Gene Patent - Examples

Examples

The "Chakrabarty patent", owned by General Electric, was filed in 1972 and issued in 1981 after the Supreme Court decision discussed above. While not commercially important, this patent and the Supreme Court case "opened the floodgates for protection of biotechnology-related inventions and helped spark the growth of an industry."

In 1978 University of California filed a patent application for the cDNA encoding human growth hormone, which issued in 1982 as US Patent 4,363,877 and listed Howard M. Goodman, John Shine, and Peter H. Seeburg as inventors. University of California licensed its patent to Lilly, leading to extended litigation among University of California, Lilly, and Genentech; each of Lilly and Genentech had introduced recombinant human growth hormone drugs, which were among the first biotech drugs brought to market.

The "Cohen/Boyer patents" were invented by Stanley Cohen of Stanford University and Herbert Boyer of University of California, San Francisco. The patents cover inventions for splicing genes to make recombinant proteins that are foundational to the biotechnology industry. Stanford managed the patents and licensed them nonexclusively and broadly, earning over $200 million for the universties.

The "Axel Patents" were invented by Richard Axel,Michael H. Wigler, and Saul J. Silverstein of Columbia University. These patents covered cotransformation, a form of transformation, another foundational method of biotechnology; Columbia licensed these patents nonexclusively and broadly and earned about $790 million.

Key methods to manipulate DNA to create monoclonal antibodies are covered by a thicket of patents, including the "Winter patent" was invented by Gregory P. Winter of the Medical Research Council which covers methods to make chimeric, humanized antibodies and has been licensed to about fifty companies. Abgenix owned a patent on methods of making transgenic mice lacking endogenous heavy chains. The "Boss patent" was owned by Celltech and covered methods of making recombinant antibodies and antibody fragments, together with vectors and host cells useful in these processes. Genentech owned the "Old Cabilly" patent that covered altered and native immunoglobulins prepared in recombinant cell culture, as well as the "New Cabilly" patent that covers artificial synthesis of antibody molecules. Medarex owned a patent that covered high affinity human antibodies from transgenic mice. These patents have been broadly licensed and have been the subject of litigation among patent holders and companies that have brought monoclonal antibody drugs to market.

A patent application for the isolated BRCA1 gene and cancer-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 US 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 startup 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 mentioned below. The patents expire, starting in 2014.