Substantive Legal Standards
Clarity about intellectual property standards in the Life Sciences is essential to appropriately respond to important questions such as whether certain substances isolated or derived from naturally occurring living organisms are "inventions" or "discoveries", what is patentable subject matter, how to appropriately apply the patentability requirements, for example, inventive-step, industrial applicability (utility) and disclosure requirements. WIPO has convened a Working Group of experts in the field of biotechnology from the private sector and governments of its Member States in 1999. This group has identified key questions related to biotechnology and intellectual property rights, which formed the basis of program activities (WIPO/BIOT/WG/99/1).
In 2001, a survey (document WIPO/GRTKF/IC/1/6) was carried out concerning practices related to the protection of biotechnological inventions under patent and/or plant variety protection systems by WIPO Member States. This survey provides a useful insight into the extent that national legislation may, or may not, be used to facilitate the granting of patents on biotechnology inventions, including information as to which countries might admit the patenting of genes, cells or of plant varieties.
In October 2002, WIPO organized a symposium, in conjunction with the International Union for the Protection of Plant Varieties (UPOV) on the Co-Existence of Patents and Plant Breeders' Rights in the Promotion of Biotechnological Developments. A second symposium took place in 2003 on Intellectual Property Rights in Plant Biotechnology.
At the invitation of the CBD Conference of Parties, the Intergovernmental Committee prepared two technical studies on the disclosure requirements in patent applications that relate to genetic resources and associated traditional knowledge used in a claimed invention (WIPO publication 786(E) [PDF] and WIPO document WO/GA/32/8; More information...).
An Open Forum on the draft Substantive Patent Law Treaty (SPLT) took place in 2006 on a number of issues that had been raised in the draft of the SPLT or that Member States wished to include in the draft SPLT. For instance, on biotechnological inventions, speakers addressed the patenting of genes and life forms, and the impact of patenting on upstream science and patents and public health, including second use patents.
