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Relevant bibliographies by topics / Pharmaceutical biotechnology – Law and legislation / Dissertations / Theses

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Dissertations / Theses on the topic 'Pharmaceutical biotechnology – Law and legislation'

Author: Grafiati

Published: 10 March 2023

Last updated: 31 July 2025

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1

Babin, Dominique. "The Canadian pharmaceutical patent regime in the world trading system /." Thesis, McGill University, 1999. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=29957.

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In 1994, the members of the World Trade Organisation (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPs Agreement") and thus committed themselves to respect certain standards for intellectual property protection. This thesis studies the scope of the standards for patent protection and their impact upon trade in medicines. The first part addresses the international dimension of the issue and explains how international trade in medicines can contribute to enhancing the level of global welfare. The first chapter argues that in order to fulfil this latter obj

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2

Vazquez, Toro Guillermo J. "Patent Quality And Company Performance| A Sample within the USA Biotechnology and Pharmaceutical Industry." Thesis, Inter-American University of Puerto Rico (Puerto Rico), 2014. http://pqdtopen.proquest.com/#viewpdf?dispub=3577982.

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<p> This Dissertation investigates the relationship between patent quality and company performance for a sample from the US Biotechnology and Pharmaceutical Industry. The methodology devised comprehensively examines patent worth (patent’s references), patent protection (claims and family patents) and patent quality (references, claims and family patents) to determine their implications on firm leverage (SE, TA), profits (ROE, ROA), and market value (B/M, MCap). The selected sample comprises 1,536 companies, and 285,000 patents from 1999 to 2009. The results show that total revenue just r

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3

Stoddard, Damon. "A new Canadian intellectual property right : the protection of data submitted for marketing approval of pharmaceutical drugs." Thesis, McGill University, 2006. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=101828.

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In order to market and sell a new pharmaceutical drug in Canada, the Minister of Health requires the initial applicant to submit clinical test results demonstrating that the drug is safe and effective for human use. Subsequent applicants, who typically lack the resources to conduct expensive clinical trials, must refer to and rely upon the initial applicant's data in their applications to market a generic version of the drug.<br>On June 17, 2006, the federal government of Canada published a proposed data protection regulation, which would provide an initial applicant with eight years of protec

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4

Ludlow, Karinne Anne. "Which little piggy to market? : legal challenges to the commercialisation of agricultural genetically modified organisms in Australia." Monash University, Faculty of Law, 2004. http://arrow.monash.edu.au/hdl/1959.1/5489.

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5

Griffiths, Robert Ian. "Industrial drug development : application of the theoretical framework of Abernathy, Clark, and Kantrow (1983) in an analysis of factors which determine productivity /." Thesis, This resource online, 1988. http://scholar.lib.vt.edu/theses/available/etd-04122010-083717/.

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6

Zeitoun, Suzanna. "Are legislators able to meet efficiency goals? : an analysis of the pharmaceutical industry." Thesis, Linköping University, Department of Management and Economics, 2004. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-2443.

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<p>During the last decades, legislators have tried to meet the goal of increased R&D in the pharmaceutical industry through an extension of the patent length. In parallel, an attempt to minimise ex post social costs has been made through the introduction of a shortened drug approval process for generic drugs as well as a so-called Bolar provision, giving generic producers earlier access to patented information. However, one can ask how efficient a patent extension possibility has been to meet the goal of increased R&D. Correspondingly, what effects on social costs can we expect from the introd

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7

Letsitsi, Ezekiel Tebogo. "Waste management in the pharmaceutical industry : an evaluation report of Dr Reddy's Laboratories." Thesis, Rhodes University, 2013. http://hdl.handle.net/10962/d1001872.

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The pharmaceutical industry must worry about managing pharmaceutical waste as it poses a health risk to human beings and its presence in the environment can also contribute to loss of biodiversity. Ngwuluka, Ochekpe, and Odumosu (2011: 11259) state that “Pharmaceuticals, though used to treat and manage diseases, are poisons, which justify the growing concerns about their presence in the environment.” Various forms of pharmaceutical waste exist, Ngwuluka et al. (2011) identified the following forms of pharmaceutical waste: Expired dosage forms, non-reworkable formulations, spilled pharmaceutica

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8

蘇柏昇. "澳門藥事法規修訂及其對公立醫院藥品供應的影響研究". Thesis, University of Macau, 2010. http://umaclib3.umac.mo/record=b2454949.

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9

Périé-Frey, Sarah. "Essai sur l'émergence d'un régime juridique autonome du médicament : entre bien public et bien marchand : Regards croisés en droit interne et en droit de l'Union européenne." Thesis, Perpignan, 2017. http://www.theses.fr/2017PERP0006/document.

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Comme tout corps de règles naissant et se constituant progressivement en système juridique spécifique, les règles applicables au médicament se nourrissent des régimes juridiques externes préexistants que ceux-ci relèvent du droit public ou du droit privé. Dans les systèmes juridiques reconnus, les emprunts faits, une logique d'appropriation se met en place qui aboutit à la transformation et la spécialisation de la règle empruntée à l'objet ou la situation spécifiquement abordée. Les règles applicables au médicament parviennent-elles effectivement, suivant ce processus classique, à s'approprier

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10

Msomi, Zuziwe Nokwanda. "The protection of indigenous knowledge within the current intellectual property rights regime: a critical assessment focusing upon the Masakhane Pelargonium case." Thesis, Rhodes University, 2013. http://hdl.handle.net/10962/d1007744.

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The use of indigenous knowledge (IK) and indigenous bio-resources by pharmaceutical and herbal industries has led to concerns about the need to protect IK in order to prevent biopiracy and the misappropriation of indigenous knowledge and resources. While some commentators believe that intellectual property rights (IPR) law can effectively protect IK, others are more sceptical. In order to contribute to the growing debate on this issue, this study uses the relatively new and as yet largely critically unanalysed Masakhane Pelargonium case to address the question of whether or not IPR law can be

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11

Strobeck, Matthew W. (Matthew William) 1972. "The drug development process : evaluation of PDUFA I/II and investigation into reducing drug development times." Thesis, Massachusetts Institute of Technology, 2004. http://hdl.handle.net/1721.1/28592.

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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2004.<br>Includes bibliographical references (p. 59-61).<br>Published findings report that it takes approximately eight years to bring a novel drug to market at an average cost of $800 million. Over the last ten years, the Food and Drug Administration (FDA) has helped to reduce the time from filing a new drug application (NDA) to granting marketing approval (i.e. the approval phase). However, there has been no al

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12

Bortoluzzi, Chiara. "La sécurité des médicaments. Législation pharmaceutique européenne et indemnisation des risques médicamenteux." Thesis, Paris 2, 2017. http://www.theses.fr/2017PA020025.

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Un niveau élevé de protection de la santé humaine est assuré dans la définition et la mise en oeuvre de toutes les politiques et actions de l’Union européenne. L’une des politiques les plus importantes, conformément aux enjeux de santé et au développement économique, est celle des médicaments. Leur sécurité est garantie par un cadre juridique donné par une législation pharmaceutique d’envergure présidant à l’octroi de l’autorisation de mise sur le marché et au suivi post-autorisation. Ce cadre juridique est supporté par un dispositif institutionnel d’exception, caractérisé par une interaction

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13

HARACOGLOU, Irina. "The duty to deal in the biopharmaceutical industry : a follow-on innovation perspective." Doctoral thesis, 2005. http://hdl.handle.net/1814/4653.

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Defence date: 26 September 2005<br>Examining board: Prof. Hans Ullrich (Supervisor, European University Institute) ; Prof. Christian Joerges (Co-Supervisor, European University Institute) ; Prof. David Vaver (Oxford University) ; Prof. Bernand Remiche (Université Catholique de Louvain)<br>PDF of thesis uploaded from the Library digitised archive of EUI PhD theses completed between 2013 and 2017<br>Using the example of research tools in biopharmaceutical research and innovation, this book examines the complexities of the relationship two fundamental areas of law and policy - intellectual proper

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14

Sibanda, McLean. "Enabling intellectual property and innovation systems for South Africa's development and competitiveness." Thesis, 2018. http://hdl.handle.net/10500/24247.

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During the last two decades, there have been a number of policy and legislative changes in respect of South Africa’s intellectual property (IP) and the national system of innovation (NSI). In 2012, a Ministerial Review of the Science, Technology and Innovation (STI) landscape in South Africa made recommendations to improve the STI landscape and effectively the national system of innovation. The study provides a critical review of drafts of the national IP policy published in 2013 as well as the IP Framework released in 2016 for public comment. The review of the IP and the NSI are within the co

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15

Tuomi, William Victor. "Appropriating the tools of research : patent law and biotechnology." Thesis, 2005. http://hdl.handle.net/2429/16808.

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Patent law creates economic incentives for individuals and companies to invest in research and development, as well as to disclose publicly and commercialize new inventions. In creating these incentives, patents also impose costs on society through reduced access to new inventions. Generally, the benefits of the patent system outweigh the costs, but in new and rapidly developing industries the patent system itself can act as a barrier to the development of new technologies. This is of particular concern in the biotechnology industry where a proliferation of patents on basic and fundament

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16

Tung, Kai-Chiang, and 董凱強. "A Study on Mergers & Acquisitions and Competition Law Issues of Biotechnology and Pharmaceutical Industries." Thesis, 2018. http://ndltd.ncl.edu.tw/handle/635d3b.

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碩士<br>國立臺灣大學<br>事業經營法務碩士在職學位學程<br>106<br>The scale of enterprises in biotechnology and pharmaceutical industries in Taiwan is too small to have competitiveness in the world. As a result, the government intends to promote cooperation and strengthen the alliance in the industries as its industrial policy, in particularly, to create a “national champion”. As a popular strategy, mergers and acquisitions may improve enterprises’ performance and thus increase competitiveness in the international market. However, mergers and acquisitions may also cause the rearrangement of market structure, resulting

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17

TIMOCIN, Zeynep. "Personalised medicine and patent law : an overview of the patenting of genetic inventions under United States and European law in relation to genetic diagnostic tests." Doctoral thesis, 2017. http://hdl.handle.net/1814/49748.

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Award date: 22 November 2017<br>Supervisor: Professor Giovanni Sartor, European University Institute<br>Following the U.S. Supreme Court decisions in Mayo Collaborative Services v. Prometheus Labs. Inc. and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the future of patentability of genetic material is uncertain. In the U.S., the decision in Myriad which allowed the patenting of cDNA molecules seems to have limited the force of the concerned voices from the genomic research community that had called for substantial limitations on the patenting genetic material based on the argument t

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18

LAZARO, Christophe. "La fabrication juridique d'un corps hybride : regard pragmatique sur les rapports entre droit et technologies prothétiques." Doctoral thesis, 2012. http://hdl.handle.net/1814/25203.

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Examining Board: Professor Giovanni Sartor, Institut Universitaire Européen (directeur de thèse); Professor Serge Gutwirth, Vrije Universiteit Brussel (codirecteur de thèse); Professor Yves Poullet, Université de Namur; Professor Loïc Azoulai, Institut Universitaire Européen.<br>Defence date: 12 December 2012<br>PDF of thesis uploaded from the Library digital archive of EUI PhD theses<br>Grâce au développement de technologies de plus en plus complexes susceptibles de s’immiscer dans l’organisme, corps et artéfacts semblent en passe de connaître un degré d’hybridation jamais atteint jusqu’alor

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19

Shongwe, Kwanele Asante. "Multinational pharmaceutical manufacturers' opposition to patent law reform in South Africa: a bitter moral pill." Thesis, 2016. http://hdl.handle.net/10539/21415.

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In partial fulfilment of the degree of MSc. Med (Bioethics & Health Law) Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand (Wits), Johannesburg June 2016<br>It is estimated that about two billion people, one-third of the world's population, lack regular access to essential medicines (Forman & Kohler 2012: 26). The situation is worst in Africa and South East Asia, where it is reported that about half the population do not have regular access to potentially life-saving drugs (Forman & Kohler 2012:26). A normative study was undertaken to probe whether l

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20

Heled, Yaniv. "Regulation of Novel Biomedical Technologies." Thesis, 2011. https://doi.org/10.7916/D8F194F9.

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This dissertation is the compilation of three separate works of research revolving around the theme of regulation of biomedical technologies that are either emerging or that have undergone significant developments over the past decade or so. Each of these three research works examines a legal response to a technological development in the areas of biotechnology and/or medicine and addresses one or more challenges - ethical, constitutional, legal or one that is related to public policy - created by that response. The first work of research, which was published in the Administrative Law Review i

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21

Mykitiuk, Roxanne. "Legal Texts, Human Bodies: Reading Embodiment in the Biotech Age." Thesis, 2013. https://doi.org/10.7916/D8959QQ2.

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This dissertation consists of two separately published articles and one book chapter linked together by their investigation of the legal regulation of reproductive and genetic technologies. In "Fragmenting the Body" I explore how law is to understand the relationship between the person and the body, and the body and its parts in the context of the instrumental uses to which reproductive and genetic material can be put. Drawing on feminist and postmodernist theories, the article critiques the liberal legal conception of personhood and argues in favour of an embodied account of personhood as cen

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22

RIZZI, Marco. "The complex case for another hard look : transnational pharmaceutical regulation and the pedagogical role of courts." Doctoral thesis, 2015. http://hdl.handle.net/1814/37581.

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Defence date: 29 September 2015<br>Examining Board: Professor Alberto Alemanno, HEC Paris; Professor Claire Kilpatrick, EUI; Professor Joana Mendes, Universiteit van Amsterdam; Professor Hans-Wolfgang Micklitz, EUI (Supervisor).<br>The thesis argues for a 'pedagogical' role for courts in the US and EU in ameliorating the increasingly transnational regulation of pharmaceutical product safety through complementary monitoring of the outputs of regulatory processes. The study is divided into two parts. First, the thesis explores the regulatory institutional design in the US and EU. The parallel de

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23

Yancey, Amy Iver. "Intellectual Property and Policy Issues in Biotechnology." 2011. http://trace.tennessee.edu/utk_gradthes/1040.

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Intellectual property, particularly patents, plays a major role in innovation and discovery in biotechnology. Likewise, since the passage of the Bayh-Dole Act in 1981, patents have become an increasingly important factor in U.S. university-driven basic research, especially in the life sciences where patented technologies have transformed agriculture. Specifically, this paper looks at the potential impacts of these trends on university driven research, the university researcher, the pharmaceutical industry, and the farm sector with an emphasis on recent and pending court cases and legis

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24

Laban, Premakanthie Rosemary. "An evaluation of the impact of legislative changes on stakeholders in the South African pharmaceutical industry." Thesis, 2003. http://hdl.handle.net/10413/2418.

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Changes in the health sector in South Africa have been widespread since 1994 with restructuring ofthe public sector being the focal point of legislation. The limelight has recently shifted focus to the health sector with the Medicine and Related Substances (MRSCA) Amendment Act, 59 of 2002 in which generic substitution was finally promulgated, after disputes in the international arena about patent rights, due to the government's policy on parallel imports. Section12 ofPharmacy Act 90, which forms part of the Act is an attempt to further regulate the industry, that eventually became effective t

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25

Neville, Warwick John. "Healing the nation : access to medicines under the Pharmaceutical Benefits Scheme - the jurisprudence from history." Phd thesis, 2007. http://hdl.handle.net/1885/150188.

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26

Joseph, Coral Jade. "Access to affordable life-saving medicines : the South African response." Thesis, 2012. http://hdl.handle.net/10413/9774.

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Patent protection grants the patent holder with a market monopoly, free from market competition allowing the patentee to charge any price; therefore medicines are sold at prices much higher than the marginal cost of production and distribution. The connection between international trade and intellectual property has aggravated human rights and public health concerns surrounding the inaccessibility of essential medicines. The World Trade Organisation‘s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement is an international instrument which has greatly impacted intellectual p

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27

Zuma, Sibusiso Memory. "Framework for provision of essential medicines for the district health services." Thesis, 2016. http://hdl.handle.net/10500/22792.

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The purpose of this study was to develop a framework for provision of essential medicines for the district health services. A qualitative descriptive, exploratory and contextual action research design was followed. The data collection was conducted through site visits and semi structured interviews targeting the responsible pharmacists who were purposively selected on the basis of their expert knowledge and experiences from the eight of the nine provinces of the Republic of South Africa which is a developing country with limited resources for provision of healthcare services. The study found

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28

Ndlovu, Lonias. "Access to medicines under the World Trade Organisation TRIPS Agreement: a comparative study of select SADC countries." Thesis, 2014. http://hdl.handle.net/10500/14185.

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Despite the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopoly prices. The WTO TRIPS Agreement gives members room to legisl

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29

Adesola, Eniola Olufemi. "Compulsory patent licensing and access to essential medicines in developing countries after the Doha Declaration." Thesis, 2014. http://hdl.handle.net/10500/18795.

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In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced i

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30

SMAGADI, Aphrodite. "The utilization of natural plant genetic resources and benefit-sharing for the production and legal protection of medicines : the impact of the implementation of the convention on biological diversity." Doctoral thesis, 2006. http://hdl.handle.net/1814/6597.

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Defence date: 14 November 2006<br>Examining board: Prof. Ernst-Ulrich Petersmann (Supervisor, European University Institute) ; Prof. Francesco Francioni (European University Institute) ; Prof. Thomas Cottier (University of Bern, Switzerland) ; Dr. Graham Dutfield (Queen Mary, University of London)<br>PDF of thesis uploaded from the Library digitised archive of EUI PhD theses completed between 2013 and 2017

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