However, with the myriad of seed patents being granted to the handful of agricultural giants controlling the world, farmers worldwide are being threatened. So is biodiversity.
By exchanging seeds, farmers ensure that different kinds of plants and plant species are cultivated and retain their intrinsic properties.

The slew of patents granted for Genetic Use Restriction Technology (GURT: colloquially known as “terminator technology”) spell the end of traditional methods of farming as we know it as well as for biodiversity. Terminator technology forces farmers to buy a fresh stock of seeds every year by genetically switching off seed germination upon triggering by a chemical. This means that the plant produces sterile seeds incapable of germination. This prevents farmers from saving seeds and re-planting them and instead forcing them to buy new seeds.

GURT was developed under a research and development agreement between Agricultural Research Service of the USDA and Delta and Pine Land Company (Information obtained from International Seed Federation). The Convention on BioDiversity further distinguishes between:

• V-Gurt technology controls reproductive processes resulting in seed sterility, thus affecting the viability of the entire variety.
• T-Gurt technology aims to control traits of plants such as insect or disease resistance or production of nutrients.

GURTs are typically used to restrict species for which hybrid technologies may not be well researched or developed. They may also be used to restrict inbreeding of crops and vegetatively multiplied crops.

It is not to say that GURTs have no advantages. Indeed, such a one-sided view would be unbecoming of a lawyer. They enable a producer to restrict trait expression especially during an onslaught of diseases which affect crops or farm animals. However, the potential impact on biodiversity is a lot more dire and outweighs the advantages.

In traditional farming systems, farmers breed and improve the quality of local seeds season after season. This method is dynamic enough that new genes kick in to maintain the fitness of the local flora. Employing GURTs would reduce or eventually completely displace the locally adapted genetic material. This would affect the local agricultural biodiversity.

Further, with V-GURT sterility kicking in in the second generation, if we factor in cross-pollination, then we have the added possibility of sterile seeds being spread in the neighboring fields/areas. This could perhaps reduce the yield over the coming years till the area collapses into a yieldless heap.

The most important repercussion if GURTs become commercially viable would be in terms of market power. The few companies that own the patents in GURTs would set non-competitive market prices. Seed supply would become a potential problem. Traditional methods of farming like seed-saving would not be allowed anymore and farmers would lose their security blanket of being able to save seeds for next season. In the event that some disaster befalls the company providing seeds, the farmer would be left high-and-dry.

According to one of the information papers submitted by the COP (Conference of Parties) to the CBD (Convention on Biological Diversity), patents in GURT may violate Art. 27.2 of TRIPS agreement which states:

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

If there is enough scientific evidence that GURT causes irreparable damage to the environment then merely rescinding the patents granted in this field is not sufficient. There has to be some other method of damage control and preventing commercialization.

Just for curiosity, I was browsing the USPTO to check who controls most of the patents in GURT and here is what I found. (Information from ETC group as of Jan 2005)

Today’s post is by Guest Barista Shalini Menezes of ::O.bi:t.er: D:ic.t:um.

Related posts:

1. Scientists Say Seed Technology Agreements Stop Research
2. Farmer David Reaps What He Has Sown: A Patent Suit
3. Re-Planting Biotech Crops A No-No

The statement may be applicable to all EPA decisions on plant incorporated protectants (PIPs), not just for the current SAP. The names of the scientists were withheld from the public docket because virtually all of them rely on cooperation from industry at some level to conduct research and they fear retaliation.

The statement:

“Technology/stewardship agreements required for the purchase of genetically modified seed explicitly prohibit research. These agreements inhibit public scientists from pursuing their mandated role on behalf of the public good unless the research is approved by industry. As a result of restricted access, no truly independent research can be legally conducted on many critical questions regarding the technology, its performance, its management implications, IRM, and its interactions with insect biology. Consequently, data flowing to an EPA Scientific Advisory Panel from the public sector is unduly limited.”

The scientists say they are going public now because of building frustration with negotiating rights with seed companies.  The problem they see is that farmers and any other buyers of genetically engineered crop seeds have to sign a technology agreement covering patent rights, environmental regulations and uses of the seeds. However, the agreements also tend to prohibit growing the crops for research purposes.  Consequently, the university scientists cannot just buy seeds and grow them for research experiments.

While the researchers can ask for permission from the seed companies, permission is sometimes denied or the company insists on the right to have an advance review of the studies’ results before they can be published.  Going far beyond the restrictions of patents, where the rights would be exhausted once the seeds we sold, the technology agreements put much tighter restrictions on the patented products even if purchased legally.

These scientists argue that restrictions over research should be void as against public policy.

See an example of Monsanto’s Technology/Stewardship Agreement here. A copy of Monsanto’s 60 page Technology Use Guide (TUG) 2009 is here.

Plant-incorporated protectants are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. For example, scientists can take the gene for a specific Bt pesticidal protein, and introduce the gene into the plant’s genetic material. Then the plant manufactures the pesticidal protein that controls the pest when it feeds on the plant. Both the protein and its genetic material are regulated by EPA; the plant itself is not regulated.

Regulation of genetically engineered foods is divided among three federal agencies.

• USDA oversees GM crop field trials and is responsible for deregulating (i.e., permitting the unregulated cultivation of) GM crops under the Plant Protection Act (PPA).
• The Environmental Protection Agency (EPA) has jurisdiction over the pesticides incorporated in GM insect-resistant plants under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FDCA); and
• FDA conducts voluntary consultations on other aspects of GM foods with those companies that choose to consult with it, under the FDCA.

Before the EPA can register a pesticide there must be sufficient data demonstrating that it will not pose unreasonable risks to human health or the environment when used according to label directions. When assessing the potential risks of genetically engineered plant-incorporated protectants, the EPA requires extensive studies examining numerous factors, such as risks to human health, nontarget organisms and the environment, potential for gene flow, and the need for insect resistance management plans.

See New York Times article:  Crop Scientists Say Biotechnology Seed Companies Are Thwarting Research

Patent Docs has some additional comments.

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2. Monsanto and Bayer Settle Dispute over Agrobacterium Technology
3. WIPO Publishes Booklet On Negotiating Technology Licensing Agreements

Human-induced climate change could trigger climate shocks in all ecosystems that will profoundly affect crops, livestock, fisheries and forests and the billions of people whose livelihoods depend on them. Extreme climate events (especially hotter, drier conditions in semi-arid regions) are likely to slash yields for maize, wheat, rice and other primary foodcrops.

Seed companies are now positioning themselves to take advantage of such changes with genetically engineered seed crops that can withstand such changes.  While good for the seed companies, this has some groups concerned.  ETC Group, a nonprofit dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights, has issued a report showing the policy implications of such a gene patent grab.

The group sites examples such as:

• A temperature increase of 3–4 degrees Celsius could cause crop yields to fall by 15–35 percent in Africa and west Asia and by 25–35 per cent in the Middle East according to an FAO report released in March 2008. 
• 65 countries in the South, most in Africa, risk losing 280 million tonnes of potential cereal production, valued at $56 billion, as a result of climate change.
• Projected increases in temperature and changes in rainfall patterns will decrease growing periods by more than 20 percent in many parts of sub-Saharan Africa.
• Farmers in dryland areas of sub-Saharan Africa will experience revenue losses of 25% per acre by 2060. The overall revenue losses of $26 billion per annum would exceed current levels of bilateral aid to the region.

The report shows that many of the world’s largest seed and agrochemical corporations are obtaining patents on genes in plants genetically engineered to withstand environmental stresses such as drought, heat, cold, floods, saline soils, and more. BASF, Monsanto, Bayer, Syngenta, Dupont and biotech partners have filed 532 patent documents (a total of 55 patent families) on so-called “climate ready” genes at patent offices around the world.

This can be seen two ways: One, it is a way for companies to prepare to meet a foreseeable demand in the face of climate change and a potential world food crisis. Or, it is an opportunity for corporations to push genetically engineered crops using climate change as a scapegoat. The truth is probably somewhere in between but the concern is that proprietary technologies will ultimately concentrate corporate power, drive up costs, inhibit independent research, and further lessen the ability of farmers to save and exchange seeds.

Beyond the U.S. and Europe, patent offices in major food producing countries such as Argentina, Australia, Brazil, Canada, China, Mexico and South Africa are also seeing huge increases in patent application filings. Monsanto and BASF have put togehter a $1.5 billion partnership to engineer stress tolerance in plants. Together, the two companies account for 27 of the 55 patent families (49%) of those identified by ETC Group.

The question now according to the ETC Group: “Will farming communities now be stampeded by climate change profiteering?”  While I disagree with their assertion that “the patent grab on so-called climate-ready traits is sucking up money and resources that could be spent on affordable, farmer-based strategies for climate change survival and adaptation,” there can be an issue when the top 10 seed companies control 57% of the global seed market.

ETC Group is now urging governments meeting at the U.N. Convention on Biological Diversity in Bonn (May 19-30) and at the joint United Nations-FAO High-Level Conference on World Food Security and the Challenges of Climate Change and Bioenergy (3-5 June 2008) must recommend that governments suspend the granting of all patents on climate change-related genes and traits.

What do you think?

more at twiigs.com…

Download the report here: “Patenting the “Climate Genes” … And Capturing the Climate Agenda”

Note:  Amended 22 May 2008 to better reflect the opinions  of ETC Group.

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Depending upon your view, this is either the free market at play in creating new and better products (so-called bioprospecting) or exploitation of developing nations (so-called biopiracy).

However, a lot of tension has arisen from such patents, such as the Enola patent derived from Mexican traditional crop mayocoba bean and the patent on Ayahuasca, a sacred plant. These disputes show that some genetic engineering exploitation and patents based on certain species may be offensive to certain indigenous people’s spiritual, religious, or cultural traditions.

Our Associates at Dannemann Siemsen, a law firm with offices in Rio de Janeiro, São Paulo and Brasília, have alerted us to a new proposed legislative bill that has recently published by the Brazilian Government. Currently, access to genetic resources and associated traditional knowledge, as well as benefit sharing in Brazil are regulated by Provisional Measure 2.186-16 of August 23, 2001.

The new bill, which is open to public consultation until February 28, 2008, is available in Portuguese at the website here. Although the proposed bill is somewhat long, some of its highlights are set forth below:

Genetic Resources And By-Products

The proposed bill makes it clear that access and benefit sharing rules will also cover activities involving the by-products of genetic resources and not only involving information of genetic origin, as provided for in the current Provisional Measure.

Records and Databases

The proposed bill provides for a number of databases and most of the activities involving access to genetic resources and traditional knowledge must be recorded.

No Need of Access Authorizations in Some Cases, in Special Research Without Commercial Purpose

Access to genetic resource for scientific and/or technological research without commercial purposes in some cases will not need previous authorization.

Benefit Sharing Agreement

According to article 86 of the proposed bill, a benefit sharing agreement may be executed after the access, provided that certain conditions are met.

Federal Sales/Royalty Tax

The proposed bill creates a sales/royalty tax (CIDE) directed to governmental funds aimed at financing R&D, supporting traditional communities, conserving biodiversity and benefit sharing.

Agricultural Biodiversity

A new category of biodiversity is created and the corresponding access and benefit sharing are regulated under more flexible rules.

Prison and Administrative Penalties

A number of penalties, such as fines and product seizure, are provided for in case of irregular access to genetic resources and traditional knowledge. Prison terms are defined, e.g., in case of the illegal remittance abroad of biological material.

Patent Disclosure

The corresponding access license must be attached to patent applications covering subject-matter obtained via access to genetic resources and to its by-products and associated traditional knowledge.

Please feel free to contact Dannemann Siemsen should you require further details on the current rules and on the provisional bill concerning biodiversity access and benefit sharing.

See also:

India Fights Back Against Biopiracy

Bioprospecting Discussed at the UN

Article on the Convention on Biological Diversity (“CBD”), the first international agreement aiming at the protection of biodiversity, sustainable use of biological resources and the sharing of benefits of its exploitation.

Related posts:

1. Bioprospecting Discussed at the UN
2. India Fights Back Against Biopiracy
3. The Real Code is Finally Published

After the district court held that Loren David knowingly infringed Monsanto’s seed patent, it awarded Monsanto damages, attorney fees, prejudgment interest, and costs of $786,989.43. On appeal, the CAFC affirmed that the patent was infringed but that some of the damages awarded were wrong. See Monsanto v. Loren David (07-1104).

Monsanto went after the farmer for breaching a technology agreement over genetically modified crops that resist glyphosphate herbicide. After planting these crops, farmers can spray glyphosphate herbicide over their fields to kill weeds while leaving the resistant crops intact. Monsanto sells seeds of the genetically modified crops, in this case soybeans, under the trade name Roundup Ready.

Monsanto’s U.S. Patent No. 5,352,605 claims a plant seed containing a genetic promoter sequence that facilitates a plant’s production of the modified enzyme that allows plants to survive exposure to glyphosphate herbicide. Monsanto distributes the patented seeds by authorizing various companies to produce the seeds and sell them to farmers. Monsanto required those seed companies to obtain a signed “Technology Agreement” from purchasers.

The Technology Agreement stipulates that buyers may use the seeds for the planting of only a single commercial crop, but that no seeds from that crop may be saved for future harvests. The Technology Agreement assures Monsanto that farmers must purchase new Roundup Ready® seeds each harvesting season, rather than simply saving seeds from the prior year’s harvest, as they normally would with conventional soybean seeds. Monsanto also charges a Technology Fee for each unit of Roundup Ready® soybean seeds sold. The Technology Agreement also contains a clause granting Monsanto the full amount of its legal fees and other costs that may have to be expended in enforcing the agreement.

Along comes Farmer David, a commercial farmer who owns soybean fields in North and South Dakota. He signs a Monsanto Technology Agreement in 1999 and plants some of the magic soybeans again in 2003. Monsanto claims that the seeds that David planted were Roundup Ready® soybeans improperly saved from the previous year’s harvest but David claims he did not save any seed.

Earlier, David purchased 645 units of Roundup Ready® soybean seeds, an amount of seeds that could not have covered David’s soybean fields in 2003. David also bought over 1,000 gallons of glyphosate-based herbicides in 2003, herbicide. Monsanto, ever vigilant for seed savers, tested David’s crops and found that they were from patented seeds.

David cleverly tried to show he purchased 993 units of Roundup Ready® soybean seed on May 31, 2003, but that was nearly a month after he claimed to have planted the majority of his soybean crop for the year. The court said “Nice try but no dice!”

Furthermore, the court found David’s testimony regarding his claimed purchase of conventional herbicides “not believable” and that David was unreliable as a witness. Hence, it ordered David to pay up.

It is important to note that the ’605 patent claims a gene sequence, not a plant variety or a seed. David tried pleading that the ’605 patent cannot be infringed merely by saving seeds from plants containing the patented gene sequence. He argued that the written description of the ’605 patent lacks the specificity that would be required of a patented plant variety under the utility patent statute; thus, the ’605 patent is limited to the gene sequence and does not cover the plant containing such a gene.

David tried to fly under the premise that under J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, plants can only receive patent protection under the Plant Patent Act of 1930, the Plant Variety Protection Act of 1970, or under a utility patent on a plant variety. Thus, a utility patent on a gene sequence does not entitle the holder of that patent to enforce its grant of exclusivity against growers of plant varieties that contain the gene sequence.

Monsanto responded by showing that the holding of J.E.M. is just the opposite of what David claims it to be; patentable subject matter remains unmodified by the existence of the P.V.P.A. and the P.P.A. Moreover, Monsanto points to various decisions of this court that have read the ’605 patent onto plants and seeds containing the patented gene and holding those who save seeds liable for infringement.

The Supreme Court’s decision in J.E.M. stated that the existence of statutes specifically authorizing the patenting of plants (the P.P.A. and the P.V.P.A.) did not eliminate the availability of utility patent protection covering plants.

In smacking David down, the CAFC scolded him saying:

David’s real complaint seems to be that he should be able to save seed from his harvest, regardless of Monsanto’s patent. We have dealt with this complaint before. See e.g. Monsanto Co. v. McFarling, 302 F.3d 1291 (Fed. Cir. 2002). In McFarling, we held that a farmer who saved seed containing a patented gene was liable for patent infringement. Id. at 1299 (citing J.E.M., 534 U.S. at 604). McFarling further established that “the right to save seed of plants registered under the PVPA does not impart the right to save seed of plants patented under the Patent Act.” Id. We note that McFarling dealt with the very patent at issue in this case—the ’605 patent. We may not disregard a prior decision of this court regarding the same matter.

…

Due to his continually changing testimony, the court disregarded much of David’s testimony. See id. Given David’s unreliability as a witness, and a complete lack of other evidence supporting his claims, we conclude that the district court did not clearly err in determining that David planted saved seed.

David also tried to get the seed report tests conducted by Monsanto and the testimony of Monsanto’s expert Koppatschek, which relied on those seed report tests, thrown out.

Rule 702 of the Federal Rules of Evidence allows expert testimony if “(1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.”

This didn’t work since the Federal Rules of Evidence establish that an expert need not have obtained the basis for his opinion from personal perception. Reliance on scientific test results prepared by others may constitute the type of evidence that is reasonably relied upon by experts for purposes of Rule of Evidence 703.

See also:

Monsanto Planted By Patent Office Re-Exam
Re-Planting Biotech Crops A No-No

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