Gene patents in the United States: Difference between revisions
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#REDIRECT [[Biological patents in the United States]] |
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{{Patent law}} |
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A '''gene potent''' is a [[potent]] on a specific isolated [[gene]] sequence, its [[chemical composition]], the processes for obtaining or using it, or a combination of such [[Claim (patent)|claims]]. With respect to subject matter, gene patents may be considered a subset of the broader category of [[biological patent]]s. As with all utility patents in the U.S, the patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention for a limited period of time - for patents filed after 1998, twenty years from the filing date.<ref>{{cite web|last=Cook-Deegan|first=Robert|title=Gene patents|url=http://www.thehastingscenter.org/publications/briefingbook/detail.aspx?id=2174|publisher=The Hastings Center|accessdate=10 December 2012}}</ref> |
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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.<ref>{{cite web|title=Federal Register - Utility Examination Guidelines - Comments and Responses|url=http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&docid=01-322-filed|date=January 5, 2001|accessdate=April 5, 2010}} See Comment 2 in which this objection is specifically raised and addressed.</ref> |
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== History == |
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The United States has been patenting chemical compositions based upon human products for over 100 years. |
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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 <ref>Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911), Learned Hand, J.</ref> [[Learned Hand|Judge Hand]] argued that natural substances when they are purified are more useful than the original natural substances.<ref>Dutfield, Graham. "DNA Patenting: Implications for Public Health Research." Bulletin of the World Health Organization, May 2006, Volume 85, Issue 5.</ref> |
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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. |
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==Examples== |
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The "Chakrabarty patent", owned by [[General Electric]], was filed in 1972 and issued in 1981 after the Supreme Court decision discussed above.<ref>[http://www.google.com/patents/US4259444 Chakrabarty - US Patent 4,259,444]</ref> While not commercially important,<ref name=Rimmer>Matthew RImmer. (2002/2003) [http://pharmalicensing.com/public/articles/view/1070133214_3fc8efde16011/genentech-and-the-stolen-gene-patent-law-and-pioneer-inventions Genentech and the Stolen Gene: Patent Law and Pioneer Inventions] Bio-Science Law Review 5(6):198-211</ref> this patent and the Supreme Court case "opened the floodgates for protection of biotechnology-related inventions and helped spark the growth of an industry."<ref>Douglas Robinson and Nina Medlock (2005) [http://www.bannerwitcoff.com/_docs/library/articles/Chakrabarty.pdf Diamond v. Chakrabarty: A Retrospective on 25 Years of Biotech Patents]. Intellectual Property & Technology Law Journal 17(10):12-15</ref> |
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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.<ref>[http://www.google.com/patents/US4363877 US Patent 4,363,877]</ref> 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.<ref name=Rimmer /> |
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The "Cohen/Boyer patents" were invented by [[Stanley Norman Cohen|Stanley Cohen]] of Stanford University and [[Herbert Boyer]] of University of California, San Francisco.<ref>[http://www.google.com/patents/US4237224 US Patent 4,237,224]</ref><ref>[http://www.google.com/patents/US4468464 US Patent 4,468,464]</ref><ref>[http://www.google.com/patents/US4740470 US Patent 4,740,470]</ref> The patents cover inventions for splicing genes to make recombinant proteins that are foundational to the biotechnology industry.<ref name=IPHandbook>Feldman MP, A Colaianni and C Liu. 2007. [http://www.iphandbook.org/handbook/chPDFs/ch17/ipHandbook-Ch%2017%2022%20Feldman-Colaianni0Liu%20Cohen-Boyer%20Patents%20and%20Licenses.pdf Lessons from the Commercialization of the Cohen-Boyer Patents: The Stanford University Licensing Program. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.]</ref> Stanford managed the patents and licensed them nonexclusively and broadly, earning over $200 million for the universties.<ref name=IPHandbook /><ref>Chris Rauber for the San Francisco Business Times. November 23, 1997. [http://www.bizjournals.com/sanfrancisco/stories/1997/11/24/story2.html?page=all $200M patent runs out]</ref> |
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The "Axel Patents" were invented by [[Richard Axel]], Michael H. Wigler, and Saul J. Silverstein of Columbia University.<ref>[http://www.google.com/patents/US4399216 U.S. Patent 4,399,216]</ref><ref>[http://www.google.com/patents/US4634665 U.S. Patent 4,634,665]</ref><ref>[http://www.google.com/patents/US5179017 U.S. Patent 5,179,017]</ref><ref>[http://www.google.com/patents/US5149636 U.S. Patent 5,149,636]</ref><ref>[http://www.google.com/patents/US6455275 U.S. Patent 6,455,275]</ref><ref name=AxelArticle>Alessandra Colaianni and Robert Cook-Deegan (2009) [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2750841/ Columbia University's Axel Patents: Technology Transfer and Implications for the Bayh-Dole Act] Milbank Q.87(3): 683–715.</ref> These patents covered [[cotransformation]], a form of [[Transformation (genetics)|transformation]], another foundational method of biotechnology; Columbia licensed these patents nonexclusively and broadly and earned about $790 million.<ref name=AxelArticle /> |
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Key methods to manipulate DNA to create [[monoclonal antibodies]] are covered by a thicket of patents,<ref name=Signals>Jennifer van Brunt (2005) [http://www.signalsmag.com/signalsmag.nsf/0/B5AEE2883036B8D9882570C9007AD54F The Monoclonal Maze] Signals Online Magazine</ref> including the "Winter patent" was invented by Gregory P. Winter of the [[Medical Research Council (United Kingdom)|Medical Research Council]]<ref>[http://www.google.com/patents/US5225539 US Patent 5,225,539]</ref> which covers methods to make chimeric, humanized antibodies and has been licensed to about fifty companies.<ref>MRC Official Website [http://www.mrc.ac.uk/Achievementsimpact/Storiesofimpact/Therapeuticantibodies/index.htm Achievements and Impact: Therapeutic Antibodies]</ref> Abgenix owned a patent on methods of making transgenic mice lacking endogenous heavy chains.<ref name=Signals /><ref>[http://www.google.com/patents/US5939598 US Patent 5,939,598]</ref> The "Boss patent" was owned by Celltech<ref>[http://www.google.com/patents/US4816397 US Patent 4,816,397]</ref> and covered methods of making recombinant antibodies and antibody fragments, together with vectors and host cells useful in these processes.<ref name=Signals /> Genentech owned the "Old Cabilly" patent<ref>[http://www.google.com/patents/US4816567 US Patent 4,816,567]</ref> that covered altered and native immunoglobulins prepared in recombinant cell culture, as well as the "New Cabilly" patent<ref>[http://www.google.com/patents/US6331415 US Patent 6,331,415]</ref> that covers artificial synthesis of antibody molecules.<ref name=Signals /> Medarex owned a patent<ref>[http://www.google.com/patents/US5770429 US Patent 5,770,429]</ref> that covered high affinity human antibodies from transgenic mice.<ref name=Signals /> 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.<ref name=Signals /> |
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A patent application for the isolated [[BRCA1]] gene and [[BRCA mutation|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;<ref name=282patent>[http://www.google.com/patents/US5747282 US5747282]</ref> 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.<ref name=492Patent>[http://www.google.com/patents/US5837492 US5837492]</ref> Myriad is the exclusive licensee of these patents and has enforced them in the US against clinical diagnostic labs.<ref name=SchwartzNYTimes>John Schwartz for the New York Times. May 12, 2009. [http://www.nytimes.com/2009/05/13/health/13patent.html Cancer Patients Challenge the Patenting of a Gene]</ref> 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;<ref>[http://investor.myriad.com/index.cfm Myriad Investor Page—see "Myriad at a glance"] accessed October 2012</ref> it also led to controversy and the [[Association for Molecular Pathology v. Myriad Genetics]] lawsuit mentioned below.<ref name=SchwartzNYTimes /> The patents expire, starting in 2014. |
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== Controversy == |
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Law professor Rebecca S. Eisenberg argues that gene patents produce an "anticommons" at odds with an ideal scientific [[commons]].<ref>http://journals.lww.com/academicmedicine/fulltext/2002/12001/why_the_gene_patenting_controversy_persists.9.aspx</ref> |
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Others claim that patents have not created this "anticommons" effect on research, based on surveys of scientists.<ref>http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2174</ref><ref>[http://www.scienceprogress.org/2009/10/do-gene-patents-hurt-research/ Science Progress Blog]</ref> |
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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.<ref name=Sweet>{{cite news|title=Association For Molecular Pathology, et al., vs. United States Patent and Trademark Office, et al. |date=March 29, 2010 |url=http://graphics8.nytimes.com/packages/pdf/national/20100329_patent_opinion.pdf|format=PDF|work=The New York Times|accessdate=March 30, 2010}}</ref> |
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Another example is a series of lawsuits filed by the Alzheimer’s Institute of America (AIA) starting in 2010, concerning a gene patent it controls. The patent covers a genetic mutation that predisposes to Alzheimer's, and more importantly, it applies to transgenic mice carrying the mutation. These mice are widely used in Alzheimer's research, both by academic scientists doing basic research and by companies that use the mice to test products in development. Two of these suits are directed to companies that were started based on inventions made at universities (Comentis and Avid), and in each of those cases, the university has been sued along with the company. While none of the suits target universities that are conducting basic research using the mice, one of the suits is against Jackson Labs, a nonprofit company that provides transgenic mice to academic and commercial researchers and is an important repository of such mice.<ref>[http://www.nature.com/news/2011/110405/full/472020a.html Patent dispute threatens US Alzheimer's research; Lawsuit could expose hundreds of scientists to property-rights litigation.] Erika Check Hayden, 5 April 2011, ''Nature'' 472, 20 (2011) | {{doi|10.1038/472020a}}</ref> |
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While there is some controversy concerning the patenting of isolated genes and the way those patents are used, and there is controversy concerning patents on the diagnostic uses of genes (the real source of dispute in the Myriad court case), it is difficult to find controversy surrounding patents on genes that are used to manufacture therapeutic proteins (for an example of patents on therapeutic proteins, the drug candidate that is the subject of the early part of the movie '[[Extraordinary Measures]]' was covered in part by a classic gene patent, US Patent 6,770,468.[http://patft1.uspto.gov/netacgi/nph-Parser?patentnumber=6770468]) There is also little controversy concerning the role of gene patents in the chemical industry—for instance in the manufacture of enzymes used in consumer products or industrial processes.[http://nzic.org.nz/ChemProcesses/biotech/12H.pdf] |
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==Myriad Genetics case== |
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{{Main|Association for Molecular Pathology v. Myriad Genetics}} |
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''[[Association for Molecular Pathology v. Myriad Genetics]]'' is a case challenging the [[Patentable subject matter|validity]] of [[gene patent]]s in the United States, specifically challenging certain claims in issued [[patent]]s owned or controlled by [[Myriad Genetics]] that cover [[DNA extraction|isolated DNA]] sequences, methods to diagnose propensity to cancer by looking for mutated [[DNA]] sequences, and methods to identify drugs using isolated DNA sequences. |
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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 diagnosic 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. As of December 2012 isolated genes remain patentable in the US. |
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On November 30, 2012, the [[Supreme Court of the United States|Supreme Court]] agreed to hear the plaintiffs' appeal of the Federal Circuit's ruling. It is anticipated that the court will rule on whether isolated genes are patentable.<ref>{{cite web |title=Supreme Court Grants Myriad’s Petition for Cert. |url=http://www.natlawreview.com/article/supreme-court-grants-myriad-s-petition-cert|publisher=Schwegman, Lundberg & Woessner, P.A. |work=The National Law Review|date=December 3, 2012|accessdate=December 5, 2012}}</ref> |
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== See also == |
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* [[Human Genome Project]] |
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* [[Implications of US gene patent invalidation on Australia]] |
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== References == |
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<!--See http://en.wikipedia.org/wiki/Wikipedia:Footnotes for an explanation of how to generate footnotes using the <ref(erences/)> tags--> |
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{{Reflist|2}} |
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== External links == |
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*[http://www.wileyrein.com/newsroom.cfm?sp=newsreleases&id=767 Amicus Brief by Dr. James Watson] |
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*[http://www.genomicslawreport.com/ Genomics Law Report.] Newsletter published by law firm of Robinson Bradshaw & Hinson. |
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*[http://genomics.energy.gov/ The Human Genome Project information pages] |
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*[http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml Human Genome Project pages on Genetics and Patenting] |
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*[http://www.wipo.int/wipo_magazine/en/2006/05/article_0008.html Bioethics and Patent Law: The Cases of Moore and the Hagahai People] by Anja von der Ropp and Tony Taubman, ''[[WIPO]] Magazine'', September 2006. |
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{{DEFAULTSORT:Gene Patent}} |
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[[Category:Genetics]] |
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[[Category:Biological patent law]] |
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[[Category:Science and law]] |
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Latest revision as of 19:13, 13 June 2013
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