Crispr Genom Düzenleme Teknolojileri: Patentlenebilirlikleri ve Covid-19 Salgınında Kullanımı

Yıl 2021, Sayı: 66, 227 - 292, 18.05.2021

Tamer Soysal

Öz

Ekim 2020’de Emmanuelle Charpentier ve Jennifer Doudna “moleküler makas” olarak da adlandırılan CRISPR/Cas9 teknolojilerine ilişkin buluşları nedeniyle Nobel Ödülü’ne layık görülmüşlerdir. Bu teknolojilerin ortaya çıkmasından sonra son on yıl önemli bir patent yarışına sahne olmaktadır. Bu yeni teknolojilerin patentlenmesi genel olarak buluş konusu ve kamu düzeni/ahlaka aykırılık ölçütleri yönünden tartışılmaktadır. Buna karşılık bu teknolojilerin yenilik içerdiği, buluş basamağı ve sanayiye uygulanabilir olduğu genel olarak kabul edilmektedir. Bu nedenle patent yarışı, buluşların patentlenebilirliğine değil, buluşların sahipliğine ilişkin oluşmaktadır. Bu yeni teknolojiden COVID-19 pandemisinde de başarıyla faydalanılmaktadır. Ancak CRISPR teknolojilerinin kullanım alanının sınırları konusundaki belirsizlikler, bu teknolojilerin patentlenmesine yönelik sınırlamalar konulmasını da gerekli kılmaktadır.

Anahtar Kelimeler

CRISPR, Genom Düzenleme, Biyoteknoloji, Patent, Buluş Konusu, Patentlenebilirlik

Kaynakça

• • Adcock, Mike; Llewellyn, Margaret, TRIPS and the patentability of microorganisms, BioScience Law Review, V. 4, I. 3, 2001.
• • Akbudak, M. Aydın; Kontbay, Kübra; Yeni Nesil Genom Düzenleme Teknikleri: ZFN, TALEN, CRISPR'lar ve Bitkilerde Kullanımı, Tarla Bitkileri Merkez Araştırma Enstitüsü Dergisi, 26, 1 (2017 (s. 111-126).
• • Amardeep, Sharma, Zaidi, Kisa;Sharma, Shalu; Sharma, Vikas; Designer Nucleases for Genome Editing in Plants: Different Approaches and Applications, International Journal of Pure &Applied Bioscience, 5 (6), 2017, http://www.ijpab.com/form/2017%20Volume%205,%20issue%206/IJPAB-2017-5-6-1389-1402.pdf (Son Erişim Tarihi: 21.03.2021).
• • Anderson, Kelly M.; Poosala, Pornthida; Lindley, Sean R.; Anderson, Douglas M.; Targeted Cleavage and Polyadenylation of RNA by CRISPR-Cas13, The Preprint Server for Biology, January 2019, https://www.biorxiv.org/content/10.1101/531111v1.full.pdf (Son Erişim Tarihi: 24.02.2021). • Attar, Azade, Gen Terapi Yöntemleri: Fiziksel ve Kimyasal Metodlar, Türk Hijyen ve Deneysel Biyoloji Dergisi, 2017, 74 (1) (s. 103-112).
• • Baer, Neal, Covid-19 is scarcy. Could a rogue scientist use CRISPR to conjure another pandemic, March 26 ,2020, https://www.statnews.com/2020/03/26/could-rogue-scientist-use-CRISPR-create-pandemic/ (Son Erişim Tarihi: 02.03.2021).
• • Bent, Stephen A.; Sachwaab, Richard L.; Conlin, David G.; Jeffrey, Donald D.; Intellectual Property Rights in Biotechnology Worldwide, Stockton Press, 1987., s. 103. (Bent ve Diğerleri).
• • Borella, Michael, The Zombie Apocalypse of Patent Eligibility Reform and a Possible Escape Route, February 4, 2020, https://www.patentdocs.org/patent_legislation/ (Son Erişim Tarihi: 17.02.2021).
• • Bozkurt Yüksel, Armağan Ebru, Yapay Zekânın Buluşlarının Patentlenmesi, Uyuşmazlık Mahkemesi Dergisi, Y. 6, S. 11, Haziran 2018 (s. 585-622).
• • Broughton, James P.; Deng, Xianding; Yu, Guixia; Servellita, Venice ve Diğerleri, CRISPR-Cas12-based detection of SARS-CoV-2, April 2020, Nature Biotechnology, (870-874), https://www.nature.com/articles/s41587-020-0513-4 (Son Erişim Tarihi: 15.03.2021).
• • Busby, Helen; Hervey, Tamara; Mohr, Alison, Ethical EU Law? The Influence of the European Group on Ethics in Science and New Technologies, University of Leicester, Law Review, December 2008 (s. 803-842).
• • Chauvin, Noah C., Custom-Edited DNA: Legal Limits on the Patentability of CRISPR-Cas9’s Therapeutic Applications, William & Mary Law Review, V. 60, I. 1, 2018 (s. 297-333).
• • Chow, Ronald, Is it Time for Artificial Intelligence to Invade Personal Privacy, for Pandemic Control, N. 28, 2020, Harvard Public Health Review, https://harvardpublichealthreview.org/artificial-intelligence-pandemic-control/ (Son Erişim Tarihi: 15.03.2021).
• • Cohen, Jon, The Latest Round in the CRISPR Patent Battle has an apparent Victor, but the fight continues, September 11, 2020, https://www.sciencemag.org/news/2020/09/latest-round-CRISPR-patent-battle-has-apparent-victor-fight-continues (Son Erişim Tarihi: 24.02.2021).
• • Corcoran, Michael; Campbell, Melissa, Clean Meat: Can Lab-Grown, or Cultivated, Meat Reduce the Threat of Future Pandemics, September 24, 2020, https://www.hilldickinson.com/insights/articles/clean-meat-can-lab-grown-or-cultivated-meat-reduce-threat-future-pandemics (Son Erişim Tarihi: 15.03.2021).
• • Corum, Jonathan; Zimmer, Carl, How the Pfizer-BionTech Vaccine Works, March 22, 2021, https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html (Son Erişim Tarihi: 27.03.2021).
• • Cumbers, John, A-20 Minute Covid-19 Test Using CRISPR Gene Editing Technology, Coming Soon to Your Doctor’s Office, Supermarket and Workplace, July 1, 2020, https://www.forbes.com/sites/johncumbers/2020/07/01/a-new-20-minute-covid-19-test-will-use-CRISPR-gene-editing-technology-to-deliver-results-at-the-doctors-office-supermarket-or-workplace/?sh=60ab74cf7a55 (Son Erişim Tarihi: 01.03.2021).
• • Çoban, Harun, Vegetatif Olarak Üretilen Bitkilerde Mutasyon Islahı, Selçuk Üniversitesi, Ziraat Fakültesi Dergisi, 17 (31), 2003 (s. 62-67).
• • Dent, Michael, Plant-based and Cultured Meat 2020-2030, https://www.idtechex.com/en/research-report/plant-based-and-cultured-meat-2020-2030/702 (Son Erişim Tarihi: 17.03.2021).
• • Depew, David J.; Weber, Bruce W., Evolution at a Crossroads: The New Biology and the New Philosophy of Science, Cambridge, MIT Press, 1985 (s. 21-42).
• • Doudna, Jennifer, Genome-Editing Revolution: My Whirlwind year with CRISPR, 22 December 2015, https://www.nature.com/news/genome-editing-revolution-my-whirlwind-year-with-CRISPR-1.19063 (Son Erişim Tarihi: 19.10.2020).
• • Erduran, Tuğçe Yıldız, DNA, Organik Bir Yazılım Olarak Tasvir Edilebilir mi? Myriad Kararı ile USPTO Yazılım Patentlerine Bir Bakış, Fikri Mülkiyet Hukuku Yıllığı 2019, Editör: Tekin Memiş, Yetkin, Ankara, 2020 (s. 93-112).
• • Ergül, Ali, Bitkilerde Fonksiyonel Genombilim, Bitkilerde Genom Düzenlemesi (CRISPR/ Cas9), s. 5 vd., https://acikders.ankara.edu.tr/course/view.php?id=4589#section-13 (Son Erişim Tarihi: 01.10.2020).
• • Gehrke, Lisa M., Is Gene Editing Patentable, Ama Journal of Ethics, December 2019, V. 21, N. 12, 2019 (s. 1049-1055).
• • Gün Gök, Zehra; Çağdaş Tunalı, Beste; CRISPR-Cas İmmün Sisteminin Biyolojisi, Mekanizması ve Kullanım Alanları, Kırıkkale Üniversitesi, Mühendislik Fakültesi, Uluslararası Mühendislik Araştırma ve Geliştirme Dergisi, C. 8, S.2, Haziran 2016 (s. 11-23).
• • Hasöksüz, Mustafa; Kılıç, Selçuk; Saraç, Fahriye; Coronaviruses and SARS-COV-2, Turkish Journal of Medical Sciences, V. 50, 2020 (s. 549-556).,s. 549., https://journals.tubitak.gov.tr/medical/issues/sag-20-50-si-1/sag-50-si-1-10-2004-127.pdf.
• • Hroncich, Caroline, The CRISPR Patent Debate, August 19, 2016, https://www.biopharminternational.com/view/CRISPR-patent-debate (Son Erişim Tarihi: 10.03.2021).
• • Ishino, Yoshizumi; Krupovic, Mart; Forterre, Patrick; History of CRISP-Cas from Encounter with a Mysterious Repeated Sequence to Genome Editing Technology, American Society for Microbiology, Journal of Bacteriology, V. 200, I. 7, April 2018, https://jb.asm.org/content/jb/200/7/e00580-17.full.pdf (Son Erişim Tarihi. 15.03.2021).
• • Jiang, Fuguo; Doudna, A. Jennifer; The Structural Biology of CRISPR-Cas Systems, Current Opinion in Structural Biology, February 2015, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4417044/ (Son Erişim Tarihi: 30.03.2021).
• • Ku, Deborah, The Patentability of the CRISPR-Cas9 Genome Editing Tool, Chicago-Kent Journal of Intellectual Property, V. 16, I. 2, Article 8, 2017 (s. 408-439).
• • Kumar, Abhinav, Towards Patentability of Essentially Biological Processes, V. 13, March 2008, Journal of Intellectual Property Rights (s. 129-138).
• • Lai, C. Jessica; Myriad Genetics and the BRCA Patents in Europe: The Implications of the US Supreme Court Decision, UC Irvine Law Review, V. 5, 2015, https://scholarship.law.uci.edu/cgi/ (s. 1041-1076)(Son Erişim Tarihi: 30.03.2021)
• • Lander, Eric S., The Heroes of CRISPR, Cell Press Journal, 164, January 2016, https://www.cell.com/cell/pdf/S0092-8674(15)01705-5.pdf, (s. 18-28).
• • Lofti, Melika; Rezaei, Nima, CRISPR/Cas13: A Potential Therapeutic Option of COVID-19, V. 131, November 2020, BioMedicine & Pharmacotheraphy, https://www.sciencedirect.com/science/article/pii/S0753332220309318 (Son Erişim Tarihi: 15.03.2021).
• • McCorduck, Pamela, Machines Who Think, A Personal Inquiry into the History and Prospects of Artificial Intelligence, CRC Press, 2019.
• • Minsky, Marvin, https://www.britannica.com/biography/Marvin-Lee-Minsky (Son Erişim Tarihi: 29.12.2019).
• • Motta, Benedetta M.; Pramstaller, Peter P.; Hicks, Andrew A.; Rossini, Alessandra; The Impact of CRISPR/Cas9 Technology on Cardiac Research: From Disease Modelling to Therapeutic Approaches, Stem Cells International Journal, 2017, https://www.ncbi.nlm. nih.gov/pmc/articles/PMC5757142/ (Son Erişim Tarihi: 15.02.2021).
• • Murphy, Kent, The Traditional View of Public Policy and Ordre Public in Private International Law, University of Georgia School of Law Journal of International & Comparative Law, V. 11-3, 1981 (s. 591-615).
• • Öztürk, Özgür, Türk Hukukunda Patent Verilebilirlik Şartları, Arıkan Yayıncılık, Haziran 2008, İstanbul.
• • Palaz, Fahreddin; Kalkan, Ali Kerem; Tozluyurt, Abdullah; Önsöz, Mehmet; CRISPR-based tools: Alternative Methods for the Diagnosis of Covid-19, V. 89, March 2021, Clinical Biochemistry, (s. 1-13), https://www.sciencedirect.com/science/article/pii/S0009912021000011 (Son Erişim Tarihi: 15.03.2021).
• • Papasavva, Panayiota; Kleanthous, Marina; Lederer, Carsten W.; Rare Opportunities: CRISPR/Cas-Based Therapy Development for Rare Genetic Diseases, Molecular Diagnosis & Therapy, April 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469594/ (Son Erişim Tarihi: 01.03.2021).
• • Razzaq, Ali; Saleem, Fozia; Kanwal, Mehak; Mustafa, Ghulam ve Diğerleri, Modern Trends in Plant Genome Editing: An Inclusive Review of the CRISPR/Cas9 Toolbox, International Journal of Molecular Sciences, August 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6720679/ (Son Erişim Tarihi: 24.09.2020).
• • Regalado, Antonio, Who Owns the Biggest Biotech Discovery of the Century, December 2014, https://www.technologyreview.com/2014/12/04/170211/who-owns-the-biggest-biotech-discovery-of-the-century/ (Son Erişim Tarihi: 24.01.2021).
• • Rinde, Melr, The Death of Jesse Gelsinger, 20 Years Later, June 4, 2019, https://www.sciencehistory.org/distillations/the-death-of-jesse-gelsinger-20-years-later (Son Erişim Tarihi: 24.01.2021).
• • Rubeis, Giovanni; Steger, Florian, Risks and Benefits of Human Germline Genome Edting: An Ethical Analysis, Asian Bioethics Review, July 2018, V. 10, I. 2, (s. 133-141), https://link.springer.com/article/10.1007/s41649-018-0056-x (Son Erişim Tarihi: 14.03.2021).
• • Saey, Tina Hesman, CRISPR enters its first human clinical trials, August 14, 2019, https://www.sciencenews.org/article/CRISPR-gene-editor-first-human-clinical-trials (Son Erişim Tarihi: 24.01.2020).
• • Safari, Fatemeh; Zare, Khadijeh; Negahdaripour, Manica ve Diğerleri, CRISPR Cpf1 Proteins: Structure, Function and Implications for Genome Editing, Cell & Bioscience Journal, 9 May 2019, https://cellandbioscience.biomedcentral.com/articles/10.1186/s13578-019-0298-7 (Son Erişim Tarihi: 24.02.2021).
• • Sarı, Onur; Türk Patent Kurumu Nezdinde Patent Edinme Sürecinin Hukuki Değerlendirmesi, TBB Dergisi, S. 144, 2019 (s. 299-354).
• • She, Qunxin; Han, Wenyuan; Archaea and CRISPR Technology, 8 August 2017, https://microbiologysociety.org/publication/past-issues/archaea/article/archaea-and-CRISPR-biology.html (Son Erişim Tarihi: 05.02.2021)
• • Shereen, Muhammad Adnan; Khan, Suliman; Kazmi, Abeer; Bashir, Nadia; Siddique, Rabeea; COVID-19 Infection: Origin, Transmission, and Characteristics of Human Coronaviruses, Journal of Advanced Research, March 2020, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113610/ (Son Erişim Tarihi: 22.03.2021).
• • Sherkow, Jacob S., Patent Protection for CRISPR: An ELSI Review, Journal of Law and Biosciences, V. 4, I. 3, December 2017, https://academic.oup.com/jlb/article/ 4/3/565/4706243 (Son Erişim Tarihi: 05.01.2021).
• • Sherkow, Jacom S., The CRISPR Patent Decision Didn’t Get the Science Right. That Doesn’t Mean It Was Wrong, September 11, 2018, https://www.statnews.com/2018/09/11/CRISPR-patent-decision-science/ (Son Erişim Tarihi: 24.02.2021).
• • Shwartz, Mark, CRISPR is a revolutionary gene-editing tool, but it’s not without risk, Winter 2018, https://stanmed.stanford.edu/2018winter/CRISPR-for-gene-editing-is-revolutionary-but-it-comes-with-risks.html (Son Erişim Tarihi: 23.02.2021).
• • Simon, Jürgen, Patent Hukuku ve Biyoteknoloji: Yaşamın Patentlenmesi mi?, Çeviri: M. Fadıl Yıldırım; Tekin Memiş, Mayıs 2005, S. 39, http://www.e-akademi.org
• • Siva, Nayanah; Myriad wins BRCA1 row, Nature Biotechnology, 27 (8), January 2009.
• • Soysal, Tamer, Bitmeyen Hikaye: Bitkilerin Patentlenebilirliği, Fikri Gündem Dergisi, AIPPI Türkiye Bülteni, Nisan 2020, (s. 23-30).
• • Soysal, Tamer, Endüstri 4.0 ve İnsan Hakları: Yeni Ortaya Çıkan Teknolojilerin İnsan Hakları Üzerindeki Dönüştürücü Etkileri, Ankara Barosu XI. Uluslararası Hukuk Kurultayı, 9-12 Ocak 2020, Bildirgeler Kitabı, (s. 245-325), http://www.ankarabarosu.org.tr/Siteler/2012yayin/2011sonrasikitap/2020-hukuk-kurultayi-1-cilt.pdf, s. 276 vd.(Soysal, Endüstri 4.0).
• • Soysal, Tamer, Tarımda Biyoteknoloji Uygulamaları ve Patent Hakları (Agricultural Biotech Patent Law), Adalet Yayınları, Mayıs 2019, s. 135. (Soysal, Agricultural Biotech Patent Law).
• • Strandburg, J. Katherine; Legal But Unacceptable: Pallin v. Singer and Physician Patenting Norms, Law & Economics Research Paper Series Working Paper. 14-42, 2014, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2538557 (Son Erişim Tarihi: 30.03.2021)
• • Suluk, Cahit; Karasu, Rauf; Nal, Temel; Fikri Mülkiyet Hukuku, Güncellenmiş 4. Baskı, Ankara, 2020.
• • Surden, Harry, Machine Learning and Law, Washington Law Review, 87, 2014, https://scholar.law.colorado.edu/articles/81/ (Son Erişim Tarihi: 01.03.2021).
• • Tekinalp, Ünal; Fikri Mülkiyet Hukuku, Vedat Kitapçılık, İstanbul, 2012.
• • Uddin, Fathema; Rudin, Charles M.; Sen, Triparna, CRISPR Gene Theraphy: Applications, Limitations, and Implications for the Future, Frontiers in Oncology, August 2020, V. 10, Article 1387, https://www.frontiersin.org/articles/10.3389/fonc.2020.01387/full (Son Erişim Tarihi: 15.03.2021).
• • Ürek, Duygu; Karaman, Sevilay, Önemli Bir Halk Sağlığı Sorunu Olarak Nadir Hastalıklar ve Yetim İlaçlar, Hacettepe Sağlık İdaresi Dergisi, 22 (4), 2019 (s. 863-878).
• • V’Kovski, Philip; Kratzel, Annika; Steiner, Silvio; Stalder, Hanspeter; Thiel, Volker; Coronavirus Biology and Replication: Implications for SARS-CoV2, Nature Reviews Microbiology, V. 19, 2021, (s. 155-170), http://www.nature.com.
• • Wachowicz, Jessica, The Patentability of Gene Editing Technologies such as CRISPR & the Harmonization of Laws Relating to Germline Editing, Intellectual Property Brief, V. 10, I. 1, 2019 (s. 34-45).
• • Warren-Jones, Amanda, Finding a 'Common Morality Codex' for Biotech - A Question of Substance, International Review of Industrial Property and Copyright Law, 6-39, 2008 (s. 638-661).
• • Yeager, Ashley, Machine Learning Algorithms Predict the Repairs Made to DNA after Cas9 Cuts, May 1, 2019, https://www.the-scientist.com/the-literature/could-ai-make-gene-editing-more-accurate-65781 (Son Erişim Tarihi: 25.02.2021).
• • Yusufoğlu, Fülurya, Patent Verilebilirlik Şartları, Vedat Kitapçılık, Ocak 2014.
• • A Brief Guide to Current CRISPR Landscape, https://www.the-scientist.com/news-opinion/a-brief-guide-to-the-current-CRISPR-landscape--66128 (Son Erişim Tarihi: 21.01.2021).
• • AccessNow, Human Rights in the Age of Artificial Intelligence, November 2018, https://www.accessnow.org/cms/assets/uploads/2018/11/AI-and-Human-Rights.pdf (Human Rights in the Age of AI, 2018).
• • Algorithms and Human Rights, Study on the Human Rights Dimensions of Automated Data Processing Techniques and Possible Regulatory Implications, Council of Europe Study, Prepared by Committee of Experts on Internet Intermediaries (MSI-NET), 2017, https://edoc.coe.int/en/internet/7589-algorithms-and-human-rights-study-on-the-human-rights-dimensions-of-automated-data-processing-techniques-and-possible-regulatory-implications.html, s. 41 vd. (Algorithms and Human Rights).
• • Artificial Intellegence, https://www.sciencedaily.com/terms/artificial_intelligence.htm (Son Erişim Tarihi: 29.12.2019).
• • Case Law of Boards of Appeal, 9th Edition, July 2019, https://www.epo.org/law-practice/case-law-appeals/case-law.html (Son Erişim Tarihi: 15.03.2021).
• • Centers for Disease Control and Prevention, Human Coronavirus Types, https://www.cdc.gov/coronavirus/types.html (Son Erişim Tarihi: 21.03.2021).
• • Covid 19 Public Health Emergency of International Concern (PHEIC), 11-12 February 2020, https://www.who.int/publications/m/item/covid-19-public-health-emergency-of-international-concern-(pheic)-global-research-and-innovation-forum.(Son Erişim Tarihi: 21.03.2021).
• • EPO, Patenting Trends in 2020, https://www.epo.org/about-us/annual-reports-statistics/statistics/2020/patenting-trends.html (Son Erişim Tarihi: 15.03.2021).
• • Genetic Scissors: A Tool for Rewriting the Code of Life, https://www.nobelprize.org/prizes/chemistry/2020/press-release/ (Son Erişim Tarihi: 25.01.2021)
• • Genetically Modified Crops, http://www.fao.org/docrep/015/i2490e/i2490e04d.pdf (Son Erişim Tarihi: 25.02.2021).
• • Guidelines for Examination in the European Patent Office, March 2021, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/index.htm (EPO Guidelines, 2021).
• • Manual of Patent Examining Procedure (MPEP), Ninth Edition, Last Revised, June 2020, . https://www.uspto.gov/web/offices/pac/mpep/index.html (Son Erişim Tarihi: 15.03.2021).
• • MERS için bkz. Centers for Disease Control and Prevention,, Middle East Respiratory Syndrome (MERS), https://www.cdc.gov/coronavirus/mers/about/index.html (Son Erişim Tarihi: 21.03.2021).
• • National Human Genome Research Institute, Genetics vs. Genomics Fact Sheet, https://www.genome.gov/about-genomics/fact-sheets/Genetics-vs-Genomics (Son Erişim Tarihi: 25.02.2021).
• • Novel Coronavirus-China, https://www.who.int/csr/don/12-january-2020-novel-coronavirus-china/en/ (Son Erişim Tarihi: 21.03.2021).
• • SARS için bkz. Centers for Disease Control and Prevention, SARS Basics Fact Sheet, https://www.cdc.gov/sars/about/fs-sars.html (Son Erişim Tarihi: 21.03.2021).
• • The European Patent Convention, Implementing Regulations to the Convention on the Grant of European Patents, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ma2.html (Son Erişim Tarihi: 30.03.2021)
• • United States Patent and Trademark Office-USPTO, https://www.uspto.gov/.