Showing posts with label gene patents. Show all posts
Showing posts with label gene patents. Show all posts

Friday, March 15, 2013

Monsanto the devil’s Death Patents

A Death Grip on Our Food Supply
by RANDALL AMSTER


Monsanto the devil has yet another case pending in the court system, this time before the U.S. Supreme Court on the exclusivity of its genetically modified seed patents. Narrowly at issue is whether Monsanto the devil retains patent rights on soybeans that have been replanted after showing up in generic stocks rather than being sold specifically as seeds, or whether those patent rights are “exhausted” after the initial planting. But more broadly the case also raises implications regarding control of the food supply and the patenting of life – questions that current patent laws are ill-equipped to meaningfully address.

On the specific legal issues, Monsanto the devil is likely to win the case (they almost always do). The extant facts make this a relatively poor platform to serve as a test case of Monsanto the devil’s right to exert such expansive powers. The farmer in this situation had previously purchased Monsanto the devil soybeans for planting (back in 1999), and in this instance bought previously harvested soybeans with the intention of planting them – even spraying Monsanto the devil’s Roundup herbicide on them in the hopes that at least some of the generic stock would be of the so-called “Roundup Ready” variety.

Despite this unfortunate posture, the case does provide another opportunity for critical inquiry regarding the unprecedented and perverse level of control Monsanto the devil is asserting over the food supply. It is estimated that 90 percent of the soybeans in the U.S. are genetically modified and thus subject to potential patents. A random handful of soybeans procured anywhere is likely to contain at least some Monsanto the devil-altered beans. Such a near-monopoly effectively gives Monsanto the devil the right to control access to a staple food item that is found in a wide range of consumer products.

Other variations on this theme include pollen from Monsanto the devil corn (similarly dominant in the U.S. market) pollinating a farmer’s crop, or seeds from Monsanto the devil-engineered grains being distributed by animals, winds, or waterways and commingling with non-GMO plantings. In each case, Monsanto the devil could have a cause of action against an unwitting farmer by claiming patent infringement.

More broadly, and unlikely to be addressed in the instant case, is whether Monsanto the devil (or any other company) should be able to patent seeds – the core of global food supplies, and thus of sustenance for billions of people – in the first place. Activists will decry the fact that Monsanto the devil is patenting life, and this is indeed an Orwellian (or perhaps a Huxleyan) prospect, to be sure. Yet I would submit that Monsanto the devil is actually patenting death, which is potentially even more disconcerting.

Consider that by exerting this level of control over the food supply, Monsanto the devil is rapidly creating a world in which people have to pay fealty to the corporation in order to grow food and/or consume it. In this sense, Monsanto the devil gains enormous power to determine who is allowed to eat – and thus who lives or dies. Consider further that Monsanto the devil’s patents also include technologies in which seeds are sold that cannot propagate themselves, resulting in plants terminating rather than perpetuating, requiring farmers to have to go back to the “company store” every season in order to replant their fields.

In the case currently before the Court, shades of the latter issue are present, with the question being whether the seeds of the seeds of Monsanto the devil creations retain their exclusive patent rights – possibly in perpetuity. This sort of argument might give us cause to wonder whether an animal (or even a human being, someday?) who consumes these proprietary foods could be implicated in such assertions if they are somehow genetically altered in the process. Perverse slippery slopes aside, the permeation of patentable materials throughout the food chain is by now a clear and present danger.

These are troubling trends indeed. Monsanto the devil wants the right to exert perpetual control, and with it the power to make decisions about who/what lives or dies. In addition to seed patents, their corporate creations include herbicides, pesticides, and biocides that toxify soils and poison waters. Genetically modified foods increasingly dominate the U.S. food supply (and supplies elsewhere, at least where they haven’t been explicitly banned) despite insufficient testing and concerns about their health impacts. The ability of corporations like Monsanto the devil to continue plying such products with little oversight constitutes a de facto consumer beta test on a mass level, the full effects of which may not be known for decades, if ever.

Taking all of this together, it increasingly appears that Monsanto the devil is patenting death, perhaps even more so than life. Their patent rights should not trump the rights of people to procure safe, healthy, living foods. Whatever the result in the Supreme Court case, we should roundly deem Monsanto the devil a loser in the court of public opinion, and strive to loosen their death grip on our food supply.

Let's also not forget that Justice Clarence Thomas was once upon a time legal counsel to Monsanto the devil for quite a few years and refuses to recuse himself,  even though his ruling on the case is a clear conflict of interest. --jef

Monday, March 11, 2013

Five Poisons of Privatization

Monday, March 11, 2013 by Common Dreams
by Paul Buchheit



It gets more maddening every day. Essential human needs are being packaged into products to be bought and sold. The right to food and water, education, health care, public spaces, and unrestricted speech shouldn't be based on who can pay the most, or on who can generate profits with the slickest marketing pitch.

The free-market capitalism that drives our economy is a doctrine of individuals pursuing profit. Nothing else matters. An executive for Roche, a healthcare company, said "We are not in the business to save lives, but to make money."

With privatization of the common good we risk losing both our heritage and our humanness.

1. The Taking of Public Land

Attempts to privatize federal land were made by the Reagan administration in the 1980s and the Republican-controlled Congress in the 1990s. In 2006, President Bush proposed auctioning off 300,000 acres of national forest in 41 states.

The assault on our common areas continues with even greater ferocity today, as the euphemistic Path to Prosperity has proposed to sell millions of acres of "unneeded federal land," and libertarian groups like the Cato Institute demand that our property be "allocated to the highest-value use." Mitt Romney admitted that he didn't know "what the purpose is" of public lands.

Examples of the takeaway are shocking. Peabody Coal is strip-mining public lands in Wyoming and Montana and making a 10,000% profit on the meager amounts they pay for the privilege. Sealaska is snatching up timberland in Alaska. The Central Rockies Land Exchange would allow Bill Koch to pick up choice Colorado properties from the Bureau of Land Management, while neighboring Utah Governor Gary Herbert sees land privatization as a way to reduce the deficit. Representative Cliff Stearns recommended that we "sell off some of our national parks." One gold mining company even invoked an 1872 law to grab mineral-rich Nevada land for which it stands to make a million-percent profit.

The National Resources Defense Council just reported that oil and gas companies hold drilling and fracking rights on U.S. land equivalent to the size of California and Florida combined. Much of this land is "split estate," which means the company can drill under an American citizen's property without consent. Unrestrained by government regulations, TransCanada was able to use eminent domain in Texas to lay its pipeline on private property and then have the owner arrested for trespassing on her own land, and Chesapeake Energy Corporation overturned a 93-year-old law to frack a Texas residence without paying a penny to the homeowners. Most recently, the oil frenzy in North Dakota has cheated Native Americans out of a billion dollars worth of revenue from drilling leases.

Away from the mountains and the plains, back in the cities of Chicago and Indianapolis and L.A. and San Diego, our streets and parking spaces have been surrendered to corporations until the time of our great-grandchildren, with some of the highest profit margins in the corporate world.

2. Water for Sale

The corporate invasion of the water market is well underway. In May 2000 Fortune Magazine called water "one of the world's great business opportunities..[It] promises to be to the 21st century what oil was to the 20th." Citigroup is on board, viewing water as a prime investment, and perhaps the "single most important physical-commodity based asset class."

The vital human resource of water is being privatized and marketed all over the country. In Pennsylvania and California, the American Water Company took over towns and raised rates by 70% or more. In Atlanta, United Water Services demanded more money from the city while prompting federal complaints about water quality. Shell owns groundwater rights in Colorado, oil tycoon T. Boone Pickens is buying up the water in drought-stricken Texas, and water in Alaska is being pumped into tankers and sold in the Middle East.

A 2009 analysis of water and sewer utilities by Food and Water Watch found that private companies charge up to 80 percent more for water and 100 percent more for sewer services. Various privatization abuses or failures occurred in California, Georgia, Illinois, Indiana, New Jersey, and Rhode Island.

Of course, water monopolization is a global concern, and a life-threatening issue in undeveloped countries, where 884 million people are without safe drinking water and more than 2.6 billion people lack the means for basic sanitation. Whether in the U.S. or in the world's poorest nation, the folly of privatizing water is made clear by the profit-seeking motives of business:
  1. Water corporations are primarily accountable to their stockholders, not to the people they serve.
  2. They will avoid serving low-income communities where bill collection might be an issue.
  3. Because of the risk to profits, there is less incentive to maintain infrastructure.

3. Owning Human Life

Monsanto the devil
and their agro-chemical partners call themselves the "life industry."

In 1980 a General Electric geneticist engineered an oil-eating bacterium, effective against oil spills, and in the first case of its kind the Supreme Court ruled that "a live, human-made micro-organism is patentable subject matter." Fifteen years later a World Trade Organization decision allowed plants, genes, and microorganisms to be owned as intellectual property.

The results, not surprisingly, have been disastrous. One-fifth of the human genome is privately owned through patents. Strains of influenza and hepatitis have been claimed by corporate and university labs, and because of this researchers can't use the patented life forms to perform cancer research. Thus the cost of life-preserving tests often depends on the whim (and the market analysis) of the organization claiming ownership of the biological entity.

The results have also been otherworldly. In 1996 the U.S. National Institutes of Health attempted to patent the blood cells of the primitive Hagahai tribesman of New Guinea. U.S. companies AgriDyne and W.R. Grace tried to gain ownership of the neem plant, used for centuries in India for the making of medicines and natural pesticides. Other examples of 'biopiracy': The University of Cincinnati holds a patent on Brazil's guarana seed; the University of Mississippi holds a patent on the Asian spice turmeric.

Most tragically, tens of thousands of Indian farmers, charged for seeds that they used to develop on their own, and forced to repurchase them every year, have been driven to suicide after experiencing crop failures and ruinous debt.

Monsanto the devil is at the forefront of GMO seeds and litigation against vulnerable farmers. To date the company has won over half of its patent infringement lawsuits. The Supreme Court is currently weighing the arguments in Bowman vs. Monsanto the devil, which asks if a company can have a claim on a farmer whose crops were derived from a seed already paid for. More significantly, the question is whether a company can claim the rights to a form of life that has been nurtured by communities of farmers for centuries.

4. Owning the Air

In polluted Beijing, wealthy entrepreneur Chen Guangbiao is selling "fresh air" in a soft drink can for about 80 cents.

While Americans are not yet dependent on (real or imagined) breathing supplements, we have relinquished public access to the air in another important way: the 1996 Telecommunications Act led the way to a giveaway of the transmission airwaves to the broadcast media. Through an effective lobbying campaign the communications industry gained all the benefits of a lucrative public space without even a licensing fee. Objected former Senate Majority Leader Bob Dole, "The airwaves are a natural resource. They do not belong to the broadcasters, phone companies or any other industry. They belong to the American people."

Closely related is our right to freedom of expression on the Internet, which has been repeatedly threatened, despite the presence of existing copyright laws, by aggressive proposals like the Stop Online Piracy Act (SOPA) and the Protect IP Act (PIPA). Privacy is at risk with the Cyber Intelligence Sharing and Protection Act (CISPA), passed in the House despite objections by Ron Paul and others who recognize the "Big Brother" implications of government monitoring of Google and Facebook accounts. The Foreign Intelligence Surveillance Act has facilitated the monitoring of foreign communications in the name of anti-terrorism.

A 2011 UNESCO report offered this worrisome insight: "..the control of information on the Internet and Web is certainly feasible, and technological advances do not therefore guarantee greater freedom of speech."

5. Children as Products

Leading capitalists like Bill Gates and Jeb Bush and Michael Bloomberg and Arne Duncan and Michelle Rhee, who together have a few months teaching experience, have decided that the business model can pump out improved assembly line versions of our children.

Charter schools simply don't work as well as the profitseekers would have us believe. The recently updated CREDO study at Stanford concluded again that "CMOs (Charter Management Organizations) on average are not dramatically better than non-CMO schools in terms of their contributions to student learning.
 
Approximately the same percentages of charters and non-charters are showing improvement (or lack of improvement) in reading and math. In addition, poorly performing charters tend not to improve over time.

Nevertheless, charters remain appealing to poorly informed parents. The schools like to represent themselves as equal opportunity educational options, but the facts state the opposite, as many of them have strict application standards that ensure access to the most qualified students. Funding for such schools drains money out of the public system.

Children are viewed as products in another way -- on the school-to-prison pipeline. Many school districts employ "school resource officers" to patrol their hallways, and to ticket or arrest kids who disrupt the academic routine, no matter the age of the offender or the nature of the "offense":
  • A twelve-year-old was arrested for wearing too much perfume.
  • A five-year-old was handcuffed for committing "battery" on a police officer.
  • A six-year-old was called a "terrorist threat" for talking about shooting bubbles at a classmate.
Along with these bizarre instances is the frightening precedent set by a private prison, Corrections Corporation of America, which despite having no law enforcement authority was allowed to participate in a drug sweep at a high school in Arizona.

An Antidote?

A successful society doesn't derive from a few Ayn-Rand-type individuals. It's the other way around, as philosopher John Dewey reasoned in the 1930s. It's easy to forget that our country's greatest success was due to a collaborative effort in the years during and after World War 2, when advances in manufacturing and technology made us the strongest economy the world had ever seen. It was a shared success. The common good was not for sale.

Sunday, August 19, 2012

U.S. Court Upholds Status Quo on Gene Patents


by Amanda Wilson 
 
Is a gene more like a tree trunk or more like a baseball bat? A federal court Thursday took a stand on the question, ruling that isolated DNA molecules are “not found in nature”, and are therefore more like inventions, such as baseball bats, than natural phenomenon, such as tree trunks.

 Using language steeped in metaphor in a packed U.S. federal courtroom, attorneys in July debated the question in a closely-watched case on the right to patent genes that has been working its way through the courts.

At stake: the right of one company – Myriad Genetics – to patent a gene as a human invention under U.S. patent law, which allows patents on inventions but not on products of nature.

In a ruling that largely upheld the status quo in a biotech industry that has been patenting genes for decades, the U.S. Court of Appeals for the Federal Circuit ruled Thursday that “isolated” human genes are patentable. Methods of “comparing” or “analysing” DNA sequences are, however, not patent eligible, it ruled.

In a two-to-one decision, the court affirmed Myriad’s right to claim intellectual property rights on the BRCA-1 BRCA-2 genes, genes where mutations indicate a woman has an 82 percent increased risk of developing breast cancer.

The company’s patents on the genes are the basis of a breast cancer indicator test that has been a profitable asset in the company’s portfolio of intellectual property.

The American Civil Liberties Union (ACLU), representing a group of about 20 plaintiffs, including the breast cancer patient advocates and geneticists, several years ago launched a legal challenge to Myriad’s right to patent the genes.

The plaintiffs, including patient advocacy group Breast Cancer Action, have argued that Myriad’s IP rights to the genes allow it to block others from testing for – or even looking at – the BRCA-1 and BRCA-2 genes, a right they say Myriad has exercised in the past with legal threats.
Plaintiffs have also argued the patents raise prices for testing and essentially create a market monopoly which blocks the poorest from getting tested and stifles scientists who want to look at the genes. Yale geneticist Ellen Matloff, a plaintiff in the case, told IPS last year the situation was “horrifying.”

Matloff told IPS that 95 percent of patients she recommended for Myriad’s 700-dollar supplementary BART test, which looks for mutations on the BRCA-1 and BRCA-2 genes, opted not to get it because of its high cost.

Furthermore, those who question gene patents have pointed out that patenting individual genes might even be myopic, especially in a world of whole genome sequencing where the scientific community is increasingly interested in gene interactions, the influence of the environment on genetics (called epigenetics), and other big-picture indicators to understand patient health.
The case has been working its way through the courts. A New York district court judge sided with the ACLU in 2010, but the Federal Circuit Court of Appeals overturned the ruling in July 2011.

The ACLU appealed to the Supreme Court last year, but the Court declined to issue a ruling in the case. Instead, it sent the case back to the Federal Circuit to re-examine in light of its unanimous spring decision that Prometheus Laboratories Inc. did not have a right to patent a certain blood test because the patent was based on observations about natural phenomena.
But Thursday, the Federal Circuit again ruled that genes are patentable. The court wrote, “The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity.”

In its majority opinion the court also highlighted that gene patenting had been standard practice for the U.S. Patent and Trademark Office (PTO) for years.

“Why hasn’t this come up in 30 years,” Circuit Judge Kimberly Moore, who sided with the majority, asked during oral arguments in the courtroom July.

Moore hinted at the biotech sector’s financial stake in gene patents, often key components of diagnostic test IP at the centre of a much-hyped personalised medicine industry. “What about the biotech sector and all the money?” Moore asked.

In his dissenting opinion, Circuit Judge William Bryson wrote, “my colleagues assign significant weight to the fact that since 2001 the PTO has had guidelines in place that have allowed patents on entire human genes… I think the PTO’s practice and guidelines are not entitled to significant weight…”

Sandra Park, an attorney with the ACLU, told IPS her team was disappointed in the Federal Circuit court’s decision, which she said she believed did not take the Supreme Court’s ruling in Prometheus adequately into consideration.

“We think that the Supreme Court’s recent decision is very clear that the Court is very concerned about how patents interfere with scientific work,” Park told IPS. “The Supreme Court has said that the interests of industry in relying on patent protection is not a factor in determining that something is patentable.”

Park said the mere fact that Prometheus argued that it needed its patents to advance its interests, in the Supreme Court’s ruling, was insufficient reason to justify patents.

If the ACLU decides, with the other plaintiffs, to appeal the Federal Circuit court’s decision, it is possible the Supreme Court might decide to hear the case. Such a scenario is not unheard of. In fact, Park said, the Supreme Court decision to overturn Prometheus’s right to its diagnostic patent came after the Federal Circuit twice upheld it.

Park said the ACLU was still deciding its next step. “We are reviewing our options, but we haven’t made any decisions yet.”

Monday, October 17, 2011

ACLU Will Take Gene Patent Case to Supreme Court

by Amanda Wilson 
 
WASHINGTON - When Jaydee Hanson, then-bioethics director for the United Methodist Church, spoke out publicly against gene patents over 15 years ago, some in the biotech industry compared his stance to the Catholic Church's persecution of Galileo, the 15th century astronomer who discovered the moons of Jupiter.

Hanson and 200 other religious leaders had released a statement that DNA in the human body and animals are natural objects and should not be subject to patenting.

"It's kind of like saying two of your genes are in jail, but we are not allowed to report this information to you, even though it would save your life."

Patent supporters in the biotech industry disagree, arguing that "isolated copies" of genes outside the human body should be patentable and that the prospect of intellectual property rights on genes serves as incentive for further research.

On Wednesday, the American Civil Liberties Union (ACLU) announced it would ask the Supreme Court to rule on a patent by Myriad Genetics, a genetic diagnostics company based in Salt Lake City, Utah, on "isolated" BRCA-1 and BRCA-2 genes, two genes that can have mutations linked to breast, ovarian and prostate cancers.

Those with a stake in the case say any ruling from the court would have a major impact on patient care, scientific research, and rights to access human genetic information, as well on legal doctrine.

The gene patenting case has been moving up through lower courts since 2009, when the ACLU first filed a civil suit in a district court in the state of New York arguing that Myriad's patent on the genes should be invalidated.

District judge Robert Sweet agreed with the ACLU in 2010, but Myriad appealed, and the Federal Circuit Court of Appeals overturned Sweet's ruling in July, with two out of three judges siding with Myriad, affirming the company's right to patents on the two "isolated" BRCA genes linked to breast cancer.

Facing a mid-December deadline to appeal the lower court's ruling to uphold gene patents, the ACLU decided to move forward with the appeal in time for National Breast Cancer Awareness Month in October, said Sandra Park, an ACLU attorney working on the case.

"We consulted with our clients and made the decision to move forward, given the importance of the issues to patients and scientists," Park told IPS, adding that the Supreme Court would likely make a decision in the spring of 2012 about whether it will hear the case.

More than 4,000 genes have been patented, including copies of genes that make up 20 percent of the human genome, according to Hanson, who now works as a policy director for the International Centre for Technology Assessment (ICTA). In the past, Hanson and ICTA have successfully challenged patents on a beagle and other animals.

In September, Myriad sent the following comment to IPS: "Myriad defended its position in the courts and recently had a favourable outcome. We believe that isolated DNA and cDNA are patent-eligible material, as both are new chemical matter with important utilities which can only exist as a product of human ingenuity."

With its patents, Myriad holds exclusive rights in the U.S. to test the BRCA-1 and BRCA-2 genes for mutations and provide that information to doctors and patients. Those mutations place women at a much greater risk of developing breast cancer and some men at greater risk of developing prostate cancer.

ACLU: Patents make tests cost-prohibitive and block research
The ACLU represents a group of 20 other plaintiffs, including geneticists, pathologists and breast cancer survivor advocates, who maintain that the patents block patient care.

They argue that patients shouldn't have to pay for genetic information they could use to make life-or- death decisions, such as whether to get a mastectomy, especially when other genetic testing providers could offer that information if Myriad didn't have exclusive rights to sequence the genes.

Five to 10 percent of breast cancer cases are linked to mutations on the BRCA-1 or BRCA-2 genes, and those with the mutations have an 85 percent risk of developing cancer. Some insurance policies cover the tests, but other plans, especially those providing insurance for the poor, don't.

According to Park, Myriad chose not to enter into contracts with about half of all insurance programs in states that cover low-income people.

Ellen Matloff, a genetic counselor at Yale for over 15 years and a plaintiff in the ACLU case, said the cost of the test was a real issue for many of her patients.

According to her, "comprehensive" breast cancer test from Myriad for other breast cancer mutations costs 3,400 dollars and a supplementary test for the BRCA-1 and BRCA-2 genes, called the BART test, costs 700 dollars. Matloff said that 95 percent of patients she recommends for supplementary testing don't end up being tested because of its high cost.

"I know that we are missing mutations," Matloff told IPS, adding that the BRCA gene mutations are passed down maternally and paternally. "It is going to impact them, their children, their siblings their grandchildren, their nieces and nephews, and from a clinician's standpoint it is horrifying."

Gene patenting opponents also argue that in a new era in which full- genome sequencing is getting faster and cheaper, patents stand in the way of access to new knowledge about how certain genes are related to disease.

"The whole next phase of [research in] genetics and disease is to understand how genes work together," Hanson told IPS. "It is a huge task, and the patents just interfere with it."

Matloff expressed a similar concern that advanced knowledge about genes without access to that knowledge could create problems for patients and care providers.

"It is almost like saying, 'we have your genes right in front of us, it came out of your body, but we are not allowed to look at it, we're not allowed to interpret it, and we are not allowed to give the information back to you,'" Matloff said.

"It's kind of like saying two of your genes are in jail, but we are not allowed to report this information to you, even though it would save your life."

Tuesday, August 2, 2011

Federal court rules human genes can be patented

(This is ridiculous and adds more corporate control over people. Can a patent owner sue you for patent infrignement if you possess the same DNA s/he patented? Total bullshit!--jef)


By Eric W. Dolan - RAW Story
Monday, August 1st, 2011

 
 
The United States Court of Appeals for the Federal Circuit ruled in a 2 to 1 decision Friday that human genes can be patented because the DNA extracted from cells is not a product of nature.
The court held (PDF) that Myriad Genetics can patent two human genes used to predict the risk of breast and ovarian cancer in women, overturning a previous decision by a federal district court in March 2010. But the court ruled that the method used to determine a patient's risk of cancer was not patentable.

The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed in May 2009 on behalf of researchers, women patients, cancer survivors and scientific associations against the U.S. Patent and Trademark Office, as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, BRCA1 and BRCA2.

The lawsuit was filed by the Public Patent Foundation and the American Civil Liberties Union, who claimed patents on human genes violate the First Amendment and patent law because genes are "products of nature."

The court disagreed.

"In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified," Judge Alan D. Lourie wrote for the majority. "They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules."

Judge Kimberly A. Moore added in a concurring opinion that isolated DNA "is a distinct molecule with different physical characteristics than the naturally occurring" DNA found in nature, noting that the DNA found in nature "is part of a much larger structure, the chromosome."

In his dissenting opinion, Judge William C. Bryson advocated the "common sense view" that "patents are for inventions" and "a human gene is not an invention." He also warned that "if sustained the court’s decision will likely have broad consequences, such as preempting methods for whole-genome sequencing."

"Because the native BRCA genes are chemically bonded to other genes and histone proteins, the majority concludes that cleaving those bonds to isolate the BRCA genes turns the isolated genes into 'different materials,'" Bryson added. "Yet there is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered."

The U.S. Patent and Trademark Office (PTO) has already granted thousands of patents on human genes. It is estimated that nearly 20 percent of human genes are patented.

Wednesday, June 8, 2011

Corporate Takeover of Food Production

Food Sovereignty Responds 
by: Yve le Grand , Truthout 
 
Introduction 

Although the credit crunch has pushed the issue of the global food crisis to the background, it is still going on today. In fact, the number of chronically hungry people worldwide has risen and is estimated to amount to 967 million people according to the new Declaration of Human Rights, launched by the Cordoba process[1] at the end of 2008, on the occasion of the Declaration's 60th anniversary.

In 1948, the of the United Nations declared "... everyone has a right to be free from hunger and to adequate food including drinking water, as set out in Article 25 of the Universal Declaration of Human Rights."[2]

The world famine in the 1970s led the Declaration to introduce the concept of food security: "... the availability at all times of adequate world food supplies of basic foodstuffs to sustain a steady expansion of food consumption and to offset fluctuations in production and prices."[3]

This definition of food security, which is basically a technical matter of providing adequate human nutrition, led to the assumption that more food production would solve the problem of mass starvation. The Green Revolution led to a spectacular increase in the amount of food produced, but the numbers of the chronically hunger did not diminish accordingly.[4]

In his landmark book on poverty and famines,[5] Amartya Sen, concluded that enough food was being produced (i.e. enough calories per capita), but that the access to food, the entitlement to it, was the core of the problem. The poor simply lacked the financial and political means to claim their share of world food production. Sen made it clear that the world food problem was, thus, not so much a matter of food production, as it was one of social inequality and injustice. To see how a perfect storm has been in the making since the first Declaration of Human Rights, it is necessary to go back to the root of all food: seeds.

The Seed Situation 

In and of themselves, "Seeds are the very beginning of the food chain. He, who controls the seeds, controls the food supply and thus controls the people."[6] To understand why this is important for current developments in the agrarian industrial complex, it is necessary to have an understanding of how "normal" agricultural practices and techniques have evolved over time, in contrast to contemporary corporate practice in the last few decades.

When people first settled down and started to grow crops for food, through a lot of hard work and through trial and error, indigenous plant breeds were improved upon over time by cross pollination. Thus, plants developed that were suited best for local circumstances and climate conditions (e.g. drought, wind, flooding, soil). Through the techniques of crop rotation, mixed crop planting and by using natural fertilizers (manure, compost), the soil was not too depleted to recover and be (re)used.

Two of the most important agricultural practices are brown bagging and seed exchange. Brown bagging is the farmer's custom to save part of the seeds from the current harvest, to sow them in the following year. Seed exchange makes for the dissemination of new strands of DNA that have been obtained through crossbreeding plants. In this way, the various genetic materials guarantee biodiversity, which is of the utmost importance in order to withstand insect attacks or other pests that threaten a growing crop.

After the Second World War, chemical companies that had already diversified into seed fertilizers, herbicides and pesticides, began to invest heavily in the research and development (R & D) of so-called "hybrid" seeds, while buying up seed companies. Hybrid seeds grow with the input of petroleum-based fertilizers, herbicides and pesticides; e.g. "Roundup Ready" seeds developed by Monsanto the devil would only be able to grow through the exclusive use of their Roundup chemicals. A short while later, R & D would focus on genetically modified (GM) seeds, for which use companies could charge money on the basis of intellectual property rights (IPR).

How has the jump from seed saving and exchange to IPR on seeds been legally possible? In 1980, in Diamond v. Chakrabarty,[7] 447 US 303, the US Supreme Court ruled that a patent covering a living organism from now on was extended to cover "a live human-made micro-organism. "

In other words, whereas prior to this process, plants and animals themselves were subject to property rights and ownership, their genetics were not. After the process, the genetics of plants and animals could be owned and, thus, subject to intellectual property rights.

As a consequence, farmers could neither freely and legally plant nor save seeds for replanting of any plant variety registered under the plant variety provisions of the new patent law. This development marked a shift from public agrarian practice in which seeds could be exchanged and saved freely, to privately owned seed DNA, subject to IPR.


Source: International Seed Federation.[8] Since 1985, the trade in commercial seed has been soaring.

IPR deprives farmers from what they and many others worldwide claim as their inherent right to save and replant seeds. Seed varieties, which have been developed over centuries, have adapted to their particular environments, while their gene pool has to survive unforeseen factors such as pests and diseases - or climate change. Thus, farmers are losing their independence and become "extensions" in the field for the biotech corporations the world over,[9] as IPR clauses in the contracts between them and the farmer forbid the farmer to save and replant their seeds. Though farmers buy the GM seeds, they do not own them. In fact, farmers are renting the GM seeds from the biotech corporation on an annual basis.

Another consequence of the court ruling is the explosion of tactical cooperations, strategic mergers and takeovers among agro-chemical-biotech companies and the ensuing consolidation of power in the hands of a few transnational corporations (TNCs).

Based on a report published by the ETC Group, the action group on Erosion, Technology and Concentration:[10]
  • From thousands of seed companies and public breeding institutions three decades ago, 10 companies now control more than two-thirds of global proprietary seed sales.
     
  • From dozens of pesticide companies three decades ago, 10 now control almost 90 percent of agrochemical sales worldwide.
     
  •  From almost 1,000 biotech start-ups 15 years ago, 10 companies now account for three-quarters of industry revenues.
The concentration of power makes for strong industry lobbies in governmental organizations such as the World Trade Organization (WTO) and the World Bank, in favor of governmental deregulation and the promotion of free trade, including agriculture. This directly affects the lives of people, in particular in the global South.

Free Trade and Agriculture

The Agreement on Agriculture (AoA) came into being at the same time as the WTO - until then GATT[11] - on January 1, 1995. The AoA, effectively considering agricultural crops as commodities, was based on three pillars for trade regulation: domestic support, market access and export subsidies.[12]

The first pillar, domestic support, is a set of rules that regulate under which circumstances local producers can be subsidized. The second pillar, market access, is aimed at reducing the tariff on imported goods, in an attempt to "create order, fair competition and a less distorted agricultural sector."[13] Non-tariff barriers on imports - such as import quotas or import restrictions - have to be "tarifficated" in order to become part of the global market process. Once bonded to a tariff, the rate will subsequently be reduced over time. The third pillar obliges developed countries to reduce the export subsidies given to local producers, in order to reduce false competition.

Only developed countries are rich enough to sponsor their agricultural producers one way or the other.[14] These subsidized crops flood the global market at below-cost prices. This both undercuts and lowers the farm gate prices for the local producers in developing countries, while these countries cannot afford to support their domestic producers or pay them export subsidies. In practice, this leads to what has become known as export dumping.

Due to the asymmetric power relations between developed and developing countries, it seems that the trade regulations have had a virtually opposite effect from that ostensibly intended: the reduction of tariff protections has negatively affected small-scale farmers - who make up 70 percent of the population in developing countries - who see the key source of their income slip away, driving them off the land and into the cities, in search of a new way to make a living.[15]

Subsistence farmers are effectively threatened by the conditions put forward once their state government takes out a loan from the World Bank or signs a WTO Trade agreement, as these come with structural adjustment programs (SAPs). SAPs are in effect prescribed economic "reform" policies, such as the reduction of government budgets and social spending; the cutting of programs and subsidies for basic goods; the elimination of restrictions on foreign ownership; the increase in interest rates; the promotion of a switch from subsistence farming to export economies, while eliminating import tariffs.[16]

Government deregulation thus favors TNCs over smallholders[17] in a bid to compete with export crops in a global market that, in fact, is seriously distorted by the agricultural subsidy policies of the developed countries.

Recently, the dash for agrofuels, diverting food crops to produce energy, has put yet more strain on the competition for land and other resources such as water.[18] The social and environmental consequences of business as usual has driven many farmers off their land toward cities, putting additional pressure on the land, as agricultural land is urbanized. Nowhere can these non-trade concerns[19] be witnessed better than in the growing number of slums around cities in the developing world.

The dispossessed are fighting back, however. They have organized themselves in all sorts of organizations, the aim of which is to resist further global appropriation of their lands and local economies. They campaign for agricultural reform and the human right to food; they demand food sovereignty for all.

Food Sovereignty

"People facing hunger and malnutrition are, to a large extent, smallholders, landless workers, pastoralists and fisherfolk, often situated in marginal and vulnerable ecological environments. Neglected by (inter)national policies, they cannot compete with increasingly subsidized industrialized agriculture, both nationally and in the world market. Many farmers tried to catch the Green Revolution train, but became stuck in the debt trap of increasing input costs and decreasing product prices. Concentration in the food market chain is another worrying trend causing increasing dependence of both consumers and producers on a declining number of seed, inputs and food products conglomerates."[20]

Food sovereignty is a term originally coined in 1996 by the members of La Via Campesina as an alternative policy framework, countering the narrow view of food security as access to global food imports by food-deficient countries as a political goal.

Emerging in 1993, Via Campesina is "an international movement of peasants, small- and medium-sized producers, landless, rural women, indigenous people, rural youth and agricultural workers that fight for the right of people to determine their own local policy to food security through agrarian reform and rural development."[21]

Via Campesina's Seven Principles of Food Sovereignty[22]

1. Food: A Basic Human Right

Everyone must have access to safe, nutritious and culturally appropriate food in sufficient quantity and quality to sustain a healthy life with full human dignity. Each nation should declare that access to food is a constitutional right and guarantee the development of the primary sector to ensure the concrete realization of this fundamental right.

2. Agrarian Reform

A genuine agrarian reform is necessary, which gives landless and farming people - especially women - ownership and control of the land they work, and returns territories to indigenous peoples. The right to land must be free of discrimination on the basis of gender, religion, race, social class or ideology; the land belongs to those who work it.

3. Protecting Natural Resources

Food sovereignty entails the sustainable care and use of natural resources, especially land, water, seeds and livestock breeds. The people who work the land must have the right to practice sustainable management of natural resources and to conserve biodiversity free of restrictive intellectual property rights. This can only be done from a sound economic basis with security of tenure, healthy soils and reduced use of agro-chemicals.

4. Reorganizing Food Trade

Food is first and foremost a source of nutrition and only secondarily an item of trade. National agricultural policies must prioritize production for domestic consumption and food self-sufficiency. Food imports must neither displace local production nor depress prices.

5. Ending the Globalization of Hunger

Food sovereignty is undermined by multilateral institutions and by speculative capital. The growing control of multinational corporations over agricultural policies has been facilitated by the economic policies of multilateral organizations such as the WTO, World Bank and the International Monetary Fund (IMF). Regulation and taxation of speculative capital and a strictly enforced code of conduct for TNCs is therefore needed.

6. Social Peace

Everyone has the right to be free from violence. Food must not be used as a weapon. Increasing levels of poverty and marginalization in the countryside, along with the growing oppression of ethnic minorities and indigenous populations, aggravate situations of injustice and hopelessness. The ongoing displacement, forced urbanization, repression and increasing incidence of racism of smallholder farmers cannot be tolerated.

7. Democratic control

Smallholder farmers must have direct input into formulating agricultural policies at all levels. The United Nations and related organizations will have to undergo a process of democratization to enable this to become a reality. Everyone has the right to honest, accurate information and open and democratic decision-making. These rights form the basis of good governance, accountability and equal participation in economic, political and social life, free from all forms of discrimination. Rural women, in particular, must be granted direct and active decision-making on food and rural issues.

The acceptance of this framework[23] in the context of the Declaration of Human Rights, is extremely important, not only for the small, food-producing people involved, but also for the end consumer in the developed world: the true right to food and the true right to produce food, mean that all people have an unalienable right to safe, nutritious and culturally-appropriate food as well as to food-producing resources, while they have the ability to sustain themselves and their societies in the process.

If the no consensus on a G8-driven global partnership against hunger is the surprise outcome of the High Level Meeting on Food Security held in Madrid in January of this year, it may well be an indication that the food sovereignty movement is conquering terrain. In the final declaration of the farmers' and civil society organizations, they state that:
"We see the proposed Global Partnership as just another move to give the big corporations and their foundations a formal place at the table, despite all the rhetoric about the 'inclusiveness' of this initiative. Furthermore it legitimates the participation of WTO, World Bank and IMF and other neoliberalism-promoting institutions in the solution of the very problems they have caused. This undermines any possibility for civil society or governments from the Global South to play any significant role. We do not need this Global Partnership or any other structure outside the UN system."[24]
After all, until a few decades ago, it was primarily the small farmers of this world who sustained us all with their hard work in the field.
Footnotes:
[1] "The Cordoba process was started at an international seminar on the right to food at CEHAP [Chair of Studies on Hunger and Poverty], Cordoba October 2007, further pursued at the Right to Food Forum organised by the FAO Right to Food Unit in October 2008 and completed in its present version following a second meeting convened in Cordoba by CEHAP on November 28-29, 2008. It will be subject of further consultations and possible revisions during 2009." Source.
[2] Source.
[3] FAO 1974
[4] See here.
[5] Sen, Amartya (1981): "Poverty and Famines: An Essay on Entitlements and Deprivation," Claredon Press, Oxford.
[6] Dominique Guillet, Association Kokopelli.
[7] Diamond v. Chakrabarty, 447 US 303 (1980)
[8] See here.
[9] For a brief history of the seed industry, see here and here.
[10] The ETC Group, an international advocacy organization based in Canada, has been monitoring corporate power in the industrial life sciences for the past 30 years, revealed this in a report in November 2008 that can be downloaded here.
[11] General Agreement on Tariffs and Trade, 1947. A tariff is a tax on goods upon importation.
[12] See here.
[13] See here.
[14] United Nations Development Programme (UNDP) Human Development Report 2005, p.129 vv.
[15] UNDP Human Development Report 2005, chapter 4.
[16] See here.
[17] Raj Patel in "Stuffed and Starved" (2007), London Portobello Books, describes this process in detail.
[18] GRAIN, "Stop the Agrofuel Craze."
[19] Fourth Special Session of the Committee on Agriculture (2000).
[20] Jonas Vanruesel, 2008. "Food as a human right: a struggle for human dignity and food sovereignty" in Omertaa Volume 2008/2.
[21] See here.
[22] A concise summary of the principles of food sovereignty can be found on the site of the organization for the defense of family farms in the USA.
[23] See here and here.
[24] Final declaration of farmers and civil society organizations.

Wednesday, August 11, 2010

Who Owns You?

20% of the Genes in Your Body are Patented
August 11th, 2010 by Drew Halley
Here’s a disconcerting thought: for the past thirty years, genes have been patentable. And we’re not just talking genetically modified corn – your genes, pretty much as they exist in your body, can and have been patented. The US government reports over three million gene patent applications have been filed so far; over 40,000 patents are held on sections of the human genome, covering roughly 20% of our genes.

Upset? You’re not alone. Critics argue that the patents stifle potential research into disease, keep new treatments off the market, and bring in serious money to Big Pharma – all by exercising property claims that shouldn’t exist. After all, genes aren’t inventions, which are patentable – they’re discoveries, which aren’t. As Luigi Palombi noted recently at the Open Science Summit, “You can’t patent Mount Everest; why can you patent a gene?” Here, we review the history of genetic law, the current state of affairs, and interview David Koepsell, an attorney and author of a recent book on gene patenting, Who Owns You?  The Corporate Gold Rush To Patent Your Genes.


The ACLU has been waging a legal war against gene patenting, and some forward progress has been made. A few months back, a major (and unexpected) victory against gene patenting came when a district judge struck down patent claims by Myriad Genetics. Back in 1998, Myriad patented several genes of the BRCA family; mutations along these genes increase susceptibility to breast and ovarian cancer. The patents gave Myriad proprietary rights over diagnostic tests for the mutations – tests they sold for over $3,000 each.


On March 29, 2010, District Judge Robert W. Sweet invalidated seven of the BRCA patents owned by Myriad. The decision shocked supporters and critics alike, and Myriad has appealed the decision. What remains to be seen is whether it will reach and survive a federal court, and thereby become precedent to strike down further gene patents owned by biotech companies.


So how are genes patentable in the first place? Parts of your body have actually been patented for over a century. Adrenalin was patented in 1906; insulin was patented in 1923. The argument for chemical patents was basically that isolated and purified forms of the naturally occurring molecules are more medically valuable than the forms floating around in your bloodstream. A comparable logic is what allows the FDA to outlaw DMT – a chemical also produced within your body, but which acts as a powerful hallucinogenic in its concentrated form.


But gene patents got their big start in 1980 in the case of Diamond v. Chakrabarty. A GE engineer developed a bacterium capable of breaking down crude oil, and filed a patent for it. After a series of rulings and appeals, the case landed in the Supreme Court. On June 16, 1980, the court ruled in GE’s favor, and the first living organism was patented in the United States. The key distinction in the Diamond case was that the bacterium was man-made, and therefore constituted an invention.


Human gene patenting works on the logic that if a patent applicant has “isolated and purified” genetic material, it constitutes an invention on their part – even if the strand is identical to the DNA sequence found in nature. Proponents of gene patenting (i.e. generally, the companies or their patent lawyers) argue that patent protection is essential to retaining strong investment in genetic research, which speeds up progress in the field.  It’s true that patents are important to the biomedical industry’s ability to attract capital – Myriad stock took a nose dive after the Supreme Count shot down their BRCA patents.  But the claim that a world without gene patents would stifle genetic research (or even make it unprofitable) seems overstated at best, and disingenuous at worst.


For years, the logic of purification and isolation has held up legally as a justification for human gene patenting – that’s what made the Myriad case such a landmark decision.  We recently interviewed Dr. David Koepsell, both a J.D. and a Ph.D. in Philosophy, about the fallout fromMyriad, the ethics of gene patenting, and intellectual property. Koepsell is an author and educator whose work centers on how ethics and public policy are shaped in emerging science and technology. His book Who Owns You? is currently being adapted into a documentary film, including interviews with experts like James Watson and Tim Hubbard. Check out the preview:





Dr. David Koepsell, author of Who Owns You?


Q: After the Myriad case, a large number of commentators reported being surprised at the outcome. I saw headlines with adjectives like “jaw-dropping” and “shocking”. Can you give us an idea of why the outcome was so unexpected?

It was surprising to people like me because we didn’t expect the court to do the right thing. The courts have been making the wrong decision on isolated and purified genes now for some time – for decades. Ever since the case in which the Supreme Court said purified and isolated adrenalin was patentable. So the Patent and Trademark Office (PTO) has been granting patents pretty routinely to isolated and purified chemical compounds, as well as isolated and “purified” (I use that term loosely) genetic sequences. So it was really quite surprising, and for me heartening, that the court in this case (a district court) saw through this notion of isolation and purification as somehow warranting a product claim.

For a lot of the patent community, it was jaw-dropping because suddenly somebody punctured the balloon, and basically said the party’s over if that becomes the law of the land. Of course, as we know, the PTO is not going to enforce this district court’s decision, and they are under no obligation to. It’ll take a long time before it makes its way up to the Supreme Court and is upheld, and there’s a fair amount of question whether that will happen.

Q: What do you expect to come of the Myriad results? Will that case set a precedent for dismantling other genetic patents?

I’ve already seen a lot of Intellectual Property (IP) professionals recommending workarounds. Instead of trying to patent the isolated genes, they’re suggesting more utility claims or process claims, which is good. One of the problems with the precedent in gene patenting is that you’ve had what I call a gold rush. It’s like a land rush: you basically squat on a territory and wait for someone to come along to make it worthwhile for you to sell it. That’s not really pro-innovative. And new drugs haven’t been developed for the most part as a result of these claims.

Recently, somebody developed a very promising vaccine that is going to go into human trials for breast cancer. That vaccine was developed with public funds, not with a patent on the breast cancer genes but despite it. Meanwhile, Myriad is making 300 million in profits per year off their breast cancer gene patent and they haven’t used it. The amount of money that went into this vaccine was only 1.5 million. Myriad could have taken a very small portion of their exorbitant profits and put it into research to develop a vaccine. But there’s no incentive in this land claim on the gene for them to do so. They can make much more money simply reaping this monopolistic pricing over the diagnostic test without having to do any beneficial research into making new drugs.

I think this case will hopefully compel a lot more investigation into real cures and treatments, and less of this sort of squatting. Even if it doesn’t go on to become precedent, if it isn’t upheld later. I think it is sort of a warning shot across the bow. You’re better off trying to come up with something useful and make new products as opposed to simply squatting on these sequences.

Q: It also seems like it’s brought genetic patenting into the public consciousness.

It has, yes. Most people I talk to still don’t understand it, and don’t know what’s going on. But there is certainly a lot more awareness, especially in the breast cancer community, which is a significant community, about what patents are on these genes and how they’re affecting research and the cost of their treatments.

Q: How do you feel about patenting synthetic life forms – wholly man-made genomes?

I wrote in my book [Who Owns You?] that that’s a legitimate thing to do. The point of patents is that if you create something new that doesn’t otherwise exist in nature, you’ve invented something. The patent system is set up to reward that sort of thing. On the other hand, if you grant those patents too far upstream – and this is a practical consideration – you really can impede innovation. So while I think it’s legally legitimate to get patents on synthetic genes, genes that don’t otherwise exist, I think it’s really imperative to have some sort of practical limit beyond which we don’t patent. You’re not going to want somebody to have a patent on a codon. That’s too far upstream, obviously. So how far downstream is it legitimate?

I think the industry has to figure out where it makes sense for them to draw a line. I think groups like the Biobricks Foundation, who are trying to build these standard parts, are doing the right thing. A repository of standard parts that is in the public domain makes sense from an engineering standpoint. If these tiny little parts can be put together in new ways that are inventive, and you get a patent on that final product, you leave open the possibility for innovators to play around with those parts. I think Biobricks is an excellent example of how the industry is heading off the problem with patenting that can develop if patent attorneys have their way.

Q: Defendants of genetic patents argue that without strong patent protection, capital investment will dry up and research progress will slow. I imagine you disagree – why?

I completely disagree. Especially in pharmaceuticals (and that’s what they’re talking about) the patent system is encouraging people to shoot for blockbusters. Those are the patents that are going to make you a lot of money, and increase your share price. So these blockbuster drugs are costing hundreds of millions of dollars, and most of that is not in R&D. Most of it comes in the marketing. There’s no evidence that they couldn’t develop useful, marketable drugs if they concentrated less on blockbusters, and more on drugs that fill a useful niche in the medical market. Instead, because the value of IP portfolios to corporations, we’re encouraging a very narrow search for baldness cures, ED drugs, etc. – drugs that are going to be marketable to a wide swath of the public instead of people who are suffering from a certain medical condition.

And in fact, history shows this is true. Aspirin is a very profitable drug, even though it went off patent long ago. There are millions of drugs whose the patents have expired that are still profitable, that have well made up for the investment in their R&D. There were actually periods of time in places like Europe, up until the mid-70’s, where you couldn’t get a patent on a chemical product itself. The pharmaceutical companies were making money, magically enough, by making drugs that served a market niche that people bought. The market demand drove the price instead of a monopolistic price structure. The evidence doesn’t bear out that contention [that gene patents are necessary to development] and I trust the free market to be able to come up with solutions.

Q: Where do you see genetic research going over the next few decades?

I personally think synthetic biology is going to be the next big field. Nanotech seems interesting, but there’s so many technical hurdles involved that I think everybody’s realizing you’ve got to use some of nature’s own innovative store of nanotechnology, and use them to do the sort of things we wanted to do with nanotech. Cataloguing the storehouse of usable biological parts and functions is going to be a huge scientific venture for the next ten years or so. Moving that into some innovative new products is where a lot of investment is going to be put, and where we’re going to see some of the promises we held in store for nanotechnology at one time.