Yamamoto, S., & Tessensohn, J. (1999). Japan’s new patent law. Tissue Engineering. 5 (5), 495-8.
In 1999, Japan initiated reforms that removed some of the obstacles to procuring patents which had previously inhibited researchers from applying for patents for their work. These laws reduced the period in which a request for examination must be filed from 7 years to 3 years; reduced patent annuity fees, examination request fees and fees per claim by 8 percent; and prevents patenting a publicly known product and provides a 6-month grace period to receive a patent for something that was publically disclosed online. These pro-patent policies speed up the patent process and will promote development and innovation in Japan
Triendl, R. (2000). Japan calls for open access to human genome data. Nature. 405 (6784), 265.
Japan’s Council for Science and Technology genome science committee will push for human genome data to be made public as a means to promote advancement in the field. Additionally, Hirofumi Nakasone, the director general of the Science and Technology Agency made an international call for rules regarding the release and availability of human genome data. The Ministry of International Trade and Industry has release the sequences of 2,220 human genes after the Japanese Patent Agency indicated that patents would not be granted to incomplete genome sequences or unknown functions. While some agencies are releasing data, a lack of uniform rules is making it difficult for agencies to create policy about information sharing.
Doring, O. (2004). Chinese researchers promote biomedical regulations: what are the motives of the biopolitical dawn in China and where are they heading? Kennedy Institute of Ethics journal , 14 (1), 39-46.
Acknowledging the lack of bioethics standards, the Chinese government has established some ethical guidelines, but two groups of bioethicists and life scientists from Shanghai and Beijing have further promulgated more detailed medical ethics codes. These codes share a number of similarities, including emphasizing confidentiality and informed consent, and banning the implantation of an embryo that was used for research into a human uterus. However, these guidelines have not been subject to open public debates or public comment, and many Chinese citizens do not have the proper education necessary to understand biomedicine or bioethics. Chinese scientists are particularly concerned that researchers from developed nations may take advantage of China’s lack of regulations and conduct research there that would be ethically questionable (or illegal) in their countries-of-origin. Furthermore, the rush to develop China’s biotech industry quickly may result in the unethical treatment of patients (as experimental subjects). For example, Chinese life scientists engage in human cloning and therapeutic cloning, even though the Chinese government has deemed it morally reprehensible.
Zhenzhen, L., Jiuchun, Z., Ke, W., et al. (2004, December). Health biotechnology in China—reawakening of a giant. Biotechnology, 22 (Supplement), DC13-DC18.
The health biotechnology industry has quickly taken off and is blossoming in China. Although bureaucracy has “hampered implementation to promote biotechnology,” a burgeoning private sector has encouraged more biotech start-ups. China is home to the first firm in the world to obtain a gene therapy drug license. Initiatives from the government, universities and research institutions, and industry are attempting to promote greater public awareness about biotechnology and its societal impact. China implemented its first patent laws in 1978, but these only protected processes, not products. Since that time, a number of revisions were made to improve upon the original legislation. Universities are increasingly conducting biotechnology research, following mainstays like the Chinese Academy of Sciences, who have long been heavily involved in basic research. Industry is increasingly moving from copycat to innovator, especially in the biotechnology and health arena. The main problems that remain are the still-limited funding in biotechnology in China, as well as the greater potential for excellence that needs to be tapped in universities and research institutes. Additionally, more domestic collaboration is necessary to fuel innovation.
Aoki, R., Kubo, K., & Yamane, H. (2006). Patent policy and public health in developing countries: lessons from Japan. Bulletin of the World Health Organization, 84 (5), 417-8.
The authors examine the patent process utilized in Japan and the various effects it has on competition and the development of new drugs and products. Japan’s patent system was designed to streamline the patent process by narrowing the parameters of the patent and developing a system of dependent-patent arbitration. Until 1995, patent examiners had to literally interpret patent claims and could only grant patents to products supported by working examples. The requirement to have a working example before a patent would be issued resulted in narrow patents. The narrow patents in turn facilitated the growth of firms with underdeveloped research and development divisions who were then able to patent products similar to others on the market. Allowing patents for similar products has also led to improvements in the safety and effectiveness of those products. While there is a belief that the so called “me-too” drugs waste R & D money, they have eliminated the need to protect products with process patents. This new patent model may prove useful in countries which are developing patent regulations, as narrow patents will encourage research and development, and the competition will keep drug prices low.
Normile, D. (2006). Mouse genetics. China takes aim at comprehensive mouse knockout program. Science, 312 (5782), 1864.
Fudan University’s Xiaohui Wu has partnered with Yale’s Tian Xu on a joint large-scale knockout mouse project, located on Fudan University proper. They currently have 20,000 mice, representing about 400 mutant strains, but they hope to increase their mouse population to 100,000 so that they can mutate a total of 70% of the mouse genome. Along with colleagues at University of Colorado, Boulder and Duke University in the U.S., Xu developed an efficient way to knock out genes in mice by using a transposon. Xu is utilizing this method in all of the knockout mice at the Fudan-Yale facility and is hoping to receive $30 million from the NIH to mass-produce, preserve, and distribute knockout mice to research facilities worldwide. Currently, the researchers at Fudan are screening their knockout mice for neurophysiological and immunological disease markers. The Chinese government on both a national and local level has already pledged $12.5 million toward the project, which sends a very positive message that China wants to work on high level research with international partners.
Salter, B., Cooper, M., Dickins, A. (2006). China and the global stem cell bioeconomy: an emerging political strategy? Regenerative medicine, 1(5), 671-683.
The UK has made it a goal to become a leader in stem cell research and technology development. A number of nations in Asia, including Singapore, China, and South Korea, are rapidly exploding their stem cell research programs, which are quickly becoming on-par with the UK. This paper specifically focuses on China and analyzes China’s strategic ability to establish itself in the “global stem cell bioeconomy.” Over 10 years ago, researchers already identified the top-down nature of the Chinese government and a lack of commercial incentives as the main obstacles hindering the commercialization of China’s science and technology research. In 1988, China initiated its Torch Program, which aims to fund projects and establish science parks and incubators. This program works similarly to venture capital markets in the U.S.. In addition to the Torch Program, China’s National Basic Research Program made investments totaling 2.5 billion RMB (300 million USD) during the first five years after it was established. However, the Basic Research Program still emphasizes application and “strategic” basic research. The Natural Science Foundation of China and the Chinese Academy of Sciences fund and perform important research as well, respectively. China now spends more money on research and development than any other country with the exception of the U.S. and Japan.
China has established strong education-based ties with the United States- from 2003-2004, almost 20% of all foreign scholars in the U.S. were Chinese; only 27% of whom returned to China after their studies. Although China attracts a great deal of Foreign Direct Investment, the nation is having difficulty attracting the venture capital necessary to pursue biotech research. One main reason deals with the lack of an exit strategy for venture capitalists; China’s current stock exchanges cannot handle venture capitalists’ usual exit strategy of an IPO. On all levels, though, the Chinese government has developed domestic venture capital firms.
The author also states that regulations are extremely important, and since China has accepted the main international bioethics guidelines, these should form the basis of the Chinese government’s regulatory policymaking. However, the “historic absence of a developed infrastructure of bioethics controls” makes enforcement a concern. There are only regulatory guidelines, not legislation; there is no “licensing for ESC research, no infrastructure of monitoring and inspection, limited ethical expertise at the institutional level, and no visible set of penalties for noncompliance.”
China is increasingly becoming the human subjects testing ground for a multitude of clinical trials in drug development as well. Because regulatory capacity has not increased apace, a number of ethically questionable situations arose involving both foreign and domestic researchers. If China provides incentives to stop the scientific brain drain, as well as enforces a regulatory structure that fosters venture capital investment, protects intellectual property, and ensures ethical research practices, it can become internationally competitive and internationally recognized in biotechnology development.
Aida, T., Konishi, A., Hagiwara, M., & Hashimoto, K. (2007). Shortened life spans of biotech pioneer patents in Japan: a lesson from the DNA chip. Nature biotechnology. 25 (5), 533-5.
Patent protections are necessary in any country in which a company markets a product. However, the great dissimilarities in patent terms and review processes among various countries are proving problematic for establishing uniform patents. Japan in particular has been stricter in its patent requirements than other countries, and as a result, patents issued in Japan are for shorter periods than those of other countries in the Europe or in the US. The reason for a longer review period and the shorter patent period is often due to review of a pioneer technology. Patent applicants should specify distinctions between their product and conventional technologies in order to earn a more favorable patent and mitigate the negative effects on business and the monopolies that result from the shorter patent period.
Salter, B. (2007). Global Politics of Human Embryonic Stem Cell Science, The. Global Governance. 13, p. 277-298.
An increasing number of countries are speaking out against therapeutic cloning, led by the United States. At the national and international level, the ethics of human embryonic stem cell (hESC) research is sparking a heated debate. The author explores the driving factors behind these stark divisions by analyzing both the science and the economics of hESC research. The state, through its funding priorities, can either incentivize or punish those that pursue stem cell research. Consumer support is garnered through more than just the promise of health gains behind this technology; community morals and cultural values also play a huge role. Patents provide an indicator of activity in the stem cell arena. Between 2000 and 2005, over 3,000 patent applications were published, with the U.S. dominating the patent landscape. Among all patents studied worldwide, about 25% relate to hESC, and the number of stem cell patents filed is continuously increasing. However, there is still a large gap between the science and successful commercialization into health products. Both venture capitalists and stock market investors demonstrate a hesitance to invest in stem cell technology development (but not other biotech development).
Tessensohn, J., & Yamamoto, S. (2007). Japan’s novelty grace period solves the dilemma of ‘publish and perish’. Nature Biotechnology. 25 (1), 55-7.
The authors explore the dichotomous relationship between patenting and publishing university research in Japan’s biotech industry. In the past, many university researchers would forgo the patent process in order to publish because they were inhibited by government red tape. This changed in October 1999 when Japan adopted provisions outlined in the US’s Bayh-Dole Act which allowed researchers to patent work which resulted from government sponsorship. Japan also adopted a six-month grace period whereby researchers seeking a patent on a product would have six months to obtain that patent after presenting or publishing research on their product. However, this grace period does not apply to situations where the novelty of the work is thus destroyed through presentation, publication or oral disclosure. Additional obstacles faced by university biotech start-ups are the lengthy development phases which thus make profits a long way off.
Chen, H., Roco, M., Li, X., & Lin, Y. (2008). Trends in nanotechnology patents. Nature nanotechnology , 3 (3), 123-5.
The United States and Japan are dominating the nanotechnology patent landscape, with Germany, France, South Korea, Switzerland, the UK, and the Netherlands also making valuable contributions. From 1976-2006, the USPTO, the EPO, and the JPO granted 7406, 3596, and 1150 nanotechnology patents, respectively. U.S.-based groups were grated the largest number of patents in both the U.S. and Europe. However, U.S. patents were cited at a similar rate as Swiss and Japanese patents on other U.S. patents, and in Europe, EPO patents held by U.S. firms were cited less than EPO patents held by Japanese, Belgian and French entities. The annual number of nanotechnology patents awarded in the U.S. and Europe is increasing practically exponentially. Most nanotechnology patents analyzed for this report were classified under: performing operations/transporting; chemistry/metallurgy; physics; and electricity.
Drahos, P. (2008). “Trust me”: patent offices in developing countries. American Journal of Law & Medicine. 34 (2-3), 151-74.
The Trilaterals, or the JPO, USPTO, and EPO issue the bulk of patents and are increasingly deepening their cooperation, principally in harmonization of patent practices. Streamlining the patenting process has successfully decreased costs, but the author argues that patent quality is not improving, only patent quantity. Other patent offices have become involved through bilateral agreements with one of the Trilaterals, creating a “hub and spoke” arrangement. The Trilaterals conduct long term development assistance programs to train and establish patent capacity in developing countries; their relatively technologically advanced systems inspire trust in their knowledge. While this technical assistance may appear philanthropic, the author posits that it may be done with an agenda in mind. For example, the EPO trains those in developing countries, and as patent applications increase, developing country patent offices increasingly rely on EPO guidance and defer to the judgment of the Trilaterals when determining the fate of a patent application. Furthermore, developing countries are given computers solely to patent-search the EPO database, increasing the ease at which the EPO can be “consulted.” Ironically, almost half of all ASEAN patents filed are European in origin, indicating that the Europeans themselves are partially responsible for creating the backlog that necessities consulting the EPO for a quicker decision.
Developing country patent offices are an interesting case- they are typically internationally-linked, the majority of their income is from sources abroad, they have better facilities than other governmental bureaucracies, and the details of their operations are vastly unknown to the rest of the country’s bureaucracy. Additionally, these offices tend to be pro-patent and will block legislation that “questions the role of patents in innovation.” This becomes a pertinent issue when considering the public health arena. As an increasing number of pharmaceutical patents are filed in developing countries, producing generics in those countries becomes extremely difficult. The author argues that governments need to better integrate their health and patent offices and increase transparency to prevent patents issued from undermining the citizenry’s access to low-cost, high-quality medicines. The author also recommends that an independent body (separate and in addition to a country’s patent office) of (health) experts further scrutinizes patent applications for patentability; preventing a questionable patent from being granted is much less costly than the litigation necessary to reverse it later.
Hashimoto, K., & Aida, T. (2008). Antibody patenting without antibodies: a global trend. Nature Biotechnology. 26 (12), 1341-3.
The scope of gene patenting inventions has expanded to include antibodies; and the Trilateral Patent offices have essentially endorsed this practice by issuing a statement allowing antibody claims without experimental antibody production. The authors conducted a survey of the patent landscape, specifically on gene patents that included antibody claims. The authors, through their analysis, conclude that there is an incentive to include antibody claims in human gene patents in order to develop medicines and diagnostic agents. Almost half of the human gene patents that included antibody claims were granted (typically to U.S. bioventures and universities) without production of experimental antibodies. In analyzing patents from all of the Trilateral Patent offices, the authors noticed that this was a global trend. Patenting the antibodies with the gene enables the patentee to have wider control over entire development process. The authors, however, believe that antibody claims do not describe the antibodies adequately (essentially, what is being patented does not “exist” yet) and prevent other parties from attempting to develop antibodies themselves.
Lawrence, S. (2008). Biotech patents-business as usual? Nature Biotechnology. 26 (12), 1326.
Cardiovascular disease and oncology patents dominate the biotech patent landscape. Among the Trilateral Patent offices, the EPO is the most expensive office at which to file a patent, at almost five times, and three times greater costs accrued in the process compared with the USPTO and the JPO, respectively. In 2006 and 2007, the top three organizations with the most U.S. biotech patents issued remained the same: Genetech, the University of California system, and the U.S. government. Among the top 20 organizations with the most U.S. biotech patents, 13 organizations remained on the list in both years.
Stem cell researchers from the Asia-Pacific region, including China, India, and South Korea sought to form a regional stem cell research network to increase localized stem cell research. In the West, innovation infrastructure is already established, with the state providing support. Western governments fear that if their policies in biotechnology development are inadequate, they will lose their hegemony to the advanced developing economies. Although Eastern economies are rising quickly, they have a large hurdle to overcome in that they do not have an established market presence in biotechnology, specifically in stem cell research. Eastern states have a number of important decisions they must make in building their research infrastructure, including most importantly the state’s level of involvement itself and how much investment risk the state wants to assume. The state also must assess how many of the necessary resources for development are available domestically.
China and India are both working to increase their respective domestic research and development investment to the level achieved in Western states. China’s 863 Program is financing the construction of new stem cell laboratories and offering competitive salaries and university appointments for Chinese graduates of foreign universities. Eastern nations may be tempted to develop so quickly that they sacrifice adherence to ethical guidelines, which can quickly break the trust of scientists worldwide. China’s Ministries of Health and Science and Technology jointly issued ethical guidelines governing hES cell research, which are similar to the UK framework. However, consistent implementation of these guidelines is a concern. In India, in-vitro fertilization is seen as a very lucrative business, making implementation of regulations and controls difficult. Like China, India is also becoming a center for conducting clinical trials, and ethical oversight is an issue. India’s government has published guidelines on stem cell research and therapy, but as in China, concerns about implementation exist. China has been promoting IPR protection since its WTO ascension, but it is unclear how well IPR will be respected on an individual level. China and India’s uneven enforcement of ethical guidelines may hamper forming international collaborations.
Zhang, Y., & Deng, M. (2008). Enforcing pharmaceutical and biotech patent rights in China. Nature biotechnology , 26 (11), 1235-40.
China is a member to all international conventions for intellectual property (IP) protection, and IP enforcement has improved considerably as the Chinese government makes efforts to comply with its WTO member obligations. China is fostering local innovation in the biotech sector. The number of Chinese patents filed is steadily increasing, as is the number of patent court cases filed. The authors advise that businesses with a “significant IP stake in China” must devise and implement an effective IP “protection and enforcement strategy” to defend their IP rights against both domestic and international competition. This article provides a detailed outline on Chinese patent law and the courses of action one can take to enforce IP rights. In general Chinese IP laws follow European (and U.S., to some extent) tradition. However, even if China implements strong patent laws, patent infringers with well-placed connections may be difficult to prosecute.
Bagley, M. (2009). The New Invention Creation Activity Boundary in Patent. Law. Wm. & Mary L. Rev.
The author discusses the new invention creation activity boundaries of patent law and the ethical and legal implication involved. The article focuses on the developing question of what to do when products are submitted for patent review when the products may be the result of unethical or circumspect practices. This question has lead to an additional boundary in patent law: invention creation activity. Previously, activities of the inventor were only considered after the filing of a patent application and before the patent was issued. But with the increasing relevance of the use of morally questionable materials such as stem cells and DNA, there is an increasing need to examine activities throughout the development of the product.
Chen, H. (2009, September). Stem cell governance in China: from bench to bedside? New Genetics and Society, 28 (3), 267-282.
The author emphases what is called “translational research,” where the goal is to commercialize and apply knowledge gained from successful laboratory (bench-scale) research in a reversal of the common “bench-to-bedside” approach. He notes that there is a huge gap between the basic medical research and the application of such research, arguing that this gap could be better bridged if there was more dialogue between basic researchers and clinical drug developers. This cross-dialogue implies a non-linear approach that involves a number and variety of actors, including the patients themselves, who need to be given an understanding of stem cells. Thus, in the author’s opinion, it is impossible to conduct translational research under the current regulatory framework. Stem cell-related regulations in particular are patchy at best; however the (Chinese) government is working to implement more strict regulations, emphasizing that the clinical application of stem cell technology “should be performed more cautiously…and follow ethical and moral norms.”
The Chinese government considers biotechnology, particularly stem cell research, as “an area with great potential,” and is investing heavily to be internationally competitive. The author discusses three case studies in Chinese stem cell research in order to illustrate the wide differences in regulation interpretation and implementation approaches: the Center of Excellence in Tissue Engineering, Chinese Academy of Medical Sciences and Peking Union Medical College’s Robert Chunhua Zhao (Beijing); Shenzhen Beike Biotech (Shenzhen); and Tianjin’s new “stem cell industry” (Tianjin). Zhao developed a stem cell therapy to reduce graft-versus-host disease. Researchers in the Zhao lab, in cooperation with the National Institute for the Control of Pharmaceutical and Biological Products, devised quality control standards for Zhao’s stem cell-based product. This project then received approval to begin clinical trials. As of report publication, Zhao’s group represents the only Chinese case where official approval was obtained to conduct clinical trials, and they are close to completing Phase II trials.
Zhao’s group took the effort to go through the strict regulatory procedures, unlike Beike Biotech, whose ethics have come under harsh criticism. This biotech company collaborates with hospitals to treat patients using stem cell therapies not yet proven by scientific literature and utilizes patient blogs as proof of treatment efficacy. Specifically, Beike’s method of treatment is to inject patients with stem cells derived from umbilical cord blood and autologous bone marrow. Beike Biotech shares profits with the hospitals; thus there is no incentive for these participating institutions to question Beike’s ethics. In 2008 alone they preformed over 8000 injections. When scrutinized, the company states that since their patients are dying and there are no alternate cures, using stem cells as experimental therapies should be permissible. There is no regulatory guidance in China to ascertain the legality of Beike’s actions.
The city of Tianjin (with other cooperating institutions) developed the National Industrial Base of Stem Cell Technology and the National Center of Stem Cell Engineering and Technology. A number of groups have combined their interests to found a company (public-private partnership) to run a stem cell bank, and they try to promote public awareness and acceptance of cord blood stem cell banking. The Chinese government is currently supporting Tianjin’s research and development efforts using these donated stem cells, and in turn, the Tianjin intuitions work to comply with all regulations and laws.
Moriguchi, H., & Sato, C. (2009). Japan should intensify embryonic stem-cell investigations. Nature. 457 (7227), 257.
The authors, in a letter to the editor, call for Japan to reduce its regulations on embryonic stem cell research so that it may contribute the same level of research to the field, and that of iPS cells, as countries such as the United States and China. Japan has contributed 2.1% to research compared to 20% from the US and 20.8% from China.
Sipp, D (2009). Stem cell research in Asia: A critical view. Journal of Cellular Biochemistry. 107(5), 853-856.
Sipp explores why Asia, once proclaimed to surpass the United States in stem cell science, has failed to reach its (hyperbolized) potential. Sipp points to many reasons for this failure: (1) confusion at the governmental level as to whether funding commitments are made primarily for knowledge and basic research goals or whether they are made with clear economic goals; (2) problems of governance and intellectual infrastructure; (3) lack of sufficient regulations in other areas, particularly the clinical translation of stem cells; (4) lack of communication and organization both within and between nations; (5) lack of a region-wide funding scheme. Sipp concludes that in order for Asia to reach its proclaimed potential it needs to address the aforementioned problems, to which he offers recommendations.
Sipp, D (2009). Gold Standards in the Diamond Age: The Commodification of Pluripotency. Cell Stem Cell. 5(4), 360-363.
Sipp argues that with the advent of induced pluripotent stem cells, pluripotency stands to become a plentiful and unencumbered commodity. Intellectual property issues, for example, will vary from traditional hESC patents owned by WARF, and will ultimately be mapped pending the development of one or more techniques for induction by small molecules, and legal tests of the strength of the resulting patents. At present, the patents surrounding iPSC remain comparatively narrow and unchallenged in court, and yet one could safely predict that much remains to be seen regarding the protection and commercialization of iPSC derivation protocols and the cell lines that are produced. Furthermore, research institutions are already struggling to deal with the volume of pluripotency, as they are a “cheap” and plentiful commodity compared to hESC. Sipp argues that if a highly reproducible, safe, and efficient method is developed for creating human pluripotent cell lines the field could change in several ways. Drawing a comparison between iPSC and diamonds Sipp concludes that although the primary value of human pluripotent stem cell has thus far been perceptual rather than economic, that we are faced with the need to reassess the value of our old standards as we approach a new frontier in stem cell science.
Sipp, D. (2009). Stem cells and regenerative medicine on the Asian horizon: an economic, industry and social perspective. Regenerative Medicine. 4(6), 911-918.
The past decade has brought much attention to the Asia-Pacific region. Its unique combination of economic pressures, competitiveness and opportunism, laissez-faire regulation, burgeoning investment in the life sciences, and rapidly growing markets, coupled with its great diversity have propelled the region to surge forward in some areas, but to stumble in others. Sipp provides a historical and scientific context to the state of stem cell research and clinical applications in the region. Sipp concludes that future stem cell science in the Asia-Pacific region seems promising but the intellectual property gap may present an obstacle to regenerative medicine companies making an impact on the global market. Ultimately, however, how and when treatments reach the market will depend on how quickly new therapies will emerge.
Salter, B. (2009). China, globalisation and health biotechnology innovation: venture capital and the adaptive state. East Asian Science.
The 11th 5-Year plan (2006-2010) made a push for developing an “indigenous science and technology platform,” emphasizing developing biomedical and health technology. Even the UK government is focusing on the same areas (principally high-value goods and services). Biomedicine, and the intellectual property surrounding it, are constantly evolving. This paper primarily discusses the Chinese venture capital industry and its capacity to contribute to fostering health technology innovation. By 2006, China was second only to the U.S. in receipt of venture capital (VC). The following can impact the supply-side path of VC development: level of economic development; existence of ownership regulations; the legitimacy afforded to private firms; educational attainment; the legal system; and business cultures. On the demand side, the ability of new firms to commercialize high-risk investments influences VC development. The influence of personal relationships in China may decrease firms’ sensitivity to market risk, as maintaining the relationships is sometimes more important than profit maximization. Because the VC industry is less developed in Asia, biotechnology companies are dependent on external funding. The author recommends that the Chinese government become an “investment enabler;” changing the regulatory framework to encourage experienced investment professionals to invest in high-risk sectors like biotechnology. Intellectual property rights (IPR) protection also greatly influences VC investment; investors will not invest in locations where adequate patent protection measures are not in place. Holding patents inspires investor confidence as well.
Since its ascension to the WTO, China has promoted IPR protection and education; however it cannot be ascertained whether IPR respect is “thoroughly embedded” in Chinese culture. As China adjudicates more IP cases, the government inspires confidence in its desire to preserve IPR, which increases investment by economic actors in biomedicine development in China. A remaining issue, though, is that venture capitalists require a highly liquid stock exchange in order to implement their desired exit strategy of the IPO. While China is making baby steps in that direction, their stock exchanges are not yet sufficiently liquid. Since state venture capital firms fall under more strict government control and are pressured to realize returns sooner, they are risk averse and will likely not invest in early stage biotechnology development. Consequently, China is still primarily dependent on foreign firms to fill this gap. What has resulted is more innovative funding mechanisms that have at their base, partnerships between domestic and foreign firms. For all its efforts to improve, China’s the majority of domestic venture capital is still allocated to “established firms with predictable markets.”
Tessensohn, J., & Yamamoto, S. (2009). Accelerated patent examination procedures spur Japanese university innovation. Nature Biotechnology. 27 (9), 815-8.
The changes to the Japanese patent system and a desire to improve Japan’s standing in the international biotech community have led to the first patent for iPS cells and a pilot system which resulted in the fastest grant issued. As a result, researchers from Japanese universities and university start-ups have increasingly sought patents for their work. Expedited patent examination will reduce backlogs as well as encourage more researchers to seek patents, and more importantly, bring important technologies and therapies to the market.
Golden, J. (2010). WARF’s stem cell patents and tensions between public and private sector approaches to research. The Journal of Law, Medicine & Ethics : A Journal of the American Society of Law, Medicine & Ethics. 38 (2), 314-31.
WARF’s three stem cell pattens have stimulated significant controversy, especially concerning the extent to which patents should limit research. The author hopes to see more of the increasingly-occurring balance between IPR enforcement and social interests. For example IPR holders sometimes decide to pursue scaled-down enforcement; government or other public sector actors frequently attempt to convince or pressure these scaled-down enforcement decisions; and alternatives to cut down research “bottlenecks” are often developed. WARF specifically is criticized for attempting to control all human embryonic stem cell (hESC) lines and maintence methods in the United States in a manner that extends beyond what is specifically utilized by Thompson in his research. Additionally, WARF’s licenses are “overly costly, cumbersome, and restrictive.” While Europe questions stem cell patents on a moral ground, WARF’s U.S. patents are mainly attacked for their patentability in terms of nonobviousness (as well as the patent being too broad in scope).
In this article, the author gives an overview of WARF’s three main stem cell patents, a discussion of WARF’s response to criticism, and what WARF’s situation indicates about the role of patents in basic research and the capacity of other actors to find solutions to the issues posed the IPRs of “platform technologies.” Over the years, though, WARF has “progressively liberalized its licensing and use-authorization practices,” so that stem cell research by a number of scientists can continue. WARF also argues, though, that its restrictive licensure practices were done as a method of quality control, and to prevent their intellectual property from “crass commercialism.” The lack of federal funding for hESC research necessitates cooperation between researchers in the United States. Though WARF dramatically decreased hESC license costs for academia, industry still had to pay upwards of $100,000, a price too staggering for most bioventure start-ups. Eventually, WARF did extend licensing exemptions to universities and nonprofits and allowed academic researchers to share WARF-provided hESCs.
Huang, K. (2010). Intellectual property. China’s innovation landscape. Science (New York, NY) , 329 (5992), 632-3.
This article presents an analysis of over 1.1 million Chinese patents granted from 1986-2006, focusing on over 200,000 granted patents in 12 major science and technology groupings. Each analysis year experienced a 13% increase in patents granted across all patent classes and assignee sectors. Since 2001, private enterprises are receiving the lion’s share of all patents, and the 12 major groups led by medical sciences, semiconductor, communications, and computing industries alone comprised over 20% of all patents granted in 2006. In comparison, over 53% of all USPTO patents were granted to these 12 categories in the same year. Interestingly, over time the less-developed interior of China is catching up to the more advanced Chinese eastern seaboard in terms of patents awarded. Additionally, an increase in Chinese patents awarded to domestic, as opposed to international entities, may indicate that more domestic innovation is occurring.
Yuan W., Sipp D., et. al (2012). Stem Cell Science On the Rise in China. Cell Stem Cell. 10(1), 12-15.
The authors describe the growth of stem cell research in China by explaining its history and its recent meteoric rise. They argue that this increase is due to vigorous public investment and infrastructure development that have enabled major productivity gains. For example, in just five years Chinese scientists leaped from producing just 2.8% of the world’s stem cell literature to over 7%—a figure that approaches that of Japan’s. While this increase has been impressive, the authors argue that without fixing the challenges present in regulation, governance, and the management of clinical expectations, China will face trouble in taking the next step towards clinical products. Overall, while China may not have the resources of a western nation, it is uniquely positioned to make great contributions in stem cell science, especially in bringing effective treatments to market.
Proprietary Challenges in Stem Cell Research 