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A biological patent is a patent protecting provides the holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery 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 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.
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."
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.
- 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.
- Association for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) 
- G2/06 WARF/Stem Cells
- 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.
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