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المجلس الأعلى للثقافة- لجنة حماية الملكية الفكرية
• <http://ec.europa.eu/competition/sectors/ الأوليـة للمسـتحض ارت المثيلـة شـر ًطا صري ًحـا يمنـع
pharmaceuticals/inquiry/communication_ التسـويق إلا بعـد انتهـاء مـدة حمايـة بـ ارءة الاختـ ارع
en.pdf> وقـد قامـت هيئـة.التـي تغطـي المسـتحضر الأصيـل
• Accessed on 15 June 2025 الـدواء المصريـة بخطـوة إيجابيـة فـي هـذا الصـدد من
• [11] Danzon (n1), Page.5. خـال تضميـن القواعـد التنظيميـة الخاصـة بتوحيـد
• [12] Whish (n9), Para 2-045, Page 23. قواعـد وإجـ ارءات تسـجيل المسـتحض ارت الصيدليـة
• [13] Julian w. Marrs, “Forever Green: An ١٢ فـي المـادة٢٠٢٣ لسـنة٤٥٠ البشـرية رقـم
Examination of Pharmaceutical Patent اسـتثنا ًء خا ًصـا للمسـتحض ارت المثيلـة لمسـتحضر
Extensions”, 18 Or. Rev. Int’l L.81 (2016),page هـذا الاسـتثناء يعفـي.أصيـل تحميـه بـ ارءة اختـ ارع
81,Content downloaded from HeinOnline, المسـتحضر المثيـل مـن شـرط ضـرورة النـزول إلـى
accessed on Fri Aug 24 18:59:35 2018 السوق خلال المدد الإجبارية التي لا يمكن تجاوزها
• [14] Nadia DE SOUZA, “Competition in ،مـن تاريـخ التسـجيل وإلا يلغـى قـ ارر التسـجيل
Pharmaceuticals: the challenges ahead post بحيـث يسـمح لـه بالتسـويق فقـط عنـد انتهـاء مـدة
AstraZeneca”, Competition Policy Newsletter,
Number 1 — Spring 2007, page 42. .حمايـة البـ ارءة
• <http://ec.europa.eu/competition/sectors/ :الم ارجع
pharmaceuticals/2007_1_39.pdf>
• Accessed on 15 January 2025. • [1] Patricia M. Danzon, “Competition and
• [15] European Drug Regulatory Directive, Antitrust Issues in the Pharmaceutical Industry”,
• https://ec.europa.eu/health/sites/health/files/ Page 6.
files/eudralex/vol-1/dir_2004_27/dir_2004_27_
en.pdf> • https://faculty.wharton.upenn.edu/wp-
• Accessed on 15 June 2025 content/uploads/2017/06/Competition-and-
• [16] Danzon (n1), Page 9. Antitrust-Issues-in-the-Pharmaceutical-
• [17] Al-khafaji, Ali, Ravaud, Philippe, IndustryFinal7.2.14.pdf>
Trinquart, Loduice, and Dr. Desvarieux,
Moise, “Evergreening: How Green is it after • Accessed on 16 June 2025
all?”, a research paper uploaded by Philippe • [2] Ibid, Page 6.
Ravaud on 26 May 2015. Pages 8 and 9. • [3] Ibid, Page 6.
• h t t p s : / / w w w . r e s e a r c h g a t e . n e t / • [4] Ibid, Page 4.
publication/265633201_Evergreening_How_ • [5] Ibid, Page 4.
Green_is_it_after_all> • [6] Jorge Mestre Ferrandiz, Jon Sussex and Adrian
• Accessed on 15 June 2025
• [18] The selling here refers to selling or purchasing Towse, “The R&D cost of a new medicine”,
the raw material and/or the purchasing the Pages 50, 74
generic product by the generic company after • https://www.ohe.org/publications/rd-cost-
it has been produced by a third party for the new-medicine#>
purpose of registration procedures. • Accessed in 16 June 2025
• [19] U.S. Patent Act - Part III, Patents and • [7] Danzon (n1), Page No. 5.
Protection of Patent Rights -Chaptr. 28, • [8] Ibid , Page No. 5
Infringement of Patents, this exemption for • [9] Richard Whish“Antitrust and Intellectual
research for the purposes of obtaining regulatory Property: The Licensing Of Standard Essential
approval is called in the US “Hatch-Waxman Patents On FRAND Terms’’, a paper provided
exemption”. to the postgraduate students in Executive LLM
programme at king’s College London, May
• [20] CANADA – Patent protection of 2017, Para 2-002 , Page7.
pharmaceutical products case WT/DS114/R •
is available at: <https://www.wto.org/english/ • [10] Pharmaceutical Sector Inquiry, page 6.
tratop_e/dispu_e/7428d.pdf >
• Accessed on 25 June 2025.
• [21] Whish (n9) , Para 2-003 - Page7.
• [22] Danzon (n1), Page 9
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