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REVIEW OF TRIPS ARTICLE 27.3(b)

Proposal:

Delete Article 27.3(b). Replace with the following:

Countries must exclude from patentability plants, animals, microorganisms and parts thereof, and any processes making use thereof, or relating thereto.

Rationale:

1.                  All plants, animals and parts thereof cannot be patented. It is established in patent law that substances, which exist in nature are a ‘discovery’ and not an invention.

2.                  If plants, animals and parts thereof are excluded from patentability, then microorganisms and for that matter, any other biological matter found in nature, including genes and cells, should also be non-patentable. There is no legal or scientific basis for the distinction that is drawn between plants and animals, on one hand, and microorganisms, genes and cells, on the other.

3.                  Gene, cell or nucleic acid (DNA or RNA) sequences also cannot be patented. Such sequences are unstable and can change by mutation, deletion, insertion and rearrangement. If a particular sequence is patented and changes occur, the sequences are no longer the same as that patented. Gene sequences are also patented on the ground of the functions of the gene (e.g., a gene exhibiting a particular characteristic such as pest resistance). However, the gene sequence by itself can do nothing – it can only have a function within a cell or an organism.  Its function will depend on which kind of cell it is in, where in the genome it is inserted, in what kind of genome, and in which environment. In other words, its functions are uncertain and unpredictable.

4.                  ‘Essentially biological processes’ are excluded from patentability, but not ‘microbiological processes’ or ‘non-biological processes’. This distinction has no scientific basis. There is no sound reason to regard microbiological as anything but biological, therefore, a microbiological process should not be patentable.

5.                  A ‘non-biological process’ is difficult to define but could be used to describe a process that does not occur naturally, or which is not normally carried out by organisms. It must be clarified that a non-biological process can only be patented where it involves novelty. Gene sequences should not be considered a non-biological process that is patentable.

 


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