As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.
Until recently, natural biological substances themselves could be patented (apart from any associated process or usage) in the United States if they were 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. However, the US Supreme Court ruled in 2013 that mere isolation by itself is not sufficient for something to be deemed inventive subject matter.
History The United States has been patenting chemical compositions based upon human products for over 100 years. The first patent for a human product was granted on March 20, 1906, for a purified form of adrenaline. It was challenged and upheld in Parke-Davis v. Mulford.Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911), Learned Hand, J. Judge Hand argued that natural substances when they are purified are more useful than the original natural substances.Dutfield, Graham. "DNA Patenting: Implications for Public Health Research." Bulletin of the World Health Organization, May 2006, Volume 85, Issue 5.
The 1970s marked the first time when scientists patented methods on their biotechnological inventions with recombinant DNA. It was not until 1980 that patents for whole-scale living organisms were permitted. In 1980, the U.S. Supreme Court, in Diamond v. Chakrabarty, upheld the first patent on a newly created living organism, a bacterium for digesting crude oil in oil spills. The patent examiner for the United States Patent and Trademark Office had rejected the patent of a living organism, but Chakrabarty appealed. As a rule, raw natural material is generally rejected for patent approval by the USPTO. The Court ruled that as long as the organism is truly "man-made", such as through genetic engineering, then it is patentable. Because the DNA of Chakrabarty's organism was modified, it was patentable.
Since that 1980 court case, there have been many patents of genetically modified organisms. This includes bacteria (as just mentioned), viruses, seeds, plants, cells, and even non-human animals. 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" (). On 13 March 2001, a second patent () was issued with the same title but focused on human embryonic stem cells. In another example, a genetically modified mouse, dubbed the Oncomouse, that is useful for studying cancer, was patented by Harvard University as .
Companies and organizations, like the University of California, have patented entire genomes.Stix, Gary. "Owning The Stuff Of Life." Scientific American, Feb. 2006, Volume 294, Issue 2. doi:10.1038/scientificamerican0206-76
Food patents An early example of a food patent is the patent granted to RiceTec for basmati rice in 1997. In 1999, a patent was filed for a peanut butter and jelly sandwich that was without crust. Agriculture giant Monsanto filed for a patent on certain pig genes in 2004.
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. With respect to subject matter, gene patents may be considered a subset of the broader category of biological patents.
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. See Comment 2 in which this objection is specifically raised and addressed.
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 U.S. Patent No. 4,363,877 and listed Howard M. Goodman, John Shine, and Peter H. Seeburg as inventors.U.S. Patent No. 4,363,877 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.U.S. Patent No. 4,237,224U.S. Patent No. 4,468,464U.S. Patent No. 4,740,470 The patents cover inventions for splicing genes to make recombinant proteins that are foundational to the biotechnology industry.Feldman MP, A Colaianni and C Liu. 2007. Stanford managed the patents and licensed them nonexclusively and broadly, earning over $200 million for the universities.Chris Rauber for the San Francisco Business Times. November 23, 1997. $200M patent runs out
The "Axel Patents" were invented by Richard Axel, Michael H. Wigler, and Saul J. Silverstein of Columbia University.U.S. Patent 4,399,216U.S. Patent No. 4,634,665U.S. Patent No. 5,179,017U.S. Patent No. 5,149,636U.S. Patent No. 6,455,275Alessandra Colaianni and Robert Cook-Deegan (2009) Columbia University's Axel Patents: Technology Transfer and Implications for the Bayh-Dole Act Milbank Q.87(3): 683–715. 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,Jennifer van Brunt (2005) The Monoclonal Maze Signals Online Magazine including the "Winter patent" was invented by Gregory P. Winter of the Medical Research CouncilU.S. Patent No. 5,225,539 which covers methods to make chimeric, humanized antibodies and has been licensed to about fifty companies.MRC Official Website Achievements and Impact: Therapeutic Antibodies Abgenix owned a patent on methods of making transgenic mice lacking endogenous heavy chains.U.S. Patent No. 5,939,598 The "Boss patent" was owned by CelltechU.S. Patent No. 4,816,397 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" patentU.S. Patent No. 4,816,567 that covered altered and native immunoglobulins prepared in recombinant cell culture, as well as the "New Cabilly" patentU.S. Patent No. 6,331,415 that covers artificial synthesis of antibody molecules. Medarex owned a patentU.S. Patent No. 5,770,429 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-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;U.S. Patent No. 5747282 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.U.S. Patent No. 5837492 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;Myriad Investor Page—see "Myriad at a glance" accessed October 2012 it also led to controversy and the Association for Molecular Pathology v. Myriad Genetics lawsuit mentioned below. The patents expire, starting in 2014.
Myriad Genetics case
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 case was originally heard in the United States District Court for the Southern District of New York, which ruled 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, and confirmed in part, finding the diagnostic claims unpatentable. The plaintiffs appealed to the Supreme Court, which granted cert and 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.
On November 30, 2012, the Supreme Court agreed to hear the plaintiffs' appeal of the Federal Circuit's ruling. In June 2013, in Association for Molecular Pathology v. Myriad Genetics (No. 12-398), the court unanimously ruled that, "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," invalidating Myriad's patents on the BRCA1 and BRCA2 genes. However, the Court also held synthesized DNA sequences, not occurring in nature, can still be eligible for patent protection.
Controversy Controversy over biological patents occurs on many levels, driven by, for example, concern over the expense of patented medicines or diagnostics testsSee for example 2009-2010 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 example legal actions by Monsanto using its patents.
The patenting of organisms or extracts from indigenous plants or animals that are already known to local populations has been called biopiracy. Critics say that such patents deny local populations the right to use those inventions, for instance, to grow food.