Biotechnology is the use of biological processes, organisms, or systems to manufacture products intended to improve the quality of human life. It covers a vast field ranging from medical and pharmaceutical products to industrial processes and agriculture. As with all other technologies, inventions in biotechnology are generally considered patentable under the law and the same general patent examination rules and processes apply to all inventions. At the EPO, biotechnology represents about 4% of all patent applications filed: 6 048 of the total number of 160 022 European patent applications received in 2015 concerned biotechnology.

The patent law in EU member countries relating to biotechnological inventions has been harmonized since 1998. This clarifies which inventions are patentable or not on ethical grounds, giving the legal certainty to organisations in the sector that is required to attract the considerable investment that is needed for innovation.

Directive 98/44/EC, the so-called ‘Biotech Directive’ on the legal protection of biotechnological inventions was adopted in 1998 and implemented by all EU countries. It consists of three chapters dedicated to the patentability of human stem cells, the patentability of patent-related inventions and the scope of protection for DNA-related inventions. It also focuses on patenting in the biotech industry and expands on how the Directive ensures that there is enough fair access to patented material of biological origin, the Directive aim is to provide more clarity on the issue for the biotech, plant and animal breeding sectors.

After information technology, biotechnology is increasingly recognized as the next wave in the knowledge-based economy. The article looks at some of the reasons why patents are so crucial for biotechnology in the pharmaceutical sector. By looking at the biotechnology model, the article seeks to identify some of the reasons on patents and the role intellectual property rights, and patents in particular.

The fact sheet presents information about the different forms of Intellectual property in Biotechnology and patents on biotechnological inventions. It also comments the biotechnology innovation cycle and its European actors. Prospects about open innovation: cooperation between SMEs, public research institutes and larger companies are discussed with practical emphasis on How to use biotechnology patent indicators, how to get innovation indicators from biotechnology patents, and how to find biotechnology patents?

This chapter is an attempt to provide an overview of arrays of concerns about increasing rate of patents as well as to analyse how academic researchers of various fields have responded to them. The information is focused on the following main issues: First, the debate surrounding patenting of life forms is presented. Second, we the issue of university scientists and academic entrepreneurs in the context of biotechnology is discussed. The third issue regards the strong science dependency of biotechnology on one hand, and its strong commercial prospect, on the other hand. Finally, it deals with issues, which have serious implications for economic development: the proprietary control of patented technologies.

This review provides a basic introduction to the law and historical development of the patenting of the biotechnology. It is focused on patenting of DNA and DNA derived products; patent sufficiency and support; recent legal decisions on DNA patents; patent infringement; biotechnology patents and morality; patenting in plant biotechnology and patenting material derived from human tissue.

The aim of this Discussion Paper is to examine the issues relating to genetics and intellectual property, particularly those that concern human healthcare and research related to healthcare. to examine ethical and legal issues within the current regulatory framework; to provide an ethical framework and policy recommendations to assist policy-makers and others, particularly the courts, patent lawyers and patent offices. describes the justification advanced for the patent system and explains how the system functions. It also summarises the current legal situation in the UK, Europe and the US, considers the effects of such patents in more detail and proposes ways of modifying the patent system to ensure that it continues to work for the benefit of all.

The paper discusses the express connection between patent law and morality. Is describes how the patent system seeks to encourage creative standards of practical application linked to moral standards. The systems of patent law that explicitly require decision-makers to consider moral standards is described as well as the paradigm of the scope of patentability that is expanding while the role of moral standards in the operation of the patent system is being increasingly limited.

The biotechnology industry is vital to human progress and America’s economy. The sector depends heavily on the incentive provided by patents to rationalize the enormous risk of investing in life science research and development (R&D). These risks pay off for society by generating solutions that help diagnose, prevent, and treat diseases and disorders; improve human health and food production; and provide greater energy security, water development, and environmental protection. These accomplishments, moreover, create well-paying jobs and drive global competitiveness. Despite these positive attributes, questions and controversies are emerging at the nexus of biotechnology and our patent system. These challenges will have significant impact on a wide array of scientific disciplines, including molecular biology, biotechnology, embryology, genetics, and bioinformatics. Indeed, these are sectors in which the United States has a comparative advantage that must be maintained. How well society addresses these issues will significantly influence the state of our economy and creative capacities for years to come.

This book, first-ever of its kind, focusses on the evolution of biotechnology patent law offering protection to biotechnology products and processes. Extensively researched with relative comparisons and examples with reference to the United States, Europe and India, the book probes into the developments of patenting living beings, invented through biotechnology such as genetically modified micro-organisms, plants, animals and even human genetic material. Given the inherent complexities and technical nature of biotechnology invention must satisfy along with the additional requirements. The book also throws light on the liberal interpretation of the patentability requirements in the case of biotechnology inventions. This book would be invaluable for practitioners of patent law, scientists, research scholars, academicians, and students in the field of biotechnology, patents and related intellectual property aspects.

The levels and patterns of biotechnology patenting in several developing countries have been investigated by examining patents, registered in the US Patent and Trademark Office (USPTO) database. The results showed, firstly, that developing countries have increased their biotechnology patenting during the period with the leading countries demonstrating inventive strengths in this field. Secondly, whereas in some countries national patenting ownership was high in others it was relatively low, which may limit the ability of the countries to harness their inventions. Thirdly, the research sector has been particularly active in patenting, especially in countries with relatively strong track records in developing biotechnology products, but industrial patenting is still limited in most of the countries studied. Finally, several of the countries we examined have a strong focus on health biotechnology compared to other types of biotechnology in their patenting rates. It remains to be seen if the increased patenting will foster biotechnology innovation.

The European Patent Convention, abbreviated as EPC, signed in Munich in October 1973 (hence also called Munich Convention), establishes a uniform patenting system for all countries signatory to the Convention. Twenty-one countries attended the Munich Diplomatic Conference in 1973 on which the Convention is based. The Convention is now (as of March 2010) in force in 36 countries. In addition to the Contracting States, States may also conclude a cooperation agreement with the European Patent Office (EPO), known as an extension agreement. The state then becomes "extension state", which means European patents granted by the EPO may be extended to those countries by the payment of additional fees and completion of certain formalities.

The paper discusses the novelties of biotechnology patents, in particular the patentability, it reveals the biotechnology patents as chemical compound. It stresses on the requirement that patents should be synonymous with inventions and applicants must have created the claimed subject matter through an ingenious mental step. In order for a substance based upon a naturally occurring phenomenon to comprise an invention that substance must be significantly transformed from the state in which it naturally occurs and so the biological function of the chemical or tissue at issue must be different from its function in nature.

The paper discusses the issues facing and options open to policymakers in the case of making their national patent legislations fully compliant with the Agreement on TRIPs in the area of biotechnology. It describes the patterns in the patenting of biotechnology providing a historical perspective; discussing the status of patentability of biotechnology; the costs and power behind legal accommodation of biotechnology; the nature of technical advance and the question of determination of scope of patent protection.