Patenting genetic materials' unresolved issues and promoting competition in biotechnology

This paper addresses the broader unresolved issues posed by the patenting of genetic materials that are central to dealing with the tension between the patenting and competition schemes, namely distinguishing between what has already been 'discovered' and economically useful innovations (including the thresholds for novelty and non-obviousness), the exclusion of some subject matter from patenting and the restrictions on access to genetic resources to facilitate further innovation. The possible solutions of raising the threshold patenting standards, taking advantage of international intellectual property law developments and compulsory licensing are examined as ways to ameliorate the possibly detrimental consequences of current genetic material patenting practices. (C) 2003 Elsevier B.V. All rights reserved.

The determinants of university patenting: Do incentives matter?

In recent years various studies have examined the factors that may explain academic patents. Existing analyses have also underlined the substantial differences to be found in European countries in the institutional framework that defines property rights for academic patents. The objective of this study is to contribute to the empirical literature on the factors explaining academic patents and to determine whether the incentives that universities offer researchers contribute towards explaining the differences in academic patenting activity. The results of the econometric analysis for the Spanish universities point towards the conclusion that the principal factor determining the patents is funding of R&D while royalty incentives to researchers do not appear to be significant.

U.S. Universities’ Net Returns from Patenting and Licensing: A Quantile Regression Analysis, September 2006

In line with the rights and incentives provided by the Bayh-Dole Act of 1980, U.S. universities have increased their involvement in patenting and licensing activities through their own technology transfer offices. Only a few U.S. universities are obtaining large returns, however, whereas others are continuing with these activities despite negligible or negative returns. We assess the U.S. universities’ potential to generate returns from licensing activities by modeling and estimating quantiles of the distribution of net licensing returns conditional on some of their structural characteristics. We find limited prospects for public universities without a medical school everywhere in their distribution. Other groups of universities (private, and public with a medical school) can expect significant but still fairly modest returns only beyond the 0.9th quantile. These findings call into question the appropriateness of the revenue-generating motive for the aggressive rate of patenting and licensing by U.S. universities.

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Patenting Strategies of the EU Pharmaceutical Industry -Crossroad between Patent Law and Competition Policy. Research Papers in Law, 1/2011

From the Introduction. The pharmaceutical sector inquiry carried out by the European Commission in 2008 provides a useful framework for assessing the relationship between the patent system on the one hand and competition policy and law on the other hand. The pharmaceutical market is not only specifically regulated. It is also influenced by the special characteristics of the patent system which enables pharmaceutical companies engaged in research activities to enter into additional arrangements to cope with the competitive pressures of early patent application and the delays in drug approval. Patents appear difficult to reconcile with the need for sufficient and adequate access to medicines, which is why competition expectations imposed on the pharmaceutical sector are very high. The patent system and competition law are interacting components of the market, into which they must both be integrated. This can result in competition law taking a very strict view on the pharmaceutical industry by establishing strict functional performance standards for the reliance on intellectual property rights protection granted by patent law. This is in particular because in this sector the potential welfare losses are not likely to be of only monetary nature. In brief, the more inefficiencies the patent system produces, the greater the risk of an expansive application of competition law in this field. The aim of the present study is to offer a critical and objective view on the use or abuse of patents and defensive strategies in the pharmaceutical industry. It shall also seek to establish whether patents as presently regulated offer an appropriate degree of protection of intellectual property held by the economic operators in the pharmaceutical sector and whether there is a need or, for that matter, scope for improvement. A useful starting point for the present study is provided by the pharmaceutical sector competition inquiry (hereafter “the sector inquiry”) carried out by the European Commission during the first half of 2008. On 8 July 2008, the Commission adopted its Final Report pursuant to Article 17 of Regulation 1/2003 EC, revealing a series of “antitrust shortcomings” that would require further investigation1.

Patenting Systems, Patentable Subject Matter, and Prior Art

The International School of Solid State Physics presented the 56th Course"Materials for Renewable Energy” in Erice (Italy), from July 18th to 28th 2012. This course was sponsored by the Italian Ministry of Education, University and Scientific Research, the Materials Research Society and the European Materials Research Society. The event was hosted at the "Ettore Majorana Foundation and Centre for Scientific Culture”. The school reviewed critical materials issues for the production and storage of renewable and sustainable energy. The aim of the School was to present the state-of-the-art and future perspectives in this critical area. It was to bring together the international community of students, young scientists, and experts in a unique atmosphere for reciprocal benefits in terms of enthusiasm, knowledge and new ideas.

Patenting mining claims and mill sites in California.

"Special publication."

Patenting the invention: application, prosecution, interference proceedings, with rules and forms.

Bibliography: p. xiv.

Mineral land surveying : a technical treatise on the surveying and patenting of mineral land, designed for the use of Deputy Mineral Surveyors and Students of Mining Engineering, with an appendix of contributed notes of interest /

Reprint. Originally published: Denver : The Mining Reporter Publishing Company, 1906.

Does patenting help high-tech start-ups?

Abstract: Using data on all high- and medium-tech start-ups in the UK in 2000, this paper assesses the effect associated with a firm's decision to patent on a firm's subsequent growth between 2001 and 2005. We propose a new approach to addressing well known issues challenging identification of any patent effect: firm heterogeneity, simultaneity between firm performance and patenting, and sample selection. Our findings suggest that patentees have higher asset growth than non-patentees of between 8% and 27% per annum. © 2011 Elsevier B.V. All rights reserved.

The impact of university research on corporate patenting

This paper analyses the association between the number of patenting manufacturing firms and the quantity and quality of relevant university research across UK postcode areas. We show that different measures of research `power' and `excellence' positively affect the patenting of small firms within the same postcode area. Patenting by large firms, in contrast, is unaffected by research undertaken in nearby universities. This confirms the commonly held view that location matters more for small firms than large firms. We also investigate specific channels of technology transfer, finding that university-industry knowledge transfer occurs through both formal and informal channels. From a methodological point of view, we contribute to the existing literature by accounting for potential simultaneity between university research and patenting of local firms by adopting an instrumental variable approach. Moreover, we also allow for the effects of the presence of universities in neighbouring postcode areas to influence firms' patenting activity by incorporating spatial neighborhood effects.

The relationship between internationalisation and innovation:internationalisation strategies, foreign firms', patenting behaviour and FDI spillovers

This thesis aims to contribute to the understanding of the relationships between internationalisation and innovation. Based on large comprehensive firm level data from China, this thesis comprises of three empirical chapters examining internationalisation from different aspects. Specifically, the first empirical work studies how firms internationalise. It links the choice of firms’ internationalisation strategies with firm characteristics. Additionally, it re-examines the stepwise internationalisation theory by distinguishing different foreign direct investment (FDI) motives. It proposes two pecking orders of firm performance in internationalisation strategies. The second empirical study investigates what kind of innovation activities internationalised firms do. It analyses the factors that drive foreign firms to patent in an emerging host country context. It stresses the importance of the intellectual property rights protection aspect of business environment at regional level in promoting patents, the role of industry dependence on external finance in shaping foreign firms’ patenting behaviour, as well as links foreign firms’ patent production with FDI motivation. The third empirical research examines the effect of internationalisation by examining the links between inward FDI and domestic innovation in a host country. It specifically examines technology spillovers from inward FDI through the direct lens of innovation (captured by grant patents), instead of adopting the indirect productivity approach widely employed by the literature. Distinguishing different types of innovation, it provides direct evidence of heterogeneous innovation spillovers from FDI.

Patents and the CGIAR system of International Agricultural Research Centres' germplasm collections under the International Treaty on Plant Genetic Resources for Food and Agriculture

A key controversy in negotiating the International Treaty on Plant Genetic Resources for Food and Agriculture, and the likely long-term effectiveness of the agreement, is the way in which the intellectual property provisions are interpreted and applied to the key genetic resources forming the Consultative Group on International Agricultural Research (CGIAR) system of International Agricultural Research Centres' (IARC) collections. This paper reviews the intellectual property provisions in the treaty and examines the likely consequences from patenting under the Patents Act 1990 over materials derived from these collections. The consequence is argued to be significant and, over time, these practices are likely to deplete the usefulness of these collections and undermine the relevance of the treaty. The paper concludes that Australia's interests might best be served by arguing that access to these collections, and the other materials under the treaty, be subject to a non-exclusive, royalty free licence for any use of the derived materials to develop useful new plant varieties.

Development and implementation of strategies for the incorporation of reinforcing elements in aluminium alloys by solid state processing

Dissertação para obtenção do Grau de Mestre em Engenharia Mecânica