RULES FOR THE PROTECTION OF UNDISCLOSED INFORMATION AND ITS RELATIONSHIP TO THE PHARMACEUTICAL INDUSTRY
Main Article Content
Abstract
The pharmaceutical industry is one of the most important vital industries at the local and global levels due to its close link to human health. International companies have worked to protect their pharmaceutical innovations and inventions, especially undisclosed information, by controlling global markets for pharmaceutical products and achieving more profits, without taking into account the conditions and conditions of developing countries.
Hence, comparative legislation has developed special protection for undisclosed information, including preventing others from violating these secrets and information using dishonest methods and practices through the lawsuit of unfair competition, and the TRIPS Agreement has also set out special rules for the protection of undisclosed information that is obligated to submit to government agencies and concerned authorities to obtain a license to market medicines.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
First: books.
B- Books in French:
- Dominique Dieng, Strategic Intelligence: Guide for research and innovation, Presses Universitaires de Namur, 2014.
- Lyle Glowka, Françoise Burhenne-Guilmin and Hygh Synge in collaboration with Jeffrey A. McNeely and Lothar Gundling, Guide to the Convention on Biological Diversity, IUCN-World Conservation Union, Switzerland and Cambridge, United Kingdom, 1996.
- Mathieu Guerriaud, Pharmaceutical law, Editions Elsevier Masson S.A.S, France, 2016.
-Jean-Claude Beaune, The philosophy of the remedy, Editions Champ Vallon, 1993.
-Nicole Ferry-Maccario, Marketing law: thwarting the legal aspects of advertising and commercial actions, Editions Person Education, France, 2008.
Second: PhD theses
Murr Siham, Civil Liability of Pharmaceutical Producers and Sellers - A Comparative Study -, PhD Thesis, Private Law, Faculty of Law and Political Science, University of Abu Bakr Belkaid, Tlemcen, 2016-2017.
Third: Articles.
- Ben Driss Halima, Protection of Intellectual Property Rights in Algerian Legislation, PhD Thesis in Private Law, Faculty of Law, University of Abou Bakr Belkaid, Tlemcen, 2013-2014.
. Riyad Ahmed Abdul Ghafour, Legal Protection of Undisclosed Information: A Comparative Study in the Light of Intellectual Property Rights Laws and Conventions and the Provisions of the Civil Code, Anbar University Journal of Legal and Political Sciences, Iraq, Volume 1, Issue Eight, 2013, p. 367.
- Farhad Saeed Al-Saidi, Parallel Importation and International Exhaustion of Intellectual Rights in International Trade: A Study in the Trade of Patented Pharmaceutical Products, Journal of the College of Law for Legal and Political Sciences, Iraq, Volume III, Issue Ten, 2014.
- Eng. Samah Hussein Ali, Protection of Trade Secrets from Unfair Competition, Journal of Human Sciences, Volume 22, Issue Two, Harizan 2015.
Fourth: Laws.
- Ordinance No. 03-07 of 19 July 2003 on patents Official Gazette No. 44 of 23/07/2003
- Law No. 15-20 of December 30, 2015, amending and supplementing Ordinance No. 75-59 of September 26, 1975 on the Commercial Code, Official Gazette No. 71 of December 30, 2015, amending and supplementing.
- Law No. 18-11 of 18 Shawwal 1493 corresponding to July 2, 2018 on health, G.R. No. 46 of 2018. - Executive Decree No. 93-140 of June 14, 1993 establishing a national laboratory for the control, organization and functioning of pharmaceutical products, G.R. No. 41 of 20-06-1993.
_Executive Decree No. 92-284 laying down the conditions for the registration of pharmaceutical products used in human medicine, G.R. No. 53, of July 12, 1992.
Fifth: Internet sites.
https://www.wipo.int/treaties/ar/ip/paris/summary_paris.html
________________________________________
(1) Dominique Dieng, Strategic Intelligence: Guide for research and innovation, Presses Universitaires de Namur, 2014, S.P
(2) Section 4 of Chapter I of the United States Uniform Act of 1979, which amended in 1985, defines trade secrecy as: "Information including structures, models, programs, technical methods and means, which: 1. It shall have a current and possible economic value, as long as it is known only to those persons who obtain its economic value through their work and use, and as long as it is not possible for others to discover or obtain it by lawful means. 2- And be informed by reasonable means according to the circumstances to maintain its confidentiality", Eng. Riyad Ahmed Abdul Ghafour, Legal Protection of Undisclosed Information: A Comparative Study in the Light of Intellectual Property Rights Laws and Conventions and the Provisions of the Civil Code, Anbar University Journal of Legal and Political Sciences, Iraq, Volume 1, Issue Eight, 2013, p. 367.
(3) The TRIPS agreement aims to create in practice a kind of substantive harmonization of the provisions of national legislation by requiring Member States to include the provisions contained in this agreement in their legislation, and to develop detailed regulation aimed at providing the greatest possible effective enforcement of intellectual property rights. In addition, in accordance with the preamble to the TRIPS Agreement, concluded at the end of 1993 and signed in early 1994, this agreement was based on the need to establish new rules and disciplines in a number of areas related to IP, including adequate standards for the existence, scope and use of intellectual property rights, as well as effective means of their implementation.
Lyle Glowka, Françoise Burhenne-Guilmin and Hygh Synge in collaboration with Jeffrey A. McNeely and Lothar Gundling, Guide to the Convention on Biological Diversity, IUCN-World Conservation Union, Switzerland and Cambridge, United Kingdom, 1996, p. 115.
(4) Eng. Riyad Ahmed Abdel Ghafour, op. cit., p. 368.
(5)Article 59, last paragraph, of Ordinance No. 03-07 of 19 July 2003 on patents, Official Gazette No. 44 of 23/07/2003 stipulates: "The competent judicial authority shall take into account the legitimate interests of the defendant when adopting any evidence it requests, by not disclosing his industrial and commercial secrets."".
(6)Article 627 of Law No. 15-20 of December 30, 2015, amending and supplementing Ordinance No. 75-59 of September 26, 1975, containing the Commercial Code, Official Gazette No. 71, issued on December 30, 2015, stipulates that: "Those in charge of management and all persons invited to attend meetings of the Board of Directors shall conceal information of a confidential nature or that is considered to be such."".
(7)Mathieu Guerriaud, Pharmaceutical law, Editions Elsevier Masson S.A.S, France, 2016, p.26
(8) Jean-Claude Beaune, The philosophy of the remedy, Editions Champ Vallon, 1993, p. 38
(9)Drug is defined in European Union legislation as: "1- Any substance or compound of substances that have therapeutic or preventive properties for diseases affecting humans. - Any substance or compound of substances that may be administered to humans for the purpose of restoration, correction or modification of physiological function by means of a therapeutic, prophylactic, metabolic or diagnostic means." U.S. legislation in Section 102 defines medicine as: "Any substance used in the diagnosis, healing, improvement, treatment or prevention of any disease affecting humans or animals. or any substances other than foodstuffs intended to affect the composition or function of the human or animal body." Farhad Saeed Al-Saidi, Parallel Importation and International Exhaustion of Intellectual Rights in International Trade: A Study in the Trade of Patented Pharmaceutical Products, Journal of the College of Law for Legal and Political Sciences, Iraq, Volume III, Issue Ten, 2014, p. 74.
(10) In chapter five of Law No. 18-11 of 2018 on health, the Algerian legislator used the term pharmaceuticals and medical supplies, unlike the French legislator, which combined pharmaceuticals, medical devices and supplies with the French Agency for the Safety of Medicines and Health Materials under one title, "Health materials". Murr Siham, Civil Responsibility of Pharmaceutical Producers and Sellers - A Comparative Study -, PhD Thesis, specializing in private law, Faculty of Law and Political Science, University of Abu Bakr Belkaid, Tlemcen, 2016-2017, p. 41..
(11) Article 208 of Law No. 18-11 of 18 Shawwal 1493 corresponding to July 2, 2018 on health, G.R. No. 46 of 2018 defines medicine as: "Any substance or composition presented as containing therapeutic or preventive properties against human or animal diseases and all substances that may be prescribed to humans or animals for the purpose of carrying out a medical diagnosis or restoring, correcting and modifying their physiological functions."
(12) Article 209 of Law No. 18-11 of 2018 on Health stipulates that: "Medicines are also considered, in particular the following: - Diet feeding products that contain non-food substances that confer beneficial properties for human health. - Persistent products derived from blood. - renal clearance concentrates or peritoneal clearance solutions - Medical gases. They shall be similar in particular: - Physical hygiene and cosmetic products containing toxic substances in quantities and concentrations exceeding those determined by regulation."
(13) Eng. Samah Hussein Ali, Protection of Trade Secrets from Unfair Competition, Journal of Human Sciences, Volume 22, Issue Two, Harizan 2015, p. 879.
(14) Article 39, first paragraph of the TRIPS Agreement states: "1. While ensuring the effective protection of unfair competition as provided for in Article 10 bis of the Paris Convention (1967), member countries shall be obliged to protect confidential information in accordance with paragraph 2, and data provided to Governments or governmental bodies in accordance with the provisions of paragraph 3."
(15) The Paris Convention was concluded in 1883 and revised in Brussels in 1900, in Washington in 1911, in The Hague in 1925, in London in 1934, in Lisbon in 1958, in Stockholm in 1967 and in 1979. Accessed 7/03/2024. https://www.wipo.int/treaties/ar/ip/paris/summary_paris.html.
https://www.wipo.int/treaties/ar/ip/paris/summary_paris.html
(16)Article 39, paragraph 2, of the TRIPS Agreement
(17)Article 39 paragraph 3 of the TRIPS Agreement.
(18) Law No. 10-06 of August 15, 2010 amending and supplementing Law No. 04-02 of June 23, 2004 laying down the rules applicable to commercial practices, Official Gazette No. 46 of August 18, 2010.
(19) Article 10 bis, paragraph (c), stipulates that: "The following shall be prohibited: 1. All acts of a nature that are found by any means whatsoever in confusion with a competitor's establishment, products or industrial or commercial activity. 2 - Allegations contrary to the truth in the practice of trade, which are of a nature to remove confidence from the establishment, products or industrial or commercial activity of a competitor. 3. Statements or allegations whose use in trade is likely to mislead the public as to the nature, method of manufacture, characteristics, suitability or quantity of the goods..
(20)Ben Driss Halima, Protection of Intellectual Property Rights in Algerian Legislation, PhD Thesis in Private Law, Faculty of Law, University of Abou Bakr Belkaid, Tlemcen, 2013-2014. , p. 145.
(21)Nicole Ferry-Maccario, Marketing law: thwarting the legal aspects of advertising and commercial actions, Editions Person Education, France, 2008, p.16
(22) Eng. Riyad Ahmed Abdel Ghafour, op. cit., p. 389
(23) Article 59, last paragraph of Ordinance 03-07 on patents.
(24) Executive Decree No. 93-140 of June 14, 1993 establishing a national laboratory for the control, organization and functioning of pharmaceutical products, G.R. No. 41 of 20-06-1993
(25) Executive Decree No. 92-284 laying down the conditions for the registration of pharmaceutical products used in human medicine, G.R. No. 53 of July 12, 1992.