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The Working Patent and Pharmaceutical Industry Development in Indonesia
The aim of this research is to analyze the panca maha bhuta services at the Fivelements Retreat Bali Hotel. In general, 4-star hotels have spa services for guests' health therapy needs. However, Fivelements Retreat Bali Hotel, as a 4-star hotel, apparently has a special guest health therapy service called panca maha bhuta. The problems are : 1) What is the form of panca maha bhuta as a health service at the Fivelements Retreat Bali Hotel?; 2) What is the new form of panca maha bhuta service as a health service at the Fivelements Retreat Bali Hotel?; 3) Is the panca maha bhuta service an innovation in health services at the Fivelements Retreat Bali Hotel?. The investigation was conducted using qualitative approaches. Primary data has been successfully collected through observation, interviews, and FGD at the Fivelements Retreat Bali Hotel. This research's secondary data was collected based on a document study. All data was analyzed qualitatively using symbol theory and practice theory. The research results show that : 1) The panca maha bhuta service at the Fivelements Retreat Bali Hotel takes the form of the panca maha bhuta retreat service and the panca maha bhuta healing energy service package; 2) the novelty of the health service called panca maha bhuta at the Fivelements Retreat Hotel Bali lies in the name of the service package, the protocol components of the service package and the operational conditions of the service package; 3) The panca maha bhuta service is recognized by guests as a type of awesome health service package at the Fivelements Retreat Bali Hotel. The Fivelements Retreat Bali Hotel has recognized the panca maha bhuta service as a special health service package for its guests. The recognition of the new form of panca maha bhuta service at the Fivelements Retreat Bali Hotel shows that the panca maha bhuta service is a health service innovation based on Balinese wisdom.
Drug discovery is a process which aims at identifying a compound therapeutically useful in curing and treating disease. This process involves the identification of candidates, synthesis, characterization, validation, optimization, screening and assays for therapeutic efficacy. Once a compound has shown its significance in these investigations, it will initiate the process of drug development earlier to clinical trials. New drug development process must continue through several stages in order to make a medicine that is safe, effective, and has approved all regulatory requirements. One overall theme of our article is that the process is sufficiently long, complex, and expensive so that many biological targets must be considered for every new medicine ultimately approved for clinical use and new research tools may be needed to investigate each new target. From initial discovery to a marketable medicine is a long, challenging task. It takes about 12 - 15 years from discovery to the approved medicine and requires an investment of about US $1 billion. On an average, a million molecules screened but only a single is explored in late stage clinical trials and is finally made obtainable for patients. This article provides a brief outline of the processes of new drug discovery and development.
Seiring dengan perkembangan teknologi, peradaban, dan jumlah penduduk, maka konsumen jamu tradisional mulai berkurang. Masyarakat cenderung untuk memilih obat-obatan kimia yang lebih praktis dari jamu tradisional dan khasiatnya yang berlangsung cepat. Penemuan-penemuan obat baru menghasilkan lebih dari 500 macam obat setiap tahunnya. Namun saat ini, kesadaran masyarakat akan back to nature semakin meningkat, dilihat dari penggunaan obat tradisional/obat herbal, baik di negara yang sedang berkembang maupun negara maju cenderung terus meningkat. Obat herbal Indonesia, yang dikenal sebagai jamu, sejak berabad-abad telah digunakan secara luas oleh bangsa Indonesia untuk memelihara kesehatan dan mengobati penyakit. Pengembangan dan penggunaan obat herbal Indonesia ke depannya, harus didasarkan bukti-bukti ilmiah yang kuat, terutama melalui penelitian dan pengembangan, serta terstandarisasi, sehingga dapat diintegrasikan dalam sistem pelayanan kesehatan nasional.
Penemuan dan pengembangan obat terus menerus dilakukan untuk terus menghasilkan produk-produk yang bermanfaat di dunia kesehatan. Target obat biasanya berupa sel, protein, gen, ataupun biofarmasetik. Uji pra klinis dan uji klinis merupakan tahapan yang penting dalam penemuan dan pengembangan obat. Dalam artikel komentar ini dibahas terkait kemungkinan pengembangan obat baru di Indonesia dari berbagai aspek seperti sumber bahan baku, target obat, penelitian, dan biaya.Kata kunci : obat baru, penemuan, uji praklinis, uji klinis
The Article explores the mini-body of antitrust provisions to be found within TRIPs. It advocates a general-principles based and systematic interpretative approach of these provisions with a view to finding in them an antidote to the ratcheting up of IP protection otherwise encouraged by TRIPs. In this framework, it is argued that member countries retain considerable flexibility to incorporate pro-competitive inputs and to give appropriate consideration to non-intellectual property interests in adopting legislation at the intersection of antitrust and IP. The Article further develops criteria to assess the TRIPs-compatibility both of antitrust intervention and of generalized, ex ante legislative measures intended to fine-tune the design of IP regimes to adequately take into account the interests of current users and future generations of innovators. Five case studies are presented discussing technology transfer, local working requirements in patent laws, refusal to deal in IP, essential facilities doctrine and software patents, with a view to testing the hypothesis in the light of the first reports by WTO panels in intellectual property cases. In this perspective, it turns out that, while consideration of TRIPs antitrust provision does not provide a complete remedy to IP overprotection, still it may make a significant contribution towards granting member states fluidity in designing their IP regimes.
This article explores treaty interpretation in dispute settlement at the World Trade Organization (WTO) by seeking to resolve the unanswered question of whether local working requirements – domestic provisions which allow the grant of a compulsory license when a patent is not “worked” in that country – are legal under the international trade regime. The issue remains in flux as local working requirements appear to be inconsistent with the Agreement on Trade-Related Aspects of International Property Rights (TRIPS) Article 27, which prohibits discrimination as to “whether products are imported or locally produced.” However, TRIPS Article 2.2 incorporates the substantial majority of the Paris Convention, including Article 5(A)(2), which may specifically allow working requirements. Analyzing the issue in strict adherence to the principles of treaty interpretation that guide decision-making in the WTO’s Dispute Settlement Body, we conclude that the incorporation of Article 5(A)(2) of the Paris Convention cannot be read down, and thus working requirements are consistent with the TRIPS Agreement. This Article is therefore intentionally and unapologetically a technical analysis which evaluates and resolves a legal conflict using all available sources of law and is not a discussion of the policy rationale behind local working requirements.
In 1989, Manning, Patel, and Borchardt wrote a review of protein stability (Manning et al., Pharm. Res. 6:903-918, 1989), which has been widely referenced ever since. At the time, recombinant protein therapy was still in its infancy. This review summarizes the advances that have been made since then regarding protein stabilization and formulation. In addition to a discussion of the current understanding of chemical and physical instability, sections are included on stabilization in aqueous solution and the dried state, the use of chemical modification and mutagenesis to improve stability, and the interrelationship between chemical and physical instability.
This article aims to analyse the working of patent requirements under Indian patent law. A patent working requirement generally entails that the patentee must work or apply the patented product in the patent granting country. This article evaluates the compatibility of the patent working requirement with the TRIPS Agreement from the perspective of international human rights law. A human rights approach suggests that the rights of the patentee must be reconciled with the interests of the general public. In such pursuance, this article argues that there is a need to recalibrate the patent working requirement under the Indian law to strike a right balance between the rights of the patentee and the public interest. Particularly, this article argues that India must modify the present patent working disclosure requirements to ensure that foreign patentees are able to do business in India without bureaucratic hassles.
This paper presents the methodology of an analytical patent database in Thailand from the Thai patent authority, Department of Intellectual Property, and provides descriptive statistics showing the technological catching up of Thai local applicants to multinational corporations investing in Thailand. The share of domestic patent applicants has increased over time, which suggests the improvement of the technological capability of Thai local applicants. However, the upward trend of patenting is explained by an increasing patenting from Thai nonprofit research organizations, including (national) universities. The share of joint R&D patents by Thai local firms and academia (research organizations and universities) and the share of local invention patents by multinationals have increased recently. Hence, spending on research organization by both the public R&D and the local R&D by multinationals could contribute to the technological upgrading of Thai local firms.
Background:
We analyzed the role that the launch of new drugs has played in reducing the number of years of life lost (YLL) before three different ages (85, 70 and 55 y) due to 66 diseases in 27 countries.
Methods:
We estimated two-way fixed-effects models of the rate of decline of the disease- and country-specific age-standardized YLL rate. The models control for the average decline in the YLL rate in each country and from each disease.
Results:
One additional drug launch 0-11 y before year t is estimated to have reduced the pre-age-85 y YLL rate (YLL85) in year t by 3.0%, and one additional drug launch ≥12 y before year t is estimated to have reduced YLL85 by 5.5%. (A drug's utilization peaks 8-10 y after it is launched.) Controlling for the number of drugs previously launched, YLL rates are unrelated to the number of drug classes previously launched.
Conclusions:
The estimates imply that, if no new drugs had been launched after 1981, YLL85 in 2013 would have been 2.16 times as high as it actually was. We estimated that pharmaceutical expenditure per life-year saved before age 85 y in 2013 by post-1981 drugs was $2837. This amount is about 8% of per capita GDP, indicating that post-1981 drugs launched were very cost-effective overall. But the fact that an intervention is cost-effective does not necessarily mean that it is 'affordable.'
My purpose in writing this chapter is to pose a number of questions that have not been satisfactorily addressed, if at all, by economists working in the area of intellectual property rights (IPRs), trade, foreign direct investment, and technology diffusion. There is always a basic tradeoff between fundamental gains and losses from protecting IPRs, or rather reforming them in a manner that offers more certainty and exclusivity to rights holders. On the one hand, such reforms may be expected to improve the functioning of formal markets in which technologies are traded across borders, at least in recipient emerging countries with supportive economic and policy frameworks. On the other hand, those reforms raise the costs of technology imitation by local firms and impose administrative burdens on domestic authorities. They may also limit the policy flexibility those authorities have to regulate the use of exclusive rights and encourage broad adoption and diffusion of incoming technical knowledge. In this chapter I offer some thoughts on these questions, with a particular emphasis on policy issues surrounding international technology transfer and IPRs. In the second section I discuss available evidence on how patent reforms seem to affect flows of technology through formal markets. Following that is a review of various policy flexibilities that matter in this context, considering the limited evidence about how well they work. In the last substantive section I address some of the broader policy questions that affect technology diffusion, most of which have not been studied systematically by empirical economists. In that context, the section sets out an agenda for economic research that would focus on understanding how broader policies and conditions could improve access to global technologies, even in the presence of IPRs reforms. That analysis is partly speculative, attempting to envision how to peel back the veil of ignorance covering key issues in this area of inquiry.
This article provides evidence about the impact that public and private research had on premature mortality and hospitalization due to cancer in the United States during the period 1999-2013. We estimate difference-in-differences models based on longitudinal, cancer-site-level data to determine whether the cancer sites about which more research-supported articles were published had larger subsequent reductions in premature mortality and hospitalization during the period 1999 to 2013, controlling for the change in the number of people diagnosed. Premature (before age 75 years) mortality is inversely related to the number of research-supported articles that had been published 9 to 15 years earlier, controlling for incidence and non-research publications. The number of hospital discharges attributed to cancer is also significantly inversely related to the number of research-supported articles previously published. Public and private research reduced the number of years of potential life lost before age 75 years due to cancer in 2013 by 566,000.
JEL Classifications: I1, I18
Recognition of some of the limitations of target-based drug discovery has recently led to the renaissance of a more holistic approach in which complex biological systems are investigated for phenotypic changes upon exposure to small molecules. The subsequent identification of the molecular targets that underlie an observed phenotypic response--termed target deconvolution--is an important aspect of current drug discovery, as knowledge of the molecular targets will greatly aid drug development. Here, the broad panel of experimental strategies that can be applied to target deconvolution is critically reviewed.
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