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Why America's Lawsuit Against The European Union Is Highly Hypocritical

Steven M. Druker
May 2004

How US Law Requires Even Greater Restrictions on GM Foods than the Europeans Have Dared to Implement

Tomorrow, the European Commission plans to end a de facto moratorium on the approval of new genetically modified foods that has endured for six years. One significant motivation for this action is concern about the lawsuit the US has filed at the World Trade Organization against the European Union's restrictions on these products. However, despite this major attempt at appeasement, the Bush Administration has indicated it intends to vigorously press ahead with its suit. Such persistence has surprised many Europeans.

But what should be even more surprising is the degree to which this suit is cloaked in hypocrisy and driven by deception. It's based on the pretence that the precautionary principle - which prescribes the course of caution when the evidence is inconclusive - cannot be legitimately applied to GM food and that the US is free to resist it. In reality, US law mandates a much stricter application of the principle than does EU law; and the Bush administration is trying to quash EU regulations that are looser than those it is legally required to implement itself - but has persistently avoided.

The US requirement to uphold the precautionary principle is neither new nor nuanced. It's unambiguous and has been on the books since 1958, when Congress enacted an amendment to the Food, Drug and Cosmetic Act requiring that any new additive to food be presumed unsafe until its safety has been demonstrated through scientific procedures. An official Senate report described its firm intent: "While Congress did not want to unnecessarily stifle technological advances, it nevertheless intended that additives created through new technologies be proven safe before they go to market." Although the term "precautionary principle" had not yet been coined, this statute clearly instituted a precautionary approach. In fact, US law mandates the strictest degree of precaution found in any food laws and demands demonstration of "a reasonable certainty" of no harm.

The US statute clearly places the burden of proof on the manufacturer and requires that foods containing new additives be presumed unsafe until proven safe. But in the case of GM foods, the US has turned the law on its head and insists they must be presumed safe until proven not to be.

Therefore, astounding as it seems, for years the US has been bullying the EU to abandon a principle that forms the cornerstone of its own food safety law - and the Europeans do not even seem to be aware of how illegitimate and ludicrous the American position is. Nor, it appears, does Mr. Bush. Based on statements by government officials, the New York Times reported last year: " The Bush Administration believes the precautionary principle is an unjustified constraint on business and does not even recognize the existence of the doctrine."

The White House's ignorance has been abetted by officials at the Food and Drug Administration (FDA), who themselves know the law but are apparently intent on keeping others confused about it - presumably in furtherance of their admitted agenda "to foster" biotechnology. They have also endeavoured to cover up the warnings of their own scientific experts about the unique risks of GM foods. This was revealed when my organization brought a lawsuit against the FDA that forced it to divulge its files, which clearly show FDA's scientists repeatedly cautioned that genetic engineering could disrupt the organism in unpredictable ways and induce production of unintended harmful substances that are difficult to detect.

The pervasiveness of concern within the FDA's scientific staff is attested by an internal memorandum in which an official reported: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (FDA Document #1 at ) Because of the potential for unexpected harmful effects, the FDA experts stated that every GM food should undergo rigorous testing to screen for them. Further, FDA's Biotechnology Coordinator acknowledged there is not a consensus about safety among experts outside the FDA either.

Moreover, although US law mandates that foods containing new additives (such as GM foods) be proven safe, FDA files confirm that such evidence is sorely lacking; and eminent experts have issued declarations that no GM food has been demonstrated safe.

By emphasizing these facts, the EU could highlight the US's hypocrisy and blunt the force of its lawsuit. Rather than withering under the US demand for proof that GM foods are harmful, EU officials should turn the tables and demand that the US honour its own laws by proving they are safe.

This comment may be copied and circulated as long as the entire document remains intact and authorship is properly attributed.

Steven M. Druker
Executive Director
Alliance for Bio-Integrity
Copyright Steven M. Druker 2004


Federal Judge's Opinion Shows Understanding Of Patented Gene Spread

by Robert Schubert
CropChoice editor
May 17, 2004

(CropChoice commentary) -- Someone in the federal judiciary finally has taken note of the issues surrounding the self-replication of patented processes in nature. This is a concern that farmers and scientists have observed with the spread of genetically modified organisms in crops.

The similarity between those organisms and a synthetic compound were noted by Judge Arthur J. Gajarsa of the U.S. Court of Appeals for the Federal Circuit in his April 23 opinion in SmithKline Beecham Corp. v. Apotex Corp.

"Paroxetine hemihydrate is presumably a synthetic compound, created by humans in a laboratory, never before existing in nature, that is nevertheless capable of 'reproducing' itself through a natural process...This crystalline compound raises a question similar to one that might arise when considering the invention of a fertile plant or a genetically engineered organism, capable of reproduction, released into the wild. Consider, for example, what might happen if the wind blew fertile, genetically modified blue corn protected by a patent, from the field of a single farmer into neighboring cornfields. The harvest from those fields would soon contain at least some patented blue corn mixed in with the traditional public domain yellow corn--thereby infringing the patent. The wind would continue to blow, and the patented crops would spread throughout the continent, thereby turning most (if not all) North American corn farmers into unintentional, yet inevitable, infringers. The implication -- that the patent owner would be entitled to collect royalties from every farmer whose cornfields contained even a few patented blue stalks -- cannot possibly be correct. The underlying question that engaged the district court, and that led it to develop numerous alternative holdings, is why this implication is incorrect. At oral argument, when faced with this hypothetical, SKB [SmithKline Beecham] expressed its belief that such a blue-corn patent would be 'very strong.' Such a belief is misplaced. The implicit concept of 'inevitable infringement' stems from the inevitable failure of the patent to provide public notice -- which, in turn, stems from the inherently unpatentable nature of the claimed subject matter..."

Such a process makes public notice of the scope of the patented process impossible. The natural, spontaneous conversion of the man-made hemihydrate into its predecessor would, Gajarsa wrote, lead to inevitable infringement: "...In short, patent claims drawn broadly enough to encompass products that spread, appear, and 'reproduce' through natural processes cover subject matter unpatentable under Section 101 -- and are therefore invalid."

Gajarsa referred frequently to a distinction in patent law: Products or processes that humans create are patentable, while those of nature are not. The Supreme Court affirmed this in two cases -- Diamond v. Chakrabarty in 1980, and Pioneer Hi-Bred Int'l, Inc. v. J.E.M. Agric. Supply, Inc. in 2001.

On the one hand, paroxetine hemihydrate would qualify for a patent under Chakrabarty because humans created it. On the other hand, because of seeded laboratories, the original paroxetine anhydrate could, without human involvement, naturally convert itself into the hemihydrate. Such a natural process is unpatentable, according to the same case.

Questions for the future

In the prefatory remarks to his opinion, Judge Gajarsa wrote what could be interpreted as a responsibility of courts judging cases involving patents to look at whether they should have been awarded in the first place. Given his lengthy discussion of the unpatentability of SmithKline's hemihydrate and the hypothetical blue corn, one might wonder whether Gajarsa was laying the groundwork for questioning existing patents on genetically modified seeds? After all, why couldn't a judge view farmers' fields as the factories and labs that are, according to many biotech skeptics and some supporters, becoming seeded, through a variety of vectors, with patented traits? And if that is true, will farmers growing patented -- and not necessarily genetically modified -- soybeans, corn, canola, wheat and other commodity crops become "inevitable infringers" who have no way of knowing the scope of the patents seeded in their fields?

With this opinion, Gajarsa is "testing the waters," said Peter DiMauro, Ph.D., director of the PatentWatch Project at the International Center for Technology Assessment . "While he has gone through a circuitous route to find the SmithKline Beecham patent invalid under section 101 of patent law, I don't think his reasoning or concerns would lead to him to want the GMO patents invalidated, but rather for judges to find exemptions to infringement." Note: DiMauro is a patent expert, but he's not a lawyer. The Project can be found on the Web at .

Even if more judges at the district and appellate court level were to read and consider Gajarsa's reasoning, that wouldn't do much in the short term to help farmers who are having to defend themselves against a biotechnology or seed company.

"Now, does this [decision] mean that American farmers are protected from accusations of patent infringement for plants containing patented genes from stray pollen," DiMauro said. "Heck no! We are not even close to such a just situation. However, the Gajarsa opinion ought to inform other judges and policy makers that the problem can exist, and that the solution is not a strict literal enforcement of draconian patent laws, but, rather, an equitable application of flexible patent laws, either the laws we have now or ones legislated in the future."


In the early 1980s, SmithKline Beecham sought to improve paroxetine hydrochloride (PHC) anhydrate, created nearly a decade earlier. From this antidepressant compound company researchers crystallized paroxetine hydrochloride (PHC) hemihydrate, which contains a water molecule making for easier packaging. A patent was awarded in 1988, and the British pharmaceutical maker began marketing it as Paxil in 1993.

In 1998, a company called Apotex wanted to process the original PHC anhydrate (no water molecule) to sell as a generic antidepressant. That's where the problems started.

SmithKline Beecham sued Apotex that year in the U.S. District Court for the Northern District of Illinois for infringing its patent. The company argued that Apotex would not be able to produce the original PHC anhydrate without making at least some of the patented version.

Indeed, the district court found that the hemihydrate SmithKline created in 1984 has spread -- seeded itself -- to more and more manufacturing environments, including those of Apotex. Under normal climactic circumstances in a seeded environment, at least some of the original anhydrate will convert spontaneously into the patented hemihydrate crystals.

The lower court decided the patent was valid, but that Apotex was not liable for infringement because its production process had resulted in small, commercially insignificant amounts of hemihydrate. Failing to limit the scope of the patent language would, the judge reasoned, lead to inevitable infringement.

SmithKline Beecham appealed the ruling to the U.S. Court of Appeals for the Federal Circuit. The three-judge panel differed with the lower court by saying that any amount of hemihydrous PHC produced, whether commercially viable or not, infringes the patent. The appellate judges also ruled that the clinical trials SmithKline had performed constituted a prior public use, which meant the compound already existed in the public domain. Based on that, they ruled the patent invalid.

In his concurring opinion, Judge Gajarsa wrote that SmithKline's patent was invalid not because it covered subject matter that had been used prior, but because it was not patentable under section 101 of patent law in the first place (35 U.S.C. 101).

"I was very heartened to see Judge Gajarsa say this because it does lend credibility to the fact that patents on self-reproducing organisms can have inherent problems and can't be treated like manufactured articles such as a toaster that doesn't reproduce itself," said DiMauro at the PatentWatch Project.


  • Decision, United States Court of Appeals for the Federal Circuit, Case no. 03-1285, -1313, SMITHKLINE BEECHAM CORPORATION and BEECHAM GROUP, P.L.C. v. APOTEX CORP., APOTEX, INC., and TORPHARM, INC.,
  • Gajarsa concurring opinion, United States Court of Appeals for the Federal Circuit, Case no.03-1285, -1313, SMITHKLINE BEECHAM CORPORATION and BEECHAM GROUP, P.L.C. v. APOTEX CORP., APOTEX, INC., and TORPHARM, INC.
  • Interview, Peter DiMauro, Ph.D., the PatentWatch Project of the International Center for Technology Assessment, ( )

UN Food Agency Comes Out In Favor Of Biotech Crops

Dow Jones Newswires
May, 17 2004

ROME (AP) -- A United Nations food agency is coming out in favor of biotech crops, saying genetically modified organisms have already helped small farmers financially, have had some environmental benefits and no ill effects on health.

In a major report being released Monday, the U.N. Food and Agriculture Organization says the main problem with agricultural biotechnology to date is that it hasn't spread fast enough to the world's poor farmers and has focused on crops that are mostly of use to big commercial interests.

The report "Agricultural Biotechnology: Meeting the Needs of the Poor?" is likely to fuel the debate about genetically modified, or transgenic crops, at a time when the technology continues to face public opposition in some European and African countries.

Proponents of GM foods say plants that can resist insects and be fortified with extra vitamins are a boon to farmers and consumers. Opponents warn that the crops pose unknown health and environmental risks and say the ones who benefit most are the corporations who develop and sell GM seeds.

The United Nation's policy to date had been that it recognized the potential of transgenic crops to help fight world hunger but that case-by-case studies were needed to assess the risks. While that position hasn't changed, the report gives an altogether positive vote to GM technology.

It said transgenic crops currently on the market are safe to eat and have posed no negative health effects. It said scientists differ on the environmental impact, noting that genes from GM crops can be transferred to wild species.

However, it said scientists differ on whether that in itself is a bad thing and said what's needed most is more research to assess the environmental consequences of this so-called "gene flow."

The report also pointed out some environmental and health benefits from using transgenic crops. It said reduction in pesticides and toxic herbicides that come with transgenic crops has had "demonstrable health benefits" for farm workers in China.

In addition, it said some GM crops, especially insect-resistant cotton, "are yielding significant economic gains to small farmers."

It noted that while private companies have been largely responsible for selling transgenic seeds, "it is the producers and consumers who are reaping the largest share of the economic benefits of transgenic crops."

"This suggests that the monopoly position engendered by intellectual property protection does not automatically lead to excessive industry profits," it said.

However, FAO said the private sector was focusing too much on technology for crops that benefit big commercial interests, such as maize, soybean, canola and cotton. Basic food crops for the poor, such as cassava, potato, rice and wheat have received little attention by scientists, it said.

In fact, FAO said that six countries: Argentina, Brazil, Canada, China, South Africa and the United States, four main crops: maize, soybean, canola and cotton and two traits: insect resistance and herbicide tolerance, accounted for 99% of the global area planted in transgenic crops in 2003.

The report is likely to be met with criticism from the anti-biotech camp, including Greenpeace, which has maintained that transgenic crops pose an unacceptable risk to human health and the environment.

Dr. Doreen Stabinsky, a Greenpeace science adviser, said Sunday that the problem of global hunger wasn't a lack of food or inadequate technologies."We know there is ample food on the planet. Most of the problems are not technical, they're about access to markets, access to credit, land," she said in a telephone interview. "Hunger is not a problem that needs technical solutions. It needs political will and appropriate policies."

While Stabinsky said she hadn't read the report, she said it appeared to be a political statement by FAO and another attempt by the biotech industry "to convince Europe that they ought to be eating the GM food that's being developed by American companies." The report is being released in the same week that the European Union's head office is to approve imports of a genetically modified corn for human consumption, ending a six-year biotech moratorium that the United States has challenged at the World Trade Organization.


FAO's Endorsement for GM Crops Will Exacerbate Farm Displacement

By Devinder Sharma

This is certainly a very sad development. I have often said in my writings/analysis that the FAO is actually riding the GM bandwagon. It has very cleverly, despite the public pronouncements that are aimed at the galleries, been pushing the GM agenda in the name of eradicating hunger and malnutrition. Biotechnology (call it genetic engineering) was among the five priority areas for FAO, but the reality is that with the kind of zeal that it was demonstrating in promoting unwanted GM crops, it overshadowed the emphasis on the remaining four initiatives for sustainable agriculture.

It is a sad day in the history of global agriculture as the world's only public agency on food and agriculture has now lost its credibility. It will no longer be viewed as an international organisation working for the public good. It has, and the process began several years back, been reduced to an extension of the US Agency for International Development (USAID) --- some call it appropriately as 'US Artificial Insemination Department' (ask the people living in Bangkok, Manila and Ho Chi Minh city) !

No wonder, the 200-page report was simultaneously released in Rome, where the Food and Agriculture Organization is based, and in Washington (where the USAID is located) !!

First the Consultative Group on International Agricultural Research (CGIAR), then the World Food Programme (WFP), and now the FAO, the USAID has successfully impregnated all these organisations which once were accountable to the public. Only recently, the WFP had tried very hard to push in unwanted and unhealthy genetically modified grains into several African countries in the name of food aid. The FAO is trying to push in unwanted GM crops in the developing world and that too in the name of minimising hunger and improving crop productivity. The truth is that while the green revolution technology bypassed the small and marginal farmers, GM crops will in addition add onto global hunger.

In reality, the agri-business industry, led by the biotech corporations, have spear-headed a global effort to further marginalise some 3-4 million farmers all over the world. Working hand in hand with the World Trade Organisation (WTO) and the Breton Woods Institutions, the entire effort is to push farmers out of agriculture. The process that began with the demise of the small farms in North America, and then spread to Europe, is now being extended to the majority world. The GM industry is all set to drive out majority of farmers in the developing countries from their meager land holdings. The world will soon be a witness to the biggest human tragedy --- displacement of farmers from agriculture, this time not due to hydel projects and big dams but from the take-over of agriculture by the GM industry.

Independent studies (including a study by the World Bank in 1995 for India) have shown that in India and China alone, home to half the world's farming populations, some 600 million people from the rural areas will migrate as a result to the urban centers by the years 2010. Thanks to FAO, by endorsing the USAID agenda, this process of social chaos and devastation can now be acerbated.

The FAO has now joined the troika -- World Bank/IMF, WTO and GM Industry --- and that too without any semblance of a meaningful public debate, to hasten the process of rural and environmental destruction and the eclipse of the farming communities. Usurping all democratic norms and against the very principles of 'good science' it has come out with a report which simply rubber-stamps the industry agenda.

What a sad day for the global farming community and the gullible consumers, what a sad day for democracy and 'good science' and what a black day for humanity.


EU Lifts Biotech Ban

By Jeremy Smith
May 19, 2004

BRUSSELS (Reuters) - The European Union has ended its controversial ban on genetically modified foods as its executive body authorises imports of a biotech maize, the first new EU approval in more than five years.

The European Commission agreed to allow imports of the maize, known as Bt-11 and marketed by Swiss agrochemicals giant Syngenta, to be sold as tinned sweetcorn on supermarket shelves across the 25-member bloc.

"Bt-11 was approved by the Commission," Commission spokeswoman Beate Gminder told reporters on Wednesday.

The decision follows months of deadlock between the EU's member states and also flies in the face of European opinion, where consumers are overwhelmingly opposed to biotech food.

Supermarkets and food manufacturers have responded to this and tend to avoid stocking produce that contains GMOs.

The last EU approval of any GMO product was in October 1998 for a type of carnation. The last food product, a type of maize, was approved in April that year.

"GM sweetcorn has been subjected to the most rigorous pre-marketing assessment in the world," said EU Health and Consumer Protection Commissioner David Byrne.

"It has been scientifically assessed as being as safe as any conventional maize," he said in a statement. "Food safety is therefore not an issue, it is a question of consumer choice."

Although the EU decision confounds the hopes of GMO-sceptic states such as Austria and Denmark, it should delight some of the EU's top trading partners such as the United States, which has challenged the bloc's ban at the World Trade Organisation.

It also comes at a time when the world's biotech giants are facing their own problems over the controversial technology.

Last week, U.S. biotech giant Monsanto shelved its launch of the world's first GMO wheat, delighting greens around the world.

Just days later, it filed a suit against rival Syngenta claiming a violation of its patent on a technique producing a popular type of GMO maize.

The EU's member states, their numbers recently swelled to 25, had been deadlocked for months over whether to approve Bt-11. Under the bloc's complex decision-making process, the Commission now has the power to rubberstamp the authorisation.

The ban was triggered when a handful of EU countries said in 1998 they would refuse new GM authorisations until there were stricter laws on testing and labelling. U.S. farmers say the EU moratorium costs them millions of dollars a year in lost sales.

But the real battle for EU biotech policy, diplomats say, is when the bloc gives a green light to plant live GM crops. That will be the acid test of whether the moratorium is really over.

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