University-industry linkages in nanotechnology and biotechnology: evidence on collaborative patterns for new methods of inventing

The nanotechnology and biotechnology “revolutions” are so-called because their enabling technological breakthroughs were not simply inventions, but discoveries of entirely new methods of inventing. We hypothesize that university participants in either or both of these areas will exhibit greater collaboration with industry than researchers in other areas. We explore this hypothesis for 454 faculty members who conducted research that was patented during the period 1994–1999. Because our data include patents, publications, and funding at the individual level, we are able to examine the industry interaction of faculty who participated in the nanotechnology and biotechnology revolutions, as well as the interaction of faculty contributing to other areas of patentable science. We examine a variety of linkages, including sponsored research, consulting, publication with firm employees and measures of the potential for cross-campus collaboration. The results are striking in that they show significant differences in collaborative behavior across patent types and across the major program areas biological sciences, physical sciences and engineering. The results are consistent with a greater degree of tacit knowledge within the new methods of inventing. We also find significant differences in the embryonic nature and importance of patents across areas.     

The battle for patent rights in plant biotechnology: evidence from opposition fillings

This paper describes and analyzes the occurrence and extent of oppositions initiated against plant biotechnology patents granted by the European Patent Office (EPO). The opposition mechanism is a legal procedure that allows any third party to challenge the validity of patents awarded by the EPO. Results indicate that the opposition rate is far greater in plant biotechnology than in other emerging industries. Consistent with theoretical predictions, the empirical findings suggest that opposed patents are disproportionately those that score high on features that proxy for their “value” or “quality”. In contrast to previous findings, however, the results show that large-volume applicants are more likely to be opposed. Because the boundaries of plant biotech patents are ill-defined, large patent portfolios do not promote cooperative behavior such as licensing or settlements. The analysis rejects the hypothesis that awardees are subject to “nuisance” or “frivolous” oppositions. Instead, the opposition procedure serves as an error correction mechanism.     

A method using two dimensions of the patent classification for measuring the technological proximity: an application in identifying a potential R&D partner in biotechnology

This paper aims to show how the information contained in patent documents can be used to identify basic and specific technological proximities between firms and therefore a potential research and development (R&D) partner. More generally, it looks at patents as a strategic tool that can be used for concluding cooperative R&D agreements (CRDA). The approach begins by looking at the state of the art on the role of technological proximity in CRDAs. This review clearly raises the problem of measuring technological proximity, which needs to be gauged at a two-fold level: general and specific. Then a dual method based on patent portfolios for analyzing the profiles of different potential partners is described along with an example of its application. Concretely, the exploratory study proposed here is based on an analysis of the patent portfolios of 14 French listed biotechnology companies and those of their main R&D partners. The analysis of 5,603 patents filed by the focal firms and their partners shows how the approach can be used to identify compatible partners that are more or less technologically matched.     

Patent first, ask questions later: morality and biotechnology in patent law

This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article explores how the United States has come to be in this position, exposes latent problems with the "patent first" approach, and considers the benefits and disadvantages of the "ask questions first, patents later" approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.     

Success Factors in Canadian Academic Spin-Offs

In the last 20 years Canadian university produced some 1200 spin-off companies, out of which 5–6% are still independent and quoted in the stock exchanges. This study analysed these public companies in terms of industry, technologies, regions, universities and growth. The paper finds that the growing companies of the 2000s are most often not in biotechnology, in spite of their frequent support by venture capital. Conversely spin-off companies that grew had often obtained patents and received support from the Industrial Research Assistance Program, a support program for R&D in smaller firms, managed by the National Research Council of Canada.     

我国医药发明专利试验例外制度研究

医药发明专利试验例外作为我国专利法上一项新生的侵权抗辩事由,在实施中尚缺乏应有的制度保障。通过追溯医药发明专利试验例外的起源和发展,考察主要国家医药发明专利试验例外制度的具体内容,分析了我国医药发明专利试验例外在实施中将面临的困惑,并从适用范围、专利补偿期限、专利链接制度三方面入手,对我国医药发明专利试验例外制度的完善提出了建议,以期能充分实现专利药物制造商与仿制药物制造商、药物制造商与社会公众之间的利益平衡。     

Chinese university patents: quantity,quality, and the role of subsidy programs

Chinese university patenting has gained importance in recent years. Using a comprehensive dataset of university patents by 155 leading Chinese universities from 1991 to 2009, our study pursues two objectives: First, we analyze the quantity and quality of patents filed by leading Chinese universities. Second, we analyze the role of subsidy programs with regard to university patenting in China. With regard to the first objective, our results show that university patents witnessed rapid growth in terms of quantity while patent quality did not increase to a similar degree. Regarding the second objective, we find that a subsidy program to promote research excellence at selected universities is a significant driver of patent quantity and quality. In contrast, a subsidy program that decreases the costs of patent applications seems to enhance patent quantity but not patent quality. We conclude that innovation policies which aim to stimulate patents of higher quality should focus primarily on increasing university R&D, and to a lesser extent on decreasing the costs of university patenting.     

Exploring the Patent Explosion

This paper looks more closely at the sources of patent growth in the United States since 1984. It confirms that the increase is largely due to U.S. patenters, with an earlier surge in Asia, and some increase in Europe. Growth has taken place in all technologies, but not in all industries, being concentrated in the electrical, electronics, computing, and scientific instruments industries. It then examines whether these patents are valued by the market. We know from survey evidence that patents in these industries are not usually considered important for appropriability, but are sometimes considered necessary to secure financing for entering the industry. I compare the market value of patents held by entrant firms to those held by incumbents (controlling for R&D). Using data on publicly traded firms 1980--1989, I find that in industries based on electrical and mechanical technologies the market value of entrants' patents is positive in the post-1984 period (after the patenting surge), but not before, when patents were relatively unimportant in these industries. Also, the value of patent rights in complex product industries (where each product relies on many patents held by a number of other firms) is much higher for entrants than incumbents in the post-1984 period. For discrete product industries (where each product relies on only a few patents, and where the importance of patents for appropriability has traditionally been higher), there is no difference between incumbents and entrants.     

Patent Production at a European Research University: Exploratory Evidence at the Laboratory Level

Most studies of academic patenting focus on the university as the unit of analysis. In contrast, we examine this phenomenon at the laboratory level. Based on a sample of 83 research laboratories of Louis Pasteur University (ULP, Strasbourg, France) from 1993 to 2000, we constructed a panel data set that allows us to discriminate between patents that are owned by the university and those that are owned by firms and other organizations but invented by faculty members. We use these data to estimate a patent production function and find that university-owned patents are more responsive to specific public funding, while non-university-owned patents are more responsive to industrial funding. Our results also highlight the importance to control for disciplinary and institutional differences, since they significantly affect the production of the different kinds of ULP patents.     

Patent litigation insurance and R&D incentives

A major policy concern regarding patenting activity is related to the actual enforceability of the patents granted by Patent Offices. The risk of facing elevated legal costs to defend patent rights can affect ex-ante incentives to invest in R&D. This paper analyses whether the availability of insurance policies that cover legal expenditures for patent litigation could increase the appropriability of the innovation. We model a situation in which an incumbent innovator is endowed with a valid patent and an entrant imitator can either directly enter the market or try to apply for a patent, hoping that an error will be made by the Patent Office. The incumbent can accommodate the entrant, file a suit to a civil court or offer a settlement agreement. We model the presence of heterogeneity in the risk that the patents will face an error by both patent examiners at Patent Offices and judges at civil court. We analyse the changes in expected profits for the innovator when given the possibility of buying an insurance policy which will cover legal costs in the event of trial. We compare the cases in which (i) coverage is voluntary and the insurer can discriminate perfectly between risky patents; (ii) coverage is voluntary and the insurer cannot discriminate between patents, and (iii) coverage is compulsory. The model highlights a set of peculiar strategic characteristics of insurance for legal expenditures which contribute to singling out the reasons underlying the underdevelopment of this market. We suggest that the crucial reason for such a failure is not adverse selection; consequently, we challenge the benefits of making coverage compulsory.     

Capturing Technological Opportunity Via Japan's Star Scientists: Evidence from Japanese Firms' Biotech Patents and Products

Using detailed data on biotechnology in Japan, we find that identifiable collaborations between particular university star scientists and firms have a large positive impact on firms' research productivity, increasing the average firm's biotech patents by 34 percent, products in development by 27 percent, and products on the market by 8 percent as of 1989–1990. However, there is little evidence of geographically localized knowledge spillovers. In early industry formation, star scientists holding tacit knowledge required to practice recombinant DNA (genetic engineering) were of great economic value, leading to incentives motivating their participation in technology transfer. In Japan, the legal and institutional context implies that firm scientists work in the stars' university laboratories in contrast to America where the stars are more likely to work in the firm's labs. As a result, star collaborations in Japan are less localized around their research universities so that the universities' local economic development impact is lessened. Stars' scientific productivity is increased less during collaborations with firms in Japan as compared to the U.S.     

Nanotechnology’s triple helix: a case study of the University at Albany’s College of Nanoscale Science and Engineering

In 2001, New York State teamed with IBM to create a research center for nanoelectronics at the University at Albany. Since then, the College of Nanoscale Science and Engineering (CNSE) has been expanded with over $6 billion in investment, attracted over 250 industrial collaborators, and awarded 72 graduate degrees. This paper discusses the formation of the triple helix center in Albany, NY. It then examines the impact of the CNSE on the regional economy and compares it with three other nanotechnology triple helix centers. The analysis finds that the CNSE is more successful at generating nanoknowledge as measured by publications and patents. Much of the research conducted at CNSE has been collaborative effort between university and industrial partners and often resulted in patents assigned to industrial partners. Since 2001, there has been qualitative and quantitative evidence of the emergence of a nanotechnology cluster in the Capital Region of NY. Upstate NY has become home to multiple nanotechnology firms and experienced growth in the employment in nanotechnology related industries. Potential explanations for the success of the CNSE are explored including the anchor tenant hypothesis and the entrepreneurial university.     

Indigenous self-determination in an age of genetic patenting: recognizing an emerging human rights norm

This Note explores how the law can help indigenous people obtain meaningful control of their genetic material. Part I will briefly discuss the background of genetics, life patents, and indigenous groups. Part II sets out the domestic common law and international human rights law and demonstrates that neither currently provide adequate protection for indigenous peoples. Part III considers the human right of self-determination in the context of indigenous research and patenting, and illustrates that an emerging international norm recognizes an indigenous people's right to control their genetic material. Part IV argues that Congress should pass legislation to adequately meet the human rights needs of indigenous peoples generated by the rapid advancement of biotechnology. This Note concludes that congressional action to protect indigenous peoples is consistent with domestic and international law, and is a natural advancement of human rights and responsible state action.     

The institutional foundation of innovativeness and competitiveness of two German industries: biotechnology and mechanical engineering compared

The article analyzes the institutional foundation of the innovativeness and competitiveness of two German industrial sectors, mechanical engineering and biotechnology. It applies a systemic innovation approach to identify what changes at the national and regional levels can explain why mechanical engineering has kept a competitive advantage for many decades while we can observe a dynamic catching-up process in biotechnology. Both sectors provide good examples of the reconfigurations that take place in national innovation systems in both territorial and functional terms.     

Technical Cooperation and the International Coordination of Patentability of Biotechnological Inventions

Within the formal international framework, the coordination and harmonization of substantive patentability is currently of a limited nature, confined to the level of general principles, in contrast to the greater degree of procedural coordination. This involves increased costs and a lack of legal certainty for those seeking patents in multiple jurisdictions, mainly transnational corporations in some research-based industries such as pharmaceuticals. The problems encountered in achieving even a basic level of international consensus have encouraged informal cooperation through what could be conceptualized as 'global patent networks'. Furthermore, the interrelationship between procedural and substantive patent law issues has led the Trilateral Patent Offices, an informal, transgovernmental regulatory network of technical specialists, to undertake projects relating to the harmonization of procedural and substantive patent law issues primarily in contentious areas of patentability such as biotechnology. This raises the possibility of developing convergent interpretations of the patentability rules, although with implications for accountability and legitimacy.     

Legal protection of biotechnological inventions. The European Parliament's perspective]

In 1996, the European Commission put forward a proposal for a Parliament and Concil Directive on the legal protection of biotechnology inventions. The article looks at vicissitudes which characterised the progress of the proposal in the Council and the European Parliament. The future directive will regulate the patentability of biological material, which is a particularly sensitive issue when the material is of human origin. The article also seeks to set the proposed directive in a wider context by referring to forthcoming international Convention Law on biotechnology and to the legal situation in Spain at present.     

University reputation and technology commercialization: evidence from nanoscale science

We study how the scientific reputations and technology transfer policies of universities affect patenting by university researchers, with particular regard to whether they assign patent ownership to their university or to an outside firm. Using data on the career output of over 33,000 researchers in nanosciences, we find a strongly positive relationship of university reputation in nanosciences with the number of university-assigned patents, but almost a negligible association with firm-assignment of patents. University technology transfer office resources are related positively to both types of patents, but with diminishing returns. In contrast, the share of license revenue offered upfront to researchers is positively associated with university-assigned patents, but negatively related to firm-assigned patents. Taken together, our results suggest that universities that streamline their technology transfer efforts and improve their research reputation through support for basic research will see long-term success in technology commercialization.     

Patenting nanotechnology

Universities and companies are rushing to the patent office in record numbers to patent nanotechnology inventions. This rush to the patent office is so significant that many law firms have established nanotechnology practice groups and the U.S. Patent and Trademark Office has now created a new technology class designed to track nanotechnology products. Three big differences between the emerging science of nanotechnology and other inventions make the role of patents more significant in this arena than elsewhere. First, this is almost the first new field in a century in which the basic ideas are being patented at the outset. In many of the most important fields of invention over the past century--computer hardware, software, the Internet, even biotechnology--the basic building blocks of the field were either unpatented or the patents were made available to all users by government regulation. In others, patents were delayed by interferences for so long that the industry developed free from their influence. In nanotechnology, by contrast, companies and universities alike are patenting early and often. A second factor distinguishing nanotechnology is its unique cross-industry structure. Unlike other new industries, in which the patentees are largely actual or at least potential participants in the market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well. This overlap may significantly affect their incentives to license the patents. Finally, a large number of the basic nanotechnology patents have been issued to universities, which have become far more active in patenting in the last twenty-five years. While universities have no direct incentive to restrict competition, their interests may or may not align with the optimal implementation of building-block nanotechnology inventions. The result is a nascent market in which a patent thicket is in theory a serious risk. Whether it will prove a problem in practice depends in large part on how efficient the licensing market turns out to be.     

论中药单方专利的创造性认定

随着中药单方专利侵权案件的日益增多,如何认定一个新中药单方是否构成对现有中药单方专利的侵权,显得尤为重要。按照我国《专利法》的规定,必须经过"三性"认定,而新中药单方"三性"认定的关键在于其与现有的中药单方专利相比是否具有创造性。因此,尽快制定中药单方专利的创造性认定标准迫在眉睫。当新中药单方与现有的中药单方专利相比使用了不同的药用部分、不同的剂型导致给药途径改变、不同的炮制方法导致归经改变、不同生产方法、工艺及增加或使用不同的引药、改变现有中药单方专利的混合物组分或组成混合物组分的剂量等时,如果其能在作用同一病症的不同类型、减少毒副作用、显著提高疗效、适应新的病症、作用新的部位等任何一方面有所突破,就应当认定该新中药单方对中药领域的普通技术人员来说具有"非显而易见性",有突出的实质性特点和显著的进步,具有创造性。