The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.
[1] 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.
Patents will only be granted for “any new and useful art, process, machine, manufacture or composition of matter”, and improvements thereon.
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.
The patent was also allowed in Europe before eventually being revoked in 2006 for a failure to pay fees and file translations.
However, in 2016 the Children's Hospital of Eastern Ontario (CHEO) sought to invalidate five Canadian patents held by Transgenomic.
[14][15] 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.
[16] Given this decision, the majority of Canadian Long QT syndrome tests were previously outsourced to the United States.
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.
In response to requests for additional clarity, the Japan Patent Office (JPO) set forth specific guidelines for biology-related inventions.
[23] A landmark ruling by the U.S. Supreme Court in June 2013 declared naturally occurring DNA sequences ineligible for patents.
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.
[27] Along with concerns about the commodification of human life, the medical community has also warned that gene patents can inhibit the practice of medicine and progress of science.
Without these patents, some worry that companies would no longer have the resources or motives to perform competitive, viable biotech research.
[32] Pharmaceutical industry executives diminished the idea of sharing intellectual property, arguing that companies would have no incentive to innovate if their patents were considered worthless during a pandemic.
However, health advocates argue that taxpayers substantially contributed to the development of the vaccines and they should thus be regarded as global public goods.
In April 2020, the Director General of the World Health Organization supported a proposal by Carlos Alvarado, to create a pool of rights for testing medicine and vaccine with free access or affordable licensing terms for all countries.
The permit allowed Israel to import a generic version of Kaletra from India to treat COVID patients.