Right: the Australian Federal Court's decision to uphold Myriad Genetics' right to patent a human gene was just one of many simlar court cases heard world-wide.
(The following information has been abbreviated from the Wikipedia entry titled 'Biological patent'.
The full text of the entry can be accessed at http://en.wikipedia.org/wiki/Biological_patent#Myriad_Genetics_case)
A gene patent is a claim made by a company or individual to exclusive intellectual property rights in relation to a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims.
Gene patents may claim the isolated natural sequences of genes, the use of a natural sequence for purposes such as diagnostic testing, or a natural sequence that has been altered by adding a promoter or other changes to make it more useful. In the United States, patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism.
Myriad Genetics Inc and BRCA1 and BRCA2 patents
A patent application for the isolated BRCA1 gene and cancer-promoting mutations, as well as methods to diagnose the likelihood of getting breast cancer, was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS) and Myriad Genetics in 1994.
Over the next year, Myriad, in collaboration with investigators from Endo Recherche, Inc., HSC Research & Development Limited Partnership, and University of Pennsylvania, isolated and sequenced the BRCA2 gene, and the first BRCA2 patent was filed in the U.S. by Myriad and other institutions in 1995.
Myriad is the exclusive licensee of these patents and has enforced them in the United States against clinical diagnostic labs. This means that legally all testing must be done through Myriad's lab or by a lab which it had licensed. This business model led from Myriad being a start-up company in 1994 to being a publicly traded company with 1200 employees and about $500M in annual revenue in 2012. It also led to controversy and the Association for Molecular Pathology v. Myriad Genetics lawsuit. The patents expire, starting in 2014.
Controversy over gene patents
Controversy over biological patents occurs on many levels, driven by, for example, concern over the expense of patented medicines or diagnostics tests (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.
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 United States 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. 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 as U.S. Patent 4,438,032 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'. Others claim that patents have not created this 'anticommons' effect on research, based on surveys of scientists.
Professional societies of pathologists have criticized patents on disease genes and exclusive licenses to perform DNA diagnostic tests. In the 2009 Myriad case, doctors and pathologists complained that the patents on BRCA1 and BRCA2 genes prevented patients from receiving second opinions on their test results. Pathologists complained that the patent prevented them from carrying out their medical practice of doing diagnostic tests on patient samples and interpreting the results.
Myriad Genetics case in the United States
Association for Molecular Pathology v. Myriad Genetics is a case challenging the validity of gene patents in the United States, specifically challenging certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences.
The case was originally heard in the United States District Court for the Southern District of New York, which ruled against Myriad Genetics Inc and found that all the challenged claims were not patentable subject matter.
Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The Circuit court overturned the previous decision in part, ruling that isolated DNA which does not exist alone in nature can be patented and that the drug screening claims were valid. The Circuit court also confirmed in part, finding that the diagnostic claims were unpatentable.
The plaintiffs appealed to the Supreme Court, which remanded the case back to the Federal Circuit. The Federal Circuit did not change its opinion, so on September 25, 2012, the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari with the Supreme Court with respect to the second Federal Circuit Decision. As of December 2012 isolated genes remain patentable in the United States.