Biological patent

The patenting of genes is a controversial issue in terms of bioethics. Some believe it is unethical to patent genetic material because it treats life as a commodity, or that it undermines the dignity of people and animals by allowing ownership of genes.[15] Some say that living materials occur naturally, and therefore cannot be patented.[16] The American Medical Association's stance is that gene patents inhibit access to genetic testing for patients and hinder research on genetic disease.[17]

While some feel that a patent on living material is unethical, others believe that not allowing patents on biotechnological inventions would also be unethical. Supporters of this idea suggest that patents allow the public, as well as policy makers, to hold the owner of the patent(s) accountable. They favor biological patents because they require disclosure of information to the public.[18] Agreements such as the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) require members of the World Trade Organization (WTO) to have intellectual property protection laws in place for most biological innovation, making it unlikely that many countries will prohibit patents on genes altogether.[16] Some say that patenting genes only commodifies life if a patent applies to an entire human being, arguing that patents on single body parts do not violate human dignity.[19]

Another area of controversy in genetic patenting is how gene samples are obtained. Prior consent is required to collect genetic samples, and collection of samples from people requires consent at the national and community levels as well as the individual level. Conflicts have resulted when consent is not obtained at all three levels. The question of benefit sharing also arises when obtaining genetic samples, specifically the potential responsibility of the collector to share any benefits or profits of the discoveries with the population or person from whom the sample came.[16]

The last major ethical issue involving gene patents is how the patents are used post-issuance. A major concern is that the use of patented materials and processes will be very expensive or even prohibited to some degree by conditions the patent owner sets.[20] Limiting access like this would directly impact agricultural institutes and university researchers, among others. Some fear that holders of biotechnology patents would exploit their rights in order to make larger profits, at the potential expense of farmers, healthcare patients, and other users of patented technologies.

The ethics of using patents to increase profits are also debated. A typical argument in favor of biotech patents is that they enable companies to earn money that the companies in turn invest in further research. Without these patents, some worry that companies would no longer have the resources or motives to perform competitive, viable biotech research.[16]

• Bioprospecting and biopiracy
• Budapest Treaty
• Human Genome Project
• The Lens

• Relevant legal provisions of the European Patent Convention:
  • Article 53(a) EPC: "Exceptions to patentability" (formerly Article 53a EPC 1973)
  • Rule 28 EPC: "Exceptions to patentability" (formerly Rule 23c EPC 1973), barring the patentability of, notably, "processes for cloning human beings" (Rule 28(a) EPC); "processes for modifying the germ line genetic identity of human beings" (Rule 28(b) EPC); and "uses of human embryos for industrial or commercial purposes" (Rule 28(c) EPC)