Advances in novel influenza vaccines: a patent review

The threat of a major human influenza pandemic such as the avian H5N1 or the 2009 new H1N1 has emphasized the need for effective prevention strategies to combat these pathogens. Although egg based influenza vaccines have been well established for a long time, it remains an ongoing public health need to develop alternative production methods that ensures improved safety, efficacy, and ease of administration compared with conventional influenza vaccines. This article is intended to cover some of the recent advances and related patents on the development of influenza vaccines including live attenuated, cell based, genomic and synthetic peptide vaccines.     

An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile

We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between “primary” (active ingredient) and “secondary” patents (patents on modified compounds, formulations, dosages, particular medical uses, etc.). There is prior evidence that secondary patents are used by pharmaceutical originator companies in the U.S. and Europe to extend patent protection on drugs in length and breadth. Using a novel dataset that comprises all drugs registered in Chile between 1991 and 2010 as well as the corresponding patents and trademarks, we find evidence that foreign originator companies pursue similar strategies in Chile. We find a primary to secondary patents ratio of 1:4 at the drug-level, which is comparable to the available evidence for Europe; most secondary patents are filed over several years following the original primary patent and after the protected active ingredient has obtained market approval in Chile. This points toward effective patent term extensions through secondary patents. Secondary patents dominate “older” therapeutic classes like anti-ulcer and anti-depressants. In contrast, newer areas like anti-virals and anti-neoplastics (anti-cancer) have a much larger share of primary patents.     

New issues and future legislation on biosafety.

The current debate on gene technology in Europe is reviewed with particular emphasis on the role of EFB and science in general. From this debate important lessons have been learned by scientists, industrial companies, legislators, parliamentarians and interest organisations. This gives confidence that the continued debate will eventually lead to public acceptance of gene technology even in the food area.     

Phytoremediation of organic contaminants in soils

Soil pollution, a very important environmental problem, has been attracting considerable public attention over the last decades. Unfortunately, the enormous costs associated with the removal of pollutants from soils by means of traditional physicochemical methods have been encouraging companies to ignore the problem. Phytoremediation is an emerging technology that uses plants to clean up pollutants in the environment. As overwhelmingly positive results have become available regarding the ability of plants to degrade certain organic compounds, more and more people are getting involved in the phytoremediation of organic contaminants. Phytoremediation of organics appears a very promising technology for the removal of these contaminants from polluted sites.     

跨国种企作物育种专利布局及对我国的启示*

当前全球种业基本形成“两超、四强、差异化发展”新格局,种业巨头主导着全球作物育种技术研发和产业发展。通过深入分析和挖掘跨国种企作物育种专利,洞察其技术研发布局,为我国合理部署作物育种技术研发、改善知识产权布局与保护具有借鉴意义。基于Derwent Innovation(DI)专利数据库,以“两超四强”跨国种企2015~2019年申请的作物生物育种专利为研究对象,通过文本聚类法全面分析了“两超四强”跨国种企的生物育种研发布局,通过计量指标结合专家咨询遴选出其重点专利,厘清其技术研发重点。据此提出我国应当瞄准生物育种核心领域加强新兴前沿技术原始创新与集成开发,加强新型抗虫基因挖掘与抗虫新机制研发,强化生物育种核心技术链、产业链知识产权协同保护与布局,提升知识产权保护水平及全球化结合重点布局的知识产权战略意识的建议。     

The Global Inventor Gap: Distribution and Equality of World-Wide Inventive Effort, 1990–2010

Applying distance-to-frontier analysis, we have used 2.9 million patents and population data to assess whether the relative capacity of world countries and major regions to create new knowledge and technology has become globally more equal or less equal between 1990 and 2010. We show with the Gini coefficient that the global distribution of inventors has become more equal between major countries and regions. However, this trend has been largely due to the improved performance of only two major countries, China and India. The worst performing regions, totalling a population of almost 2 billion, are actually falling behind. Our results suggest that substantial parts of the global population have fallen further behind countries at the global frontier in their ability to create new knowledge and inventions, and that the catch-up among the least developed and middle-income countries is highly uneven, prompting questions about the nature and future of the global knowledge economy.     

Opposition to Myriad Genetics patents and their total or partial revocation in Europe: early conclusions

The proceedings instituted against three European patents held by the US company Myriad Genetics, on the BRCA1 gene and the breast cancer diagnosis gene, resulted in the total or partial revocation of these patents. These decisions put an end to the legal monopoly claimed by Myriad Genetics on the BRCA1 gene and on breast cancer gene tests, and left the field open to European geneticists to develop and implement their test methods within the framework of a clinical not-for-profit organization. The opposition procedure, through which any actor is allowed to challenge European patents, was used by geneticists doctors in Europe to refuse the emergence of an industrial monopoly on a medical service offered in a clinical context. The decision to revoke or strongly limit these patents was based on the European Patent Office's refusal to establish an invention priority on a sequence that had errors at the time the application was filed by the patent holder, in September 1994. The patent holder was granted an invention priority only on 24 March 1995, when it filed an application for a corrected sequence of the gene. But by then the BRCA1 gene sequence had already been divulged in a public data base, Genbank, from October 1994, notably by Myriad. Myriad Genetics' patents were thus victims of the patent race that prompted the firm to file multiple patent applications on insufficiently validated sequences, and of the conflict between diffusion in the public domain and the novelty requirement. Opposition to the patents, undertaken by a coalition of medical institutions, human genetic societies, two States, Holland and Austria, an environmental protection organization (Greenpeace), and the Swiss Labour Party, made it possible to preserve and develop the clinical economy of genetic tests in Europe. It resulted in amendments to intellectual property laws in France and thus extended the possibility of using compulsory licences for public health purposes to in vitro diagnosis.     

Patents Associated with High-Cost Drugs in Australia

Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by “evergreening” blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug''s originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.     

Translational Science by Public Biotechnology Companies in the IPO“Class of 2000”: The Impact of Technological Maturity

The biotechnology industry plays a central role in the translation of nascent biomedical science into both products that offer material health benefits and creating capital growth. This study examines the relationship between the maturity of technologies in a characteristic life cycle and value creation by biotechnology companies. We examined the core technology, product development pipelines, and capitalization for a cohort of biotechnology companies that completed an IPO in 2000. Each of these companies was well financed and had core technologies on the leading edge of biological science. We found that companies with the least mature technologies had significantly higher valuations at IPO, but failed to develop products based on these technologies over the ensuing decade, and created less capital growth than companies with more mature technologies at IPO. The observation that this cohort of recently public biotechnology companies was not effective in creating value from nascent science suggests the need for new, evidence-based business strategies for translational science.     

Biotechnology in South Africa

Since adopting the National Biotechnology Strategy in 2001, the South African government has established several regional innovation centres and has put in place initiatives to encourage international partnerships that can spur internal development of life science ventures. This strategy seeks to capitalize on the high quality of research carried out in public research institutions and universities but is hampered, somewhat, by the lack of entrepreneurial culture among South African researchers due to, among other reasons, the expenses involved in registering foreign patents. Although private sector development is still relatively embryonic, start-ups are spinning out of universities and pre-existing companies. These represent a vital source of innovations for commercialization in the future, provided that the challenges facing the emerging South African biotechnology industry can be overcome.     

Power Law Distributions of Patents as Indicators of Innovation

The total number of patents produced by a country (or the number of patents produced per capita) is often used as an indicator for innovation. Here we present evidence that the distribution of patents amongst applicants within many countries is well-described by power laws with exponents that vary between 1.66 (Japan) and 2.37 (Poland). We suggest that this exponent is a useful new metric for studying innovation. Using simulations based on simple preferential attachment-type rules that generate power laws, we find we can explain some of the variation in exponents between countries, with countries that have larger numbers of patents per applicant generally exhibiting smaller exponents in both the simulated and actual data. Similarly we find that the exponents for most countries are inversely correlated with other indicators of innovation, such as research and development intensity or the ubiquity of export baskets. This suggests that in more advanced economies, which tend to have smaller values of the exponent, a greater proportion of the total number of patents are filed by large companies than in less advanced countries.     

The granuloma in cryptococcal disease

Although we have recognized cryptococcosis as a disease entity for well over 100 years, there are many details about its pathogenesis which remain unknown. A major barrier to better understanding is the very broad range of clinical and pathological forms cryptococcal infections can take. One such form has been historically called the cryptococcal granuloma, or the cryptococcoma. These words have been used to describe essentially any mass lesion associated with infection, due to their presumed similarity to the quintessential granuloma, the tubercle in tuberculosis. Although clear distinctions between tuberculosis and cryptococcal disease have been discovered, cellular and molecular studies still confirm some important parallels between these 2 diseases and what we now call granulomatous inflammation. In this review, we shall sketch out some of the history behind the term “granuloma” as it pertains to cryptococcal disease, explore our current understanding of the biology of granuloma formation, and try to place that understanding in the context of the myriad pathological presentations of this infection. Finally, we shall summarize the role of the granuloma in cryptococcal latency and present opportunities for future investigations.     

全球虾青素研究专利计量分析

由于虾青素具有极高的应用价值,近几十年来,虾青素的应用研究取得了很大的进展。本文以Derwent Innovations Index(DII)数据库为统计分析源,检索并分析了数据库中关于虾青素的所有专利产出,利用Thomson Data Analyzer(TDA)分析工具和Thomson Inovation分析平台进行数据挖掘。通过对专利申请趋势、高产机构、核心技术、专利布局、热点技术领域等方面的计量分析,揭示了全球虾青素技术的发展现状,探索我国发展虾青素技术面临的机遇与挑战。虾青素的应用集中在鱼类饲料的添加剂和疾病治疗两个领域。日本、美国和中国为排名前三的优先权受理国,日本公司的申请数量占主导地位,从专利布局看,杜邦和东曹公司几乎全部集中在发酵或使用酶的方法合成目标化合物或组合物或从外消旋混合物中分离旋光异构体和微生物或酶其组合物这两个领域,而排名靠前的日本公司的研究领域主要集中在医用、牙科用或梳妆用的配制品、食品、食料或非酒精饮料制备或加工处理以及化合物或药物制剂的特定治疗活性三个领域。     

Indian pharma enters the global arena

Although known as a major supplier of generic drugs, India has begun to forge new alliances with big US and European pharma companies. Such collaborations are helping to shepherd Indian drug companies into a new era of innovative drug discovery, but regulations governing patents, drug approvals, and clinical trials are still in the process of being updated.     

Wall Street's assessment of plastic surgery--related technology: a clinical and financial analysis

Many plastic surgeons develop technologies that are manufactured by Wall Street-financed companies. Others participate in the stock market as investors. This study examines the bioengineered skin industry to determine whether it integrates clinical and financial information as Wall Street tenets would predict, and to see whether the financial performance of these companies provides any lessons for practicing plastic surgeons. In efficient markets, the assumptions on which independent financial analysts base their company sales and earnings projections are clinically reasonable, the volatility of a company's stock price does not irrationally differ from that of its industry sector, and the buy/sell recommendations of analysts are roughly congruent. For the companies in this study, these key financial parameters were compared with a benchmark index of 69 biotech companies of similar age and annual revenues (Student's t test). Five bioengineered skin companies were included in the study. Analysts estimated that each company would sell its product to between 24 and 45 percent of its target clinical population. The average stock price volatility was significantly higher for study companies than for those in the benchmark index (p < 0.05). Similarly, buy/sell recommendations of analysts for the study companies were significantly less congruent than those for the benchmark companies (p < 0.05). These results indicate clinically unrealistic projections for market penetration, significantly high price volatility, and significantly high discordance among professional analysts. In all cases, the market is inefficient-an unusual finding on Wall Street. A likely explanation for this market failure is a cycle of poor clinical correlation when assigning sales projections, which in turn leads to price volatility and discordance of buy/sell recommendations. This study's findings have implications for plastic surgeons who develop new technology or who participate in the equities markets as investors. Plastic surgeons who develop new medical devices or technology cannot universally depend on the market to drive clinically reasonable financial performance. Although inflated sales estimates have benefits in the short term, failure to meet projections exacts severe financial penalties. Plastic surgeons who invest in the stock market, because of their unique clinical experience, may sometimes be in the position to evaluate new technologies and companies better than Wall Street experts. Well-timed trades that use this expertise can result in opportunities for profit.     

Agricultural R&D, technology and productivity

The relationships between basic and applied agricultural R&D, developed and developing country R&D and between R&D, extension, technology and productivity growth are outlined. The declining growth rates of public R&D expenditures are related to output growth and crop yields, where growth rates have also fallen, especially in the developed countries. However, growth in output value per hectare has not declined in the developing countries and labour productivity growth has increased except in the EU. Total factor productivity has generally increased, however it is measured. The public sector share of R&D expenditures has fallen and there has been rapid concentration in the private sector, where six multinationals now dominate. These companies are accumulating intellectual property to an extent that the public and international institutions are disadvantaged. This represents a threat to the global commons in agricultural technology on which the green revolution has depended. Estimates of the increased R&D expenditures needed to feed 9 billion people by 2050 and how these should be targeted, especially by the Consultative Group on International Agricultural Research (CGIAR), show that the amounts are feasible and that targeting sub-Saharan Africa (SSA) and South Asia can best increase output growth and reduce poverty. Lack of income growth in SSA is seen as the most insoluble problem.     

The development of synthetic biology: a patent analysis

In the past decades, synthetic biology has gained interest regarding research and development efforts within the biotechnology domain. However, it is unclear to what extent synthetic biology has matured already into being commercially exploitable. By means of a patent analysis, this study shows that there is an increasing trend regarding synthetic biology related patent applications. The majority of retrieved patents relates to innovations facilitating the realisation of synthetic biology through improved understanding of biological systems. In addition, there is increased activity concerning the development of synthetic biology based applications. When looking at potential application areas, the majority of synthetic biology patents seems most relevant for the medical, energy and industrial sector. Furthermore, the analysis shows that most activity has been carried out by the USA, with Japan and a number of European countries considerably trailing behind. In addition, both universities and companies are major patent applicant actor types. The results presented here form a starting point for follow-up studies concerning the identification of drivers explaining the observed patent application trends in synthetic biology.     

我国生物仿制药发展现状与策略研究

随着生物药专利失效期到来所带来的成本降低、药物可及性增加及巨大市场空间等因素影响,各大企业对生物仿制药的开发表现出浓厚的兴趣,纷纷涉足这一领域,然而由于生物仿制药的特殊性,开发及产业化困难重重。基于以上背景,首先分析了国内外生物医药行业宏观经济环境、行业政策环境、法律监管环境等外部环境,然后对当前生物仿制药开发存在的关键性技术共性问题进行了阐述。在此基础上对国内外主要生物仿制药企业现状进行分析,提出了我国与国外生物仿制药方面存在的主要差距。在上述分析的基础上,利用SWOT工具进行战略分析,指出我国生物仿制药应该执行的SO战略为主,SW战略为辅的策略。最后提出了一些参考建议。     

Right on target: using plants and microbes to remediate explosives

Abstract

While the immediate effect of explosives in armed conflicts is frequently in the public eye, until recently, the insidious, longer-term corollaries of these toxic compounds in the environment have gone largely unnoticed. Now, increased public awareness and concern are factors behind calls for more effective remediation solutions to these global pollutants. Scientists have been working on bioremediation projects in this area for several decades, characterizing genes, biochemical detoxification pathways, and field-applicable plant species. This review covers the progress made in understanding the fundamental biochemistry behind the detoxification of explosives, including new shock-insensitive explosive compounds; how field-relevant plant species have been characterized and genetically engineered; and the major roles that endophytic and rhizospheric microorganisms play in the detoxification of organic pollutants such as explosives.