India's product patent protection regime: Less or more of "pills for the poor"?

The year 2005 marks the end of transition period for many developing countries with competent pharmaceutical sectors that competed in supplying generic versions of patented drugs to LDCs before, thereby inducing price competition and enhancing access to medicines. In a post-2005 scenario, the critical issue is whether LDCs without adequate manufacturing capabilities can make use of compulsory licensing expeditiously to induce price competition and secure lower prices. This paper uses empirical evidence collected during a firm-level survey of the Indian pharmaceutical sector to generate evidence on emerging strategies of firms. It shows that the vigour of compulsory licensing as a price-leveraging instrument post-2005 is incumbent mainly on its economic feasibility. It shows that Indian firms view the market potential (in terms of market size and profits involved in such supply, especially if they have to make specific technological investments to produce the drug) of the mechanism much more severely than before, and may be less inclined to engage in such production if their commercial expectations are grossly unmet. The analysis assesses implications of emerging strategies of firms in the Indian pharmaceutical sector for access to medicines both domestically and internationally, and highlights the challenges involved.product patents, Indian pharmaceuticals, generics, access

Estimating the Effects of Global Patent Protection in Pharmaceuticals: A Case Study of Quinolones in India

Under the TRIPS agreement, WTO members are required to enforce product patents for pharmaceuticals. The debate about the merits of this requirement has been extremely contentious. Many low income economies claim that patent protection for pharmaceuticals will result in substantially higher prices for medicines, with adverse consequences for the health and well-being of their citizens. On the other hand, research-based global pharmaceutical companies, argue that prices are unlikely to rise significantly because most patented products have therapeutic substitutes. In this paper we empirically investigate the basis of these claims. Central to the ongoing debate is the structure of demand for pharmaceuticals in poor economies where, because health insurance coverage is so rare, almost all medical expenses are met out-of-pocket. Using a detailed product-level data set from India, we estimate key price and expenditure elasticities and supply-side parameters for the fluoroquinolones sub-segment of the systemic anti-bacterials (i.e., antibiotics) segment of the Indian pharmaceuticals market. We then use these estimates to carry out counterfactual simulations of what prices, profits, and consumer welfare would have been, had the fluoroquinolone molecules we study been under patent in India as they were in the U.S. at the time. Our results suggest that concerns about the potential adverse welfare effects of TRIPS may have some basis. We estimate that in the presence price regulation the total annual welfare losses to the Indian economy from the withdrawal of the four domestic product groups in the fluoroquinolone sub-segment would be on the order of U.S. $305 million, or about 50$50 million. The overwhelming portion of the total welfare loss therefore derives from the loss of consumer welfare. In contrast, the profit gains to foreign producers in the presence price regulation are estimated to be only around $19.6 million per year.

Injectable polypeptide hydrogels via methionine modification for neural stem cell delivery.

Injectable hydrogels with tunable physiochemical and biological properties are potential tools for improving neural stem/progenitor cell (NSPC) transplantation to treat central nervous system (CNS) injury and disease. Here, we developed injectable diblock copolypeptide hydrogels (DCH) for NSPC transplantation that contain hydrophilic segments of modified l-methionine (Met). Multiple Met-based DCH were fabricated by post-polymerization modification of Met to various functional derivatives, and incorporation of different amino acid comonomers into hydrophilic segments. Met-based DCH assembled into self-healing hydrogels with concentration and composition dependent mechanical properties. Mechanical properties of non-ionic Met-sulfoxide formulations (DCHMO) were stable across diverse aqueous media while cationic formulations showed salt ion dependent stiffness reduction. Murine NSPC survival in DCHMO was equivalent to that of standard culture conditions, and sulfoxide functionality imparted cell non-fouling character. Within serum rich environments in vitro, DCHMO was superior at preserving NSPC stemness and multipotency compared to cell adhesive materials. NSPC in DCHMO injected into uninjured forebrain remained local and, after 4 weeks, exhibited an immature astroglial phenotype that integrated with host neural tissue and acted as cellular substrates that supported growth of host-derived axons. These findings demonstrate that Met-based DCH are suitable vehicles for further study of NSPC transplantation in CNS injury and disease models

Motivations, Capability Handicaps and Firm Responses in the Early Phase of Internationalization from Emerging Economies: A study in the Indian Pharmaceutical Industry

This paper identifies and analyses the motivations, capability handicaps and responses of a sample of Indian pharmaceutical firms in the early phase of internationalization. It distinguishes between the experiences of two types of internationalisers –initial internationalisers and later internationalisers - in the industry. It argues that the initial internationalisers face several discontinuities vis-a-vis the experience of meeting the needs of domestic market. They need to cultivate new capabilities by leveraging on whatever is available within the firms and the external environment. Their capability to cultivate depends on their internal processes to absorb the new experiences. The later internationalisers do not experience these handicaps. They can benefit from the industry experience and congregate capabilities to move faster. Their capability to congregate depends on the initial endowments of the founders. Based on its findings, the paper outlines scope for further research in capability building for internationalization in the context of emerging economies.

An Evaluation of Ecolabels, Standards & Certifications in the Chemical Industry

In recent years, ecolabels, standards and certifications (ESCs) have been increasingly utilized to signal a product’s environmental and socially responsible profile, both in the business-to-business and business-to-consumer spheres. The growing demand for this sustainability information from consumers, retailers, and governments has put pressure on the suppliers to provide qualitative and quantitative data on products’ environmental footprint. A multi-national chemical company and the University of Michigan School of Natural Resources team have collaborated to conduct this master’s project, An Evaluation of Ecolabels, Standards & Certifications in the Chemical Industry. The purpose of this project is to provide a strategy for multinational chemical companies to better engage their customers in the marketplace in a way that supports the transfer of sustainability information throughout the value chain. The student team engaged with stakeholders in sustainability reporting, studied a number of ecolabel schemes, and developed a survey addressing members of the home and personal care industry to learn from their experience and priorities. Results of the survey indicate that home and personal care manufacturers expect to double the percentage of their products labeled with an ESC in the next five years. Manufacturers use ESCs on finished products to differentiate, and to increase market penetration and perception of product quality. The main barriers to this use of ESCs are the lack of accredited raw materials and supplier information. The R&D department is most often the agent pursuing ingredients labeled with an ESC and the most important decision-making factors influencing procurement are unsurprisingly, performance and price. Suppliers of ingredients to home and personal care manufacturers can use valuable ESCs as a short-term measure to communicate the ingredient sustainability information, but given the ongoing development of the ESC marketplace, businesses throughout the value chain should continue to collaborate with stakeholders and watch for trends.Master of ScienceNatural Resources and EnvironmentUniversity of Michiganhttp://deepblue.lib.umich.edu/bitstream/2027.42/90877/1/An_Evaluation_of_Ecolabels,_Standards_and_Certifications_in_the_Chemical_Industry[1].pd

Overseas Acquisition versus Greenfield Foreign Investment: Which Internationalization Strategy is better for Indian Pharmaceutical Enterprises?

Very recently overseas acquisition and outward greenfield foreign investment have emerged as the two important modes of internationalization of the Indian pharmaceutical enterprises. This study examines the relative strengths and weaknesses of these strategies so as to suggest which between the two is a more effective internationalization strategy for the Indian pharmaceutical firms, given the nature of their ownership advantages. This analysis has been conducted in three stages. First, the nternationalization process of the Indian pharmaceutical industry has been embedded into a four stage theory emphasizing on the emergence of different modes of internationalization like inward foreign investment, imports, exports, outward greenfield investment, overseas acquisition and contract manufacturing including inter-firm strategic alliances. Second, theoretical perspectives have been developed with regard to the different ways in which greenfield investment and overseas acquisition can maximize the revenue productivity of pharmaceutical firms’ competitive advantages and/or to strengthen their competitive position. Third, case study of Ranbaxy Laboratories has been undertaken to empirically assess its experience with overseas acquisitions. The analysis indicates that the growth and internationalization of Indian pharmaceutical enterprises was critically dependent upon strategic government policies pursued in the past. The Indian experience offers a number of policy lessons to other developing countries wanting to build their domestic base in the pharmaceutical sector. Theoretical understandings indicate that acquisition is a more effective internationalization strategy than greenfield investment since the former not only provides all the benefits that the latter gives, but also several other competitive advantages important for firms’ performance in world market. The experience of Ranbaxy shows that overseas acquisitions have augmented its intangible asset bundle including distribution and market networks and have provided access to an existing market.Indian Pharmaceutical Industry; Foreign Investment; M&As; Trade; Strategic Alliances

Wavelet-based response spectrum compatible synthesis of accelerograms-Eurocode application (EC8)

An integrated approach for addressing the problem of synthesizing artificial seismic accelerograms compatible with a given displacement design/target spectrum is presented in conjunction with aseismic design applications. Initially, a stochastic dynamics solution is used to obtain a family of simulated non-stationary earthquake records whose response spectrum is on the average in good agreement with the target spectrum. The degree of the agreement depends significantly on the adoption of an appropriate parametric evolutionary power spectral form, which is related to the target spectrum in an approximate manner. The performance of two commonly used spectral forms along with a newly proposed one is assessed with respect to the elastic displacement design spectrum defined by the European code regulations (EC8). Subsequently, the computational versatility of the family of harmonic wavelets is employed to modify iteratively the simulated records to satisfy the compatibility criteria for artificial accelerograms prescribed by EC8. In the process, baseline correction steps, ordinarily taken to ensure that the obtained accelerograms are characterized by physically meaningful velocity and displacement traces, are elucidated. Obviously, the presented approach can be used not only in the case of the EC8, for which extensive numerical results/examples are included, but also for any code provisions mandated by regulatory agencies. In any case, the presented numerical results can be quite useful in any aseismic design process dominated by the EC8 specifications

Segment Routing: a Comprehensive Survey of Research Activities, Standardization Efforts and Implementation Results

Fixed and mobile telecom operators, enterprise network operators and cloud providers strive to face the challenging demands coming from the evolution of IP networks (e.g. huge bandwidth requirements, integration of billions of devices and millions of services in the cloud). Proposed in the early 2010s, Segment Routing (SR) architecture helps face these challenging demands, and it is currently being adopted and deployed. SR architecture is based on the concept of source routing and has interesting scalability properties, as it dramatically reduces the amount of state information to be configured in the core nodes to support complex services. SR architecture was first implemented with the MPLS dataplane and then, quite recently, with the IPv6 dataplane (SRv6). IPv6 SR architecture (SRv6) has been extended from the simple steering of packets across nodes to a general network programming approach, making it very suitable for use cases such as Service Function Chaining and Network Function Virtualization. In this paper we present a tutorial and a comprehensive survey on SR technology, analyzing standardization efforts, patents, research activities and implementation results. We start with an introduction on the motivations for Segment Routing and an overview of its evolution and standardization. Then, we provide a tutorial on Segment Routing technology, with a focus on the novel SRv6 solution. We discuss the standardization efforts and the patents providing details on the most important documents and mentioning other ongoing activities. We then thoroughly analyze research activities according to a taxonomy. We have identified 8 main categories during our analysis of the current state of play: Monitoring, Traffic Engineering, Failure Recovery, Centrally Controlled Architectures, Path Encoding, Network Programming, Performance Evaluation and Miscellaneous...Comment: SUBMITTED TO IEEE COMMUNICATIONS SURVEYS & TUTORIAL

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products