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Gene Editing Technology Patents or Monopolization of Scientific Knowledge and Health Care?

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A Critical Mind

Part of the book series: MPI Studies on Intellectual Property and Competition Law ((MSIP,volume 30))

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Abstract

This contribution deals with gene editing technology from the perspective of patent law. The monopolization of scientific knowledge and its effects on health care are under scrutiny. The contribution is based on the premise that the gene editing sector and its peculiarities require a reassessment of patent law principles, and this challenge is undertaken by reference to Hanns Ullrich’s academic legacy. Various aspects of the controversial—but at the same time promising—domain of genome editing are discussed from the perspective of its monopolization, availability for research and commercial downstream development.

This contribution was completed in June 2020 and reflects the applicable law and developments up until that date.

Agnieszka A. Machnicka, Mgr (University of Warsaw), D.E.S.S. (Université de Poitiers), LL.M. (University of Ottawa), M.Res. (European University Institute), Ph.D. (University of Warsaw), Ph.D. (European University Institute) is Lecturer in Comparative Private Law at The Hague University of Applied Sciences.

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Notes

  1. 1.

    Eg Giulio Mandich, ‘Primi riconoscimenti veneziani di un diritto di privative agli inventori’ (1958) Rivista di diritto industriale 101; Giulio Mandich, ‘Le privative industriali veneziane (1450–1550)’ (1936) 34 Rivista di diritto commerciale 511; Frank D Prager, ‘Brunelleschi’s Patent’ (1946) 28 JPatOffSoc’y 109.

  2. 2.

    Eg Neil Davenport, The United Kingdom Patent System. A Brief History (Kenneth Mason 1979); William Cornish, David Llewelyn and Tanya Aplin, Intellectual Property: Patents, Copyright, Trade Marks and Allied Rights (9th edn, Sweet & Maxwell 2019).

  3. 3.

    Martin **ek and others, ‘A Programmable Dual RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity’ (2012) 337(6096) Science 816-821.

  4. 4.

    Ibid. The authors of the publication are scientists from various scientific institutions in Europe and the United States: Martin **ek, Krzysztof Chylinski, Ines Fonfara, Michael Hauer, Jennifer A Doudna and Emmanuelle Charpentier. It is worthy of note that Emmanuelle Charpentier and Jennifer A. Doudna were awarded the Nobel Prize in Chemistry 2020 for their work on the CRISPR/Cas9 technology.

  5. 5.

    US Patent Application No 13/842,859 (filed 15 March 2013); Patent Application Publication (Doudna and others) No US 2014/0068797 A1, ‘Methods and Compositions for RNA-Directed Target DNA Modification and for RNA-Directed Modulation of Transcription’.

  6. 6.

    Le Cong and others, ‘Multiplex Genome Engineering Using CRISPR/Cas Systems’ (2013) 339(6121) Science 819-823.

  7. 7.

    US Patent Application No 14/054,414 (filed 15 October 2013); US Patent Application No 14/256,912 (filed 18 April 2014) – continuation of previous application; United States Patent (Zhang) No US 8,945,839 B2, ‘CRISPR-Cas Systems and Methods for Altering Expression of Gene Products’, Date of Patent: 03 February 2015.

  8. 8.

    University of California v Broad Institute Inc, 17-1907, US Court of Appeal for the Federal Circuit (Washington).

  9. 9.

    ‘CRISPR/Cas’ meaning: CRISPR-associated. See Martin **ek and others (2012, supra n 3).

  10. 10.

    University of California v Broad Institute Inc, 17-1907, US Court of Appeal for the Federal Circuit (Washington).

  11. 11.

    Ibid.

  12. 12.

    EPO Board of Appeal, Case T 844/18 CRISPR-Cas/BROAD INSTITUTE of 16 January 2020, ECLI:EP:BA:2020:T084418.20200116.

  13. 13.

    EP 2771468 – ‘Engineering of Systems, Methods and Optimized Guide Compositions for Sequence Manipulation’.

  14. 14.

    See: EP3241902 (A1) ‘Methods and Compositions for RNA-Directed Target DNA Modification and for RNA-Directed Modulation of Transcription’ (08.11.2017); EP2800811 (07.04.2017); EP3401400 (01.03.2019).

  15. 15.

    For instance, Vilnius University – patent holder for CRISPR systems; Rockefeller University – joint applicant with the Broad Institute; ToolGen Inc. – South Korean corporation that develops genome editing technology for human therapeutics as well as plant and animal breeding (<http://eng.toolgen.com/>); other corporate patent holders, such as Sigma-Aldrich (<https://www.sigmaaldrich.com/germany.html>) or Cellectis (<https://www.cellectis.com/>). See: Michael A Stramiello, ‘CRISPR: The New Frontier of Biotechnology Innovation’ (2018) Landslide Vol 10 No 3 <https://www.paulhastings.com/docs/default-source/default-document-library/crispr%2D%2D-the-new-frontier-of-biotechnology-innovation.pdf> accessed 1 March 2022.

  16. 16.

    Eg Editas Medicine (license to Broad’s patents); Intellia Therapeutics and Crispr Therapeutics (licenses to Dr Doudna’s patents); Caribou Biosciences (Dr Doudna as co-founder); ERS Genomics (linked to IP rights held by Dr Emmanuelle Charpentier). In Andrew Pollack, ‘Harvard and M.I.T. Scientists Win Gene-Editing Patent Fight’, The New York Times (New York, 15 February 2017); Website of Caribou Biosciences (<cariboubio.com>); Website of ERS Genomics (<ersgenomics.com>).

  17. 17.

    Jacob S Sherkow, ‘CRISPR, Patents, and the Public Health’ (2017) 90 YJBM 667.

  18. 18.

    Eg Nicolas Wade, ‘Scientists Seek Ban on Method of Editing the Human Genome’ The New York Times (New York, 19 March 2015) <https://www.nytimes.com/2015/03/20/science/biologists-call-for-halt-to-gene-editing-technique-in-humans.html> accessed 1 March 2022; Jon Cohen, ‘New Call to Ban Gene-Edited Babies Divides Biologists’ (Science News, 13 March 2019) <https://www.sciencemag.org/news/2019/03/new-call-ban-gene-edited-babies-divides-biologists#> accessed 1 March 2022; Julia Belluz, ‘After China’s Gene-edited Baby Debacle, CRISPR Scientists Want a Moratorium’ (Vox, 13 March 2019) <https://www.vox.com/science-and-health/2019/3/13/18261888/crispr-gene-editing-china-babies> accessed 1 March 2022; Ian Sample, ‘Scientists Call for Global Moratorium on Gene Editing of Embryos’ The Guardian (London, 13 March 2019) <https://www.theguardian.com/science/2019/mar/13/scientists-call-for-global-moratorium-on-crispr-gene-editing> accessed 1 March 2022; David Cyranoski, ‘The CRISPR-Baby Scandal: What’s Next for Human Gene-Editing’ (2019) 566 Nature 440-442.

  19. 19.

    Sara Reardon, ‘Human-Genome Editing Summit to Sample Global Attitudes’ (Nature News, 30 November 2015) <doi:10.1038/nature.2015.18879> accessed 1 March 2022.

  20. 20.

    These issues have been indicated in various publications. Eg David Baltimore and others, ‘A Prudent Path Forward for Genomic Engineering and Germline Gene Modification’ (2015) 348(6230) Science 36-38; Edward Lanphier and others, ‘Don’t Edit The Human Germ Line’ (2015) 519 Nature 410-411; David Cyranoski, ‘Scientists Sound Alarm over DNA Editing of Human Embryos’ (Nature News, 12 March 2015) <https://www.nature.com/news/scientists-sound-alarm-over-dna-editing-of-human-embryos-1.17110> accessed 1 March 2022.

  21. 21.

    Edward Lanphier and others (2015, supra n 20); David Baltimore and others (2015, supra n 20). The issue has also been discussed during the IGI Forum on Bioethics (Napa, California, 24 January 2015).

  22. 22.

    The National Academies of Sciences, Engineering and Medicine, ‘On Human Gene Editing: International Summit Statement’ (International Summit on Human Gene Editing, Washington DC, 01-03 December 2015) <http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12032015a> accessed 1 March 2022. Also published in: Adrian Thrasher, David Baltimore, Duanqing Pei, Eric S Lander, Ernst-Ludwig Winnacker, Françoise Baylis, George Q Daley, Jennifer A Doudna, Paul Berg, Pilar Ossorio, Qi Zhou and Robin Lovell-Badge, ‘On Human Gene Editing: International Summit Statement by the Organizing Committee’ (2016) 32 (3) Issues in Science and Technology <https://issues.org/on-human-gene-editing-international-summit-statement-by-the-organizing-committee/> accessed 1 March 2022.

  23. 23.

    Ibid.

  24. 24.

    Such as: risks of inaccurate editing; uncertainty of genetic changes on the human population; difficulty of removal of genetic alterations once they are introduced into human population; the global impact of any such alterations; dangers involved with ‘enhancement’ of human capabilities and potential of resulting social inequalities; moral aspects of changing human evolution through technology. See: The National Academies of Sciences, Engineering and Medicine, ‘On Human Gene Editing: International Summit Statement’, 3 December 2015 (supra n 22).

  25. 25.

    Ibid.

  26. 26.

    The National Academies of Sciences, Engineering and Medicine, ‘On Human Genome Editing II. Statement by the Organizing Committee of the Second International Summit on Human Genome Editing’ (Second International Summit on Human Genome Editing, Hong Kong, 27-29 November 2018) <http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b> acce accessed 1 March 2022. Proceedings of a workshop published in: The National Academies of Sciences, Engineering and Medicine, ‘Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a Workshop - in Brief’ (The National Academies Press 2019) <https://www.ncbi.nlm.nih.gov/books/NBK535994/pdf/Bookshelf_NBK535994.pdf> accessed 1 March 2022.

  27. 27.

    Ibid.

  28. 28.

    Ibid.

  29. 29.

    National Academies of Sciences, Engineering and Medicine, Report: Human Genome Editing: Science, Ethics, and Governance (National Academies Press 2017).

  30. 30.

    Eric Lander and others, ‘Adopt a Moratorium on Heritable Genome Editing. Comment’ (2019) 567 Nature 165-168.

  31. 31.

    Ibid 166.

  32. 32.

    Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, OJ of 30.07.1998, L 213 [1998] 13-21.

  33. 33.

    Michael Kosicki, Kärt Tomberg and Allan Bradley, ‘Repair of Double-Strand Breaks Induced by CRISPR-Cas9 Leads to Large Deletions and Complex Rearrangements’ (2018) 36(8) Nature Biotechnology 765-771; Emma Haapaniemi, Sandeep Botla, Jenna Persson, Bernhard Schmierer and Jussi Taipale, ‘CRISPR–Cas9 Genome Editing Induces a p53-Mediated DNA Damage Response’ (2018) 24 Nature Medicine 927-930.

  34. 34.

    Christi J Guerrini, Margaret A Curnutte, Jacob S Sherkow and Christopher T Scott, ‘The Rise of the Ethical License’ (2017) 35(1) Nature Biotechnology 22-24 p 23.

  35. 35.

    See: Sharon Begley, ‘Monsanto Licenses CRISPR Technology to Modify Crops – with Key Restrictions’ (STAT - Business, 22 September 2016) <https://www.statnews.com/2016/09/22/monsanto-licenses-crispr/> accessed 1 March 2022; Issi Rozen, ‘Licensing CRISPR for Agriculture: Policy Considerations’ (Broad Institute News, 29 September 2016) <https://www.broadinstitute.org/news/licensing-crispr-agriculture-policy-considerations> accessed 1 March 2022.

  36. 36.

    Christi J Guerrini, Margaret A Curnutte, Jacob S Sherkow and Christopher T Scott (2017, supra n 34) 23.

  37. 37.

    Andrew V Anzalone, Peyton B Randolph, Jessie R Davis, Alexander A Sousa, Luke W Koblan, Jonathan M Levy, Peter J Chen, Christopher Wilson, Gregory A Newby, Aditya Raguram and David R Liu, ‘Search-and-Replace Genome Editing Without Double-Strand Breaks or Donor DNA’ (2019) 576 Nature 149-157.

  38. 38.

    Ibid; Heidi Ledford, ‘Super-Precise New CRISPR Tool Could Tackle a Plethora of Genetic Diseases’ (2019) 574 Nature 464-465.

  39. 39.

    Suzanne Scotchmer, ‘Standing on the Shoulders of Giants: Cumulative Research and the Patent Law’ (1991) JEP 5(1) 29.

  40. 40.

    Ibid at 30.

  41. 41.

    Ibid at 31.

  42. 42.

    Ibid at 32-33.

  43. 43.

    This is a well-known problem that forcefully emerged in the BRCA1/2 genetic testing practice by Myriad Genetics. The diagnostic tests - which examined the patients’ predisposition to breast and ovarian cancer - used by Myriad Genetics during its patent monopoly period costed about USD 4.000, while similar tests used by the competing laboratories ranged from USD 250. See: David B Agus, ‘The Outrageous Cost of a Gene Test’, The New York Times (New York, 20 May 2013) <https://www.nytimes.com/2013/05/21/opinion/the-outrageous-cost-of-a-gene-test.html> accessed 1 March 2022; Elizabeth Lopatto, ‘Genetic Testing for Breast Cancer Gets More Affordable. Welcome to the Post-Patent World’ The Verge (Washington DC, 21 April 2015) <https://www.theverge.com/2015/4/21/8458553/color-breast-cancer-gene-testing-brca-myriad> accessed 1 March 2022.

  44. 44.

    Hanns Ullrich, ‘Intellectual Property: Exclusive Rights for a Purpose – The Case of Technology Protection by Patents and Copyright’ (19 November 2012) Max Planck Institute for Intellectual Property and Competition Law Research Paper No 13-01 at 16 <https://ssrn.com/abstract=2179511> accessed 1 March 2022.

  45. 45.

    Ibid at 35.

  46. 46.

    Ibid.

  47. 47.

    Ibid at 35-36.

  48. 48.

    Such as: ‘promote innovation, improve competitiveness, enable broad dissemination, support the development of the labour market, fight organized crime, in sum: help mankind!’. In Hanns Ullrich (2012, supra n 44) at 15 n 61.

  49. 49.

    Jacob S Sherkow, ‘Who Owns Gene Editing? Patents in the Time of CRISPR’ (2016) Biochemical Society 26 at 26-27.

  50. 50.

    Hanns Ullrich, ‘Strategic Patenting by the Pharmaceutical Industry: Towards a Concept of Abusive Practices of Protection’ in Josef Drexl and Nari Lee (eds), Pharmaceutical Innovation, Competition and Patent Law (Edward Elgar 2013) at 252.

  51. 51.

    Jacob S Sherkow (2016, supra n 49) at 27, 29.

  52. 52.

    Hanns Ullrich (2012, supra n 44) at 16.

  53. 53.

    Jacob S Sherkow (2017, supra n 17) at 668.

  54. 54.

    Ibid.

  55. 55.

    Michael A Heller and Rebecca S Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280 Science 698. This concern about privatization of biomedical upstream research (and its underuse) was directly linked to the policy of the US Congress to use the patent system in relation to inventions made by the universities and research institutions that arise from federal funding for the purpose of making these inventions subsequently available to private commercial actors (35 USC §200; introduced by Act of 12 December 1980, Pub L No 96-517, 94 Stat 3015-28 (1980) and known as the Bayh-Dole/ University and Small Business Patent Procedures Act of 1980). The authors suggested that privatization of basic research by too many entities can eventually impede future research and creation of downstream product development (‘a tragedy of the anticommons’).

  56. 56.

    Rebecca S Eisenberg, ‘Noncompliance, Nonenforcement, Nonproblem – Rethinking the Anticommons in Biomedical Research’ (2008) 45 HousLRev 1059 at 1061-1062, 1065-1067. See also: William Lesser, ‘Whither the Research Anticommons?’ in Nicholas Kalaitzandonakes, Elias G Carayannis, Evangelos Grigoroudis and Stelios Rozakis (eds), From Agriscience to Agribusiness. Theories, Policies and Practices in Technology Transfer and Commercialization (Springer 2018) 131-144.

  57. 57.

    Ibid at 1063-1064, 1075, 1078-1079.

  58. 58.

    Jonathan M Barnett, ‘The Anti-Commons Revisited’ (2015) HarvJOLT 29(1) 128 at 144; Geertrui Van Overwalle, ‘Patent Pools and Clearinghouses in the Life Sciences: Back to the Future’ in Duncan Matthews and Herbert Zech (eds), Research Handbook on Intellectual Property and the Life Sciences (Edward Elgar 2017) 304 <https://ssrn.com/abstract=2729809> accessed 1 March 2022.

  59. 59.

    Rebecca S Eisenberg (2008, supra n 56) at 1071-1072; Mildred K Cho, Samantha Illangasekare, Meredith A Weaver, Debra GB Leonard and Jon F Merz, ‘Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services’ (2003) 5(1) JMolDiagn 3-8.

  60. 60.

    Jorge L Contreras, ‘The Anticommons at Twenty: Concerns for Research Continue’ (2018) 361(6400) Science 335.

  61. 61.

    Michael A Heller and Rebecca S Eisenberg (1998, supra n 55) at 700, 701.

  62. 62.

    Hanns Ullrich (2013, supra n 50) at 243.

  63. 63.

    Jorge L Contreras (2018, supra n 60) at 336.

  64. 64.

    Robert Cook-Deegan and Amy L McGuire, ‘Moving Beyond Bermuda: Sharing Data to Build a Medical Information Commons’ (2017) 27 Genome Res 897-901; See also: National Institutes of Health (NIH) Website <https://ghr.nlm.nih.gov/primer/precisionmedicine/initiative> and <https://allofus.nih.gov/protecting-data-and-privacy/precision-medicine-initiative-privacy-and-trust-principles> accessed 1 March 2022.

  65. 65.

    NIH, National Cancer Institute Website <https://gdc.cancer.gov/> accessed 1 March 2022.

  66. 66.

    Hanns Ullrich (2013, supra n 50) at 251.

  67. 67.

    Ibid at 251.

  68. 68.

    For example, the University of California has patent rights over 16 CRISPR-Cas9 inventions. See: Public Affairs of UC Berkeley, ‘UC Now Holds Largest CRISPR-Cas9 Patent Portfolio’ (Berkeley News, 01 October 2019) <https://news.berkeley.edu/2019/10/01/uc-now-holds-largest-crispr-cas9-patent-portfolio/> accessed 1 March 2022.

  69. 69.

    Hanns Ullrich (2013, supra n 50) at 246.

  70. 70.

    Ibid.

  71. 71.

    Ibid at 247, 248-249.

  72. 72.

    Ibid at 247.

  73. 73.

    Hanns Ullrich, ‘Patent Pools – Policy and Problems’ in Josef Drexl (ed), Research Handbook on Intellectual Property and Competition Law (Edward Elgar 2008) 139 at 143-144.

  74. 74.

    Ibid at 144.

  75. 75.

    Jorge L Contreras (2018, supra n 60) at 336.

  76. 76.

    Broad Institute, ‘Press Releases: Broad Institute of MIT and Harvard Joins Discussions to Create Worldwide CRISPR-Cas9 Licensing Pool’ (Broad Institute News, 10 July 2017) <https://www.broadinstitute.org/news/broad-institute-mit-and-harvard-joins-discussions-create-worldwide-crispr-cas9-licensing-pool> accessed 1 March 2022; Broad Institute, ‘Broad Institute and MilliporeSigma announce CRISPR License Framework to Encourage Innovation’ (Broad Communications News, 18 July 2019) <https://www.broadinstitute.org/news/broad-institute-and-milliporesigma-announce-crispr-license-framework-encourage-innovation> accessed 1 March 2022.

  77. 77.

    MPEG LA Website: <https://www.mpegla.com/>; MPEG LA CRISPR page: <https://www.mpegla.com/crispr/> accessed 1 March 2022.

  78. 78.

    MPEG LA, ‘MPEG LA News Release: MPEG LA Invites CRISPR-Cas9 Patents to be Pooled in a One-Stop License’ (MPEG LA, 25 April 2017) <https://www.mpegla.com/wp-content/uploads/CRISPRPatentCallPrsRls2017-04-25.pdf> accessed 1 March 2022.

  79. 79.

    Peter Leung, ‘Patent Pool Seeks to Ease Gene-Editing Tech Licensing’ (2017) BNA’s Patent, Trademark & Copyright Journal – Daily Edition of 02 August 2017, 147 PTD <https://www.mpegla.com/wp-content/uploads/Patent-Pool-Seeks-to-Ease-Gene-Editing-Tech-Licensing.pdf> accessed 1 March 2022.

  80. 80.

    Broad Institute (2017 and 2019, supra n 76).

  81. 81.

    Broad Institute, ‘Information About Licensing CRISPR Systems, Including for Clinical Use’ <https://www.broadinstitute.org/partnerships/office-strategic-alliances-and-partnering/information-about-licensing-crispr-genome-edi> accessed 1 March 2022.

  82. 82.

    See: Editas Medicine, ‘Press Release: Editas Medicine Licenses Genome Editing Technology From Broad Institute and Harvard University’ (Editas Medicine, 01 December 2014) <https://ir.editasmedicine.com/news-releases/news-release-details/editas-medicine-licenses-genome-editing-technology-broad?ID=2125239&c=254265&p=irol-newsArticle> accessed 1 March 2022.

  83. 83.

    James Love, ‘NIH Response to KEI Request for NIH Policy on the Licensing of Federally-Funded CRISPR Patented Inventions’ (Knowledge Ecology International, 03 August 2017) <https://www.keionline.org/23413> accessed 1 March 2022.

  84. 84.

    Michael A Stramiello (2018, supra n 15).

  85. 85.

    Peter Leung (2017, supra n 79).

  86. 86.

    See: ‘University of California Awarded Additional US Patent for Regulating Gene Editing and Expression’ (BioSpace, 04 June 2019) <https://www.biospace.com/article/releases/university-of-california-awarded-additional-u-s-patent-for-regulating-gene-editing-and-expression/> accessed 1 March 2022. Source: University of California, Office of the President.

  87. 87.

    Peter Leung (2017, supra n 79).

  88. 88.

    Aggie Mika, ‘Flux and Uncertainty in the CRISPR Patent Landscape’ (The Scientist, 30 September 2017) <https://www.the-scientist.com/bio-business/flux-and-uncertainty-in-the-crispr-patent-landscape-30228> accessed 1 March 2022.

  89. 89.

    As expressed by Jacob S Sherkow in ibid.

  90. 90.

    See: Andrew Pollack, ‘Myriad Genetics Ending Patent Dispute on Breast Cancer Risk Testing’, The New York Times (New York, 27 January 2015) <http://www.nytimes.com/2015/01/28/business/myriad-genetics-ending-patent-dispute-on-breast-cancer-risk-testing.html?_r=0> accessed 1 March 2022; Tess Stynes, ‘Quest, Myriad Settle Patent Dispute on Breast Cancer Tests’ (The Wall Street Journal, 09 February 2015) <http://www.wsj.com/articles/quest-myriad-settle-patent-dispute-on-breast-cancer-tests-1423493273> accessed 1 March 2022.

  91. 91.

    Association for Molecular Pathology v Myriad Genetics, 569 US 12-398, 133 SCt 2107 (US 2013).

  92. 92.

    Hanns Ullrich (2008, supra n 73) at 143.

  93. 93.

    Hanns Ullrich, ‘Gene Patents and Clearing Models’ in Geertrui Van Overwalle (ed), Gene Patents and Collaborative Licensing Models. Patent Pools, Clearinghouses, Open Source Models and Liability Regimes (CUP 2009) 339 at 343.

  94. 94.

    Ibid at 340.

  95. 95.

    Arti K Rai and Robert Cook-Deegan, ‘Racing for Academic Glory and Patents: Lessons from CRISPR’ (2017) 358(6365) Science 874-876 at 874.

  96. 96.

    Birgit Verbeure, ‘Patent Pooling for Gene-based Diagnostic Testing’ in Geertrui Van Overwalle (ed), Gene Patents and Collaborative Licensing Models (CUP 2009) 3 at 15.

  97. 97.

    Hanns Ullrich (2008, supra n 73) at 146.

  98. 98.

    Arti K Rai and Robert Cook-Deegan (2017, supra n 95) at 876.

  99. 99.

    Jorge L Contreras and Jacob S Sherkow, ‘CRISPR, Surrogate Licensing and Scientific Discovery’ (2017) 355(6326) Science 698-700 at 699.

  100. 100.

    Broad Institute (18 July 2019, supra n 76); Broad Institute, ‘MilliporeSigma to Offer Non-Exclusive Licenses to CRISPR IP’ (Genetic Engineering & Biotechnology News, 23 July 2019) <https://www.genengnews.com/news/broad-institute-milliporesigma-to-offer-non-exclusive-licenses-to-crispr-ip/> accessed 1 March 2022.

  101. 101.

    Christi J Guerrini, Margaret A Curnutte, Jacob S Sherkow and Christopher T Scott (2017, supra n 34) at 23.

  102. 102.

    OECD, Guidelines for the Licensing of Genetic Inventions (OECD 2006) at 16.

  103. 103.

    As was recommended by the US National Institutes of Health (NIH) in 1999 in relation to research obtained with federal funding. See: Jorge L Contreras and Jacob S Sherkow (2017, supra n 99) at 700.

  104. 104.

    Hanns Ullrich (2013, supra n 50) at 254-255.

  105. 105.

    Ibid at 255-266.

  106. 106.

    William Lesser (2018, supra n 56) 131-144.

  107. 107.

    James Love (03 August 2017, supra n 83).

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  1. The Hague University of Applied Sciences, The Hague, Netherlands

    Agnieszka A. Machnicka

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  1. Law Institute, Carl von Ossietzky University Oldenburg, Oldenburg, Germany

    Christine Godt

  2. Max Planck Institute for Innovation and Competition, Munich, Germany

    Matthias Lam**

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Machnicka, A.A. (2023). Gene Editing Technology Patents or Monopolization of Scientific Knowledge and Health Care?. In: Godt, C., Lam**, M. (eds) A Critical Mind. MPI Studies on Intellectual Property and Competition Law, vol 30. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-65974-8_24

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