The question of whether genetic material can or should be patented by pharmaceutical companies is being tested in courts both in the U.S. and overseas.
On Monday, the U.S. Supreme Court heard an appeal by the American Civil Liberties Union and the Public Patent Foundation against Myriad Genetics Inc., a Utah-based private biotechnology company that holds patents on the BRCA1 and BRCA2 genes, two genetic mutations associated with breast and ovarian cancer.
The case pits groups that want freer access to gene mutations against companies who argue that they need patent protection to recoup research and development costs.
According to Myriad’s website, approximately 7 percent of breast cancer cases and up to 15 percent of ovarian cancer cases are caused by mutations in the BRCA1 and BRCA2 genes. It says people with mutations of either gene have “risks of up to 87 percent for breast cancer and up to 44 percent for ovarian cancer by age 70.” The company’s $3,340 BRACAnalysis test identifies the mutations.
The Supreme Court decision is expected by June, and Credit Suisse analysts have said other firms would quickly enter the market if the company loses patent protection, forcing Myriad to lower prices.
“The frustration that many in the medical community have toward the way (Myriad) has profited from its BRCA patents should not be underestimated when they are given an opportunity to help find an alternative to using (Myriad) for their BRCA tests going forward,” Credit Suisse analysts Vamil Divan and Jeremy Joseph wrote in a note entitled “Assessing How SCOTUS May Move MYGN.”
Under U.S. law, a DNA sequence can be considered for patenting by the U.S. Patent and Trademark Office if the patentee alters its environment or structure. Myriad’s patents were approved because the BRCA genes were isolated from their natural environment, giving Myriad the right to prevent anyone else from testing, studying or even looking at the genes.
The American Civil Liberties Union (ACLU), which represents the Association for Molecular Pathology, argues that patents on human genes violate the First Amendment and U.S. patent law because genes are “products of nature” and therefore can’t be patented.
“By patenting the genes, Myriad obtained the rights to exclude all other medical and scientific work on the genes,” ACLU attorney Sandra Park told The Financialist. “It enforced its patents to create a monopoly on BRCA genetic testing offered to patients. It therefore faces no competition for its genetic testing services, even when other laboratories could provide testing that is more comprehensive or lower-priced.”
Myriad declined to comment, but argued on its blog that patent protection encourages innovation. In its most recent quarterly earnings report, Myriad said revenue from the BRACAnalysis test, which represented 74 percent of the company’s total quarterly revenue, was $110.3 million, a 9 percent increase over the same period of the prior year.
“Without the patents, our work would not have been possible,” the company said. “We would not have been able to raise the funds necessary to decode the genes, design and deliver the tests, interpret the results, and help patients.”
“We did not patent the genes in your body, and neither does any other company,” it continued. “Instead, we patented synthetic molecules based on the genes that were created in the lab in order to deliver life-saving tests to patients.”
In February, Australian Federal Court Justice John Nicholas dismissed a 2010 lawsuit brought by advocacy group Cancer Voices Australia and breast cancer patient Yvonne D’Arcy against Melbourne-based Myriad and Genetic Technologies, which has exclusive rights to the testing in Australia and New Zealand. The plaintiffs attempted to block the companies’ Australian patent, which covers mutations of BRCA1. No Australian court had ever been asked to consider the question of whether isolated human genes are patentable, and Justice Nicholas decided that the process of isolating the BRCA1 gene for testing constitutes a patentable action. But in his ruling, Nicholas said there was “no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent.”
The ruling means that in Australia, only Myriad can continue carrying out tests with the gene mutation. Genetic Technologies is not currently enforcing its ownership rights under patent laws, though it could at any time, potentially halting medical research and testing in Australia.
Lawyer Rebecca Gilsenan, who represented Cancer Voices Australia and D’Arcy, has said her clients would appeal. That appeal is likely to be heard later this month.
The ACLU contends that unless gene patents are overturned, scientists at universities, laboratories, and biotechnology companies will continue to face difficulty developing new tests, drugs and other information based on genetic information and sequencing.
“Genetic tests currently exist to screen the multiple genes now associated with breast and ovarian cancer, but these clinical tests cannot include the BRCA genes because geneticists would be legally liable,” Park said. “Scientists are aware of which genes are patented and choose not to pursue research on those genes for fear of patent liability. Moreover, gene patents allow a single laboratory to use its patents to control most of the data about a gene.”
Steven L. Salzberg, Professor of Medicine, Biostatistics, and Computer Science at
Johns Hopkins University, told The Financialist the argument that isolating DNA means it’s somehow different is a “very unscientific argument.”
Salzberg said there are patents on thousands of human genes already, but only a few have such a significant influence on the chance of developing cancer.
“The outcome of this case might see a whole lot of companies come out and enforce [their patents],” said Salzberg.
Corporations have been given the power to own seeds. And they are eliminating competing varieties and crowning their own patented seeds as the only choice in the marketplace.
Seeds. They seem like such a small thing when compared to the big, complex problems the world is facing — climate change, poverty, war, famine, peak oil and an exploding population. They’re so small, in fact, that most will fit easily under your thumb.
But stop and think again. Without those tiny grains, what would be left on Earth?
Seeds are the bedrock of our food chain, the basic element of our sustenance. If they were to disappear tomorrow, we would follow them into oblivion with lightning speed. And, the most pressing issue people are often unaware of is that they are currently under grave and direct threats.
Sounds ominous, huh? Wondering why? Well, the answer is two-fold. First, we have witnessed a staggering loss of genetic diversity. In the past century, world agriculture has lost 75% of its genetic diversity to globalization, standardization and monoculture farming; 95% of the tomato varieties that existed in 1909 have become extinct; 91% of corn – gone. In addition, 95% of the cabbage varieties your great-great grandma grew have been consigned to oblivion. And though this may not seem on the surface to be a big deal, in reality it could mean the difference between full bellies and famine.
Genetic diversity in the food plants we grow is more than just the number of tomatoes listed in your favorite seed catalog. Diversity ensures that there are sufficient, genetically diverse and well-adapted varieties of any given plant to respond to any given situation. When a crisis arises, such as a new fungal disease or a severe drought, diverse genetics ensure that some varieties will naturally have genes that enable them to resist the threat and grow on, passing their genetic strengths on to the next generation. Without that diversity, with a significantly narrower gene pool to draw upon, crops and plants become susceptible to complete annihilation when these new threats arise. Such a disaster is not unprecedented.
The Irish Potato Famine of the 1840’s had such a devastating effect on Ireland’s population not only because they depended so heavily upon that one crop, but because they relied on only one variety. When the fungus hit, the one variety in wide cultivation was extremely susceptible and the mainstay of the Irish diet was destroyed within two seasons. Even as recently as the United States corn blight of the 1970’s, when 80% of American corn was of a similar genetic heritage and some 10 million acres of the crop were lost in a single season, we have seen the perils of lack of diversity.
The second threat to our seeds comes from industrial agriculture’s relative recent access to patents, as well as genetically modified organisms and seed company acquisitions, resulting in significant industry consolidation. Understanding this requires just a little micro-course in plant patent history (For a more complete history, check out the three-part series at Cooking Up A Story). In 1930, the Plant Patent Act was passed, which allowed plant breeders, a relatively new profession, to patent a single, specific plant that they had bred themselves. Patents were limited to only that specific plant and any asexual propagations of said plant. Seeds, as the result of sexual reproduction, were specifically barred from patent. Fast-forward to 1970 and the passage of the Plant Variety Protection Act. This legislation gave plant breeders the right to patent an entire variety of genetically similar plants, as well as their seeds and all subsequent generations. Fast-forward again, this time to 1980. The United States Supreme Court decision of Diamond v. Chakrabarty, a 5-4 split decision, gave individuals, and corporations acting as individuals, the right to a utility patent for laboratory engineered organisms, including seeds, under the 1952 Patent Act. Yes, that’s a bunch of gobblety-gook.
Several years ago, I began to learn about what I would come to regard as one of the great crimes in human history, whereby millions of people in Africa and elsewhere were cynically allowed to die of Aids, while western governments and pharmaceutical companies blocked access to available low-cost medication. The outrage I felt as I discovered the details of this story was exceeded only by a deep sense of betrayal mixed with shame for not having known more about it in the first place.
Today, I find those feelings mirrored in audiences who see my film, Fire in the Blood, which, incredibly, is the first comprehensive account of this horrendous atrocity and how it was eventually halted. As anyone who knows anything about pharmaceuticals will tell you, the name of the game is monopoly. In the case of medicine, monopolies emanate from patents. Typically a patent lasts for 20 years, but drug companies are expert at getting them extended. As long as the monopoly is in place, the company selling the drug can essentially charge whatever they want for it. Pricing is unrelated either to the cost of production (normally a few pennies per pill) or how much was spent in development, but a simple calculation of how to maximise revenue. Though most western countries do have price controls, these typically only keep price levels consistent with other comparable countries, so restraints are minimal.
Why does society accept this? The narrative the industry has been immensely successful in selling is that it spends vast sums of money on research and development, that this R&D is very high risk, and that monopolies and high prices are a “necessary evil” needed to finance innovation of new medicines. These arguments do not hold up under scrutiny. 84% of worldwide funding for drug discovery research comes from government and public sources, against just 12% from pharma companies, which on average spend 19 times more on marketing than they do on basic research (paywalled link). When we screened our film at the Sundance festival last month, audiences were dismayed to learn how much of their tax money goes to discover medicines which are then sold back to them at monopoly prices nearly half of all Americans surveyed say they have trouble affording.
In developing countries, where people typically pay for medicines out of pocket, the situation is far worse. Pharmaceutical company representatives have told me that in (relatively prosperous) South Africa, they price their products for the top 5% of the market, while in India their customer base might be just the top 1.5%. The rest of the population is of no interest. At the same time, drug companies are working tooth-and-nail to cut off supplies of lower-cost generic drugs originating in countries such as India, Brazil and Thailand, to make sure that they don’t miss out on a single customer who could possibly pay their sky-high prices.
At the industry’s behest, governments in the US and Europe use a dizzying variety of trade mechanisms, threats of sanctions and so on to curtail supplies of affordable medicine in the global south. The potential impact of these measures in human terms is nothing less than cataclysmic. As Peter Mugyenyi, director of Africa’s largest Aids treatment centre says: “We are on standby awaiting another bloodbath.”
To any suggestion that the prevailing system of monopolies on medicine is hugely inefficient, immoral and unsustainable, industry apologists contend that “it’s tried and tested”, whereas any proposed alternative would represent a massive gamble. This, again, is totally disingenuous. A vital first step is to raise the bar for granting patents: 90% of drug patents have no meaningful clinical advantages for patients, but nonetheless impede access.
More significantly, for 70 years Canada had a system prohibiting monopolies on medicine, where patent holders received a statutory royalty on sales of generic equivalents. This maintained profit incentives for innovation, while ensuring the public was not held to ransom by monopoly pricing (it did not, however, produce the windfall profits to which the industry is addicted – so US trade negotiators had it killed under Nafta).
This year may well be a tipping point. Relentless pressure is being applied to poor countries by western governments determined to strangle supplies of lower-cost medication relied upon by the vast majority of the world’s people who will never be able to afford branded drugs, and the outlook for access to medicine in the global south grows bleaker by the day. As unthinkable as it may seem, the horror that saw millions of people die unnecessarily of HIV/Aids while being denied safe and effective generic medicines produced at a fraction of the prices brand-name companies were charging, could be a mere taste of things to come.
On Tuesday, the U.S. Supreme Court will hear a 75-year-old soybean farmer’s appeal against biotech giant Monsanto, in a case that could permanently reshape the genetically modified (GM) crop industry. Victor “Hugh” Bowman has been battling the corporation since 2007, when Monsanto sued him for violating their patent protection by purchasing second-generation GM seeds from a grain elevator. An appeals court ruled in favor of Monsanto, and despite the Obama administration’s urging to let the decision stand, the nine justices will hear Bowman make his case today.
Monsanto is notorious among farmers for the company’s aggressive investigations and pursuit of farmers they believe have infringed on Monsanto’s patents. In the past 13 years, Monsanto has sued 410 farmers and 56 small farm businesses, almost always settling out of court (the few farmers that can afford to go to trial are always defeated). These farmers were usually sued for saving second-generation seeds for the next harvest — a basic farming practice rendered illegal because seeds generated by GM crops contain Monsanto’s patented genes.
Monsanto’s winning streak hinges on a controversial Supreme Court decision from 1981, which ruled on a 5-4 split that living organisms could be patented as private property. As a result of that decision, every new generation of GM seeds — and their self-replicating technology — is considered Monsanto’s property.
Unfortunately, second- and third-generation seeds are very hard to track, which may explain why Monsanto devotes $10 million a year and 75 staffers to investigating farmers for possible patent violations. Seeds are easily carried by birds or blown by the wind into fields of non-GM seeds, exposing farmers who have never bought seeds from Monsanto to lawsuits. Organic and conventional seeds are fast becoming extinct — 93 percent of soybeans, 88 percent of cotton, and 86 percent of corn in the US are grown from Monsanto’s patented seeds. A recent study discovered that at least half of the organic seeds in the US are contaminated with some genetically modified material.
Bowman’s appeal gives the Supreme Court an opportunity to determine whether or not Monsanto is using patent enforcement to control their monopoly on a vital resource. As GM seeds become more ubiquitous, farmers who want to avoid Monsanto’s strict patents have few alternatives. As a recently released Center for Food Safety report notes, the concentration of market power among Monsanto and a handful of other companies has led to skyrocketing seed prices and less innovation by smaller firms:
USDA data show that since the introduction of GE seed, the average cost of soybean seed to plant one acre has risen by a dramatic 325 percent, from $13.32 to $56.58. Similar trends exist for corn and cotton seeds: cotton seeds spiked 516 percent from 1995-2011 and corn seed costs rose 259 percent over the same period.
[…] USDA economists have found that seed industry consolidation has reduced research and likely resulted in fewer crop varieties on offer: “Those companies that survived seed industry consolidation appear to be sponsoring less research relative to the size of their individual markets than when more companies were involved… Also, fewer companies developing crops and marketing seeds may translate into fewer varieties offered.”
Furthermore, emerging evidence indicates that Monsanto has hardly perfected the technology. A core argument for GM seeds in the 1990s claimed they would reduce chemical pesticide use because the plants themselves would repel pests and weeds. But studies have confirmed the spread of so-called “superweeds” that have developed a resistance to Monsanto’s gene, leading farmers to deploy even heavier doses of herbicides like Monsanto’s own product, Roundup. Another new report debunked the company’s argument that GM seeds would have higher yields; in fact, two of Monsanto’s most popular genes caused yields to drop.
Despite the mounting evidence against their products, the biotech industry enjoys a cozy relationship with government regulators. In December, the Justice Department abruptly dropped their investigation into anti-competitive practices in the industry without so much as a press release. The stalled Farm Bill also contains generous provisions that would allow these companies to put their products on the market with cursory or no review by the USDA.
Today’s oral argument is a study in these intertwined interests: the Obama administration is presenting their own defense of Monsanto, and Supreme Court Justice Clarence Thomas was once a Monsanto lawyer (but will not recuse himself from Bowman’s case). Still, the same high court that enabled the current state of American agriculture in 1981 now finds itself in a position to check Monsanto’s power — or help them tighten their hold on the industry.