kb/data/en.wikipedia.org/wiki/Biological_patent-0.md

title	chunk	source	category	tags	date_saved	instance
Biological patent	1/3	https://en.wikipedia.org/wiki/Biological_patent	reference	science, encyclopedia	2026-05-05T07:01:47.000684+00:00	kb-cron

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 ==

=== 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. In October 2015, the High Court of Australia ruled that naturally occurring genes cannot be patented.

=== Canada === 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. The OncoMouse was one of the first transgenic mice developed for use in cancer research, and the first mammal to be the subject of a patent application. Writing for the majority, Bastarache J. asserted that it was the role of Parliament to address whether higher life forms should be patentable. In contrast, the United States Patent & Trademark Office issued the patents covering methods for providing a cell culture from a transgenic non-human anima to Harvard College. The patent was also allowed in Europe before eventually being revoked in 2006 for a failure to pay fees and file translations. Although animals cannot be patented, Canada allows for the patent of antibodies obtained through immunizing animals. Methods of medical treatment cannot be patented in Canada, however, medical use claims such as the use of an antibody for the treatment of a particular disease is patentable. Further, antigens which have not been previously characterized are also patentable. Gene patents confer a property right to the patent holder. While CIPO will grant patents for isolated gDNA and cDNA, the Supreme Court of Canada has not yet ruled on gene patentability. However, in 2016 the Children's Hospital of Eastern Ontario (CHEO) sought to invalidate five Canadian patents held by Transgenomic. The gene patents covered the genes associated with, and genetic testing for Long QT syndrome. The parties reached a settlement. The patent was not invalidated, but, Transgenomic provided Canadian health institutions the right to test Canadians for the disease on a non-profit basis. In Association for Molecular Pathology v Myriad, the United States Supreme Court determined that genes were unpatentable products of nature and that no intellectual property existed as nothing was invented. Given this decision, the majority of Canadian Long QT syndrome tests were previously outsourced to the United States. After the settlement, domestic testing levels increased in Canada. The terms of the settlement could set a precedent for the repatriation of further genetic testing.

=== 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." The European Patent Office has ruled that European patents cannot be granted for processes that involve the destruction of human embryos. In the case of the oncomouse, the European Patent Office (EPO) allowed for the patent. The EPO's patent standards prohibits patents for inventions contrary to ordre public and morality. Patents also could not be issued for “animal varieties or essentially biological processes for the production of…animals”. The EPO undertook a utilitarian balancing test to make their determination on the ordre public and morality exceptions. They found that the likelihood of advancing cancer research and medical benefits outweighed potential suffering of the animal. The EPO also determined that the oncomouse was not an animal variety, and thus not excluded. An amended patent with claims limited to mice was issued.

=== 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. 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.

=== United States ===