The Harvard Oncomouse Case

Backgrounder to Dec. 4/02 Media Release

Dec 04 2002

CELA intervened before the Supreme Court of Canada in this case together with Greenpeace, CAPE (Canadian Association of Physicians for the Environment, CIELAP (Canadian Institute of Environmental Law and Policy) and the Action Group on Erosions, Technology and Conservation (formerly RAFI). This is the precedent case in Canada regarding whether Canada will allow the patenting of higher life forms, in this case, a genetically-modified mammal. Harvard University applied for a patent on its GE mouse, modified to develop cancer to be used in research. Although the US grants patents on animals, Canada did not do so until Harvard obtained a decision in its favour from the Federal Court of Appeal. This decision was appealed to the Supreme Court. The Canadian Patent Office grants patents on single-cell life forms, including human cell lines and genes, but not on multicellular "higher" life forms. Unknown to many, Harvard obtained a patent on the mouse that it developed. Its patent also covered other non-human mammals ("from a shrew to a whale" including all primates) which it might theoretically modify in the same way in the future. In our intervention, CELA, Greenpeace, CIELAP, CAPE, and AGETC argued that the Court should not grant the patent, but rather, maintain the current practice in Canada of not patenting higher life forms. This is a matter that involves many important public issues, and a decision on whether or not to make this change in the law should only be made after a full public debate and examination of impacts and alternatives. Such a full examination is not possible in this legal proceeding. Parliament should conduct a review of the Patent Act. We made three public interest arguments to the Court:

  • that patents are increasingly causing barriers to the free and rapid dissemination of science research results, and to the development of drugs, diagnostic tests and treatments;
  • environmental and health risks arise from the biotechnological interventions that are the subject of these patents;
  • genetic resources are not equitably shared due to the exclusive property interest of holders of such patents.
We also argued that in making a decision whether or not to allow such patents in Canada, Parliament should also consider mechanisms to protect the public interest in patenting, such as:
  • Whether such patents are a spur or a deterrence to innovation in medical fields;
  • What the thresholds should be for novelty, inventiveness and utility;
  • What the duties of patent holders should be regarding licensing their patented inventions, particularly regarding licensing in the public sector;
  • Whether the results of research in the public sector, or funded by public monies, should be placed in the public domain rather than being patented;
  • Whether an exemption to patent rights should be made available to researchers;
  • What legal remedies should be made available to developing countries to ensure equitable access to genetic resources and products of medical research;
  • Mechanisms for ethical review in the patenting decision-making process;
  • Provisions to protect the rights of farmers in the use of plants or animals;
  • Provisions to facilitate the rapid dissemination of scientific research results;
  • Assessment of environmental and human health risks as an element of decision-making regarding patenting of plants and animals and consideration of potential safeguards.