Patentability of Biotechnology Under the International Patent Regime: Differentiation v. Harmonisation



International patent regime faces a great challenge to cope up with the new biotechnological advances. The international patent regime struggles to provide effective patent protection to biotechnology inventions (especially genetic inventions). The TRIPS Agreement sets minimum standards for the member nations to follow while granting patents; however, it leaves potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes and essentially biological processes. These gaps and uncertainties affect developing countries seriously given their relatively slow pace of scientific and technological development. The technology-neutral character of TRIPS does not allow special treatment to biotechnology inventions. International patent regime is the result of the efforts made by member nations to harmonise the patent laws and provide a uniform set of standards for the world. However, in the context of biotechnology patents, the divergence in patent practices among member nations makes it difficult to provide a uniform standard for the whole world. Moreover, there is a political divide between developed and developing countries as developed countries push for expanding the scope of patent eligible subject matter boundary by eliminating the exceptions from the text of TRIPS while developing countries are against this approach. In the biotechnological context, creating a single set of patenting guidelines for the entire world has proved very difficult to achieve given the controversy over issues such as patenting plants and animals. Both uniformity and diversity have potential and pitfalls, and the relevant question is to what extent inter-jurisdictional diversity and competition should be sacrificed to achieve global uniformity.


Biotechnology Gene Patents International patent regime TRIPS Agreement Differentiation versus harmonisation Draft Substantive Patent Law Treaty (SPLT) 


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© Springer India 2015

Authors and Affiliations

  1. 1.Amity Law SchoolNoidaIndia

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