Monsanto's '435 Patent: Now You See It, Now You Don't

by Robert Schubert
CropChoice editor
July 1, 2004

(Thursday, July 1, 2004 -- CropChoice commentary) -- Just what is Monsanto trying to hide?

Patents are the cornerstone of the biotech revolution. Without them, there would be no profit or control. For years Monsanto, the St. Louis-based chemical and biotechnology corporation, has used the patents on its genetically engineered seed varieties as the legal basis for persecuting farmers.

But when Mississippi farmer Mitchell Scruggs recently questioned the validity of what is perhaps one of Monsanto's most valued patents in a lawsuit the company initiated, the presiding judge allowed it to remove the patent from the case. Monsanto wouldn't return calls or e-mails about this.

This '435 patent (No. 5,633,435) covers a gene that Monsanto engineered into canola, corn, cotton and soybeans. Armed with the gene, the crop plants are RoundUp Ready; they resist the glyphosate herbicide that Monsanto makes and markets as RoundUp. The technology allows farmers to spray RoundUp to kill weeds without harming the RoundUp Ready crops.

Monsanto sued Scruggs in September 2000 for infringing the '435 and other patents by saving seed he'd harvested from RoundUp Ready cotton and soybean plants and then sowing them the following season. Such practice violates the technology agreement requiring that farmers who choose to grow Monsanto's intellectual property must buy new seed every year from licensed dealers. (Monsanto itself doesn't sell seed, though its subsidiaries Asgrow, DeKalb and Hartz do.)

Scruggs denied the charges, but went further by attacking the validity and enforceability of '435 and four other patents. "We had the ‘435 patent in our sights," said Scruggs' lead counsel James L. Robertson, who practices law in Jackson, Miss.

In mid-May of 2002, Monsanto asked the Court to disregard everything Scruggs had done in the case up to that time, with one exception. "Monsanto was strangely silent regarding the ‘435 patent," Robertson said. "That was our first signal that Monsanto knew it had a problem."

Indeed, Monsanto's approach may be changing. In new saved seed lawsuits it has filed since 2003, the company hasn't mentioned this patent.

In the Scruggs case, court papers show that Monsanto first filed a motion to remove the patent from the lawsuit in July of 2002, supposedly to simplify matters. The request was denied in January 2003. Undaunted, Monsanto tried again the following December. This time it offered to dismiss all claims against Scruggs on the patent with prejudice and to promise -- in a binding covenant -- not to sue Scruggs again on '435. Monsanto initially filed these documents under seal, out of view of the public and the media. On June 16, the court agreed to Monsanto's motion for dismissal, ordered the company to repay Scruggs the money he'd spent on that portion of his defense, and unsealed the documents. However, Monsanto will maintain its infringement lawsuit on a second patent said to cover the RoundUp Ready trait product.

"Monsanto has been hammering farmers with this RoundUp Ready patent since 1998," Robertson said. "We’ve seen some 20 suits Monsanto has filed, citing the 435 patent as Count One. For at least five years, Monsanto has used the 435 patent to force farmers into costly settlements, preliminary injunctions and a few big damage awards, plus Monsanto’s attorney’s fees...The practice was particularly pernicious because of a doctrine holding that a patent upheld in one case is evidence of its validity in the next. For example, in January 2001 in the Scruggs case, Monsanto presented the 435 patent in Count One. Its expert told the Court how wonderful it was. Scruggs had no patent lawyer and no expert and got killed with a preliminary injunction. Three months later, Monsanto got a preliminary injunction hearing in April 2001 in St. Louis against Homan McFarling [another Mississippi farmer we've reported on recently; see http://www.cropchoice.com/leadstry.asp?recid=2540 ]. Monsanto presented the 435 patent again, just like in Scruggs, but added 'Judge, this patent has been upheld in Scruggs case, and you should consider that as evidence of its validity here' and on and on. When a farmer finally has the wherewithal to stand up and fight, Monsanto moves heaven and earth to get its important ‘435 patent out of the line of fire."

Scruggs certainly opposed the withdrawal of the ‘435 patent, but to no avail. "We had found major problems with the ‘435 patent. Monsanto’s extraordinary efforts to get it out of the case leave little doubt that the problems are serious," said Jager Smith, a Jackson, Miss. patent lawyer and a member of Scruggs' defense. "Monsanto appeared to be worried that even more problems will become publicly known if the case had gone forward with the ‘435 patent in it."

"The whole purpose of the patent system is to have a public record of patent claims, and it looks like Monsanto was trying to ‘hide the ball,’" said Gary Myers, who teaches intellectual property law at the University of Mississippi and consults the Scrugss legal team.

The Patent Act requires a patent applicant to disclose the best way to use the invention. But lawyers for Scruggs had pointed out in court filings that Monsanto’s ‘435 patent application had not disclosed that RoundUp herbicide cannot be sprayed on RoundUp Ready cotton crops after the fourth true leaf has emerged. However, in its Technology Use Guides, Monsanto does warn farmers that they can damage their RoundUp Ready crops if they spray RoundUp herbicide over the top after the fourth true leaf has appeared.

Monsanto provided the court a copy of an Application for Reissuance of the '435 patent dated July 18, 2003, Robertson said. His office checked periodically with the U.S. Patent and Trademark Office and was told it had no record of any such application to re-issue the application. Re-issue notice is supposed to be published in the PTO's Official Gazette, but it hasn't appeared there either.

This reporter called the PTO customer service line earlier this week about the matter and was told that indeed the re-issue application, numbered 10-622-201, was dated July 18, 2003. The official was curious as to why it's still in the pre-examination process. Like Robertson and his staff, I couldn't find the application on the PTO website or in the Official Gazette. I inquired at length about the matter in an e-mail to the patent office, but was told such questions couldn't be answered over e-mail.

Given all this, one might wonder why other farmers facing lawsuits didn't challenge the validity of this patent. Most likely because they don't have the money to hire the specialized lawyers and experts. But Monsanto's biotech competitors do. Why didn't they go after '435? "Maybe they figured if you can't knock out all of Monsanto's patents, what's the point," Robertson said. Instead, they all jumped into bed together. Witness the many cross-licensing agreements Monsanto has made -- DuPont/Pioneer in 2002, DowAgrosciences in 2002 and Bayer CropScience in 2003.

Indeed, Bayer has been trying to exploit the issue by advertising that farmers can spray over the top of its BXN herbicide resistant cotton product well past the fourth true leaf. BXN cotton is the only competing herbicide tolerant cotton trait product commercially available to farmers. BXN has a very small market share.

Not to be outdone, Monsanto has publicly announced that it is developing a new product -- RoundUp Ready Flex cotton -- that will not be subject to the fourth true leaf limitation. It probably won't be commercially available to farmers before 2006.

The Scruggs case is set for trial in U. S. District Court in Greenville, Mississippi beginning August 2, 2004.

Bush's 'Sound Science'
Turning a Deaf Ear to Reality

By David Schubert
San Diego Union-Tribune
July 7, 2004

The foundation of our modern society and its continued existence is dependent upon our scientific understanding of the world around us.

During the last three years, we have witnessed an unprecedented assault by the executive branch of our government upon the ability of U.S. scientists to freely share their data and insights about our world with the public. Much of the justification for this repression of scientific communication falls under the Orwellian concept of "sound science," which is clearly understood by the scientific community to mean the misrepresentation of scientific data to reflect the administration's political and social agendas.

This political manipulation of U.S. science began well below the level of public awareness within days after the current administration took office. Highly respected scientists on dozens of advisory committees were replaced with individuals who promote the sound science defined by industry and the religious right.

The concept of sound science, not to be confused with good science, was coined by Newt Gingrich and the incoming 1994 Republican Congress as part of an effort to bypass regulatory hurdles. Sound science required endless analysis and an extreme burden of proof of harm before anything could be regulated by federal agencies such as the Environmental Protection Agency. However, the legislation proposed by this group was never made into law.

Now that the Republicans are in total control of the government, the promises of sound science are coming to fruition. The egregious censorship and interference with independent scientific inquiry by the Bush administration were explicitly documented on a case-by-case basis in a recent report published by the Union of Concerned Scientists. The report was endorsed by over 60 Nobel prize winners and leading scientists.

During the last few weeks, the administration has added to this list an unprecedented series of declarations that have the potential to even more seriously affect public health and safety.

First, they have demanded the power to approve all U.S. scientists who sit on World Health Organization committees. The WHO is the public health arm of the United Nations responsible for coordinating responses to epidemics like SARS and eradicating diseases such as smallpox. It also makes recommendations on environmental and industrial threats. The WHO's expert panels have historically been made up of the very best scientists chosen on the basis of expertise and merit, not political ideology.

Second, the U.S. Department of Health and Human Services blocked the travel of over 150 U.S. scientists to the International AIDS Conference to be held in Bangkok next week. Many believe that this is because the organizer of the conference refused a request by U.S. officials to invite the Rev. Franklin Graham, the evangelist Billy Graham's son, as the keynote speaker to promote faith-based approaches to the global AIDS epidemic.

Third, in the name of sound science, the U.S. Department of Agriculture denied the Creekstone Farms slaughterhouse in Kansas a request to test all of its cattle for mad cow disease. The testing was an effort by Creekstone to promote the sale of its beef to Japan, where all cattle are routinely tested.

The most likely reason for the denial of this increased safety precaution is that the government fears additional cases of the disease will be found, for only a tiny fraction of the 35 million cattle slaughtered each year are examined. Indeed, another case of the disease was recently identified, but the USDA rapidly proclaimed the test to be a false positive without giving any details.

This incident brings me to the most frightening administration policyof all, which is an attempt by the White House Office of Management and Budget to gain complete control over the release of all public declarations from federal agencies responsible for public safety, health and the environment. OMB's Office of Information and Regulatory Affairs uses the excuse of sound science to justify stripping scientists of their traditional authority and adding an additional layer of political review for such life-threatening scenarios as epidemics, nuclear accidents and cases of mad cow disease?

Although this policy has been criticized by every scientific organization in the country, the OMB has already silenced EPA statements regarding public health threats due to arsenic, lead and mercury in our environment, rewritten the EPA science on global warming and prevented the EPA from declaring a public health emergency due to a case of asbestos contamination in Montana.

Just as the Bush administration manipulated the intelligence on Iraq, it is now trying to change the facts of nature to meet their political and ideological goals. This distortion of reality is going to have long-term consequences for our health, safety and the environment.

If you believe that Big Brother is taking care of you, you can rest assured that he is doing it in the name of sound science.

Schubert is a professor and laboratory head of the Cellular Neurobiology Laboratory at the Salk Institute for Biological Studies in La Jolla.

Puerto Rico's Biotech Harvest

By Carmelo Ruiz-Marrero
AlterNet July 13, 2004

Puerto Rico, known for its pineapples and its world-renowned coffee crop, now has a new crop: the biotech harvest.

Much of the genetically engineered (GE) corn and soybean seed planted in the United States comes from this Caribbean island. Furthermore, Puerto Rico is also a preferred location for agricultural biotechnology experiments. According to data from the US Department of Agriculture, between 1987 and 2002, the island hosted 2,957 such experiments. This figure was surpassed only by Iowa (3,831), Illinois (4,104) and Hawaii (4,566).

When one considers the vast difference in size (Illinois and Iowa have just over 50,000 sq. miles each, whereas Puerto Rico has less than 4,000 sq. miles) it becomes evident that Puerto Rico has more such experiments per square mile than any state, with the possible exception of Hawaii. Puerto Rico also tops California, with 1,709 experiments, although it is approximately 40 times larger than PR and has a vastly larger agricultural output.

These experiments are mostly aimed at the two most widely used GE traits: herbicide resistance (like Roundup Ready crops) and insect control (like the insecticidal Bt corn). But they also include research on biopharmaceutical crops -- plants that produce pharmaceutical and industrial chemicals in their tissues -- and has also included the controversial "Terminator" crops, which produce sterile seed.

Why Puerto Rico?

The island's friendly tropical weather permits as many as four harvests per year, making it a favorite for seed breeders for agribusines and biotechnology corporations like Dow, Syngenta, Pioneer and Monsanto, which got together in 1996 to form the PR Seed Research Association (AISPR).

But another reason for choosing Puerto Rico is its "good political climate." Puerto Rico is not an independent country, nor is it a state of the American union. It is an "unincorporated territory." Puerto Ricans are US citizens subject to US laws, yet they cannot vote in presidential elections and have no representation in Congress. There are no anti-biotech campaigns or protesters, not even the mildest criticism. If the American people are for the most part unaware of genetic engineering and food biotechnology issues, the people of Puerto Rico are blissfully in the dark.

Is agricultural biotechnology safe?

The US government and the biotech industry argue vehemently that biotech crops and products are safe, are extremely well tested and regulated, and present no new risks to public health or the environment. But many scientists, farmers and environmental NGOs beg to differ.

Genetic Contamination

"The Food and Drug Administration (FDA) does not regulate GE foods," stated the environmental group Friends of the Earth USA (FoE USA) in a report issued in 2003. Instead, says the report, the FDA has a "voluntary consultation" process that allows biotechnology companies to decide which, if any, safety tests to conduct and how they will be performed. "The company determines which data, if any, are shared with regulators. In fact, the company even determines whether it will consult with the FDA at all."

Other groups, like the UK-based Institute of Science in Society and the US-based Center for Critical Genetics, claim that the scientific assumptions behind genetic engineering are plain wrong and obsolete.

One of the biotech critics' main concerns is genetic contamination -- the uncontrolled proliferation of GE crops through pollination, inventory errors and other means. In late 2002 I gave a presentation at a symposium on biotechnology organized by the Puerto Rico Agricultural Extension Service in which I warned that it is only a matter of time before a biopharmaceutical crop (for example one that produces a powerful pharmaceutical substance) accidentally ends up on supermarket shelves, causing a biological Chernobyl, a public health emergency of horrific and unprecedented nature.

After my talk, Dow corporation representative Victor Torres-Collazo, himself a former AISPR president, respectfully disagreed with me. He assured me that genetic contamination is not a problem because of very strict precautionary measures mandated by law.

But fears of GE contamination are indeed well founded. In 2000, over 300 US supermarket products were found to be tainted with Starlink, a variety of GE corn that the FDA had deemed unfit for human consumption. Some 140 million bushels were contaminated, food processors and grain traders spent around $1 billion over six months trying to locate it and get rid of it, and even today traces of Starlink keep showing up occasionally in American corn exports.

The following year GE corn was discovered growing in Mexico's rural communities, a development whose long-term consequences for biodiversity, agriculture and human health remain uncertain.

In February 2004 the Union of Concerned Scientists (UCS) unveiled a pilot study that shows that breeders' varieties of corn, soy, canola and cotton seed in the United States are contaminated with GE material. This means that farmers in the USA -- and wherever American seed is exported -- could be planting GE seed without knowing it.

"Seeds will be our only recourse if the prevailing belief in the safety of genetic engineering proves wrong," warns UCS. "Heedlessly allowing the contamination of traditional plant varieties with genetically engineered sequences amounts to a huge wager on our ability to understand a complicated technology that manipulates life at the most elemental level."

Uncontrolled Experiments

The aforementioned genetic experiments in Puerto Rico are not carried out in sealed greenhouses or fermentation vats. "These are outdoor, uncontrolled experiments," said Bill Freese, of FoE USA. "These experimental GE traits are almost certainly contaminating conventional crops just as the commercialized GE traits are. And the experimental GE crops aren't even subject to the cursory rubber-stamp 'approval' process that commercialized GE crops go through -- so I think the high concentration of experimental GE crop trials in Puerto Rico is definitely cause for concern."

I asked P.R. agriculture secretary Luis Rivero-Cubano if he thought GE crops were any reason for concern. He said that the GE fields here are "just experimental." The agriculture secretary himself seemed unaware of the massive commercial production of GE seed right here in Puerto Rico.

I then spoke with P.R. Farm Bureau president Ramon Gonzalez, who told a somewhat different story. According to Gonzalez, there are no GE experiments in Puerto Rico; all biotech crops grown here are for commercial use.

Gonzalez himself grows GE corn and soy -- for export to the USA as seed -- in his farm in the town of Salinas. He claimed to be particularly happy with the soy, which is genetically engineered to be resistant to the Roundup herbicide. He said Roundup is "environmentally benign," a claim disputed by environmentalists and organic farmers.

Next on my list was the USDA, which has to approve every open-air biotech crop field test. None of Department's employees seemed to know anything about genetically engineered crops. After an exasperating and fruitless exchange, one of them provided me a USDA phone number in Washington, which turned out to be that of the Meat and Poultry Inspection Service.

The local office of the U.S. Environmental Protection Agency proved no more helpful. Its spokesman Jose Font stated that agriculture does not concern the agency unless toxic pesticides are used.

Finally, I tried the P.R. Environmental Quality Board. No dice. A spokeswoman said that since Puerto Rico has no laws or regulations for GM crops, it has no mandate to intervene or investigate.

Civil society organizations?

Forget it. Their leaders have no position on the issue, to the extent that any of them even know what biotech is. A "good political climate," indeed.

No protests, no opposition. Not yet, anyway.

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