Biotechnology

Introduction

The issues surrounding patents and biotechnological inventions can be grouped into a number of categories, which are partly inter-related. The first area of concern relates to the legal standards in respect of the scope of patent protection for inventions in the field of biotechnology. The question as to whether certain substances isolated or derived from naturally occurring living organisms are "inventions" or "discoveries" has triggered widespread discussion. In addition to the question of patentable subject matter, the appropriate application of the patentability requirements, for example, inventive-step, industrial applicability (utility) and disclosure requirements, to biological inventions has been subject to an intense debate. Since the exclusive right conferred by a patent is justified by the public disclosure of the full scope of the patented invention, defining the breadth of the claims which are supported by the disclosure of the invention is a cornerstone of the patent system.

Secondly, licensing and other issues related to the exploitation of patents are also areas of discussion. Since one of the characteristics in the field of life sciences is that it requires broad range of comprehensive research activities, down-stream innovations may be covered by a broad patent granted at an early stage of innovation. The number and breadth of patents granted to early fundamental research have raised concerns about patent thickets and royalty stacking. In particular, reach-through claims in patents, especially for research tools, were flagged as a potential impediment to further research and development. Since universities and governmental research institutions also play an important role in the area of biotechnological research, it is essential to stimulate public-private partnership, generate revenue and protect investments. Facilitating the transfer of technology from basic research to applied research and commercialization is one of the key elements for the successful research and commercialization of biotechnological inventions.

Thirdly, issues arise concerning the relationship between patents and other forms of intellectual property protection. In the field of plant biotechnology, plant varieties are, in many countries, protected by a sui generis system, such as the UPOV system. In the era of post-genome research, innovation in the area of, for example, bioinformatics, is characterized by biological information and its processing methods. Copyright protection and protection of databases, if available, are other forms of intellectual property protection which may be of relevance in this area.

Finally, the relationship with other relevant issues, such as the conservation and preservation of the environment (including the protection of biodiversity), and moral and ethical dimensions of the protection and commercialization of biotechnological inventions has been discussed in many fora. As to the former, reference is made to the issue Access to Genetic Resources and Benefit Sharing.

 

Studies and Articles

Links on these pages, including those to studies commissioned for WIPO, do not imply the agreement of WIPO, its Member States or the International Bureau with the views expressed.

 

Related Sites

The inclusion of a link to a site does not imply the agreement of WIPO, its Member States or the International Bureau with any of the views expressed on the site.

World Intellectual Property Organization

• Report on the International Patent System
• Exclusion from Patentable Subject Matter and Exceptions and Limitations to the Rights
• Open Forum on the Draft Substantive Patent Law Treaty, March 1 to 3, 2006
• Intellectual Property and Life Sciences
• Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Protection of Patent Procedure (Budapest Treaty)
• Bibliographies of academic papers on the WIPO Worldwide Academy web site
  • Patentable subject matter
  • Biotechnological Patents - The Tension between IP Protection and Other Goals (Bio-Diversity, Ethical Concerns, Fairness)

 

Other Intergovernmental Organizations

• The Convention on Biological Diversity (CBD)
• European Commission
  
  • Life Sciences and Biotechnology
  • Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions
  • European Group on Life Sciences (EGLS)
• Food and Agriculture Organization of the United Nations (FAO)
• Organisation for Economic Co-operation and Development (OECD)
  • Biotechnology
  • Biotechnology Policies, Biotechnology Statistics in OECD Member Countries:  On-line Inventory
  • Workshop on Genetic Inventions, Intellectual Property Rights and Licensing Practices, January 2002
  • Guidelines for the Licensing of Genetic Inventions
• International Union for the Protection of New Varieties of Plants (UPOV)
• United Nations Educational, Scientific and Cultural Organization (UNESCO)
  • Bioethics
• World Trade Organization (WTO)
  • Article 27.3(b), protection for plants and animals, traditional knowledge and biodiversity

   

Non-Governmental Organizations

• AIPPI
  • Q150: Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), single Nucleotide Polymorphisms (SNPs) and Entire Genomes [PDF]
  • Q178 Questionnaire - Scope of Patent Protection [PDF]
• Biotechnology Industry Organization (BIO)
  • Guide to Biotechnology 2005-2006, June 2005
  • Biotechnology patents in light of precedent and current patents
• CAMBIA
• FICPI
  • Resolution "The Patenting of Human Embryonic Stem Cells in the EU", 2004
• The Human Genome Organization (HUGO)
  • The HUGO Intellectual Property Committee
• International Intellectual Property Institute (IIPI)
• International Structual Genomics Organization (ISGO)
  • ISGO Policies
• National Academy of Sciences (NAS)
  • Committee on Intellectual Property in Genomic and Protein Research and Innovation
• Public Intellectual Property Resources for Agriculture (PIPRA)
• The SNP Consortium