Academic literature on the topic 'Drug patents'

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Journal articles on the topic "Drug patents"

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Grimes, Warren. "Perverse Results from Pharmaceutical Patents in the United States." IIC - International Review of Intellectual Property and Competition Law 52, no. 5 (2021): 596–605. http://dx.doi.org/10.1007/s40319-021-01055-9.

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AbstractIn the United States, pharmaceutical patents have had a number of perverse and anticompetitive effects on the development and marketing of prescription drugs. Although some of these effects are unique to the United States, others have implications for patent policy across the world. Among the negative effects of drug patents are: (1) examples of misguided, anti-social, and anticompetitive promotion of patented drugs; (2) misguided incentives that push drug firms toward too much or too little research and development in critical areas: and (3) cartel-facilitating conduct linked to patent licenses or settlements of litigation involving drug patents. Some of these issues can be addressed directly through reforms in patent and competition law policy. There is, however, a need for a broader study of the role of patents in promoting drug research. That study should consider alternatives to the patent system, such as a prize system structured to supplement or partially replace patent rewards for pharmaceutical R&D.
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Liu, Li, and Hongzhou Lu. "Technology Development Through Pooling ARV Drug Patents: A Vision from China." Open AIDS Journal 4, no. 1 (2010): 54–59. http://dx.doi.org/10.2174/1874613601004020054.

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Unaffordable prices still bar the end-users in China from accessing ARV drugs. Patent protection of ARV drugs has dramatically limited the availability of these lifesaving drugs to AIDS patients in China. The way Chinese government can go to breakthrough the ARV drug patents are suggested as: - Make more generic drugs available through compulsory licensing, impartment from other countries or building ARVs plants by partnerships between governments or generic drug companies. - Do a thorough and detailed research on the patent application of ARV drugs to find out the loophole. - Try patent pool to make AIDS medicines more affordable and appropriate for patients.
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Anaya-Ruiz, Maricruz, Cindy Bandala, Gerardo Landeta, et al. "Nanostructured Systems in Advanced Drug Targeting for the Cancer Treatment: Recent Patents." Recent Patents on Anti-Cancer Drug Discovery 14, no. 1 (2019): 85–94. http://dx.doi.org/10.2174/1574892813666181031154146.

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Background: Cancer is one of the leading causes of death in the world and it is necessary to develop new strategies for its treatment because most therapies have limited access to many types of tumors, as well as low therapeutic efficacy and high toxicity.Objective:The present research aims to identify recent patents of drug delivery nanostructured systems that may have application in improving cancer treatment.Methods:Recent patents regarding the drug delivery nanostructured systems for cancer treatment were obtained from the patent databases of the six main patent offices of the world: United States Patent and Trademark Office, European Patent Office, World Intellectual Property Organization, Japan Patent Office, State Intellectual Property Office of China and Korean Intellectual Property Office.Results:A total of 1710 patent documents from 1998 to 2017 including "drug delivery nanostructured systems for cancer treatment" were retrieved. The top five countries in patent share were USA, China, South Korea, Canada and Germany. The universities and enterprises of USA had the highest amount of patents followed by institutions from China.Conclusion:There is a strong tendency for the development of new nanostructured systems for the release of drugs; particularly, in recent years, the development of nanoparticles has focused on nanodiscs, gold nanoparticles and immunoliposomes.
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Wang, Ling, Xu Zhi, Haokun Ke, et al. "Global patent statistical analysis for drug testing technology." Technology and Health Care 29 (March 25, 2021): 415–25. http://dx.doi.org/10.3233/thc-218039.

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BACKGROUND: In recent decades, illicit drug testing has become a high priority area in law enforcement and forensic analysis. OBJECTIVE: Since patents are the largest source of technical information in the world, patent database analysis for illicit drug testing is extremely important to effectively promote the development and protection of the related intellectual property rights. METHODS: In the present study, we first retrieve a database of 1732 drug detection patents using keywords and logical expressions related to the title, abstract, and claims, and subsequently discuss the current global patent statistics in detail. RESULTS: The relevant patent information is presented, including patent application quantity, filing country, ownership, and technical field. CONCLUSIONS: Finally, we summarize the current development trend in drug testing and propose several suggestions focused on the bottleneck of analytical techniques.
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Gharge, Vikram S., Mukesh B. Shinde, Bipin D. Pustake, Krishna B. Kinage, and Anup A. Kulkarni. "Nanosuspensions: Recent Patents and Pharmaceutical Aspects as Drug Delivery Systems." International Journal of Pharmaceutical Sciences and Nanotechnology 10, no. 2 (2017): 3631–44. http://dx.doi.org/10.37285/ijpsn.2017.10.2.1.

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Solubility is an essential factor for drug effectiveness, independent of the route of administration. Poorly soluble drugs are often a challenging task for formulators in the industry. Conventional approaches for enhancement of solubility have limited applicability, especially when the drugs are poorly soluble simultaneously in aqueous and in non-aqueous media. Nanosuspension technology can be used to improve the stability as well as the bioavailability of poorly soluble drugs. Nanosuspensions are biphasic systems consisting of pure drug particles dispersed in an aqueous vehicle, stabilized by surfactants. These are simple to prepare and are more advantageous than other approaches. Techniques such as wet milling, high-pressure homogenization, emulsification–solvent evaporation and super critical fluid have been used in the preparation of nanosuspensions. It has the advantage of delivery by various routes, including oral, parenteral, pulmonary and ocular routes. The present article reviews the current methods used to prepare nanosuspensions and their application in drug delivery. More than 100 patents have been published on nanosuspensions in the recent days. This patent reviews covers different methods of pharmaceutical preparation and applications in drug delivery as well as the recent marketed published or granted patent surveys. This patent review is useful in enhanceing the knowledge of pharmaceutical application in drug delivery.
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Abbas, Muhammad Z. "Evergreening of pharmaceutical patents: A blithe disregard for the rationale of the patent system." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 15, no. 2 (2019): 53–60. http://dx.doi.org/10.1177/1741134319848797.

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Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavours to question the legitimacy of the evergreening of pharmaceutical patents. This study applies all the recognized theories in support of the patent system – namely the ‘natural law’ or ‘natural rights’ theory, the ‘reward by monopoly’ theory, the ‘monopoly-profit incentive’ theory, the ‘exchange for secrets’ theory or the ‘contract’ theory, and the ‘prospect’ theory – to the practice of evergreening of drug patents in order to check whether or not any of these theories can be used to justify the practice. The study concludes that the practice of evergreening is not consistent with any of these theories and therefore lacks any plausible justification.
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Singh, Ruchita, Charles Brumlik, Mandar Vaidya, and Abhishek Choudhury. "A Patent Review on Nanotechnology-Based Nose-to-Brain Drug Delivery." Recent Patents on Nanotechnology 14, no. 3 (2020): 174–92. http://dx.doi.org/10.2174/1872210514666200508121050.

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Background: Current cerebral drug delivery to the brain and Cerebrospinal Fluid (CSF) is limited by the Blood-Brain Barrier (BBB) or the blood-blood Cerebrospinal Fluid (CSF) barrier. The popular, non-invasive, intranasal delivery provides an exciting route for topical and systemic applications. For example, intranasal drug delivery of Central Nervous System (CNS) drugs can be designed to pass the BBB barrier via the nose-to-brain pathways. Recent nanotechnology research and patenting focus mainly on overcoming typical limitations including bioavailability, transport, BBB penetration, targeted delivery, controlled release rate and controlled degradation. Objective: The aim of the present study was to assess the state-of-the-art of nose-to-brain drug delivery systems and the role of nanotechnology in targeted delivery for the treatment of CNS and related therapeutic conditions. Methods: Patent and related searches were made with analytics to explore and organize nanotech work in intranasal drug delivery to the brain. Technical advancements were mapped by API, formulation and performance criteria. Patents and published patent applications were searched with concept tables of keywords, metadata (e.g., assignee) and patent classes (e.g., International Patent Classes and Cooperative Patent Classes). Results: The reviewed patents and published applications show a focus on formulations and therapeutic indications related to the nano-based nose-to-brain drug delivery. The main patented materials were surface modifiers, delivery systems and excipients. Conclusion: Surface modified nanoparticles can greatly improve drug transport and bioavailability of drugs, particularly higher molecular weight drugs. The most commonly used surface modifiers were chitosan, lectin and cyclodextrin-cross-linker complex. Nanoformulations of herbal drugs could increase drug bioavailability and reduce toxicity. Biotechnology-related drug delivery approaches such as monoclonal antibodies and genetically engineered proteins (molecular Trojan horses) deliver large molecule therapeutics.
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Phelps, Charles E. "Extending Exclusivity for Biopharmaceuticals to Deter Competing Generics: A Review of Strategies, Potential Mitigation, and Similarities to Infringement." Technology & Innovation 21, no. 3 (2020): 215–27. http://dx.doi.org/10.21300/21.3.2020.215.

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Some patents confront infringement—unauthorized use of the inventions in the patent—thus violating the exclusive use intent of the U.S. Constitution's creation of the patent system to encourage innovation. In other situations, the reverse occurs—patent holders seek to extend their exclusivity period to prevent competitive entrants. This commonly occurs in biopharmaceutical products markets, where annual revenues on many patented drugs exceed $1 billion per year and (most importantly) where several pathways allow extension of exclusivity. This paper reviews the relevant legislation (Bayh-Dole Act, Orphan Drug Act, Hatch-Waxman Act, and Food and Drug Administration (FDA) Modernization Act) as well as the safety and efficacy regulations of the FDA that control marketing of biopharmaceutical products. The paper then assesses methods used to extend patent exclusivity—some legal, some clearly illegal, and some with ambiguous legal status—in order to deter generic entrants. These methods include using FDA "citizen's petitions," creating generic equivalents of branded drugs to block other generic entrants, deterring potential generic competitors from gaining samples to prove bioequivalence to original formulations, seeking additional patents to extend exclusivity (sometimes for trivial changes), paying potential entrants to delay entry, subdividing the potential patient population to qualify for extensions granted by "orphan drug" status, and (most recently) selling patents to Native American tribes to prevent challenges to their validity. The paper concludes by discussing remedies—primarily legislative—that could either eliminate these actions and/or clarify their legality. Then follows a comparison between these entry-delaying strategies and patent infringement itself.
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CONTRACTOR, SUNIL H., PIYUSH KUMAR, and THOMAS W. LEIGH. "THE IMPACT OF GOVERNANCE MECHANISMS ON ESCALATION OF COMMITMENT." International Journal of Innovation Management 16, no. 04 (2012): 1250023. http://dx.doi.org/10.1142/s1363919612500235.

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There are conflicting opinions on whether the existing US legal and economic environment for pharmaceutical research is conducive for the repurposing of patent-protected drugs. This article therefore addresses the following innovation policy questions: Does US patent law and regulatory policy assign sufficient value to new use patents in the pharmaceutical industry? If present law and regulatory policy does assign sufficient value, what evidence is there that the pharmaceutical industry is actively involved in technology strategies to repurpose existing pharmaceuticals? Based on an evaluation of the extant legal literature, US pharmaceutical firms are generally successful at legally enforcing their new use patents against infringement. Furthermore, the truncating of the time and resources dedicated to the drug discovery, development, and regulatory review process provide sufficient economic "value" on both the front end of the pharmaceutical regulatory approval process, and the back end of the drug patent term for encouraging pharmaceutical industry repurposing.
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Sachs, Rachel. "The Uneasy Case for Patent Law." Michigan Law Review, no. 117.3 (2018): 499. http://dx.doi.org/10.36644/mlr.117.3.uneasy.

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A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights. This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of the role of patents in the emerging field of microbiome research. Scientists have recently begun to appreciate the important role played by the human microbiome, the community of microbes that lives within each of our bodies, in preventing and treating disease. The microbiome has been linked to autoimmune disorders, mental health conditions, and a range of conditions affecting our intestinal systems. Put simply, research involving the microbiome has the potential to change the future of medicine. There’s just one problem: the microbiome can’t meaningfully be patented. Several doctrines within patent law will make it extremely difficult for companies to obtain and enforce patents like the ones that are so readily available in most areas of medicine. Drawing on patent doctrine, patent searches, and interviews with scientists and lawyers, this Article demonstrates that companies are developing microbiome-based therapies largely in the absence of patent protection. Instead, the companies are relying on other innovation incentives to fill the gap. The microbiome’s unpatentability presents an opportunity to evaluate whether patents are truly necessary for the development of new drugs. Congress, the NIH, and the FDA have implemented many innovation incentives throughout the development process, and we should not be astonished that removing a single such incentive, patent law, does not disrupt the entire system. Perhaps scholars should reconsider, if only selectively, our focus on patents as an irreplaceable driver of pharmaceutical innovation.
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Dissertations / Theses on the topic "Drug patents"

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Oliveira, Carlos Fernando Lopes de. "Patentes de fármacos: as tensões existentes entre os interesses da indústria farmacêutica e as necessidades das populações." Universidade Federal da Paraí­ba, 2010. http://tede.biblioteca.ufpb.br:8080/handle/tede/4363.

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Made available in DSpace on 2015-05-07T14:27:05Z (GMT). No. of bitstreams: 1 arquivototal.pdf: 2044681 bytes, checksum: 09d18643545c26dd327be8c0d35cd1d2 (MD5) Previous issue date: 2010-04-27<br>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior<br>It is a study focused on the medicament patent from the analysis of the existing tensions among the pharmaceutical industry and the population necessities regarding medicine access. It is well-known the inner nature of the fundamental rights the condition of its social function. In this context, reasoning regarding the protection limits conferred to human nature property is posed, the so-called intellectual property, particularly in the health field, in a concentrated pharmaceutical industry context in the hands of transnational economic conglomerates. Drug Patent-letters are industrial property titles of core application in this universe, as they confer the temporal exclusivity right of exploration in the registered invention. The exercise of the patent right confronts itself with the necessity of the drug access of the population. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Intellectual Property Act rise as rigid diplomas for protecting these rights. The tenet of intellectual property shows a path for a well limited protection, from its technical requisites. In the Mercosur context, a need for enhancement on the mechanisms of regional protection, and the political articulation maintenance is seen, in the sense of avoiding the adherence to bilateral instruments which foresees more rigid protective conditions than the existing ones at the TRIPS. Data stress the importance of a severe protection for an innovation process, at the same time that it is questioned. The drug access becomes more important in situations for the AIDS and other epidemics treatment. At the same time, the sense of investments of the pharmaceutical industry points to the negligence of the P&D on tropical diseases, privileging researches on the high incident diseases of cold countries, or global diseases. The fall on the drug prices is shown, due to the introduction of the generics, and also the way the piracy implies into barrier towards the population access to the drugs. The necessity of a more objective legal mechanism definition is stated aiming to avoid the me-too drug patenting, with a consequent time gap lag on the temporal exclusivity patent right. The formation of the PPP for the realization of P&D of medicament in the industrial phase and the concession technology transferring definition in one of the requisites to form partnerships and international acquisitions, is also shown as relevant. The creation of a new useful capitalism to the reduction of the regional inaqualities passes for the process to endow with flexibility the rights on the pharmaceutical patents.<br>Trata-se de um estudo sobre as patentes de medicamentos a partir da análise de tensões existentes entre os interesses da indústria farmacêutica e as necessidades das populações no tocante ao acesso aos remédios. Sabe-se ser inerente ao direito de propriedade uma função social, devendo servir à promoção de justiça social. Neste contexto, são tecidos questionamentos sobre os limites de proteção conferidos à propriedade decorrente da criação humana, a chamada propriedade intelectual, particularmente na área da saúde, em um contexto de concentração da indústria farmacêutica nacional em poder de conglomerados econômicos transnacionais. Cartas-patentes de medicamentos são títulos de propriedade industrial de utilidade chave neste universo, pois conferem o direito de exclusividade temporal de exploração da invenção registrada. O exercício do direito patentário defronta-se com a necessidade de acesso das populações a medicamentos. O Tratado sobre os Direitos de Propriedade Intelectual Relacionados com o Comércio (TRIPS) e a Lei de Propriedade Industrial despontam como diplomas rígidos de proteção destes direitos. Os princípios da propriedade intelectual fornecem um caminho para uma proteção bem delimitada, a partir de requisitos técnicos. No contexto do Mercosul verifica-se a necessidade de aprimoramento dos mecanismos de proteção regional e da manutenção de uma articulação política no sentido de não ser realizada a adesão a instrumentos bilaterais que prevejam condições mais rígidas de proteção do que as previstas no TRIPS. Dados enaltecem a importância de uma severa proteção para um processo de inovação, ao mesmo tempo que a põe em dúvida. O acesso aos fármacos torna-se mais premente em situações de medicamentos para o trato de epidemias, como a AIDS. Ao mesmo tempo, o sentido dos investimentos da indústria farmacêutica indica a negligência de P&D sobre doenças tropicais, privilegiando pesquisas sobre doenças de maior incidência em países de clima temperado, ou doenças globais. Demonstra-se a queda de preços de medicamentos em função da introdução de genéricos e como a pirataria implica em uma barreira ao acesso da população aos fármacos. Constata-se a necessidade de definição de mecanismos jurídicos objetivos com a finalidade de evitar-se o patenteamento de drogas &#8213;me-too&#8214;, com o consequente prolongamento do lapso temporal do direito de exclusividade patentário. A formação de Parcerias Público-Privadas (PPPs) para a realização de P&D de medicamentos em fase industrial e a definição da concessão de transferência de tecnologia como um dos requisitos para a formatação de parcerias e aquisições internacionais, mostra-se igualmente relevante. A criação de um novo capitalismo útil à redução das desigualdades regionais passa pelo processo de flexibilização dos direitos sobre as patentes de medicamentos.
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Figueiredo, Luciano Lima. "A função social das patentes de medicamentos." Universidade Federal da Bahia, 2008. http://www.repositorio.ufba.br/ri/handle/ri/12373.

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248 f.<br>Submitted by Ana Valéria de Jesus Moura (anavaleria_131@hotmail.com) on 2013-07-31T14:26:22Z No. of bitstreams: 1 LUCIANO LIMA FIGUEIREDO.pdf: 1277407 bytes, checksum: 4a9e492e2ca9afe642e59c6fa5a8d6d0 (MD5)<br>Approved for entry into archive by Ana Valéria de Jesus Moura(anavaleria_131@hotmail.com) on 2013-07-31T14:28:27Z (GMT) No. of bitstreams: 1 LUCIANO LIMA FIGUEIREDO.pdf: 1277407 bytes, checksum: 4a9e492e2ca9afe642e59c6fa5a8d6d0 (MD5)<br>Made available in DSpace on 2013-07-31T14:28:27Z (GMT). No. of bitstreams: 1 LUCIANO LIMA FIGUEIREDO.pdf: 1277407 bytes, checksum: 4a9e492e2ca9afe642e59c6fa5a8d6d0 (MD5) Previous issue date: 2008<br>Este trabalho tem por objetivo analisar a aplicação do princípio da função social da propriedade às patentes de medicamentos. Verifica se o princípio da função social impõe aos titulares das cartas-patentes o dever de comercializar remédios a um preço razoável, o qual não gere lucros astronômicos e seja apto a tornar o bem industrial acessível à população mais pobre. Para tanto, foi dividido o trabalho em cinco temas principais, abordados em capítulos específicos: A Constitucionalização do Direito Civil; A(s) Propriedade(s); A Propriedade Industrial; As Patentes de Medicamentos; e a Função Social das Patentes de Medicamentos. Perpassa o trabalho pela migração das normas do direito civil para o bojo da Constituição Federal (constitucionalização); a existência de propriedades; o estudo da espécie propriedade industrial, com atenção às patentes; as patentes de medicamentos, seu custo e inserção da ciência para o pilar da produção; e a aplicação do princípio da função social às patentes de medicamentos. Há a análise de questões atuais, como os remédios genéricos, o patenteamento de genes e do genoma humano, as patentes de transgênicos, diversos acordos internacionais, “quebra” de patentes. Após a pesquisa realizada, concluiu-se que a função social da propriedade, núcleo duro e elemento unificador das propriedades, têm plena aplicação às patentes de medicamentos. Consiste a função social da propriedade em princípio constitucional, sendo sua maximização a observância da legalidade constitucional. Com esta premissa, parte o autor a traçar caminhos para a concretização nacional e global de acesso aos remédios, consignando no seu trabalho medidas funcionais. Devido ao caráter interdisciplinar, para a confecção do trabalho foram analisadas doutrina e legislação de direito constitucional, civil, internacional, comercial, bem como jurisprudência dos principais tribunais pátrios e de direito comparado. De igual maneira recorreu-se a referências relacionadas a questões ligadas a medicamentos e de direito alienígena, legitimando ao máximo a pesquisa realizada.<br>Salvador
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Basheer, Shamnad. "The invention of an investment incentive for pharmaceutical innovation." Thesis, University of Oxford, 2011. https://ora.ox.ac.uk/objects/uuid:b53d2ab0-dcdd-4adc-8728-cdf32e948df6.

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Pharmaceutical drugs are often hailed as the poster child for the proposition that patents foster accelerated rates of innovation. This sentiment stems, in large part, from the significantly high research and development (R&D) costs endemic to the pharmaceutical sector. I argue that if the role of the patent regime is one of fostering higher amounts of investment in the R&D process, it is better served by a direct investment protection regime, where the protection does not depend upon whether or not the underlying idea behind the drug is 'new' and 'inventive', the two central tenets of patent law. Rather, any drug that successfully makes it past the regulatory filter ought to be entitled to protection, since its discovery and development entail significant investment and risk. Owing to the inadequacy of the current patent regime in appropriately protecting intensive pharmaceutical R&D investments from free-riders, I propose a comprehensive investment protection regime that protects all the investment costs incurred during the drug discovery and development process. Though similar to existing data protection regimes in some respects, it differs in others. Firstly, it enables a recovery of all R&D costs, and not only costs associated with clinical trials. Secondly, unlike patents and data exclusivity which offer uniform periods of protection, it rewards investments in a proportionate manner, wherein drug originators are entitled to protection against free-riders only until such time as they recoup their specific investments and earn a rate of return on investment that is dependent on the health value of the drug. Given that a pure market exclusivity based investment protection regime is likely to foster excessive pricing and subject the market to the dictates of a single firm, I advocate a compensatory liability model based on a novel cost sharing methodology, where follow-on entrants are free to manufacture the drug, but must pay a reasonable amount of compensation to the originator.
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袁慶文. "基於引證網絡的藥品專利價值分析". Thesis, University of Macau, 2018. http://umaclib3.umac.mo/record=b3952162.

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胡元佳. "Pharmaceutical patent valuation based on technology innovation and applications in the industry." Thesis, University of Macau, 2009. http://umaclib3.umac.mo/record=b2150641.

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Harnisch, Sandy. "Die Zwangslizenz im südafrikanischen und deutschen Patentrecht : ein Rechtsvergleich unter besonderer Berücksichtigung der Arzneimittelerfindungen /." Berlin : BWV, Berliner Wiss.-Verl, 2006. http://deposit.ddb.de/cgi-bin/dokserv?id=2792408&prov=M&dok_var=1&dok_ext=htm.

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Rigestam, Björn. "Pharmaceutical patents and generic drugs : When may interim injunctions be issued against an attempt or preparation to offer generic drugs on the market?" Thesis, Internationella Handelshögskolan, Högskolan i Jönköping, IHH, Rättsvetenskap, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-18933.

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Since the implementation of Directive 2004/48 EC on the Enforcement of Intellectual Property Rights in Sweden there is today a possibility for pharmaceutical companies holding a patent to issue interim injunctions against a generic company on the grounds of an attempt or preparation to a pharmaceutical patent infringement. It has been shown that one of the earliest steps in which a generic company may infringe a pharmaceutical patent is to offer the generic drugs onto the market. However, since the implementation of the attempt and preparation rule in the Swedish Patent Act questions have been raised as to in what stage interim injunctions may be issued against an attempt or preparation to offer generic drugs onto the market made by generic companies. This thesis has therefore intent to investigate at what stage interim injunctions may be applied for against a generic company on the grounds of an attempt or preparation to offer generic drugs. In the thesis the writer argues that in order for an attempt or preparation to offer generic drugs to exist an overall assessment must be made of the particular situation and that there is no specific principles to follow in order to determine either an attempt or a preparation to offer generic drugs. However, some guidance might be brought from Danish case law in order to establish a preparation to offer generic drugs in Sweden.
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Chan, Yuen Cheung. "Quality evaluation and anti-chronic glomerulonephritis properties of a patent herbal drug yi-shen-hua-shi granule." HKBU Institutional Repository, 2020. https://repository.hkbu.edu.hk/etd_oa/825.

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Yi-Shen-Hua-Shi (YSHS) granule is a Chinese patent drug for treating chronic glomerulonephritis (CGN). It was marketed in 2009. However, up to now, there is no report about the quality and pharmacological activities of this product. In this work,we evaluated the quality and anti-CGN effects of the drug. To evaluate the quality of the granule, a qualitative and quantitative HPLC-DAD analytical method was developed. For qualitative analysis, HPLC fingerprint of ten batches of YSHS granule was established. The fingerprints were analyzed using similarity evaluation, hierarchical cluster analysis (HCA), principal components analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) based on 15 characteristic fingerprint peaks. Similarity values of 10-batche samples were all above 0.960, indicating a stable quality. Minor differences were observed among batches by HCA and PCA. For quantification analysis, contents of six constituents in the granule were simultaneously measured. To establish the chemical profile of the granule, a HPLC-Q-TOF- MS/MS method was developed. A total of 105 peaks were detected using HPLC-Q-TOF-MS/MS in the granule, of which, 99 were tentatively identified as terpenoids, flavonoids, coumarins, alkaloids, phenols and other types of compounds, and 15 were further validated with reference substances. HPLC fingerprint chromatogram establishment, quantification analysis of 6 constituents and compound identification should improve the quality control of YSHS granule. To study the pharmacological activities of the granule, we investigated its anti-CGN effects and TGFβ signaling-related mechanism of action. A CGN rat model was established by injection of cationization-bovine serum albumin (C-BSA) for five weeks. After C-BSA injection, drugs were intragastrically administered to the rats once daily for four weeks. Clinical signs were recorded daily. Urine and serum biochemical parameters were analyzed using respective kits. Protein levels were examined by Western blotting. Pathological changes of renal tissues were evaluated using HE and Masson's trichrome staining. No significant differences in body weights and clinical signs were found among normal, model and drug treatment groups. Proteinuria; albuminuria; increased urine volume; elevated creatinine, urea nitrogen, triglyceride levels and total cholesterol in serum; decreased serum total protein and albumin; as well as renal pathological damages and fibrosis were observed in CGN model rats. YSHS granule ameliorated all the abnormal behavioral and biochemical changes in the model rats. Mechanistic investigations revealed that YSHS granule down-regulated proteins levels of TGFβ1, phospho-Smad2/3 (Thr 8) and Smad4 in rat renal tissues. These findings indicate that the drug has anti-CGN effects in rats, and inhibiting TGFβ signaling contributes to the underlying mechanisms. In summary, our chemical analytical studies will help in improving the quality control of YSHS granule. Our bioactivity and mechanistic studies provide a pharmacological basis for the clinical use of the granule in treating CGN.
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Hedner, Erik. "Implementering av "Life Cycle Management" i svensk läkemedelsindustri." Thesis, University of Gävle, Department of Business Administration and Economics, 2009. http://urn.kb.se/resolve?urn=urn:nbn:se:hig:diva-5169.

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<p>It generally takes 10 to 12 years for a new drug to hit the market. The pharmaceutical industry invests huge sums in these early stages of research and development. In spite of the rapidly rising research and development expenditures fewer and fewer blockbuster drugs are being developed. Longer lead times and aggressive generic post-patent competition have narrowed the timeframe for the pharmaceutical companies to profit on their investments.</p><p>In the face of these threats the pharmaceutical industry has developed a battery of strategies to prolong market exclusivity and to maximize return on investment. These emerging strategies are commonly known as Life cycle management (LCM), which actually is more of a concept than a method. A life cycle is a sequence that stretches all the way from early research and development, through marketing to finally end when the product is withdrawn from the market. By managing the product through these different stages the company can improve the commercial lifespan.</p><p>This thesis analyzes how Life cycle management is implemented in the Swedish pharmaceutical industry. The data is based on interviews from people who are active in the pharmaceutical business. Further, the thesis studies the strategies that AstraZeneca used for their gastrointestinal drugs Losec and Nexium.</p><p>Based on the collected data from the interviews a clear view of the role and involvement of LCM strategies appears. The value and importance of LCM have steadily increased during the last 10 years. LCM is heavily embedded in the decision processes of drugs today. Several strategies such as OTC switching and patent prolongation through pediatric indication application are common practice. The Swedish pharmaceutical industry has a prominent position in the advancement of LCM.</p><br><p>Idag lanseras mindre innovativa nya läkemedel än under 80- och 90-talet. Kostnaderna för att utveckla ett läkemedel har ökat och det tar dessutom längre tid från upptäckt till lansering. Läkemedel har endast en begränsad marknadsexklusivitet som styrs av patentskyddet. Vid patentutgång så utsätts läkemedlet för stenhård konkurrens från aggressiva generika tillverkare. De ställs hårdare krav på forskande farmaceutiska företag för att vara lönsamma i detta klimat.</p><p>Det finns en tydlig trend att läkemedelsföretag har blivit mer beroende av sina storsäljande läkemedel. Ett flertal offensiva strategier har utvecklats för att förlänga lönsamheten hos de mest framgångsrika läkemedlen, t.ex. genom att minska utvecklingstiden, utveckla nya formuleringar och expandera indikationerna. ”Life cycle management” (LCM) är ett samlingsbegrepp på dessa strategier, som används under en produkts livscykel för att förbättra den kommersiella livslängden. Försäljning och marknadsföring för innovativa läkemedel passerar distinkta faser och olika strategier krävs beroende på vilka fas en produkt befinner sig i.</p><p>I denna uppsats analyserar jag hur LCM är implementerat i den svenska läkemedelssektorn. Slutsatserna bygger på data från intervjuer av personer som är sysselsatta inom läkemedelsbranschen. Uppsatsen studerar dessutom de strategier som AstraZeneca har använt för sina två magtarmläkemedel Losec och Nexium.</p><p>Baserat på insamlad intervjudata så framkommer tydligt att LCM är starkt involverat i beslutsprocesserna runt ett läkemedel. Betydelsen av LCM har successivt ökat under de senaste 10 åren. Flera strategier för t.ex. patentförlängning är idag vanligt förekommande. Den svenska läkemedelsbranschen ligger relativt långt fram i denna utveckling.</p>
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譚偉民. "活血化瘀中成藥處方和製備工藝改進 : 雲南白藥劑型的質量比較分析". HKBU Institutional Repository, 2010. http://repository.hkbu.edu.hk/etd_ra/1132.

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Books on the topic "Drug patents"

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Environment, United States Congress House Committee on Energy and Commerce Subcommittee on Health and the. Drug issues. U.S. G.P.O., 1988.

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Patently innovative: How pharmaceutical firms use emerging patent law to extend monopolies on blockbuster drugs. Biohealthcare, 2012.

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Shachar, Josh Yehoshua. Frontiers in drug delivery: Pharmaco-kinesis collected patents. Pharmaco-Kinesis Corporation, 2010.

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Significant pharmaceuticals reported in recent US patents. Elsevier, 2007.

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Ahn, Hyewon. Second generation patents in pharmaceutical innovation. Nomos, 2014.

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Voet, Martin A. The generic challenge: Understanding patents, FDA & pharmaceutical life-cycle management. 2nd ed. BrownWalker Press, 2008.

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Intellectual property, pharmaceuticals and public health: Access to drugs in developing countries. Edward Elgar, 2011.

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United States. Congress. Senate. Committee on Labor and Human Resources. Animal Drug Amendments and Patent Term Restoration Act of 1986: Report together with minority views (to accompany S. 2407). U.S. G.P.O., 1986.

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United States. Congress. Senate. Committee on Labor and Human Resources. Animal Drug Amendments and Patent Term Restoration Act of 1986: Report together with minority views (to accompany S. 2407). U.S. G.P.O., 1986.

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Resources, United States Congress Senate Committee on Labor and Human. Animal Drug Amendments and Patent Term Restoration Act of 1986: Report together with minority views (to accompany S. 2407). U.S. G.P.O., 1986.

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Book chapters on the topic "Drug patents"

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Wang, Jeffrey, and Jonathan Hirohiko Watanabe. "Major ADC Companies, Current Clinical Trials, Recent Patents Issued and Patent Applications, and Cost Analysis of Drug Therapy." In Antibody-Drug Conjugates. Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-13081-1_9.

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Soares, Jaqueline, and Eduardo Guimarães. "Polymorph Drug Patents and Their Public Health Impact." In Health Innovation and Social Justice in Brazil. Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-76834-2_8.

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Patel, Rashmin B., Shivam D. Thakore, and Mrunali R. Patel. "Patents Survey: Treatment of Alzheimer’s Disease Through Nanotechnology-Based Drug Delivery System." In Nanotechnology Applied To Pharmaceutical Technology. Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-70299-5_14.

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Imam, Syed Sarim, and Mohammed Aqil. "Penetration-Enhancement Strategies for Dermal and Transdermal Drug Delivery: An Overview of Recent Research Studies and Patents." In Percutaneous Penetration Enhancers Drug Penetration Into/Through the Skin. Springer Berlin Heidelberg, 2017. http://dx.doi.org/10.1007/978-3-662-53270-6_20.

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Borsos, Mark A. "Patent Protection Strategy." In Early Drug Development. Wiley-VCH Verlag GmbH & Co. KGaA, 2018. http://dx.doi.org/10.1002/9783527801756.ch25.

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Armstrong, MaryAnne. "Patent Considerations in Collaborative Drug Development." In Early Drug Development. Wiley-VCH Verlag GmbH & Co. KGaA, 2018. http://dx.doi.org/10.1002/9783527801756.ch27.

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Brougher, Joanna T., and Audrey Ogurchak. "Patent Law Relevant to Early Drug Development." In Early Drug Development. Wiley-VCH Verlag GmbH & Co. KGaA, 2018. http://dx.doi.org/10.1002/9783527801756.ch24.

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Atkinson D.Phil EPA C Chem. FRSC, Jonathan D. M. "Intellectual Property: The Patent Landscape Viewed from Generic and Originator Perspectives." In Early Drug Development. Wiley-VCH Verlag GmbH & Co. KGaA, 2018. http://dx.doi.org/10.1002/9783527801756.ch26.

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Pariza, Richard J. "From Patent to Prescription: Paving the Perilous Path to Profit." In Drug Discovery and Development. John Wiley & Sons, Inc., 2006. http://dx.doi.org/10.1002/0471780103.ch1.

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Courage, Noel, and Lynn C. Tyler. "Patent Exclusivities Affecting Biosimilars in the United States, Canada, and Europe." In Biosimilar Drug Product Development. CRC Press, 2017. http://dx.doi.org/10.1201/9781315119878-14.

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Conference papers on the topic "Drug patents"

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Fornaro, M., V. Venerito, L. Cantarini та ін. "SAT0307 Impact of the modified rheumatic disease comorbidity index(MRDCI) on drug survival of first line anti-tnfΑ drugs in patents affected with psoriatic arthritis in real life setting". У Annual European Congress of Rheumatology, EULAR 2018, Amsterdam, 13–16 June 2018. BMJ Publishing Group Ltd and European League Against Rheumatism, 2018. http://dx.doi.org/10.1136/annrheumdis-2018-eular.2216.

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Suryakrishna, S. S., K. Praveen, S. Tamilselvan, and S. Srinath. "IoT Based Automation and Blockchain for Medical Drug Storage and Smart Drug Store." In Intelligent Computing and Technologies Conference. AIJR Publisher, 2021. http://dx.doi.org/10.21467/proceedings.115.8.

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The increase in the work stress and decrease in the time for oneself has led to the rise in the dependency on the medicines and drugs. The drugs and medicines are the key sources for saving the human life when the patient is in the danger. In order to maintain regular and quality supply of the drugs and medicines has to monitor on the regular basis. There are numerous medicines and drugs brought in the store but usually drugs and medicines are stolen to satisfy one’s greed, get expired or placed at unknown locations in the store. So to prevent such situation and saving the life of the patient Drug and Medicine Monitoring Model can be used. The model uses the RFID and IoT technology in order to monitor the drugs and medicines in the store. In medical and drug using systems which are increasing work stress and decreasing the time for oneself that has risen in dependency. The danger situation drugs and medicine is the main source for saving human life when the people are in danger. A daily regular basis to maintain a quality supply of the drug and medicine has been monitored. While traveling and transportation time is numerous medicines and drugs brought from the store but usually it is stolen to one’s greed and the medicines and drugs or placed at unknown locations. To prevent and save a patent life and monitoring model can be used to check the medicine and drug. In our model RFID tag and IoT technology can be used to monitor medicine and drug storage with the help of hospitals and how having a knowledge of the system and chemist of the medical and drugs available, the medicines and drugs quality of location and their safety.
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Timmis, A. D., B. Griffin, J. C. P. Crick, J. S. Flax, E. Sowton, and D. E. Cool. "APSAC VERSUS PLACEBO: THE FIRST PLACEBO CONTROLLED CORONARY RECANALISATION STUDY WITH PRE AND POST TREATMENTCORONARY ARTERIOGRAPHY." In XIth International Congress on Thrombosis and Haemostasis. Schattauer GmbH, 1987. http://dx.doi.org/10.1055/s-0038-1643620.

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40 patients entered the first double-blind placebo controlled invasive arteriographic study of intravenous anisoylated plasminogen streptokinase activator complex (APSAC) for coronary recanalisation in acute myocardial infarction. Coronary arteriography was performed before and 90 minutes after a single intravenous injection of APSAC or matched placebo given over 2-5 minutes. Pre-treatment coronary arteriography was performed in all 40 patients 3.1 ± 1.2 hours after the onset of major symptoms of myocardial infarction. All coronary arteriograms were read blindly and scored according to the TIMI criteria by an independent cardiologist. Following randomisation occlusion of the infarct related coronary artery was demonstrable in 29 of the 40 cases at pre-treatment coronary arteriography. Patients were given either APSAC 30 units (n=l6) or matched placebo (n=13),3.3 ± 1.3 hours after the onset ofsymptoms. Repeat coronary arteriography was performed 90 minutes after administration of study drug. 9 of the 16 patients who received APSAC had demonstrable coronary recanalisation of the infarct related vessel compared with only one patient inthe placebo group (P 0.05).A third full diagnostic coronary arteriogram was performed three days after treatment and this showed persistent patency of all the recanalised coronary arteries except one in the APSAC group as well as late recanalisation in a further 4 cases, 3 of whom had received APSAC.Of the 11 patients who had patent infarctrelated arteries on initial arteriography, 4 received APSAC and 7 placebo. Patency was maintained in all these throughout the study period.There were haemorrhagic complications related to APSAC therapy. This data confirms the thrombolytic efficacy of APSAC in acute myocardial infarction, and indicates that the drug may be used safely by the intravenous route with a 56 per cent recanalisation rate at 90 minutes. Re-occlusion of the recanalised vessel was rare.
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Zhide, Zhou, and Yu Shanshan. "Research on Compulsory Drug Patent Licensing in China Under Covid-19." In 2020 4th International Seminar on Education, Management and Social Sciences (ISEMSS 2020). Atlantis Press, 2020. http://dx.doi.org/10.2991/assehr.k.200826.082.

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Schroeder, Jr., Arthur J., James E. Chitwood, Tom A. Gay, et al. "Key Technology Qualification for Increasing Subsea Well Production via Drag Reducing Agents." In Offshore Technology Conference. OTC, 2021. http://dx.doi.org/10.4043/31054-ms.

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Abstract Drag reducing agents (DRAs) are a cost-effective method to reduce pipeline pressure losses and maximize flowrates of onshore and offshore pipelines with over 40 years of proven results. With recent developments, production can also be significantly increased by injecting DRA into flow restricted subsea flowlines. This paper will provide a summary of the development and testing of a full-scale prototype subsea DRA storage and injection unit built to achieve the industry goal of alleviating flow restricted subsea pipelines. While DRA applications are proven in thousands of offshore and onshore applications, it has never been successfully injected subsea. System integration testing (SIT) is currently under way on the prototype unit, after which it will be qualified for offshore use. The technology is covered by numerous patents issued and pending in the US and other countries.
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Ming Chung Yang, Fang-Pei Su, Yu-Hsin Chang, Kuei Kuei Lai, Chien Yu Lin, and Han Yun Chang. "“Expand/offense” and “deepen/defense” strategy of patent acquisition for leader and follower: Evidence from drug-eluting stent." In 2016 Portland International Conference on Management of Engineering and Technology (PICMET). IEEE, 2016. http://dx.doi.org/10.1109/picmet.2016.7806630.

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He, Wei, Xiang Yu, and Minghan Sun. "Research and Development Situation Analysis of Anti-breast Cancer Drugs from Patent Intelligence Perspective." In 2018 Portland International Conference on Management of Engineering and Technology (PICMET). IEEE, 2018. http://dx.doi.org/10.23919/picmet.2018.8481872.

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Cavalcante, Dayane Silva, Thalita Carvalho, Martina Costa Cerqueira Pinto, Eliane Pereira Cipolatti, and Evelin Andrade Manoel. "UTILIZAÇÃO DE LIPASES IMOBILIZADAS NA INDÚSTRIA FARMACÊUTICA." In I Congresso de Engenharia de Biotecnologia. Revista Multidisciplinar de Educação e Meio Ambiente, 2021. http://dx.doi.org/10.51189/rema/1336.

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Introdução: A demanda por processos industriais que causem menos impacto ambiental está crescendo ao passo que as indústrias produzem insumos cada vez mais complexos. A catálise química normalmente requer condições mais agressivas, algumas vezes são menos eficientes e mais danosas ao meio ambiente quando comparadas à catálise enzimática, dessa forma, processos enzimáticos surgem como alternativas. É muito comum a utilização de enzimas imobilizadas na indústria, inclusive na produção de substâncias biologicamente ativas, como derivados farmacológicos. Uma das enzimas que vem se destacando nesses processos biocatalíticos são as lipases, principalmente por sua ampla especificidade e possibilidade de atuação em solventes orgânicos e neotéricos. Tendo em vista a produtividade dos processos de biocatálise, condições relativamente mais brandas nas quais elas podem ser empregadas, menor impacto ambiental e a enantiosseletividade das lipases, fica clara a importância da síntese enzimática para a produção de derivados farmacológicos. Objetivo: Mostrar o crescimento da síntese de derivados farmacológicos via biocatálise a partir de dados quantitativos e avaliar as técnicas de imobilização mais empregadas na área farmacêutica. Material e métodos: Os dados foram obtidos por meio das plataformas Scopus e Patent Inspiration relativos ao número de publicações e patentes nos últimos 5 anos na área. As palavras-chave utilizadas foram lipase AND immob* AND pharm* OR drug. As técnicas de imobilização, os tipos suportes e os solventes mais utilizados na área estão sendo avaliados. Resultados e discussão: Os dados obtidos indicam uma tendência de crescimento e desenvolvimento na área. É possível destacar o uso de líquidos iônicos, que aparecem em aproximadamente 50% dos resultados obtidos, evidenciando ainda mais a preocupação com a redução dos impactos ambientais, visto que estes são classificados como solventes verdes. O trabalho ainda está em desenvolvimento, os resultados estão sendo cuidadosamente avaliados e serão apresentados em sua totalidade na próxima etapa. Conclusão: Há uma tendência na busca por processos mais verdes e pelo uso de lipases na área farmacêutica. Os dados reafirmam a importância dos processos biocatalíticos, tanto na área farmacêutica, como na biotecnologia industrial de forma geral, evidenciando também uma busca pela redução dos danos ao meio ambiente.
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Blaser, Wade P. "Induction Heat Tube Extraction for Generating Bank Replacement." In 19th Annual North American Waste-to-Energy Conference. ASMEDC, 2011. http://dx.doi.org/10.1115/nawtec19-5444.

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Induction is used to rapidly heat generating bank tubes in situ to 1000 C, which causes plastic deformation due to thermal expansion under restraint by the tube sheet (drum). When cooled, the tube shrinks, breaking contact with the drum, providing for ease of removal. A second process has also been developed, and Patented, for the removal of previously over expanded tube stubs from headers and drums. The Heat and PullSM method extracts the stub by hydraulic jacking from outside the drum while Induction heating from inside the drum. Prior bell removal is not required, as the bell collapses and is pulled through with the stub. Cost and schedule improvements may be achieved with both Induction Heat Tube Extraction processes. Both processes eliminate the risk of tube seat damage often caused by the traditional tube removal methods of arc air gouging or flame cutting. This paper describes the technology of both Induction Heat Tube Extraction methods as well as developments on current boiler generating bank replacement jobs.
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Theofanis, Michail, Ioannis Spyridonidis, Panagiotis Kitrou, Panagiotis Papadimatos, Konstantinos Katsanos, and Dimitrios Karnabatidis. "Drug-Coated Balloon use in Dysfunctional Arterio-Venous Access Treatment the Effect of Consecutive Treatments in Target Lesion Primary Patency." In PAIRS Annual Meeting. Thieme Medical and Scientific Publishers Pvt. Ltd., 2019. http://dx.doi.org/10.1055/s-0041-1730623.

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Reports on the topic "Drug patents"

1

Cockburn, Iain, Jean Lanjouw, and Mark Schankerman. Patents and the Global Diffusion of New Drugs. National Bureau of Economic Research, 2014. http://dx.doi.org/10.3386/w20492.

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Conti, Rena, and Ernst Berndt. Specialty drug prices and utilization after loss of U.S. patent exclusivity, 2001-2007. National Bureau of Economic Research, 2014. http://dx.doi.org/10.3386/w20016.

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Lanjouw, Jean. Patents, Price Controls, and Access to New Drugs: How Policy Affects Global Market Entry. National Bureau of Economic Research, 2005. http://dx.doi.org/10.3386/w11321.

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Galasso, Alberto, and Mark Schankerman. Licensing Life-Saving Drugs for Developing Countries: Evidence from the Medicines Patent Pool. National Bureau of Economic Research, 2021. http://dx.doi.org/10.3386/w28545.

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Perceptions of community pharmacists, patent and proprietary medicine vendors, and their clients regarding quality of family planning services: The IntegratE Project. Population Council, 2021. http://dx.doi.org/10.31899/rh17.1016.

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The IntegratE Project is a four-year initiative (2017–21) implemented by the Population Council and partners that seeks to increase access to contraceptive methods by involving the private sector (community pharmacists [CPs] and patent and proprietary medicine vendors [PPMVs]) in family planning (FP) service delivery in Lagos and Kaduna States, Nigeria. The project aims to establish a regulatory system with the Pharmacists Council of Nigeria to ensure that CPs and PPMVs provide quality FP services, comply with FP regulations, and report service statistics to the Health Information Management System (HMIS). To achieve this, the project is implementing: a pilot three-tiered accreditation system for PPMVs; a supervisory model to ensure standard drug-stocking practices; building the capacity of CPs and PPMVs to provide a wider range of FP services and data report to the HMIS. This brief focuses on quality of care received by women voluntarily seeking FP services from CPs and PPMVs. CPs and PPMVs and their clients appear to be satisfied with the FP services offered by CPs and PPMVs; on-going learning opportunities, and a supportive supervision system that is properly coordinated should be sufficient to maintain the quality of services offered by CPs and PPMVs.
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