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A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.
Biological patents in different jurisdictions
In February 2013, Judge Justice John Nicholas ruled in the Federal Court of Australia in favour of a Myriad Genetics patent on the BRCA1 gene. This was a landmark ruling, affirming the validity of patents on naturally occurring DNA sequences. However, the U.S. Supreme Court came to the opposite conclusion only a few months later. The Australian ruling has been appealed to the Full Bench of the Federal Court; submissions in the case include consideration of the U.S. Supreme Court ruling. This decision was decided in 2014, affirming Nicholas J's decision in favor of Myriad, confirming that isolated genetic material (genes) are valid subjects of patents. As of June 2015 the case was pending hearing in the High Court of Australia. In October 2015 the Australian high court ruled that naturally occurring genes cannot be patented.
European Union directive 98/44/EC (the Biotech Directive) reconciled the legislation of biological patents among certain countries under 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, applications for patents on biological inventions are examined according to general guidelines for patents. In response to requests for additional clarity, the Japan Patent Office (JPO) set forth specific guidelines for biology-related inventions. Over the years, the JPO has continued to amend these guidelines to clarify their application to new technologies. These amendments have broadened the scope of patents within the biotechnology industry. The Japanese Patent Act requires that patented inventions be “industrially applicable”, i.e. they must have market or commercial potential. 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, 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.
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. The American Medical Association's stance is that gene patents inhibit access to genetic testing for patients and hinder research on genetic disease.
While some feel that 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 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. 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[why?], making it unlikely that many countries will prohibit patents on genes altogether. Some[who?] say that patenting genes only commodifies life if a patent applies to an entire human being, arguing that[who?] patents on single body parts do not violate human dignity.
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. A major concern[who?] 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. Limiting access like this would directly impact agricultural institutes and university researchers, among others. Some[who?] 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.
- 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.
- "Full Federal Court Upholds Gene Patents: D'Arcy v Myriad Genetics Inc  FCAFC 115".
- "D'Arcy v. Myriad Genetics Inc & Anor".
- "Genes can't be patented, rules Australia's High Court". www.newscientist.com. 7 October 2015. Retrieved 27 September 2018.
- Decision G2/06 of 25 November 2008, WARF/Stem Cells (OJ EPO 2009, 306). See also Decision T 2221/10 of 4 February 2014, Culturing stem cells/TECHNION.
- iPS Cell Technology Spurs Biological Patenting in Japan (PDF), World Intellectual Property Review, May 2013
- Crouch D (23 May 2012). "Guest Post: Myriad Misunderstanding of Parke-Davis v. Mulford". Patentlyo. Retrieved 26 Mar 2017.
- "Why People with Diabetes Can't Buy Generic Insulin". Johns Hopkins Medicine. 18 Mar 2015. Retrieved 26 Mar 2017.
- Zuhn D (9 Jun 2009). "Gene Patenting Debate Continues". PatentDocs: Biotech & Pharma Patent Law & News Blog. Retrieved 26 Mar 2017.
- Cook-Deegan R, Heaney C (22 Sep 2010). "Patents in Genomics and Human Genetics". Annu Rev Genom Hum Genet. 11: 383–425. doi:10.1146/annurev-genom-082509-141811. PMC 2935940. PMID 20590431.
- Association for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) 
- Dresser R. 1988. Ethical and Legal Issues in Patenting New Animal Life. Jurimetrics 28:399-435
- 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
- "Gene Patenting".
- 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. doi:10.1038/nrg909.
- 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)