABS) regime to be voted upon in 2006, biotech and pharmaceutical companies may be inhibited from gene hunting and genetic resource development. Consider the Brazilian delegation's proposal. Under the CBD, this plan would permit revocation of the patent and partial or full transfer of patent ownership and even financial penalties if the patent application lacked complete disclosure of origin and traditional knowledge. But how complete is complete? For example, what if Tribe A was taught by the ancestors of Tribe B how to cultivate a particular plant -- who is the true "owner" of this traditional knowledge?

Granted, the Brazilian proposal may be excessively punitive. Nonetheless, opportunities for uncertainty -- and hence litigation -- abound. How to calculate the contribution of genetic material to the value of the product when a company invests millions to bring it to market? What if the use of genetic resources or traditional knowledge was incidental, rather than directly connected, to the invention? And how to deal with India's new patent law, a Catch-22 that requires that the application include specific information about the benefits of "any invention based on any research or information on a biological resource obtained from India." Can the applicant be expected to know in advance what the benefits of his research will be, or if there will be a useable product?

With WIPO estimating that there are 3000 representatives of traditional knowledge holding communities in 60 locations around the world, the potential for disclosure irregularities and hence litigation is staggering.

And this brings us back to Wolfe and Zycher. Their study suggests that an ABS system that concentrates on the forfeiture of intellectual property creates a vast disincentive to invest in biotechnology that could somehow be traced to a country's genetic resource or related cultural knowledge. The spectre of patent revocation, Wolfe and Zycher have found, would reduce the value of biotech and pharmaceutical capital stock by $144 billion over 20 years across 27 countries. This represents a 27 percent decline in what the stock would otherwise be valued at.

In terms of actual medicines, as mentioned earlier, the authors estimate that 150-200 fewer drugs would be realized over the next 20 years should an anti-patent regime be accepted by CBD members. Considering that 38 new drugs became available in 2004 in the U.S., this is the equivalent of 4 to 5 dormant years for the pharmaceutical industry with no new treatments for the patients who are its beneficiaries.

To appreciate the impact on patients -- just focusing, for argument's sake on HIV/AIDS and cancer -- simply look at a tiny sample of the drugs that emerged in the last 4-5 years … and then imagine they never were developed.

In October 2001, the FDA approved Viread (Gilead) for HIV. It belongs to a new class of drugs called Nucleotide Reverse Transcriptase Inhibitors. The body converts Viread into a chemical that prevents HIV from reproducing in uninfected cells, thus making it the first drug to prevent HIV. Then in March 2003, Fuzeon (Roche) was approved. It was the first drug in the long awaited new class of HIV medications called entry, or fusion, inhibitors. While other HIV medications work after HIV has entered the cell, entry inhibitors prevent HIV from entering the cell at all. Experts believe that this represents a major breakthrough in the treatment of HIV and AIDS. Fuzeon blocks HIV's ability to infect healthy immune system cells.

On the cancer front, Avastin (Genentech) was approved last year. It is used in combination with chemotherapy and is first-line treatment of patients with metastatic carcinoma of the colon or rectum. It works by preventing the proliferation of blood vessels within a tumor. By literally cutting the life line to the tumor, Avastin is the first anti-angiogenic therapy proven to help people with metastatic colorectal cancer live longer.

Many other HIV-AIDS and cancer drugs are in development. Sadly, these diseases will be with us always but as the demographics are shifting to longer lifespans, another disease -- Alzheimer's -- is expected to grow dramatically in the coming decades. For mild Alzheimer's disease, two drugs are showing promise -- Flurizan (Myriad Genetics) and Alzhemed (Neurochem) These two therapies would work by interfering with the production of beta-amyloid (the protein plaques that build up in the brain causing inflammation that disrupts and then destroys nerve cells). Currently available medications treat only disease symptoms.

Wolfe and Zycher made the rounds at the WIPO and WTO meetings, presenting their data as a momentously cautionary tale. India and Africa, one hopes, took special note. These countries are two of the most vocal anti-patent members of the Convention on Biodiversity; at the same time they are overwhelmed with new HIV-AIDS cases and stand to lose resoundingly if development of new anti-retrovirals or HIV vaccines is suppressed.

At the close of the meetings on June 15, a vision of the ABS proposal should come into greater focus. Delegates heeding the economists' findings will surely think twice before overturning a contractual system and supplanting it with a patent-encumbering regime. If not, pharmaceutical innovation will be at stake.