Biopatent in pionts in easy language
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- A patent in the field of biology
- 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,[1] 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
Australia
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.
Europe
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."
Japan
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.
United States
Main article: Biological patents in the United States
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.