In another example, a genetically modified mouse, dubbed the Oncomouse, that is useful for studying cancer, was patented by Harvard University as US 4736866 .
[9] The "Chakrabarty patent", owned by General Electric, was filed in 1972 and issued in 1981 after the Supreme Court decision discussed above.
[10][11] While not commercially important,[10] this patent and the Supreme Court case "opened the floodgates for protection of biotechnology-related inventions and helped spark the growth of an industry".
[14][15][16] The patents cover inventions for splicing genes to make recombinant proteins that are foundational to the biotechnology industry.
[24] Key methods to manipulate DNA to create monoclonal antibodies are covered by a thicket of patents,[25] including the "Winter patent" was invented by Gregory P. Winter of the Medical Research Council[26] which covers methods to make chimeric, humanized antibodies and has been licensed to about fifty companies.
[27] Abgenix owned a patent on methods of making transgenic mice lacking endogenous heavy chains.
[25] Medarex owned a patent[32] that covered high affinity human antibodies from transgenic mice.
[25] 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;[33] 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.
Association for Molecular Pathology v. Myriad Genetics was a 2013 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 covered 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 plaintiffs appealed to the Supreme Court, which granted cert and remanded the case back to the Federal Circuit.
Critics say that such patents deny local populations the right to use those inventions, for instance, to grow food.
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".
[44][45] 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 patent 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.