#GM #Canola #DownUnder; Demands for better #GM #testing / Crop Biotech Update

**

**Excerpts from Crop Biotech Update, dated July 9, 2010
**

***GM Canola Yield Triples in Western Australia*

The Australian Oilseeds Federation (AOF) estimates that national GM canola acreage more than tripled as a result of the commercialization of genetically modified (GM) canola in Western Australia. Despite having been grown for only a year in Western Australia, planting of GM canola is over 50 percent of total production. AOF projects that GM plantings will make up around 8 percent of the total canola crop of around 1.61 million hectares.

“This rapid uptake by technologically savvy Australian growers supports how useful the GM varieties can be in a production system to better manage weeds, reduce tillage, lower fuel use and provide alternatives to residual herbicides,” said Peter O’Keeffe, head of Monsanto Australia. He added that figures “clearly indicate that approved GM canola varieties are being embraced by farmers, and that the NSW, Victorian and Western Australian government’s decisions have benefited agriculture by enabling choice-based access to the technology.”

For the original article see http://sl.farmonline.com.au/news/nationalrural/grains-and-cropping/general/gm…

*Demand Increasing for Suitable GM Testing and Approval Process*

The global and scientific challenge of GMO testing was discussed during the fourth EuroScience Open Forum in Turin last July 6, 2010. According to experts, the challenge includes choosing suitable sampling techniques and finding ways to come up with credible results. The development and adoption of GM crops continue to advance through the years. However, the approval processes for commercializing the GM crops vary from country to country, which affects the global food trade. Thus, it is difficult to come up with a consistent and similar testing and approval process.

Senior Scientist Claudia Paoletti of the European Food Safety Authority (EFSA) said that extensive research is required on the genetic variations that can take place among the samples of particular GM products, which also need complex sampling procedures. “It is not only important to know how many samples are being tested but also how they have been taken,” Paoletti said. “We need to find the balance between good science and time and financial constraints.”

Visit http://ec.europa.eu/dgs/jrc/index.cfm?id=5740&lang=en#14 to view the summary of the workshop.

patenting of gene sequences…

Chris Holman blogs on patent protection of gene sequences…

“…[The EU] ruling could have a substantial impact on biotechnology. Obviously, it provides an opening for growers to circumvent gene patents used to protect genetically modified crops by growing the crops in a country where the gene is not patented, such as Argentina in this case, or in a jurisdiction with weak patent enforcement, and then importing the product into a European Union member wherein the patent is in force with impunity…I personally do not think gene patents will substantially impede whole genome sequencing, in the US or elsewhere. But if I am wrong, and patents on genes pose a substantial impediment to whole genome sequencing in the US, the patents could be circumvented by exporting the process to a place like Europe. The EU court decision could substantially reduce the likelihood that whole genome sequencing in Europe will result in liability for patent infringement.”

Excerpt from the Holman blog:

Monsanto v. Cefetra: EU Court of Justice Limits Scope of Patent
Protection Available to Gene Sequences

Chris Holman

Friday, July 9, 2010

A couple of years ago I posted an article (available at: http://holmansbiotechipblog.blogspot.com/2008/05/limitations-on-scope-of-dna-… discussing the case of Monsanto v. Cefetra. Essentially, in that case a European court held that Monsanto patents claiming the gene responsible for its Roundup Ready trait were not infringed by the importation of soy meal containing the gene, because the grinding of the soybeans to make the meal rendered the DNA incapable of expressing the encoded protein, and thus unprotectable pursuant to the 1998 European Union Directive on biotechnology.

On Tuesday, July 6, that decision was affirmed by the Court of Justice of the European Union. This is the highest judicial body of the European Union, so there will be no further appeals, and this would appear to be the final word on the subject. The decision was reported in an article posted on IPKat, a respected European IP blog, available at http://ipkitten.blogspot.com/2010/07/monsanto-court-makes-meal-of-soya.html. I am no expert on European law, but here are a few thoughts on the significance of this case.

First, my interpretation of the decision.

In a nutshell, the Court of Justice held that although the so-called Biotech Directive, promulgated by the European Union in 1998, permits the patenting of naturally occurring DNA sequences, the scope of patent protection only extends to products incorporating the DNA if the DNA is capable of performing “the function for which it was patented.” Applying this criterion to the facts of the case, the Court held that the patentable function of the gene at issue was to confer glyphosate (i.e., RoundUp) resistance upon a plant, and that since the soy meal is dead and thus incapable of expressing this function, the DNA residing in the soy meal is ineligible for patent protection.

The Court went on to hold that the Biotech Directive supersedes national law, and precludes individual European nations from enacting legislation that would permit patenting of DNA sequence per se. It also held that the prohibition against patenting DNA sequences per se applies retroactively to patents predating the EU’s adoption of Directive in 1998. In short, this unappealable ruling appears to be binding upon all 27 European Union Member States, and all DNA patents, no matter when they were issued.

See full article on Holman’s blog at: http://holmansbiotechipblog.blogspot.com/2010/07/monsanto-v-cefetra-eu-court-…