---
title: "Biological patent"
chunk: 2/3
source: "https://en.wikipedia.org/wiki/Biological_patent"
category: "reference"
tags: "science, encyclopedia"
date_saved: "2026-05-05T04:27:06.993445+00:00"
instance: "kb-cron"
---

In the United States, up until 2013 natural biological substances themselves could have been patented (apart from any associated process or usage) if they were sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents include those on adrenaline, insulin, vitamin B12, and various genes. A landmark ruling by the U.S. Supreme Court in June 2013 declared naturally occurring DNA sequences ineligible for patents.

== Ethics ==

=== Patenting genes ===
Gene patents are a form of intellectual property which provide the patent holder with the exclusive right to exclude others from making, using, selling, or importing the invention for a specified period of time, typically twenty years.
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. Some say that living materials occur naturally, and therefore cannot be patented. Along with concerns about the commodification of human life, the medical community has also warned that gene patents can inhibit the practice of medicine and progress of science. For example, the American Medical Association's stance is that gene patents inhibit access to genetic testing for patients and hinder research on genetic disease. A contrary position is that forbidding patents on biotechnological innovations 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 favour biological patents because they require disclosure of information to the public.
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. The cost of research and development for innovations such as biologics is extremely high. Such protection regimes help to protect innovators from free-riders. Based on these provisions, it is unlikely that many countries will prohibit patents on genes altogether.
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.
The last major ethical issue involving gene patents is how the patents are used post-issuance. The use of patented materials and processes will be very expensive or even prohibited to some degree by conditions the patent owner sets. Limiting access like this would directly impact agricultural institutes and university researchers, among others. There is potential that holders of biotechnology patents will 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 favour 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.