إشكاليات منح حق براءة الاختراع للأدوية المطورة ببرامج الذكاء الاصطناعي دراسة تحليلية في قانون حماية حقوق الملكية الفكرية المصري رقم 82 لسنة 2002 والإرشادات الدولية

نوع المستند : المقالة الأصلية

المؤلف

قسم القانون الخاص, كلية الشريعة والقانون, جامعة الأزهر, القاهرة, مصر.

المستخلص

يتناول هذا البحث الإشكاليات التي تعوق اجتياز الأدوية الطبية التي تم تطويرها بواسطة برامج الذكاء الاصطناعى لمتطلب عدم الوضوح اللازم للحصول على حق براة الاختراع، وذلك من خلال دراسة تحليلية في قانون حماية حقوق الملكية الفكرية المصري رقم 82 لسنة 2002، وارشادات المنظمة العالمية للملكية الفكرية. وقد هدف البحث إلى معالجة أهم الإشكاليات التي تثيرها استخدام برامج الذكاء الاصطناعى في صناعة الأدوية الجديدة، وبوسائل تتفق مع طبيعة تلك التقنية المتطورة، وذلك من خلال ثلاث مباحث؛ الأول: في تعريف الذكاء الاصطناعي في مجال البحوث الصيدلانية. وتناولنا خلاله الحديث عن مفهوم الذكاء الاصطناعي، ثم نبذه عن ابرز تطبيقات برامج الذكاء الاصطناعي في مجال تطوير الأدوية. والثاني: في التعريف بحق براءة الاختراع، وبينا من خلاله ماهية البراءة ومتطلبات الحصول على تلك البراءة وخاصة ضرورة استيفاء الاختراع المطالب به معيار عدم الوضوح أو الابتكارية. أما المبحث الثالث فقد خصصناه للحديث عن عوائق استخدام الذكاء الاصطناعي في اختراعات الأدوية و الوسائل العلاجية للحد من تلك الاشكاليات. وقد انتهى البحث إلى جملة من النتائج والتوصيات حول موضوعه، وأهمها يدور حول ضرورة تعديل المعياير المطلوبة لاستيفاء متطلب عدم الوضوح بما يتناسب مع التطور المتسارع لاستخدامات برامج الذكاء الأصطناعى في مجال البحوث الصيدلانية، وبما يتسق مع القواعد العامة والمتطلبات التشريعية لمنح حق براءة الاختراع.
This research addresses the problems that impede the passage of medical medicines developed by artificial intelligence (AI) software for the lack of clarity required to obtain patent rights, through an analytical study in Egypt's Intellectual Property Rights Protection Law No. 82 of 2002 and the WIPO Guidelines. The research aimed to address the main problems raised by the use of artificial intelligence programs in the manufacture of new medicines, in ways consistent with the evolving nature of that technology, through three research papers; The first is the definition of artificial intelligence in pharmaceutical research. We talked about the concept of artificial intelligence, and then we talked about the main applications of artificial intelligence programs for drug development. The second is the definition of the right to a patent, and it explains the nature of the patent and the requirements for obtaining it, in particular the need for the invention claimed to meet the criteria of non-clarity or innovation. And the third research topic we dedicated was to talking about the barriers to using artificial intelligence in the invention of medicines and therapeutic methods to reduce those problems. The research concluded with a number of conclusions and recommendations on its subject, the most important of which is the need to adjust the criteria required to meet the requirement of lack of clarity in line with the rapid development of the uses of artificial intelligence programs in the field of pharmaceutical research, and in line with the general rules and legislative requirements for granting the right to patent.

الكلمات الرئيسية

الموضوعات الرئيسية


  • المراجع باللغة العربية

    القوانين:

    • قانون حماية حقوق الملكية الفكرية رقم 82 لسنة 2002

    المواقع الاليكترونية:

    • مدير مكتب براءات الاختراع: اتفاقية باريس تلزمنا بـ«الفحص»

    https://www.almasryalyoum.com/news/details/617645

     

    المراجع باللغة الإنجليزية

    Cases:

    • Le Roy v. Tatham, 55 U.S. (14 How.) 156 (1852),

    Journal Articles:

    • Weber, Emily N. "Balancing Purpose, Power, and Discretion Between Article III Courts and the Patent Office."  L. Rev.86 (2021): 1019.
    • Liu, Weidong, et al. "Patent transformation opportunity to realize patent value: Discussion about the conditions to be used or exchanged." Information Processing & Management4 (2021): 102582.
    • Weber, Emily N. "Balancing Purpose, Power, and Discretion Between Article III Courts and the Patent Office."  L. Rev.86 (2021): 1019.
    • Liu, Weidong, et al. "Patent transformation opportunity to realize patent value: Discussion about the conditions to be used or exchanged." Information Processing & Management4 (2021): 102582.
    • Ebrahim, Tabrez Y. "Artificial Intelligence Inventions & Patent Disclosure." Penn St. L. Rev.125 (2020): 147.   
    • Yosuke Watanabe, " Inventor: Patent Inventorship for Artificial Intelligence Systems." 57 Idaho L. Rev. 475 (2021).
    • Philip C. Jackson, Jr., Introduction To Artificial Intelligence 292 (Dover Publ’n, Inc., 2d ed. 1985)
    • Mizuki Hashiguchi, The Global Artificial Intelligence Revolution Challenges Patent Eligibility Laws, 13 J. Bus. & Tech. L. 6 (2017)
    • Chikhaoui, Emna, and Saghir Mehar. "Artificial intelligence (AI) collides with patent law." Journal of Legal, Ethical and Regulatory Issues2 (2020): 1
    • Timothy L. Butler, Can a Computer be an Author - Copyright Aspects of Artificial Intelligence, 4 Hastings Comm. & Ent. L.J. 708 (1982).
    • Schuster, W. Michael, and Gregory Day. "Colluding against a Patent."  L. Rev 537 (2021).
    • Safrin, Sabrina. "The Predictive Power of Patents."  Ill. JL Tech. & Pol'y 43 (2021).
    • Caleb A Holland " Prep" aring for a Challenge to Government-Owned Patents." 70 UL Rev. 493 (2021).
    • Seokbeom Kwon, "The prevalence of weak patents in the United States: A new method to identify weak patents and the implications for patent policy “ 64 Technology in Society 101469 (2021).
    • Mark A., Perry, and Jaysen S. Chung. "Alice at Six: Patent Eligibility Comes of Age." 20 -Kent J. Intell. Prop. 64 (2021).
    • Jeonghun Jee, "Six different approaches to defining and identifying promising technology through patent analysis, Technology Analysis & Strategic Management 1 (2021)
    • Alaa Fotouh R. Mansour Bedair, "Insights into the FDA 2018 new drug approvals." Current Drug Discovery Technologies2 (2021): 293
    • Jonas Anderson, Applying Patent-Eligible Subject Matter Restrictions, 17 Vanderbilt Journal of Entertainment and Technology Law 274 (2020)
    • Golden, John M. "Patentable Subject Matter and Institutional Choice."  L. Rev.89 (2010): 1041.
    • Zhang, Li. "Alice Gets a Haircut: Berkheimer and Aatrix Restore Factual Inquiry to Patent Subject Matter Eligibility under Sec. 101." Berkeley Tech. LJ34 (2019): 1081.
    • Marsnik, Susan J., and Robert E. Thomas. "Drawing a line in the patent subject-matter sands: does Europe provide a solution to the software and business method patent problem." BC Int'l & Comp. L. Rev.34 (2011): 234
    • Menell, Peter S. "Forty Years of Wondering in the Wilderness and No Closer to the Promised Land: Bilski's Superficial Textualism and the Missed Opportunity to Return Patent Law to Its Technology Mooring."  L. Rev.63 (2010): 1295
    • He, Jianxing, et al. "The practical implementation of artificial intelligence technologies in medicine." Nature medicine1 (2019): 30-36.
    • Szolovits, Peter, ed. Artificial intelligence in medicine. Routledge, 2019.
    • Ernest Fok "Challenging the International Trend: The Case for Artificial Intelligence Inventorship in the United States."19 Santa Clara J. Int'l L 51 (2021):.
    • Romm, Connor. "Putting the Person in Phosita: The Human's Obvious Role in the Artificial Intelligence Era." BCL Rev.62 (2021): 1413.
    • Reinbold, Patric M. "Taking Artificial Intelligence Beyond the Turing Test."  L. Rev.(2020): 873.
    • Huhn, Michael. "Can an artificial intelligence model be the in-ventor of a molecule designed by the model and how can patentability be assessed?." Journal of Business Chemistry (2020): 4, 5
    • Fabris, Daniele. "From the PHOSITA to the MOSITA: Will “Secondary Considerations” Save Pharmaceutical Patents from Artificial Intelligence?." IIC-International Review of Intellectual Property and Competition Law6 (2020): 696
    • Schlander, Michael, et al. "How much does it cost to research and develop a new drug? A systematic review and assessment." PharmacoEconomics11 (2021): 1243-1269.
    • Vertinsky L, Rice TM (2002) Thinking about thinking machines: implications of machine inventors for patent law. Boston Univ J Sci Technol Law 8:574
    • Katopis, Chris J. "The Curious Crypto Question: Do Patents Advance Fintech Innovation? The Paradox Arising from Five Key Recent Trends." Santa Clara High Tech. LJ38 (2021): 1.
    • Gurgula, Olga. "AI-assisted inventions in the field of drug discovery: readjusting the inventive step analysis." International Journal of Social Science and Public Policy, Forthcoming(2020).

    Websites:

    • World Intellectual Property Organization, Examination Guideline Part 3 Chapter 3, Section 4, 5
    • https://www.wipo.int/export/sites/www/scp/en/meetings/session_22/comments_received/republic_of_korea.pdf
    • Jack Clark, Why 2015 Was a Breakthrough Year in Artificial Intelligence, BLOOMBERG TECH. (Dec. 8, 2015, 8:00 AM), https://www.bloomberg.com/news/articles/2015-12-08/why-2015-was-a-breakthrough-year- in-artificial-intelligence.

    ·             Patents and Artificial Intelligence: An ‘Obvious’ Slippery Slope https://news.bloomberglaw.com/ip-law/patents-and-artificial-intelligence-an-obvious-slippery-slope

     

     

     

    References in Arabic

    Laws:

    • Al-Shorfa: Intellectual Property Rights Protection Act No. 82 of 2002

    Websites:

    • Al-Shorfa: Director of the Patent Office: Paris Agreement obligates us to "examine"

    https://www.almasryalyoum.com/news/details/617645

    References in English

    Cases:

    • Le Roy v. Tatham, 55 U.S. (14 How.) 156 (1852),

    Journal Articles:

    • Weber, Emily N. "Balancing Purpose, Power, and Discretion Between Article III Courts and the Patent Office." Mo. L. Rev.86 (2021): 1019.
    • Liu, Weidong, et al. "Patent transformation opportunity to realize patent value: Discussion about the conditions to be used or exchanged." Information Processing & Management58.4 (2021): 102582.
    • Weber, Emily N. "Balancing Purpose, Power, and Discretion Between Article III Courts and the Patent Office." Mo. L. Rev.86 (2021): 1019.
    • Liu, Weidong, et al. "Patent transformation opportunity to realize patent value: Discussion about the conditions to be used or exchanged." Information Processing & Management4 (2021): 102582.
    • Ebrahim, Tabrez Y. "Artificial Intelligence Inventions & Patent Disclosure." Penn St. L. Rev.125 (2020): 147.      
    • Yosuke Watanabe, " Inventor: Patent Inventorship for Artificial Intelligence Systems." 57 Idaho L. Rev. 475 (2021).
    • Philip C. Jackson, Jr., Introduction To Artificial Intelligence 292 (Dover Publ’n, Inc., 2d ed. 1985)
    • Mizuki Hashiguchi, The Global Artificial Intelligence Revolution Challenges Patent Eligibility Laws, 13 J. Bus. & Tech. L. 6 (2017)
    • Chikhaoui, Emna, and Saghir Mehar. "Artificial intelligence (AI) collides with patent law." Journal of Legal, Ethical and Regulatory Issues2 (2020): 1
    • Timothy L. Butler, Can a Computer be an Author - Copyright Aspects of Artificial Intelligence, 4 Hastings Comm. & Ent. L.J. 708 (1982).
    • Schuster, W. Michael, and Gregory Day. "Colluding against a Patent."  L. Rev 537 (2021).
    • Safrin, Sabrina. "The Predictive Power of Patents."  Ill. JL Tech. & Pol'y 43 (2021).
    • Caleb A Holland " Prep" aring for a Challenge to Government-Owned Patents." 70 UL Rev. 493 (2021).
    • Seokbeom Kwon, "The prevalence of weak patents in the United States: A new method to identify weak patents and the implications for patent policy “ 64 Technology in Society 101469 (2021).
    • Mark A., Perry, and Jaysen S. Chung. "Alice at Six: Patent Eligibility Comes of Age." 20 -Kent J. Intell. Prop. 64 (2021).
    • Jeonghun Jee, "Six different approaches to defining and identifying promising technology through patent analysis, Technology Analysis & Strategic Management 1 (2021)
    • Alaa Fotouh R. Mansour Bedair, "Insights into the FDA 2018 new drug approvals." Current Drug Discovery Technologies2 (2021): 293
    • Jonas Anderson, Applying Patent-Eligible Subject Matter Restrictions, 17 Vanderbilt Journal of Entertainment and Technology Law 274 (2020)
    • Golden, John M. "Patentable Subject Matter and Institutional Choice."  L. Rev.89 (2010): 1041.
    • Zhang, Li. "Alice Gets a Haircut: Berkheimer and Aatrix Restore Factual Inquiry to Patent Subject Matter Eligibility under Sec. 101." Berkeley Tech. LJ34 (2019): 1081.
    • Marsnik, Susan J., and Robert E. Thomas. "Drawing a line in the patent subject-matter sands: does Europe provide a solution to the software and business method patent problem." BC Int'l & Comp. L. Rev.34 (2011): 234
    • Menell, Peter S. "Forty Years of Wondering in the Wilderness and No Closer to the Promised Land: Bilski's Superficial Textualism and the Missed Opportunity to Return Patent Law to Its Technology Mooring."  L. Rev.63 (2010): 1295
    • He, Jianxing, et al. "The practical implementation of artificial intelligence technologies in medicine." Nature medicine1 (2019): 30-36.
    • Szolovits, Peter, ed. Artificial intelligence in medicine. Routledge, 2019.
    • Ernest Fok "Challenging the International Trend: The Case for Artificial Intelligence Inventorship in the United States."19 Santa Clara J. Int'l L 51 (2021):.
    • Romm, Connor. "Putting the Person in Phosita: The Human's Obvious Role in the Artificial Intelligence Era." BCL Rev.62 (2021): 1413.
    • Reinbold, Patric M. "Taking Artificial Intelligence Beyond the Turing Test."  L. Rev.(2020): 873.
    • Huhn, Michael. "Can an artificial intelligence model be the in-ventor of a molecule designed by the model and how can patentability be assessed?." Journal of Business Chemistry (2020): 4, 5
    • Fabris, Daniele. "From the PHOSITA to the MOSITA: Will “Secondary Considerations” Save Pharmaceutical Patents from Artificial Intelligence?." IIC-International Review of Intellectual Property and Competition Law6 (2020): 696
    • Schlander, Michael, et al. "How much does it cost to research and develop a new drug? A systematic review and assessment." PharmacoEconomics11 (2021): 1243-1269.
    • Vertinsky L, Rice TM (2002) Thinking about thinking machines: implications of machine inventors for patent law. Boston Univ J Sci Technol Law 8:574
    • Katopis, Chris J. "The Curious Crypto Question: Do Patents Advance Fintech Innovation? The Paradox Arising from Five Key Recent Trends." Santa Clara High Tech. LJ38 (2021): 1.
    • Gurgula, Olga. "AI-assisted inventions in the field of drug discovery: readjusting the inventive step analysis." International Journal of Social Science and Public Policy, Forthcoming(2020).

    Websites:

    https://www.bloomberg.com/news/articles/2015-12-08/why-2015-was-a-breakthrough-year- in-artificial-intelligence.

    ·             Patents and Artificial Intelligence: An ‘Obvious’ Slippery Slope

    https://news.bloomberglaw.com/ip-law/patents-and-artificial-intelligence-an-obvious-slippery-slope