Monsanto’s patent rights on its Roundup Ready soybeans have been restricted in Europe
On 6th July, a little-noticed ruling by the highest court in Europe delivered a major blow to the ambitions of agricultural giant Monsanto. The company was attempting to claim ownership of crop products bearing traces of its patented DNA sequence. The judgment represents a legal landmark because it limits what can be claimed by biotechnology companies holding patents on stretches of genetic material. In the words of one patent lawyer, a “wild west-style landgrab in the DNA landscape” has been averted. The story begins in Argentina, the world’s third-biggest soybean market (after the US and Brazil). The vast majority of soybeans grown there are the “Roundup Ready” variety produced by Monsanto. This is a transgenic crop—one that has had its DNA tinkered with, in this case to make it resistant to the Roundup Ready herbicide (also produced by Monsanto). The company has been supplying Argentinian farmers with the soybean seeds in the hope of securing patent protection and collecting royalties on its use, as happens in Brazil, but talks on a financial agreement with Argentina’s government have stalled. Monsanto does, however, enjoy patent protection in Europe, where much of the Argentine soybean crop ends up (some of Europe’s cattle are fed on processed Argentine soybean meal). So, frustrated by the negotiations in Argentina, Monsanto decided to lay in wait at the European border. When the Dutch animal feed company Cefetra imported a batch of processed soy meal from Argentina, Monsanto sued Cefetra for infringing its European patents. Even though the case was settled out of court on 5th July—under undisclosed terms—the European Court of Justice in Luxembourg delivered its clarification on whether Monsanto’s action was justified. And when that clarification came, it was emphatically not in Monsanto’s favour. The reason? In the imported meal, the DNA sequence was no longer serving its purpose: it was not conferring herbicide resistance, therefore Monsanto could not claim its patent had been infringed. In the words of the nine judges involved, the legal protection provided by gene patents must be “purpose-bound.” This means companies like Monsanto cannot now claim blanket ownership of specific gene sequences without regard to what function they perform in a product. The ruling, which is binding across all 27 EU member states and cannot be appealed, “sends out a very strong signal to players who seek to use patents to control the use of biotechnology,” says Jonathan Radcliffe, an intellectual property lawyer at the British firm Nabarro. Vitally, it stops corporations planting flags in sections of plant genomes and announcing that other products incorporating these gene stretches are off-limits. But it still allows companies to protect and benefit from the fruits of their research. The winners in this case, Radcliffe says, are consumers, who are no longer at risk of having the entire food supply controlled by biotech companies through patents. Of course, “flag-planting” goes on in the human genome as well—and there are signs that legal opinion is turning away from patents tied to human genes, too. In March, a district judge in Washington, DC invalidated patents relating to two genes for breast and ovarian cancer held by Myriad Genetics, which had been selling a single test for both for around $3,000. The legal challenge came from a coalition of patient groups, individual patients, legal scholars and the American Civil Liberties Union, who argued that the patents allowed Myriad to charge an inflated price. Myriad had asserted that its method of isolating the relevant DNA was patentable. But the judge regarded the company’s claim as a land-grab: an attempt to assert rights over something in nature (a discovery, as opposed to an invention, is not patentable). Myriad has appealed; the case may well end up at the supreme court. So where now? Around 20 per cent of the human genome is subject to patents, many granted in the heady era of the 1980s and 1990s, when biotechnology was going to change the world and cure diseases. Now that those cures are largely failing to materialise, it’s high time that regulators rip out some of those speculative flags and encourage more productive exploration.
On 6th July, a little-noticed ruling by the highest court in Europe delivered a major blow to the ambitions of agricultural giant Monsanto. The company was attempting to claim ownership of crop products bearing traces of its patented DNA sequence. The judgment represents a legal landmark because it limits what can be claimed by biotechnology companies holding patents on stretches of genetic material. In the words of one patent lawyer, a “wild west-style landgrab in the DNA landscape” has been averted. The story begins in Argentina, the world’s third-biggest soybean market (after the US and Brazil). The vast majority of soybeans grown there are the “Roundup Ready” variety produced by Monsanto. This is a transgenic crop—one that has had its DNA tinkered with, in this case to make it resistant to the Roundup Ready herbicide (also produced by Monsanto). The company has been supplying Argentinian farmers with the soybean seeds in the hope of securing patent protection and collecting royalties on its use, as happens in Brazil, but talks on a financial agreement with Argentina’s government have stalled. Monsanto does, however, enjoy patent protection in Europe, where much of the Argentine soybean crop ends up (some of Europe’s cattle are fed on processed Argentine soybean meal). So, frustrated by the negotiations in Argentina, Monsanto decided to lay in wait at the European border. When the Dutch animal feed company Cefetra imported a batch of processed soy meal from Argentina, Monsanto sued Cefetra for infringing its European patents. Even though the case was settled out of court on 5th July—under undisclosed terms—the European Court of Justice in Luxembourg delivered its clarification on whether Monsanto’s action was justified. And when that clarification came, it was emphatically not in Monsanto’s favour. The reason? In the imported meal, the DNA sequence was no longer serving its purpose: it was not conferring herbicide resistance, therefore Monsanto could not claim its patent had been infringed. In the words of the nine judges involved, the legal protection provided by gene patents must be “purpose-bound.” This means companies like Monsanto cannot now claim blanket ownership of specific gene sequences without regard to what function they perform in a product. The ruling, which is binding across all 27 EU member states and cannot be appealed, “sends out a very strong signal to players who seek to use patents to control the use of biotechnology,” says Jonathan Radcliffe, an intellectual property lawyer at the British firm Nabarro. Vitally, it stops corporations planting flags in sections of plant genomes and announcing that other products incorporating these gene stretches are off-limits. But it still allows companies to protect and benefit from the fruits of their research. The winners in this case, Radcliffe says, are consumers, who are no longer at risk of having the entire food supply controlled by biotech companies through patents. Of course, “flag-planting” goes on in the human genome as well—and there are signs that legal opinion is turning away from patents tied to human genes, too. In March, a district judge in Washington, DC invalidated patents relating to two genes for breast and ovarian cancer held by Myriad Genetics, which had been selling a single test for both for around $3,000. The legal challenge came from a coalition of patient groups, individual patients, legal scholars and the American Civil Liberties Union, who argued that the patents allowed Myriad to charge an inflated price. Myriad had asserted that its method of isolating the relevant DNA was patentable. But the judge regarded the company’s claim as a land-grab: an attempt to assert rights over something in nature (a discovery, as opposed to an invention, is not patentable). Myriad has appealed; the case may well end up at the supreme court. So where now? Around 20 per cent of the human genome is subject to patents, many granted in the heady era of the 1980s and 1990s, when biotechnology was going to change the world and cure diseases. Now that those cures are largely failing to materialise, it’s high time that regulators rip out some of those speculative flags and encourage more productive exploration.
