Biological patent

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. 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. In October 2015, the High Court of Australia ruled that naturally occurring genes cannot be patented. Per Canada’s Patent Act, patents are granted by the Canadian Intellectual Property Office (CIPO). Patents will only be granted for “any new and useful art, process, machine, manufacture or composition of matter”, and improvements thereon. Patents will not be granted for “mere scientific principle or abstract theorem.” In the case of pharmaceuticals, along with obtaining a patent, applicants must also seek approval from Health Canada. This process is governed by the Patented Medicines (Notice of Compliance) Regulations. In Harvard College v Canada (Commissioner of Patents), also referred to as the oncomouse case, the Supreme Court of Canada ruled that higher life forms were not patentable subject matter.