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This article analyzes the spread of intellectual property in trade agreements. We explain how the integration of intellectual property with international trade rules led to the globalization of pharmaceutical patenting, and then how additional provisions related to pharmaceutical products have been introduced by regional and bilateral trade agreements. We describe the additional 'TRIPS-Plus' rules contained in recent trade agreements, which go beyond the requirements of the World Trade Organization's TRIPS Agreement, and explain the potential challenges that they may create for developing countries. We draw attention to the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, with particular emphasis on the importance of timing. Depending on when countries began allowing drugs to be patented, TRIPS-Plus provisions have different effects; and when pharmaceutical patenting has been in place for more countries for more time, the effects of TRIPS-Plus provisions will change again. [ABSTRACT FROM AUTHOR]

The rigid interface between the enforcement provisions of patents under TRIPS standards and the institutional, technical and human resource capacity deficiencies means that political decisions to exploit the TRIPS flexibilities to promote access to medicines in the context of Africa is almost an exercise in futility. Notably, the Development Agenda under the auspices of WIPO often follows the North-South model, and the failings are well documented in the empirical literature, as this has brought little institutional change. For instance, the judiciary that could help to provide an interpretation of the TRIPS flexibilities to promote public health simply lacks capacity. At the same time, the Indian judiciary, through the lens of human rights norms, is widely known for its functional activism in the interpretation of the TRIPS provisions consistent with public health protection, and is the best example for African countries. It is on this basis that this paper attempts a critical exploration of judicial cooperation based on a South-South model with a view to underlining its doctrinal significance for African countries. Therefore, the author questions the rationality of African countries' exclusive reliance on socalled North-South capacity building and argues that the South-South judicial cooperation model would provide a logical platform that could operate alongside the conventional North-South system for building institutional, technical, and human resource-based aspects of capacity for its judiciary to interpret TRIPS in a manner consistent with human rights norms to promote access to medicines. [ABSTRACT FROM AUTHOR]

Public health advocates aim to maximise affordable access to good quality essential medicines. This goal often conflicts with the profitseeking ambitions of the pharmaceutical industry. Since the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights agreement, the extension and enforcement of intellectual property (IP) rights has become the dominant discourse in global medicines governance. Public health advocates operating within this framework face significant obstacles and challenges. This paper presents an historical perspective to the contemporary debate over medicines and patents by examining the evolution of international medicines governance between the 1940s and 1970s. This research indicates that debates around IP and medicines were more advanced in terms of equity and access in the 1960s and 1970s than they are today. While acknowledging the existence of obstacles and challenges for advocates, the paper argues that alternative frameworks can and should be reasserted in global debates about medicines governance. [ABSTRACT FROM AUTHOR]

Recent social science scholarship has employed the term “pharmaceuticalization” in analyses of the production, circulation and use of drugs. In this paper, we seek to open up further discussion of the scope, limits and potential of this as an analytical device through consideration of the role of law and legal processes in directing pharmaceutical flows. To do so, we synthesize a range of empirical and conceptual work concerned with the relationships between access to medicines and intellectual property law. This paper suggests that alongside documenting the expansion or reduction in demand for particular drugs, analysts of pharmaceuticalization attend to the ways in which socio-legal developments change (or not) the identities of drugs, and the means through which they circulate and come to be used by states and citizens. Such scholarship has the potential to more precisely locate the biopolitical processes that shape international agendas and targets, form markets, and produce health. [ABSTRACT FROM AUTHOR]

The author reflects on the aid provided to the lower courts of the U.S. in understanding the antitrust litigation with respect to reverse payments in reference to the U.S. Supreme Court lawsuit FTC v. Actavis Inc. Topics discussed include legislative history of the Sherman Antitrust Act, impact of the U.S. Supreme Court decision on the pharmaceutical market and the disputes regarding the policies of Sherman Antitrust Act and the Hatch-Waxman Act.

The World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS), which made product patents compulsory for countries to follow, meant that the entire market for generic drugs was out of bounds for manufacturing till the time the products went off-patent. The TRIPS has generated widespread discussions and debates around the costs and benefits of new patent regimes on countries such as India. This article analyses whether the post-WTO system was consistent with, and conducive to, improved public health in India. It is a first-of-its-kind effort in which the data on pharmaceutical patents applications were collected, collated, cleaned and classified according to IPC codes, to enable preliminary understanding of the nature and type of the applications. The patent applications that are filed in India are not found to be consistent with the disease burden of the country. [ABSTRACT FROM AUTHOR]

This article highlights potential public health effects of India's Patents Act of 2005, which was implemented to conform to the requirements of the World Trade Organisation's Trade-Related Aspects of Intellectual Property Agreement (TRIPS), a new legal regime that will likely have a significant impact on access to HIV/AIDS medications in much of the world. This new patent law may play a role in keeping new antiretroviral (ARV) medications, including improved first-line medications and second-line drugs that are being developed for first-line drug resistant HIV, financially out of reach for many people living with HIV/AIDS in poor countries. India's drug industry, which had thrived under earlier patent laws that protected processes but not products in the case of medications, had brought down the price of ARV drugs in South Asia and Africa by more than 90%. While most existing drugs are grandfathered under the new patent laws, newer ARV medications may be barred from manufacture by Indian companies. This article analyses the effects of the coming together of this new legal regime, the global political economy and emerging resistance to HIV/AIDS medications, and evaluates efforts to mitigate the negative public health effects of the new patent laws. [ABSTRACT FROM AUTHOR]

The years following the end of World War II saw a rapid increase in the rate of the introduction of new products by the pharmaceutical industry in Europe and North America. Patenting played an increasingly significant role in the industry and the companies, which were investing heavily in research, needed to develop strategies of appropriation to ensure that they recouped the rewards of innovation. This paper explores the use of patents by UK companies during the therapeutic revolution and beyond. It suggests that within a framework of competition, the use of patents and the practice of licensing, combined with the growing complexity of products led to the creation of networks of cross-licensing, often linked to a variety of collaborative arrangements. In this process, the companies created corporate capabilities which contributed to their growth and international development within the period covered by the paper. By the 1960s, however, the nature of licensing had changed but some collaborative arrangements and the capabilities they created continued to play a significant role in the further international development of the industry. From the late 1970s, as new drugs became more elusive and expensive, as well taking much longer to get into the market, patents for the much sought after 'blockbuster' drugs were eagerly pursued. Patents, licensing and various forms of collaboration assumed a new significance in the approaches made by the pharmaceutical corporations to the innovative discoveries of the biotechnology industry in the last two decades of the century. [ABSTRACT FROM AUTHOR]

The author examines the changing view of the pharmaceutical industry on the issue of patenting drugs in the twentieth century. He explains that the industry has previously opposed for the imposition of patents because it believed that it could cause conflict of interest between medical researchers and the industry. However, he points out that its growing investments in drug development has urged the industry to advocate for drug patents so that it could recoup the costs from such endeavor.

This paper analyzes the patenting activities of the Berlin pharmaceutical company Schering in the 1920s and 1930s when the firm was developing preparations of sex hormones in collaboration with the Kaiser-Wilhelm Institute für Biochemie. Although in France and Germany, the law declared drugs not patentable, the massive use of process patents by German firms to circumvent this ban opposes the weakness of such practices in France. This case illustrates the creation of a patent milieu between academic researchers, industrial managers, and lawyers that contributed to normalize the intellectual property of drugs. More precisely the paper shows how the changing ways of investigating and producing the sex hormones, i.e. their molecularization, became a legal operator. The paper also highlights the deep influence questions of intellectual property have had on biological research. The 1930s saw a rapid expansion of research on metabolic pathways. Within bio-industrial networks, these pathways were deemed essentials as they were (a) patentable and (b) examples of both biological and technological synthesis of drugs. Finally, the hormone cartel Schering and its main European competitors established in the 1940s reveals that drug patents had then become so important that the fear of a tragedy of the anti-commons became a strong incentive in the formation of cartels grounded in patent pools. [ABSTRACT FROM AUTHOR]

In this article, a method to map the knowledge base (KB) of firms is developed and applied to the study of strategic changes, mergers and acquisitions. The empirical data are related to three firms, Hoechst, Rhône-Poulenc and Aventis, which resulted from the merger of the first two. Our study shows how the KB of both Hoechst and Rhône-Poulenc changed gradually reflecting their strategic reorientation away from chemistry and towards the life sciences. While the previous transition produced a segmented KB with the chemistry and biology subsets largely separated, the merger led a more closely integrated KB. The KB of some Aventis subsidiaries have been studied as well. [ABSTRACT FROM AUTHOR]

In some new regions, an innovative drug of the original region was not marketed. However, after the patent of the innovative drug is expired, a generic copy of the innovative drug from the original region was introduced and approved for marketing in the new region. Another generic copy manufactured by the local sponsor of the new region is seeking for approval in the new region. Despite unavailability of the innovative drug, the regulatory authority of the new region still wants to approve the local generic copy based on assessment of bioequivalence between the local generic drug and the innovative drug. Following the bridging concept suggested by the ICH E5 guidance, we propose a method to evaluate average bioequivalence between the generic copy of the new region and the innovative drug of the original region using the generic copy of the original region as the bridging reference formulation. Sample size required by the bioequivalence study in the new region is also provided. Numerical examples illustrate the proposed method. [ABSTRACT FROM AUTHOR]

Presents literature on drug patents. 'Process for preparing solid-state microspheres of sodium alginate for treating vascular embolism by Zhang Xinguo; 'Local drug delivery with peptide affinity vehicles for treatment of vascular disease,' by Sakharov Dmitri, Emeis Josephus Jan and Rijken Dingeman Cornelis; 'Transdermal drug delivery system for moxonidine,' by Theobald Frank.

Presents several patents on drugs and drug delivery system. Development of microparticle-containing injection anesthesia agent; Manufacture of microcapsules using transglutaminase-modified proteins; Composition of microspheres for wound healing; Formation of liposome with lowered toxicity.

Presents several patents of pharmaceutical technologies worldwide.

The article presents a list of patents related to drug delivery system including Oral biomacromolecular drug delivery system based on bioadhesive microsphere, Release-controlling process for nano drug, preparation of new drug delivery system of retinoic acid-like compound and its application and Drug delivery vehicles and uses thereof.

Presents news about drug patents as of October 2002. Preparation of magnetic polymeric microspheres; Process and polymer-based system for controlled-release drug delivery; Pharmaceutical and cosmetic liposomes containing a photo-sensitizing agent.

Presents several drug patents. Use of drug-carrier conjugates for drug delivery; Application of repetitive direct current pulse electroporation method for gene transfection or drug delivery; Composition of epothilone liposome.

Presents patent briefings on pharmaceuticals at different countries. Thermoplastic microspheres and their manufacture; Use of complexes among cationic liposomes and polydeoxyribonucleotides; Liposome vector complexes for gene therapy; Colored microcapsules for aqueous dispersible inkjet ink; Detection of nucleic acid reactions on microspheres or bead arrays.

Presents several patents of pharmaceutical industry. 'Oral Delivery Systems for Microparticles, by J.G.J. Russell and S.W. Westwood; 'Liposome Spray of Low-molecular-weight Heparin' by L. Zou, T. Zhang, G. Zhai and S. Ji; 'Liposomes Containing Polyols' by S. Sakuyama.

Lists patents of drugs published in the March 2000 issue of the journal 'Drug Delivery.' Prolamin-vegetable polar lipid combinations; Drug delivery system using vesicular stomatitis virus-based fusogenic liposomes; Carboxyl group-containing polyoxyalkylene compounds as drug delivery systems; Fat-soluble anticancer liposomes.

Presents several drug patent briefing. Manufacture of cellulose microspheres; Production of liposomes; Preparation of liposome dispersions and cosmetics containing liposome dispersions.

Presents several patents on microencapsulation and other pharmaceutical technologies.

Comments on an article which proposed conditions that should be met before the U.S. federal government overrides drug patents. Implication of the anthrax incident in the U.S. to the pharmaceutical industry; Possible contribution of bioethicists to the account of industry responsibility; Recommendations.

Argues that the government's practice of manufacturing or distributing of a patented drug without the patent holder's express authorization is use and is not taking.

This study explores how an ‘Intellectual Property Rights (IPR)/trade regime’ has generated a particular set of problems regarding access to medicines despite patents on drugs being presented as economically necessary for reward and future drug innovation. These problems have also inspired and informed activities by so-called new actors in global health. This study argues that a parallel ‘pro-access regime’ has developed in order to correct some of the most high-profile issues associated with a dysfunctional global pharmaceutical market, especially problems regarding price and innovation that have been exacerbated by stringent global patent rights on new drugs. Therefore, the IPR/trade regime's basic role in global-health governance diverges from how it has been framed and understood, not least of all by its constituent agents and donors. The pro-access regime encompasses new actors in health such as Global Health Partnerships (e.g., GAVI Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria), major philanthropic foundations (e.g., the Gates and Clinton Foundations) and new access initiatives (e.g., UNITAID). The study problematises these actors' governance roles with respect to the overarching authority of the IPR/trade regime and makes a case that the two regimes should be understood as being closely connected with respect to the governance of access to medicines and the global political economy of pharmaceuticals. [ABSTRACT FROM PUBLISHER]