| 英文摘要 |
This article revisits the Onco-Mouse controversy as a foundational problem in biotechnology patent law. The dispute concerned whether a genetically modified animal, deliberately made susceptible to cancer for research purposes, could be protected by patent without offending the morality and ordre public exclusions in European patent law under the European Patent Convention (EPC). The article proceeds from the central concern that patent law is not a morally neutral mechanism when it confers proprietary control over living organisms. It argues, however, that the contemporary legal position is now more structured than it was when the Onco-Mouse controversy first arose. European law has developed a specific test for genetically modified animals under Article 53(a) EPC and Rule 28 EPC: animal suffering, substantial medical benefit, and the correspondence between the two must be examined in relation to the scope of the claim. The Onco-Mouse case therefore remains important not because it supplies an easy answer, but because it exposes the continuing inadequacy of purely technical patent examination when the claimed subject matter involves sentient animals, human biological material, embryos, and modern genetic engineering. The article concludes that a defensible biotechnology patent system must combine technical patent standards with a limited but real moral inquiry, informed by animal welfare, proportionality, environmental risk, the 3Rs, and public accountability. |
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