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A biological patent is a patent on an invention in the field of biology, thus providing the patentee with the right to exclude others from making, using, selling, or importing the claimed invention in biology for a limited period of time. Patentable entities vary between jurisdictions and may include biological products, genetically modified organisms and genetic material. The applicability of patents for entities wholly or partially natural in origin is a subject of debate.
Biological patents in different jurisdictions
In February 2013, Judge John Nicholas ruled in the Federal Court of Australia in favour of a Myriad Genetics patent over the BRCA1 gene. This was a landmark ruling, affirming the validity of patents over naturally occurring DNA sequences; the U.S. Supreme Court came to the opposite conclusion only a few months later. The Australian ruling is being appealled to the Full Bench of the Federal Court and submissions in the case include consideration of the U.S. Supreme Court ruling.
European Union directive 98/44/EC (the Biotech Directive) harmonised legislation in regards to biological patents for countries in the jurisdiction of the European Patent Organisation. It allows for the patenting of natural biological products, including gene sequences, as long as they are "isolated from [their] natural environment or produced by means of a technical process."
Under the umbrella of biotechnology, biological inventions are examined according to general examination guidelines for patents. In response to requests for additional clarity, the Japan Patent Office (JPO) set forth specific guidelines for biological-related inventions. Through the years, the JPO has continued to amend these guidelines to bring greater clarity to new technologies. The result of these amendments has been a broadening of the scope of patentability within the biotechnology industry. The Japanese Patent Act requires that all patentable inventions be “industrially applicable”. Essentially, inventions must have market or commercial potential to be patentable. The JPO explicitly lists “medical activities” among inventions that fall outside the scope of industrially applicable inventions, meaning that methods of surgery, therapy and the diagnosis of human diseases cannot be patented.
In the United States, natural biological substances themselves can be patented (apart from any associated process or usage) if they are sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents on isolated products of nature include adrenaline, insulin, vitamin B12, and gene patents. However, a landmark ruling by the U.S. Supreme Court in June 2013 declared naturally occurring DNA sequences ineligible for patents.
The patenting of genes is a controversial issue in the area of bioethics. There are three main concerns voiced about genetic patenting. First, some believe that it is unethical to have a patent on genetic material because it treats life as a commodity. Second, others say that living materials occur naturally, and therefore, should not be able to be patented. Some also fear that allowing patents on genetic material will undermine the dignity of people and other animals by subjecting their genes to ownership by other people.
While some[who?] feel that having a patent on living material is unethical, others[who?] believe that not allowing patents on biotechnological inventions would also be unethical. Supporters of this idea say that allowing patents lets the public, as well as policy makers, have an entity to hold accountable, the owner of the patent. These supporters are in favor of 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 innovations. Because of this, it is not likely that many countries will prohibit patents on genes altogether. 
Although some[who?] say that having a patent on a gene turns people into a commodity, there are other people[who?] who disagree.[vague] Other people[who?] say that patenting genes only commodifies life if a patent is obtained on an entire human. These groups[who?] argue that having patents on single body parts does not violate human dignity.
Another area that creates controversy in the issue of gene patenting is how the gene samples are obtained. Prior consent is required for collecting genetic samples. When collecting samples from people, consent needs to be obtained from the national and community level, as well as the individual level. Controversies have come about when consent from all three levels of decision making is not obtained by researchers. Benefit sharing also comes into question when obtaining genetic samples. The question of whether the collector of the sample has any ethical responsibility to share any benefits or profits of the discoveries with the population or person from whom the sample came.
The last major issue involving gene patents is how the patents are used post-issuance. The problem over which many people[who?] express concern is that the patents will be very expensive and inaccessible to some degree due to conditions the patent owner sets. Limited access like this would directly areas such as institutes, agriculture, and university researchers. People[who?] argue that holders of biotechnology patents exploit their rights in order to make larger profits. They also argue that the patent holders do this at the risk of people such as farmers, healthcare patients, and any other user of the patented technology.
Although using a patent in order to increase profit is considered unethical by some,[who?] it is considered ethical by others.[who?] Without these patents, many companies could not raise and invest the money they need to make significant medical contributions.
- Sharples, Andrew (2011-03-23). "Gene Patents in Europe Relatively Stable Despite Uncertainty in the U.S.". Genetic Engineering and Biotechnology News. Retrieved 2013-06-13.
- Corderoy, Amy (February 15, 2013). "Landmark patent ruling over breast cancer gene BRCA1". Sydney Morning Herald. Retrieved June 14, 2013.
- Corderoy, Amy (March 4, 2013). "BRCA1 gene patent ruling to be appealed". Sydney Morning Herald. Retrieved June 14, 2013.
- Corderoy, Amy (June 14, 2013). "Companies can't patent genes, US court rules". Sydney Morning Herald. Retrieved June 14, 2013.
- G2/06 WARF/Stem Cells
- iPS Cell Technology Spurs Biological Patenting in Japan (PDF), World Intellectual Property Review, May 2013
- Association for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) 
- Marchant GE. 2007. Genomics, Ethics, and Intellectual Property. Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. Ch 1.5:29-38
- Dresser R. 1988. Ethical and Legal Issues in Patenting New Animal Life. Jurimetrics 28:399-435
- Caulfield TA, Gold ER. 2000. Genetic Testing. Ethical Concerns, and the Role of Patent Law. Clinical Genetics 57:370-75
- Resnik DB. 2001. DNA Patents and Human dignity. The Journal of Law, Medicine & Ethics. 29(1):152-165.
- Andrews LB. 2000. Genes and Patent Policy: Rethinking IP Rights. Nature Reviews Genetics 3:803-8