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A biological patent is a patent relating to an invention or discovery in biology. It can be a composition of matter, a method for obtaining or using one or more thereof, or a product combining such things. Even when a natural biological substance itself is patented (apart from any associated process or usage), this has been permitted in the United States as long as 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.
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The 1970s marked the first time when scientists patented methods on their biotechnological inventions with recombinant DNA. It wasn’t until 1980 that patents for whole-scale living organisms were permitted. In Diamond v. Chakrabarty, the U.S. Supreme Court established the patentability of living matter, provided it was truly "man-made." The subject for this particular case was a genetically engineered bacterium that was specifically modified to help clean up and degrade oil spills.
Since that 1980 court case, there has been much patenting of genetically modified organisms. This includes bacteria (as just mentioned), viruses, seeds, plants, and even non-human animals. For example, a genetically modified mouse, dubbed the Oncomouse, that is useful for studying cancer, was patented by Harvard University.
Isolated and manipulated cells - even human cells - can also be patented. In 1998, the U.S. Patent and Trademark Office (PTO) issued a broad patent claiming primate (including human) embryonic stem cells, entitled "Primate Embryonic Stem Cells" (Patent 5,843,780). On 13 March 2001, a second patent (6,200,806) was issued with the same title but focused on human embryonic stem cells.
New plants and seeds are also patentable. There are two ways that new plants can be protected. One is a "plant patent" that protects Plant breeders' rights when new plants are bred as opposed to be genetically created. These rights are different from those provided by the more commonly considered patent rights under the utility model. In one example of a utility patent on a genetically modified seed and the plants that come from it, the biotechnology company Monsanto developed and patented a glyphosate-resistant gene for the canola plant which has the effect of producing canola that is resistant to their Roundup brand of herbicide. Monsanto has enforced this patent against farmers who used the seed without paying Monsanto -- see Monsanto Canada Inc. v. Schmeiser.
Companies and organizations, like the University of California, have patented entire genomes.[1]
Controversy over biological patents occurs on many levels, driven by, for example, concern over the expense of patented medicines or diagnostics tests (see for example recent litigation against Myriad Genetics with respect to their breast cancer diagnostic test), concerns over genetically modified food which comes from patented genetically modified seeds as well as farmer's rights to harvest and plant seeds from the crops (for both issues see Monsanto article), as well as concerns and fears based on ignorance of patent law and inflamed by the media (see for example the title of a 2010 60 Minutes segment called "Should Firms Be Able to Own Your Genes?", generated in reaction to the Myriad patent litigation mentioned above; the title is absurd as "your genes" are not patentable subject matter -- see article on gene patents.)
Each nation has its own patent law, and what is patentable in some countries is not allowed to be patented in others. Stem cells derived from humans are a good example of these differences. In the United States, isolated stem cells are patentable subject matter. However, a challenge against some US stem cell patents is being litigated by two non-profit organizations: The Foundation for Taxpayer & Consumer Rights and Public Patent Foundation along with molecular biologist Jeanne Loring of the Burnham Institute. The European Patent Office has ruled that certain stem cell lines, derived from destruction of human embryos, were not to be granted a European patent.[2]
In the United States, biological material derived from humans can be patented if it has been sufficiently transformed. In litigation that was famous at the time, a cancer patient, John Moore, sued the University of California (see John_Moore_(patent) article). Cancer cells had been removed from Moore as part of his medical treatment; these cells were studied and manipulated by researchers. The resulting cells were "immortalized" and were patented by the university and have become widely used research tools. The subject of the litigation was the financial gain that the university and researchers achieved by additionally charging money to companies by licensing the cell line.
Michael Heller and Rebecca Eisenberg are academic law professors who believe that biological patents are creating a "tragedy of the anticommons," "in which people underuse scarce resources because too many owners can block each other."[3] The argument that there are negative effects on basic research appears to be mostly driven by academic law professors, and not by practicing university scientists. See for example this page at The Hastings Center's website and this document at the journal, Academic Medicine. There is data showing that such patents have little to no effect on basic university research provided at the Science Progress Blog.