840:
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.
1377:
1398:
639:. 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" (
962:(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.
564:
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
839:
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
631:
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.
1486:
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,
1045:
carrying it; the mutation that is important in
Alzheimers. The 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
938:
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
871:
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
738:
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
755:, 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".
1050:, a nonprofit company that provides transgenic mice to academic and commercial researchers and is an important repository of such mice. Ultimately all the suits failed; the suit against Jackson Labs failed after the NIH granted it protection as a government contractor.
1046:
inventions made at universities (Comentis and Avid), and in each of those cases, the university was 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
1033:
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.
974:
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
1003:
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.
872:
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
1018:," "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.
993:, 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
596:
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
1187:
1393:, Chakrabarty, Ananda M., "Microorganisms having multiple compatible degradative energy-generating plasmids and preparation thereof", published 1981-03-31, assigned to
1037:
Another example is a series of lawsuits filed by the
Alzheimer's Institute of America (AIA) starting in 2003 with the last ending in 2013, concerning a gene patent it controlled on the
923:
989:
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,
809:
that are foundational to the biotechnology industry. Stanford managed the patents and licensed them nonexclusively and broadly, earning over $ 200 million for the universities.
739:
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.
1025:
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
1485:
944:
970:
Controversy over biological patents occurs on many levels, driven by, for example, concern over the expense of patented medicines or diagnostics tests (against
931:
891:
885:
873:
367:
863:
in 1994; over the next year, Myriad, in collaboration with investigators from Endo
Recherche, Inc., HSC Research & Development Limited Partnership, and
1160:
1595:
856:
775:
532:
2199:
675:
656:
645:
1980:
2204:
1316:
501:
2116:
896:
2128:
2044:"The Mouse That Trolled: The Long and Tortuous History of a Gene Mutation Patent That Became an Expensive Impediment to Alzheimer's Research"
623:, upheld the first patent on a newly created living organism, a bacterium for digesting crude oil in oil spills. The patent examiner for the
828:, another foundational method of biotechnology; Columbia licensed these patents nonexclusively and broadly and earned about $ 790 million.
661:) was issued with the same title but focused on human embryonic stem cells. In another example, a genetically modified mouse, dubbed the
1950:
2194:
465:
1780:
1220:
1081:
982:
The patenting of organisms or extracts from indigenous plants or animals that are already known to local populations has been called
836:
624:
450:
2122:
1955:
From Birth to Death and Bench to Clinic: The
Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns
1330:
802:
141:
525:
506:
2091:
Patent dispute threatens US Alzheimer's research; Lawsuit could expose hundreds of scientists to property-rights litigation.
934:. The Circuit court overturned the previous decision in part, ruling that isolated DNA which does not exist alone in nature
617:. It was not until 1980 that patents for whole-scale living organisms were permitted. In 1980, the U.S. Supreme Court, in
707:
rice in 1997. In 1999, a patent was filed for a peanut butter and jelly sandwich that was without crust. Agriculture giant
485:
322:
1623:
735:. With respect to subject matter, gene patents may be considered a subset of the broader category of biological patents.
491:
480:
372:
136:
2168:
2162:
955:
585:
460:
377:
126:
986:. Critics say that such patents deny local populations the right to use those inventions, for instance, to grow food.
2184:
518:
352:
1295:
1060:
786:
had introduced recombinant human growth hormone drugs, which were among the first biotech drugs brought to market.
588:
ruled in 2013 that mere isolation by itself is not sufficient for something to be deemed inventive subject matter.
1805:
1753:
1736:
1498:
1247:
2010:
1164:
2163:"An Examination of the Issues Surrounding Biotechnology Patenting and its Effect Upon Entrepreneurial Companies"
2189:
1007:
940:
636:
1592:
1094:
455:
219:
835:
are covered by a thicket of patents, including the "Winter patent" was invented by
Gregory P. Winter of the
610:
argued that natural substances when they are purified are more useful than the original natural substances.
613:
The 1970s marked the first time when scientists patented methods on their biotechnological inventions with
296:
1831:
1090:
782:, leading to extended litigation among University of California, Lilly, and Genentech; each of Lilly and
2144:
1988:
1015:
864:
1390:
671:
652:
641:
1129:
1104:
927:
825:
183:
162:
111:
80:
1376:
2011:"Association For Molecular Pathology, et al., vs. United States Patent and Trademark Office, et al"
1413:
759:
684:
628:
338:
315:
224:
131:
2149:
1958:
1086:
994:
748:
619:
393:
245:
1569:
Columbia University's Axel Patents: Technology Transfer and Implications for the Bayh-Dole Act
553:
holder with the right to exclude others from making, using, selling, or importing the claimed
1139:
1134:
1124:
1114:
832:
779:
398:
362:
189:
49:
44:
561:
for a limited period of time - for patents filed after 1998, 20 years from the filing date.
2090:
1109:
851:, as well as methods to diagnose the likelihood of getting breast cancer, was filed by the
806:
790:
763:
728:
54:
1716:
1210:
Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911), Learned Hand, J.
8:
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817:
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424:
308:
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214:
204:
199:
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95:
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agreed to hear the plaintiffs' appeal of the Federal Circuit's ruling. In June 2013, in
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70:
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1921:
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1394:
1038:
821:
752:
403:
255:
121:
85:
1296:"Monsanto files patent for new invention: the pig | Greenpeace International"
1885:
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1076:
1042:
971:
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429:
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281:
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are academic law professors who believe that biological patents are creating a "
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732:
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1634:
1611:
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1459:
1448:
1437:
999:
2178:
848:
798:
475:
470:
434:
1331:"Federal Register - Utility Examination Guidelines - Comments and Responses"
1219:
Dutfield, Graham. "DNA Patenting: Implications for Public Health Research."
951:
with the Supreme Court with respect to the second Federal Circuit Decision.
2077:
2039:
1935:
1343:
See Comment 2 in which this objection is specifically raised and addressed.
1022:
915:
sequences, methods to diagnose propensity to cancer by looking for mutated
813:
607:
286:
39:
1894:
2059:
900:
601:
574:
1733:
1414:"Diamond v. Chakrabarty: A Retrospective on 25 Years of Biotech Patents"
1188:"The Supreme Court Holds Genes Are Patent-Ineligible Products of Nature"
903:
in the United States, specifically challenging certain claims in issued
948:
919:
sequences, and methods to identify drugs using isolated DNA sequences.
771:
597:
566:
265:
1910:"Why the Gene Patenting Controversy Persists : Academic Medicine"
1867:"Can Patents Deter Innovation? The Anticommons in Biomedical Research"
1844:"Known Instances of Patenting on the UES of Medicinal Plants in India"
1497:
Chris Rauber for the San Francisco Business Times. November 23, 1997.
1248:"India outraged as US company wins patents on rice | World news"
1071:
1066:
983:
783:
662:
554:
146:
2133:
2102:
731:, the processes for obtaining or using it, or a combination of such
2150:
Bioethics and Patent Law: The Cases of Moore and the Hagahai People
2136:
Newsletter published by law firm of Robinson Bradshaw & Hinson.
1361:
976:
708:
2171:, United States Congressional Research Service, September 10, 2001
1362:"Genentech and the Stolen Gene: Patent Law and Pioneer Inventions"
924:
United States District Court for the Southern District of New York
704:
700:
570:
558:
876:
lawsuit mentioned below. The patents expire, starting in 2014.
2169:"Stem Cell Research and Patents: An Introduction to the Issues"
2165:, United States Congressional Research Service, August 31, 2000
1098:
904:
778:
as inventors. University of California licensed its patent to
766:, which issued in 1982 as U.S. Patent No. 4,363,877 and listed
688:
550:
34:
2139:
1293:
2038:
1030:
1026:
868:
844:
635:
Since that 1980 court case, there have been many patents of
2154:
1760:. Schwegman, Lundberg & Woessner, P.A. December 3, 2012
805:. The patents cover inventions for splicing genes to make
724:
699:
An early example of a food patent is the patent granted to
1245:
916:
712:
1846:. PIB, Ministry of Environment and Forests. May 6, 2010
960:
Association for Molecular Pathology v. Myriad Genetics
932:
United States Court of Appeals for the Federal Circuit
926:, which ruled that all the challenged claims were not
892:
Association for Molecular Pathology v. Myriad Genetics
886:
Association for Molecular Pathology v. Myriad Genetics
874:
Association for Molecular Pathology v. Myriad Genetics
665:, that is useful for studying cancer, was patented by
1781:"Supreme Court Rules Human Genes May Not Be Patented"
2145:
Human Genome Project pages on Genetics and Patenting
545:
As with all utility patents in the United States, a
1806:"Supreme Court says human genes cannot be patented"
1717:"Cancer Patients Challenge the Patenting of a Gene"
1567:Alessandra Colaianni and Robert Cook-Deegan (2009)
857:
National Institute of Environmental Health Sciences
1710:
1708:
1421:Intellectual Property & Technology Law Journal
627:had rejected the patent of a living organism, but
1754:"Supreme Court Grants Myriad's Petition for Cert"
1412:Robinson, Douglas; Medlock, Nina (October 2005).
762:filed a patent application for the cDNA encoding
723:A gene patent is a patent on a specific isolated
2176:
816:, Michael H. Wigler, and Saul J. Silverstein of
2042:; Vishnubhakat, S; Cook-Deegan, R (July 2015).
1864:
1705:
1624:Achievements and Impact: Therapeutic Antibodies
1411:
1274:"Can You Patent a Sandwich? - Lifestyle - GOOD"
104:Patentability requirements and related concepts
1563:
1561:
1487:U.S.A. Available online at www.ipHandbook.org.
1734:Myriad Investor Page—see "Myriad at a glance"
1480:
1478:
1294:Feature story - August 2, 2005 (2005-08-02).
1246:Luke Harding in New Delhi (August 23, 2001).
526:
316:
1948:
1558:
1389:
1359:
1315:: CS1 maint: numeric names: authors list (
1271:
789:The "Cohen/Boyer patents" were invented by
2140:The Human Genome Project information pages
1587:
1585:
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1579:
1577:
1475:
533:
519:
323:
309:
2067:
1978:
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1907:
1884:
1865:Heller, M. A.; Eisenberg, R. (May 1998).
1694:
1683:
1484:Feldman MP, A Colaianni and C Liu. 2007.
1355:
1353:
1351:
1349:
1221:Bulletin of the World Health Organization
1082:Commercialization of indigenous knowledge
625:United States Patent and Trademark Office
451:United States Patent and Trademark Office
2200:Genetic engineering in the United States
1714:
1232:Stix, Gary. "Owning The Stuff Of Life."
997:and were patented by the university as
831:Key methods to manipulate DNA to create
2152:by Anja von der Ropp and Tony Taubman,
2032:
1979:Caulfield, Timothy (October 29, 2009).
1858:
1574:
1158:
879:
803:University of California, San Francisco
2205:Environmental law in the United States
2177:
1908:Eisenberg, Rebecca S (December 2002).
1778:
1346:
843:A patent application for the isolated
683:Companies and organizations, like the
650:). On 13 March 2001, a second patent (
2003:
1163:. The Hastings Center. Archived from
922:The case was originally heard in the
1095:genetically modified micro-organisms
812:The "Axel Patents" were invented by
486:Manual of Patent Examining Procedure
16:Type of patents in the United States
1185:
13:
2195:Biotechnology in the United States
2093:Erika Check Hayden, 5 April 2011,
2048:Journal of Law and the Biosciences
1836:
600:. It was challenged and upheld in
378:Title 35 of the United States Code
127:Inventive step and non-obviousness
14:
2216:
2110:
1236:, Feb. 2006, Volume 294, Issue 2.
353:American Inventors Protection Act
2129:Amicus Brief by Dr. James Watson
1981:"Do Gene Patents Hurt Research?"
1957:. pp. 69–72. Archived from
1927:10.1097/00001888-200212001-00009
1375:
1061:American Type Culture Collection
895:was a 2013 case challenging the
2084:
1972:
1942:
1901:
1824:
1798:
1772:
1746:
1727:
1715:Schwartz, John (May 12, 2009).
1672:
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1536:
1525:
1514:
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1431:
1405:
1383:
1223:, May 2006, Volume 85, Issue 5.
718:
694:
373:Leahy–Smith America Invents Act
1323:
1287:
1265:
1239:
1226:
1213:
1204:
1179:
1152:
965:
941:American Civil Liberties Union
930:. Myriad then appealed to the
711:filed for a patent on certain
637:genetically modified organisms
1:
1779:Liptak, Adam (13 June 2013).
1360:Rimmer, Matthew (2002–2003).
1146:
867:, isolated and sequenced the
456:Patent Trial and Appeal Board
1949:Cook-Deegan, Robert (2008).
1886:10.1126/science.280.5364.698
176:By region / country
7:
1091:United States Supreme Court
1053:
742:
10:
2221:
1953:. In Crowley, Mary (ed.).
1830:See for example 2009-2010
1591:Jennifer van Brunt (2005)
1272:Peter Smith (2011-09-28).
1093:case dealing with whether
1021:Professional societies of
1016:tragedy of the anticommons
954:On November 30, 2012, the
883:
865:University of Pennsylvania
849:cancer-promoting mutations
591:
233:By specific subject matter
1679:U.S. Patent No. 5,770,429
1668:U.S. Patent No. 6,331,415
1657:U.S. Patent No. 4,816,567
1646:U.S. Patent No. 4,816,397
1635:U.S. Patent No. 5,939,598
1612:U.S. Patent No. 5,225,539
1571:Milbank Q.87(3): 683–715.
1554:U.S. Patent No. 6,455,275
1543:U.S. Patent No. 5,149,636
1532:U.S. Patent No. 5,179,017
1521:U.S. Patent No. 4,634,665
1471:U.S. Patent No. 4,740,470
1460:U.S. Patent No. 4,468,464
1449:U.S. Patent No. 4,237,224
1438:U.S. Patent No. 4,363,877
1105:Genetically modified food
928:patentable subject matter
820:. These patents covered
184:Patent Cooperation Treaty
163:Sufficiency of disclosure
142:Person skilled in the art
112:Patentable subject matter
2185:United States patent law
1395:General Electric Company
945:Public Patent Foundation
939:September 25, 2012, the
837:Medical Research Council
760:University of California
685:University of California
507:List of patent law cases
339:United States patent law
155:Other legal requirements
132:Industrial applicability
1758:The National Law Review
1701:U.S. Patent No. 5837492
1690:U.S. Patent No. 5747282
1602:Signals Online Magazine
907:owned or controlled by
687:, have patented entire
1499:$ 200M patent runs out
1366:Bio-Science Law Review
1130:Plant breeders' rights
1087:Diamond v. Chakrabarty
620:Diamond v. Chakrabarty
603:Parke-Davis v. Mulford
394:Article of manufacture
386:Types of patent claims
2190:Biological patent law
1743:accessed October 2012
1622:MRC Official Website
1510:U.S. Patent 4,399,216
1159:Cook-Deegan, Robert.
1140:Traditional knowledge
1135:Stem cell controversy
1125:Pharmaceutical patent
1115:Intellectual property
1000:U.S. patent 4,438,032
947:filed a petition for
833:monoclonal antibodies
399:Composition of matter
363:Invention Secrecy Act
2134:Genomics Law Report.
1110:Human Genome Project
880:Myriad Genetics case
807:recombinant proteins
764:human growth hormone
729:chemical composition
1593:The Monoclonal Maze
1234:Scientific American
1120:John Moore (patent)
979:using its patents.
818:Columbia University
795:Stanford University
425:Inter partes review
63:Procedural concepts
2060:10.1093/jlb/lsv011
2018:The New York Times
1812:. Associated Press
1739:2012-10-18 at the
1598:2013-01-16 at the
1167:on 15 January 2013
853:University of Utah
749:Chakrabarty patent
667:Harvard University
497:Biological patents
168:Unity of invention
2159:, September 2006.
2097:472, 20 (2011) |
1920:(12): 1381–1387.
1914:Academic Medicine
1879:(5364): 698–701.
1333:. January 5, 2001
1012:Rebecca Eisenberg
768:Howard M. Goodman
547:biological patent
543:
542:
333:
332:
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2071:
2036:
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2029:
2027:
2025:
2020:. March 29, 2010
2015:
2007:
2001:
2000:
1998:
1996:
1991:on April 4, 2011
1987:. Archived from
1985:Science Progress
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1298:. Greenpeace.org
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1186:Sheehan, Teige.
1183:
1177:
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1156:
1039:Swedish mutation
1002:
822:cotransformation
776:Peter H. Seeburg
753:General Electric
679:
678:
674:
660:
659:
655:
649:
648:
644:
586:US Supreme Court
557:or discovery in
535:
528:
521:
502:Software patents
368:Hatch-Waxman Act
335:
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19:
18:
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2103:10.1038/472020a
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443:Other topics
287:Pirate Party
117:Inventorship
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1764:December 5,
1171:10 December
966:Controversy
629:Chakrabarty
345:Legislation
220:Netherlands
76:Prosecution
71:Application
2179:Categories
1965:2018-08-24
1832:litigation
1391:US 4259444
1302:2012-08-03
1280:2012-08-03
1258:2012-08-03
1147:References
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772:John Shine
672:US 4736866
653:US 6200806
642:US 5843780
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241:Biological
81:Opposition
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2040:Bubela, T
2024:March 30,
1276:. Good.is
1072:Biopiracy
1067:Bioethics
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555:invention
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190:Australia
147:Prior art
91:Licensing
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1936:12480648
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476:Racism
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