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Whatever happened to the Enola Bean patent challenge?

(Monday, Jan. 2, 2006 -- CropChoice news) --

1. Whatever happened to the Enola Bean patent challenge?
2. EPA to look at GM food allergies
3. Differential effects of Glyphosate and Roundup on human placental cells and aromatase

Whatever happened to the Enola Bean patent challenge?

21 December 2005

On the shortest day of the year [in the North] - ETC Group provides a brief update on one of the longest-running patent challenges.

The Enola bean patent case demonstrates that intellectual property challenges are not a viable means of "correcting" abuses in the patent system. Just about everyone agrees that the Enola bean patent is technically invalid - the bean, in fact, is genetically identical to a pre-existing Mexican bean variety that was previously known and grown in the United States. The patent is also morally unacceptable because it is predatory on the knowledge and genetic resources of indigenous peoples and farming communities, who are the true innovators of Mexico's yellow beans. The real crime is that, despite the legal challenge, the US patent system has allowed the patent owner to use bureaucratic delays and diversion to legally extend his exclusive monopoly on a bean variety of Mexican origin for over 6 years (and potentially more) - that's nearly one third of the 20-year patent term. In essence, the system enables holders of unjust patents to monopolize markets and destroy competition - neither farmers nor firms can tread water for 6 years waiting for the outcome of a protracted patent challenge.

In recent years many people have inquired, whatever happened to the Enola bean patent challenge? Why has the US Patent & Trademark Office (US-PTO) taken so long to reach a decision? Here's an update on the case:

Background: Almost six years ago, ETC Group (then RAFI) denounced the Enola bean patent as "Mexican bean biopiracy" and demanded that the patent be legally challenged and revoked. We requested that FAO and the Consultative Group on International Agricultural Research (CGIAR) investigate the patent as a likely violation of their 1994 Trust agreement that obliges them to keep designated crop germplasm in the public domain and off-limits to intellectual property claims.

It was five years ago that the Colombia-based International Center for Tropical Agriculture (CIAT, a CGIAR center), with support from FAO, filed an official challenge of the now infamous Enola bean patent at the US-PTO in Washington.

Bean Biopiracy: The Enola bean patent case holds a special place in the "biopiracy hall of shame" because the owner of the patent, the president of a Colorado-based seed company, Larry Proctor, won his patent on a yellow bean variety of Mexican origin. US patent number 5,894,079 was issued April 13, 1999. (Proctor bought a bag of commercial beans in Mexico, planted them in Colorado [US], and did several years of selection.) Not long after, armed with both a US patent and plant breeders' rights certificate, Proctor charged that Mexican farmers were infringing his monopoly by selling yellow beans in the USA. Shipments of yellow beans were stopped at the Mexico/US border, and Mexican farmers lost lucrative markets. Proctor also filed lawsuits against seed companies and farmers in the USA, charging that they infringed his monopoly rights for selling or growing yellow beans from Mexico.

Not-So-Final Rejection: On April 14, 2005 the US-PTO released its "final rejection" - a 26-page decision in which the PTO examiner explains her decision to cancel or reject all of the patent's 64 claims. But wait-not so fast! The PTO bends over backwards to give the patent holder the last word. Proctor was given a six-month period to prepare and file a request to extend the re-examination period. On 14 October 2005 Proctor filed his request and won a 3-month reprieve. ETC Group learned today that the US-PTO has just issued another "final" rejection in response to Proctor's amendments. But, it's still not final! Proctor could file for one more extension - or take the case to a higher board of appeals.

ETC Group does not know when the US-PTO will issue its truly final decision. We do know that expert bean breeders and geneticists have offered unambiguous findings that the Enola bean is not new or unique.

In 2003 geneticists performed "genetic fingerprinting" of Proctor's patented yellow bean and found that his claim of novelty was spurious - the patented Enola bean is, not surprisingly, identical to a pre-existing Mexican cultivar. (1) "We conclude that Enola is neither a novel nor non-obvious derivative from a Mexican yellow bean cultivar, probably 'Azufrado Peruano 87.'"(2)

If the patent is ultimately rejected, it will be a hollow victory because hundreds of Mexican and US farmers who suffered damages as a result of the unjust monopoly will not be compensated for their losses. Patent law has no mechanism to compensate those who have been victimized by patent abuses.

ETC Group will continue to monitor the patent challenge, and we will report on the final outcome. But don't hold your breath!

The Action Group on Erosion, Technology and Concentration, ETC Group, is dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights. ETC Group is also a member of the Community Biodiversity Development and Conservation Programme (CBDC). The CBDC is a collaborative experimental initiative involving civil society organizations and public research institutions in 14 countries. The CBDC is dedicated to the exploration of community-directed programmes to strengthen the conservation and enhancement of agricultural biological diversity. CBDC website is www.cbdcprogram.org All ETC Group publications are available on our website: http://www.etcgroup.org

2. EPA to look at GM food allergies

December 19, 2005

Starting in 2006, the EPA will offer an estimated 3 million dollars for allergy research with genetically modified foods.

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing to develop methods to assess the potential allergenicity of genetically engineered foods. The development of these methods will help in identifying substances that induce dietary allergy in humans and lead to improved evaluation of the relative potency of unknown proteins.

Currently, the Food and Agriculture Organization of the United Nations and the World Health Organization (FAO/WHO) have proposed a decision tree to be used in assessing the potential allergenicity of novel dietary proteins. However, many of the components recommended in this decision tree have not been sufficiently developed or validated.

The STAR program is issuing this request for applications (RFA) for research on appropriate methods, either within or outside the framework of the current decision tree, primarily to assess human allergenicity of proteins in genetically engineered foods and, secondarily, to improve our understanding of the basic mechanisms underlying food allergy and susceptibility to food allergy as it pertains to genetically engineered foods.

Ideal methods would improve hazard identification and enhance the ability to estimate the potency of unknown proteins relative to known allergenic and non-allergenic proteins in a logistically feasible and cost effective manner. Development of methods that are further amenable to the investigation of factors that influence susceptibility for sensitization to dietary allergens are also of interest.

Due Date for Applications: Mar 21, 2006; Estimated Funding: $3,000,000.00
For more information: http://es.epa.gov/ncer/rfa/2005/2005_star_biotech.html

3. Differential effects of Glyphosate and Roundup on human placental cells and aromatase

Sophie Richard, Safa Moslemi, Herbert Sipahutar, Nora Benachour, and Gilles-Eric Seralini
Environ Health Perspect. 2005 June; 113(6): 716-720. Published online 2005 February 25. doi: 10.1289/ehp.7728.

Roundup is a glyphosate-based herbicide used worldwide, including on most genetically modified plants that have been designed to tolerate it. Its residues may thus enter the food chain, and glyphosate is found as a contaminant in rivers. Some agricultural workers using glyphosate have pregnancy problems, but its mechanism of action in mammals is questioned. Here we show that glyphosate is toxic to human placental JEG3 cells within 18 hr with concentrations lower than those found with agricultural use, and this effect increases with concentration and time or in the presence of Roundup adjuvants. Surprisingly, Roundup is always more toxic than its active ingredient......


Our studies show that glyphosate acts as a disruptor of mammalian cytochrome P450 aromatase activity from concentrations 100 times lower than the recommended use in agriculture; this is noticeable on human placental cells after only 18 hr, and it can also affect aromatase gene expression. It also partially disrupts the ubiquitous reductase activity but at higher concentrations. Its effects are allowed and amplified by at least 0.02% of the adjuvants present in Roundup, known to facilitate cell penetration, and this should be carefully taken into account in pesticide evaluation. The dilution of glyphosate in Roundup formulation may multiply its endocrine effect. Roundup may be thus considered as a potential endocrine disruptor. Moreover, at higher doses still below the classical agricultural dilutions, its toxicity on placental cells could induce some reproduction problems.

For more, go to http://www.pubmedcentral.gov/articlerender.fcgi?artid=1253709