Concept: Intellectual property law
Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation.The ‘open access’ approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism.The ‘restricted access’ approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who ‘needs to know’ about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial.It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.
BACKGROUND: Realizing constructive applications of synthetic biology requires continued development of enabling technologies as well as policies and practices to ensure these technologies remain accessible for research. Broadly defined, enabling technologies for synthetic biology include any reagent or method that, alone or in combination with associated technologies, provides the means to generate any new research tool or application. Because applications of synthetic biology likely will embody multiple patented inventions, it will be important to create structures for managing intellectual property rights that best promote continued innovation. Monitoring the enabling technologies of synthetic biology will facilitate the systematic investigation of property rights coupled to these technologies and help shape policies and practices that impact the use, regulation, patenting, and licensing of these technologies. RESULTS: We conducted a survey among a self-identifying community of practitioners engaged in synthetic biology research to obtain their opinions and experiences with technologies that support the engineering of biological systems. Technologies widely used and considered enabling by survey participants included public and private registries of biological parts, standard methods for physical assembly of DNA constructs, genomic databases, software tools for search, alignment, analysis, and editing of DNA sequences, and commercial services for DNA synthesis and sequencing. Standards and methods supporting measurement, functional composition, and data exchange were less widely used though still considered enabling by a subset of survey participants. CONCLUSIONS: The set of enabling technologies compiled from this survey provide insight into the many and varied technologies that support innovation in synthetic biology. Many of these technologies are widely accessible for use, either by virtue of being in the public domain or through legal tools such as non-exclusive licensing. Access to some patent protected technologies is less clear and use of these technologies may be subject to restrictions imposed by material transfer agreements or other contract terms. We expect the technologies considered enabling for synthetic biology to change as the field advances. By monitoring the enabling technologies of synthetic biology and addressing the policies and practices that impact their development and use, our hope is that the field will be better able to realize its full potential.
Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.
Canadian reports have recommended that health as a human right must be Canada’s overarching global commitment and that the primacy of human rights should be prioritized over other elements of international law including international trade and investment law as it applies to access to pharmaceuticals. This paper uses a series of case reports to examine Canada’s commitment to this goal. Specifically it examines cases where improved access has been in conflict with increased intellectual property rights. The 6 cases are: Canada’s position when 39 pharmaceutical companies took South Africa to court in 1998 over its legislation to allow parallel importation of patented medicines and to regulate the price of medications; the stance that Canada took in the negotiations around the Doha Declaration in 2001; the passage of Canada’s Access to Medicines Regime in 2004 and subsequent attempts to amend the legislation in 2011 and 2012; Canada’s involvement in the final declaration at the United Nations High-Level meeting on non-communicable diseases in 2012; Canada’s views about the terms in the Anti-Counterfeiting Trade Agreement as expressed in 2009; and Canada’s 2013 position on the extension of the exemption for least developed countries from having to comply with the terms of the Trade Related Aspects of Intellectual Property Rights Agreement. In the first case Canada was neutral but in the remaining 5 cases Canada prioritized intellectual property rights over access. This position is consistent with how Canada has acted around domestic issues involving intellectual property rights for pharmaceutical products. Canada has supported strengthened rights despite the fact that their touted benefits have not been realized either domestically or in developing countries. As a result Canada has failed in its humanitarian duty to protect the human right to health in the form of safe and low cost medicines for the people in developing countries.
This article focuses on the initial steps of commercial development of a patentable scientific discovery from an academic center through to marketing a clinical product. The basics of partnering with a technology transfer office (TTO) and the complex process of patenting are addressed, followed by a discussion on marketing and licensing the patent to a company in addition to starting a company. Finally, the authors address the basic principles of obtaining clearance from the Food and Drugs Administration, production in a good manufacturing practice (GMP) facility, and bringing the product to clinical trial.
This article is based upon data gathered during a study conducted in partnership with the World Intellectual Property Organization on the patent status of products appearing on the World Health Organization’s 2013 Model List of Essential Medicines (MLEM). It is a statistical analysis aimed at answering: in which developing countries are patents on essential medicines being filed?
Potentially divergent objectives and thereby obligations under the Convention on Biodiversity and Trade-Related Aspects of Intellectual Property Rights Agreement are also reflected in respective domestic legislations in India. The review article focuses on Biological Diversity Act, 2002 vis-à-vis Patents Act, 1970 of India with intricacies involved thereunder. Authors have analyzed the obligations under these domestic legislations. The article goes on to make a few suggestions to aid effective implementation of both the statutes. The scope of this review article is limited in two aspects; first, it speaks only about Indian landscape and second, it discusses about interplay of biodiversity law only with respect to patent law instead of all the domestic Intellectual Property enactments of India.
It has been argued that patents impede the development and access of medicines for tropical diseases such as malaria. However, we believe that intellectual property can be a key tool to enable timely progression of drug development projects involving multiple partners and to ensure equitable access to successful products.
Scientific Productivity is a demand of policy makers for a judicious utilization of massive R&D budget allocated and utilized. A huge mass of intellectual assets is employed, which after investing manpower, infrastructure and lab consumables demand for a major outcome which contributes towards building nation’s economy. Scientific productivity was only measured thorough publications or patents. Patents, earmarked as a strong parameter for innovation generation, where, Word Intellectual Property Organisation generated a data on applications for the top 20 offices for patents, where Australia, Brazil and Canada occupied top 3 positions. India ranked 9th with the total patent applications rising from 39762 (2010) to 42854 (2014) i.e. 15%, whereas, it contributes around 2% Patents (innovative productivity) on global scale. Many studies have come forward interestingly within scientific and academic domains in the form of measurement of scientific performance, however, development of productivity indicators and calculation of Scientific Productivity (SP) as a holistic evaluation system is significant demand. SP, a herculean task is envisaged for productivity analysis and would submit significant factors towards fabricating an effective measurement engine in a holistic manner viable for an individual and organization, being supplementary to each other. This paper projects the significance of performance measurement in R&D through identification and standardization of key parameters of performance measurement for a laboratory as whole comprising of scientists, lab technical staff as well as lab as a facility. This review aims at providing an insight to the evaluators, policy makers, and high level scientific panels to stimulate the scientific intellects on identified indicators so that they work proceeds on generating productive outcomes that contributes economic growth.
Diosgenin (3b-hydroxy-5-spirostene), saponin is a steroid with wide therapeutic application in different areas, with cardiovascular protective action and performance in the control of dyslipidemia. The objective of study was to conduct a systematic review of this Diosgenina, its pharmaceutical applications and the outlook on the application in Cardiovascular System diseases. Periodicals bases, such as ScienceDirect, PubMed and Virtual Health Library, were used, as well as technological basis of European Patent Office, World Intellectual Property Organization, United States Patent and Trademark Office and data bank from Brazilian National Institute of Industrial Property. The keywords used were diosgenin, cardiovascular system, hypertension, atherosclerosis and dyslipidemia and their correlations in English and Portuguese from January 2010 to June 2015. There are many publications on diosgenin in international literature, present a wide range of pharmacological and commercial applications as production of hormones, hypolipodemic, antiviral, reducing inflammation e control of dyslipidemias. In reference to technological bases there are a reduced number of patents related to pharmacological activities proposed here. Therefore, it is necessary to explore diosgenin, which present high pharmacological potential from scientific and technological points of view, in search of transference of technologies to generate economical and industrial growth.