Browse by title

You are looking at 1 - 10 of 101 items :

  • Intellectual Property Law x
  • Law - Academic x
Clear All
You do not have access to this content

Global Genes, Local Concerns

Legal, Ethical, and Scientific Challenges in International Biobanking

Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
This content is available to you

Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

You do not have access to this content

Brian J. Clark and Tina Bossow

In the context of this chapter, “bioscience industries” refers to companies involved in research, development and manufacturing of products that improve diagnosis, treatment, or prevention of human diseases, or the provision of enabling technologies or services in support of the same aims. This diverse grouping includes the pharmaceutical, diagnostics, biotechnology, and research and development services industries. Many companies within the bioscience industries use biological samples derived from humans (“human biosamples”) in their research, development, or manufacturing processes and some finished products may contain human biosample components. While the for-profit business model of commercial companies sometimes leads to mistrust and questions over their legitimacy as users of human biosamples (HBS), such companies are and will remain essential for the discovery, development, and delivery of innovations in healthcare that are of benefit for populations. Therefore, the legitimacy of the bioscience industries as valid users of HBS for purposes intended to deliver public benefit should not be in doubt. Instead, the pivotal question should be whether the bioscience industries can demonstrate that they use HBS in ways that are socially responsible, ethical, compliant with applicable laws or regulations, and safe, such that they merit access to precious HBS. In fact, this same question should equally apply to any user of HBS, whether a for-profit industrial user or a not-for profit or public institutional user. All users should be able to demonstrate that they are legitimate and responsible users of HBS.

You do not have access to this content

Conclusion

The Requirement of Industrial Application

Marta Díaz Pozo

You do not have access to this content

The European requirement of industrial application

The Requirement of Industrial Application

Marta Díaz Pozo

This chapter relates to the European patent law requirement of industrial application. It studies the historical development and rationale behind this criterion, and then, based on the EPO legal texts and case law, analyses the interpretation and practical implementation of the EPC provisions regarding the requirement of industrial application as applicable to all fields of technology. Finally, the chapter gives an account of the differences between the arguments for and against the adoption of a strict approach towards the assessment of an invention’s practical utility.

You do not have access to this content

Genetic inventions and patent law in Europe

The Requirement of Industrial Application

Marta Díaz Pozo

This chapter reviews the issues surrounding the role of patents in innovation in life sciences industries, especially in gene technologies. The chapter first presents the rationale behind the establishment of patent systems and explores how these arguments relate to objectives of promoting creativity and technical innovation. Based on economic and other relevant studies, the chapter then demonstrates the importance of patent protection for promoting innovation in the field of human genetics. Finally, the chapter discusses the historical background and process for the adoption of the Biotech Directive as well as related EU policies for the promotion of research and innovation in biotechnology.

You do not have access to this content

Human gene patents, patent clusters and innovative progress

The Requirement of Industrial Application

Marta Díaz Pozo

After having explored the impact of the Biotech Directive’s approach towards the industrial application of human genetic inventions in different contexts in the previous chapters of the book – that is, the assessment of the industrial application of human gene sequences and related proteins, the distinction between discoveries and inventions, and the determination of the scope of protection – this chapter discusses the role that this criterion could play in reducing the negative effects associated with extensive patenting in the field of genetics. To this end, this chapter analyses the serious consequences that excessive patenting and fragmentation of rights may have on the progress of innovation in gene technologies and why existing access mechanisms fall short in addressing this issue. Following this, the chapter explains how, besides other ex post promising solutions, the Biotech Directive’s strict approach towards the implementation of the industrial application requirement can help to impede the formation of unduly restrictive patent conglomerates.

You do not have access to this content

The industrial applicability of human genetic inventions

The Requirement of Industrial Application

Marta Díaz Pozo

This chapter focuses on the issues surrounding the assessment of the industrial application of inventions concerning human DNA. The chapter first explains from a scientific perspective how inventions based on human genetic information are developed, and then discusses the concerns regarding the high number of patent claims over isolated gene fragments and their corresponding proteins of unknown applicability in industry. Following this, the chapter explores the background, objectives and practical implementation of Article 5(3) of the Biotech Directive, which deals with the industrial applicability of human genetic inventions by requiring applicants to disclose the specific function of the human genetic material claimed in the patent application. In this regard, the chapter includes a discussion of the case of Eli Lilly v Human Genome Sciences before both the United Kingdom (UK) Supreme Court and the EPO, and its implications in legal and practical terms.

This content is available to you

Introduction

The Requirement of Industrial Application

Marta Díaz Pozo

This chapter provides a general introduction to the book. The chapter reviews the historical development of the biotechnology industry and the difficulties in applying conventional European patent law rules to genetic inventions. In particular, the chapter presents the concerns regarding the lack of industrial application of patent claims over isolated human DNA sequences and the importance of this requirement in the patenting of inventions concerning human genes.

You do not have access to this content

Patenting Genes

The Requirement of Industrial Application

Marta Díaz Pozo

This book constitutes a fascinating and in-depth analysis of the significance of the requirement of industrial application within gene patenting and how this influences innovation in Europe and the US. The author addresses an area normally overlooked in biotechnology patenting due to the predominance of the ethical debate, and in doing so produces a unique approach to dealing with concerns in this field.