The Monsanto Decision: the Edge Or the Wedge

PATENTS

The Monsanto decision: The edge or the wedge

Left out of almost all reporting on the Canadian Federal Court’s recent ruling in Monsanto v. Schmeiser were the implications of the decision on patenting plants—something that Canada has not permitted. E. Richard Gold and Wendy A. Adams

he Federal Court of Canada’s decision in product at a lower cost, given that he would cells, Canadian patent office policy would TMonsanto Company v. Percy Schmeiser not have to recoup any investment in not have permitted this. (reported last month1) has potentially far- research and development. With patent pro- The implications of this decision go far reaching and disturbing implications. tection, the inventor is given the exclusive beyond agriculture. Although Canada has Intellectual property protection for biotech- right to build the better mousetrap. been liberal in granting patents over genes nological innovation has been granted with Customers may indeed sell the mousetraps and cells whether of plant, animal, or human the tacit understanding that whereas corpo- they have purchased, but unless they receive origin, the Canadian patent system is only rations may acquire patents for genes and permission from the inventor, they are not now coming to grips with the issue of processes using genes—for example, genetic allowed to start up rival production facilities. whether whole plants and animals are sub- testing for breast cancer—the scope of pro- ject to patent law. The issue may soon reach tection does not extend to the plants and the Supreme Court of Canada if leave to animals in which patented genes are insert- appeal is granted from the decision of the ed. The Federal Court’s decision allows Federal Court of Appeal of August 2000, Monsanto to do indirectly what Canadian with respect the so-called Harvard onco- patent law has not allowed them to do mouse, which was genetically engineered to directly: namely, to acquire patent protec- be susceptible to cancer. tion over whole plants. The distinction between genes and cells Monsanto, through genetic engineering, on the one hand and whole plants, animals, has produced a strain of canola resistant to and humans on the other has been the sub- Monsanto’s herbicide marketed under the ject of fierce debate among biotechnology name Roundup. The purported advantage to companies, environmental groups, acade- herbicide-resistant “Roundup Ready” canola mics, researchers, and government represen- is that Roundup herbicide can be sprayed tatives. In fact, the Canadian Biotechnology © http://biotech.nature.com Group 2001 Nature Publishing liberally after the crop has emerged, killing Advisory Committee has recently held off all other plant life but leaving the canola roundtable discussions across Canada with

untouched. Monsanto claims that this pro- Canola Council of Canada representatives from industry, nongovern- cedure offers significant cost savings over mental agencies, and governments on the more traditional methods of cultivation. patenting of higher life forms. The commit- In 1993, Monsanto was issued a Canadian tee is seeking input from stakeholders and patent for the genetically engineered gene members of the public in order to formulate and cells containing those genes. Monsanto recommendations to be delivered to the fed- does not sell its genetically modified seeds. Canola seed being loaded for delivery to a farm eral government this summer. The Monsanto Instead, it has developed licensing arrange- east of Winnipeg, Manitoba. decision preempts this debate, because it ments whereby farmers, in exchange for a effectively grants a patent holder rights in licensing fee and other commitments, are not only a gene, but in the whole life form. permitted to use the seed for planting one In relation to inventions resulting from Other legal tools were available to protect crop only. Seeds resulting from this crop, genetic modifications, it is important to note Monsanto’s commercial interests without however, cannot be used for replanting in the difference between an inventor’s exclu- needing to push patent law in this direction. subsequent years. sive right to the blueprint for a better mouse- Following the reasoning of the decision to As the well-known adage would have it, trap, and building a better mouse. The prin- its logical conclusion, we believe that we build a better mousetrap and the world will cipal distinction between traditional patent- have reason to be concerned. Read literally, beat a path to your door. Without patent pro- ed technologies and the products of biotech- the decision means that by the simple act of tection, however, the deserving inventor nological innovation is the capacity for reproduction, patients treated with germline would not necessarily receive a steady flow of progeny. A mousetrap cannot replicate itself, gene therapy could be liable for patent traffic. The first customer to buy the better but a canola plant can. Any plant containing infringement. The fact that germline gene mousetrap would be free to duplicate the Monsanto’s genetic modification, regardless therapy is very much fraught with ethical process in his own workshop. He would of whether generated through insertion problems and echoes of eugenics at the probably be able to turn around and offer the directly into the DNA of canola cells or moment suggests that this is unlikely to through natural means, is now subject to occur in practice any time soon; however, the Monsanto’s intellectual property rights. Had possibilities signal that the decision in the E. Richard Gold and Wendy A. Adams are Monsanto attempted from the outset, how- Monsanto case leaves much to be desired. assistant professors on the faculty of law at the ever, to acquire patent protection for the University of Western Ontario, London, ON, genetically modified whole plant itself, Canada N6A 3K7 ([email protected]). instead of merely the modified gene and 1. Fox, J.L. Nat. Biotechnol. 19, 396–397 (2001).

http://biotech.nature.com • JUNE 2001 • VOLUME 19 • nature biotechnology 587