Lawyers debate a European court decision on patents involving genetic material.
Richard Van Noorden
A decision by the European Court of Justice on a DNA patent held by global seed company Monsanto has caused a stir in the biotechnology industry, with concerns that the ruling could limit the protection companies enjoy on their European patents. Nature explains more.
What is the judgment all about?
Since 1996, Monsanto has held a European patent on genes that give soya beans resistance to the company's Roundup herbicide — specifically the active ingredient glyphosate. But the firm has not managed to obtain a patent in Argentina, where soya-bean crops (known as Roundup Ready) expressing the glyphosate-resistance genes can be cultivated without a licensing agreement. Argentinian growers are exporting soya meal — harvested and processed from these crops — to Europe, especially the Netherlands.
A ruling on Monsanto's Roundup Ready soya could have wider repercussions for the biotechnology industry.
In an attempt to recoup payments it has not yet managed to get from Argentinian growers, Monsanto had sued importers such as Cefetra, based in Rotterdam, the Netherlands, to try to prevent this practice, claiming that the imported soya meal contained the DNA sequence that it had patent protection for in Europe.
The European Court of Justice — Europe's top court, based in Luxembourg — ruled on 6 July that Monsanto couldn't bar imports of the soya meal. It argued that citing the fact that the DNA in the soya meal was not performing the function for which Monsanto had gained patent protection in the first place.
Why does it matter?
The decision reflects a wider question about the scope and strength of DNA patents: how easy is it to infringe a European patent on genetic material? The court said that such a patent can be enforced only when the DNA is performing the function for which it was originally patented — known as purpose-bound protection.
The ruling is being viewed as the first test of the European Union's biotechnology directive, passed in 1998, which set down policy on what kind of genetic material was patentable, and on what protection that patent enjoyed. Lawyers disagree about the wider impact of the court ruling, but some feel that it will restrict the scope of European patents on DNA.
Is the decision a surprise?
Not really. Monsanto were hoping for a broad interpretation of the biotechnology directive, which says: "The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material ... in which the product in [sic] incorporated and in which the genetic information is contained and performs its function."
Patent lawyer Devanand Crease, who works at the London-based law partnership Keltie, says that most people would have interpreted this wording as narrowly as the European court has done. "Continental Europe, especially France, really favours purpose-bound limitations, whereas the UK has as yet resisted," he says.
Indeed, Monsanto had already withdrawn its complaint against Cefetra after an undisclosed out-of-court settlement in June, following a preliminary opinion on the case from one member of the European Court of Justice.
Still, the court continued with its final ruling in order to clarify and harmonize decisions on purpose-bound patent protection across the European Union — and to remove any doubts within the biotech industry.
What wider impact will this decision have?
It "marks a significant restriction on the powers biotech companies can wield with their patents", says Jonathan Radcliffe of UK law firm Nabarro in London. Although lawyers will have to be careful about how they file patents for products containing genetic material, most contacted by Nature feel that the ruling will probably not dampen innovation or investment in the European biotech industry as a whole. If anything, notes Radcliffe, the court decision shows that DNA patents are acceptable in Europe, even if their scope is quite narrow.
"There will be a number of patentees nervously casting an eye over the other independent claims of their patents in order to gauge the degree of protection that remains for their invention," says Gareth Morgan of London legal firm DLA Piper. He thinks that diagnostic firms and other agribusiness companies might be affected if they cannot gain patents in some countries, as Monsanto have failed to do in Argentina.
However, most patents incorporate other legal claims that could be used to enforce protection on products containing genetic material — without resorting solely to claims over DNA sequences as Monsanto had to do, notes Martin MacLean of intellectual-property lawyers Mathys and Squire in London.
The court decision also highlights existing uncertainties in the biotechnology directive, such as its hazy definition of 'genetic material', and whether the DNA's 'function' is the production of a particular protein (with all its uses), or a specific use of that protein. The ruling might push these uncertainties higher up lawyers' agendas, notes Radcliffe.
As for the wider impacts on Monsanto, the company stated that overall patent protection of the company's Roundup Ready soya bean was not at issue, and that it is continuing to work in Argentina "for a fair and equitable solution".
GMO grapevines destroyed (AFP)
