Biological patent
Encyclopedia
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 unmodified genes (the latter becoming its own notable controversy as of late).
. 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 genome
s.
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.
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." 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.
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
relating to an invention
Invention
An invention is a novel composition, device, or process. An invention may be derived from a pre-existing model or idea, or it could be independently conceived, in which case it may be a radical breakthrough. In addition, there is cultural invention, which is an innovative set of useful social...
or discovery in biology
Biology
Biology is a natural science concerned with the study of life and living organisms, including their structure, function, growth, origin, evolution, distribution, and taxonomy. Biology is a vast subject containing many subdivisions, topics, and disciplines...
. 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 unmodified genes (the latter becoming its own notable controversy as of late).
History
The 1970s marked the first time when scientists patented methods on their biotechnological inventions with recombinant DNARecombinant DNA
Recombinant DNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms...
. It wasn’t until 1980 that patents for whole-scale living organisms were permitted. In Diamond v. Chakrabarty
Diamond v. Chakrabarty
Diamond v. Chakrabarty, , was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.-Background:...
, 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
Oncomouse
The OncoMouse or Harvard mouse is a type of laboratory mouse that has been genetically modified using modifications designed by Philip Leder and Timothy A Stewart of Harvard University to carry a specific gene called an activated oncogene. The activated oncogene significantly increases the mouse’s...
, 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
Plant breeders' rights
Plant breeders' rights , also known as plant variety rights , are rights granted to the breeder of a new variety of plant that give him exclusive control over the propagating material and harvested material of a new variety for a number of years.With these rights, the breeder can choose...
when new plants are bred as opposed to be genetically created. These rights are different from those provided by the more commonly considered patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
rights under the utility model
Utility model
A utility model is an intellectual property right to protect inventions. This right is available in a number of national statutes, as described below...
. 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
Gene
A gene is a molecular unit of heredity of a living organism. It is a name given to some stretches of DNA and RNA that code for a type of protein or for an RNA chain that has a function in the organism. Living beings depend on genes, as they specify all proteins and functional RNA chains...
for the canola
Canola
Canola refers to a cultivar of either Rapeseed or Field Mustard . Its seeds are used to produce edible oil suitable for consumption by humans and livestock. The oil is also suitable for use as biodiesel.Originally, Canola was bred naturally from rapeseed in Canada by Keith Downey and Baldur R...
plant which has the effect of producing canola that is resistant to their Roundup brand of herbicide
Herbicide
Herbicides, also commonly known as weedkillers, are pesticides used to kill unwanted plants. Selective herbicides kill specific targets while leaving the desired crop relatively unharmed. Some of these act by interfering with the growth of the weed and are often synthetic "imitations" of plant...
. Monsanto has enforced this patent against farmers who used the seed without paying Monsanto -- see Monsanto Canada Inc. v. Schmeiser
Monsanto Canada Inc. v. Schmeiser
Monsanto Canada Inc. v. Schmeiser [2004] 1 S.C.R. 902, 2004 SCC 34 is a leading Supreme Court of Canada case on patent rights for biotechnology. The court heard the question of whether growing genetically modified plants constitutes "use" of the patented invention of genetically modified plant...
.
Companies and organizations, like the University of California
University of California
The University of California is a public university system in the U.S. state of California. Under the California Master Plan for Higher Education, the University of California is a part of the state's three-tier public higher education system, which also includes the California State University...
, have patented entire genome
Genome
In modern molecular biology and genetics, the genome is the entirety of an organism's hereditary information. It is encoded either in DNA or, for many types of virus, in RNA. The genome includes both the genes and the non-coding sequences of the DNA/RNA....
s.
Controversy
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 GeneticsMyriad Genetics
Myriad Genetics, Inc. is a molecular diagnostic company based in Salt Lake City, Utah. Myriad employs a number of proprietary technologies that permit doctors and patients to understand the genetic basis of human disease and the role that genes play in the onset, progression and treatment of disease...
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
Monsanto
The Monsanto Company is a US-based multinational agricultural biotechnology corporation. It is the world's leading producer of the herbicide glyphosate, marketed in the "Roundup" brand of herbicides, and in other brands...
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
Gene patents
A gene patent is a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims...
.)
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
Public Patent Foundation
Public Patent Foundation, or PUBPAT, is a nonprofit organization that seeks to limit perceived abuse of the United States patent system. It was founded in 2003 by Dan Ravicher. , there was growing concern by many technology professionals over the number of patents granted that are either too...
along with molecular biologist Jeanne Loring of the Burnham Institute. The European Patent Office
European Patent Office
The European Patent Office is one of the two organs of the European Patent Organisation , the other being the Administrative Council. The EPO acts as executive body for the Organisation while the Administrative Council acts as its supervisory body as well as, to a limited extent, its legislative...
has ruled that certain stem cell lines, derived from destruction of human embryos, were not to be granted a European patent.
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"
Biological immortality
Biological immortality refers to a stable rate of mortality as a function of chronological age. Some individual cells and entire organisms in some species achieve this state either throughout their existence or after living long enough. This requires that death occur from injury or disease rather...
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." 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.
See also
- American Type Culture CollectionAmerican Type Culture CollectionThe American Type Culture Collection is a private, not-for-profit biological resource center whose mission focuses on the acquisition, authentication, production, preservation, development and distribution of standard reference microorganisms, cell lines and other materials for research in the...
(ATCC) - BiopiracyBiopiracy- Biopiracy and bioprospecting :Bioprospecting is an umbrella term describing the discovery of new and useful biological samples and mechanisms, typically in less-developed countries, either with or without the help of indigenous knowledge, and with or without compensation...
- Budapest TreatyBudapest TreatyThe Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, or Budapest Treaty, is an international treaty signed in Budapest, Hungary, on April 28, 1977. It entered into force on August 9, 1980, and was later amended on September 26,...
- Diamond v. ChakrabartyDiamond v. ChakrabartyDiamond v. Chakrabarty, , was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.-Background:...
was a United States Supreme Court case dealing with whether genetically modified micro-organismGenetically modified organismA genetically modified organism or genetically engineered organism is an organism whose genetic material has been altered using genetic engineering techniques. These techniques, generally known as recombinant DNA technology, use DNA molecules from different sources, which are combined into one...
s can be patentPatentA patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
ed. - Gene patent
- Human Genome ProjectHuman Genome ProjectThe Human Genome Project is an international scientific research project with a primary goal of determining the sequence of chemical base pairs which make up DNA, and of identifying and mapping the approximately 20,000–25,000 genes of the human genome from both a physical and functional...
- John Moore (patent)
- Stem cell controversyStem cell controversyThe stem cell controversy is the ethical debate primarily concerning the creation, treatment, and destruction of human embryos incident to research involving embryonic stem cells. Not all stem cell research involves the creation, use, or destruction of human embryos...
External links
- Biotechnology on the WIPOWorld Intellectual Property OrganizationThe World Intellectual Property Organization is one of the 17 specialized agencies of the United Nations. WIPO was created in 1967 "to encourage creative activity, to promote the protection of intellectual property throughout the world"....
web site
Papers
- "An Examination of the Issues Surrounding Biotechnology Patenting and its Effect Upon Entrepreneurial Companies", United States Congressional Research Service, August 31, 2000
- "Stem Cell Research and Patents: An Introduction to the Issues", United States Congressional Research Service, September 10, 2001