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Home >> Patenting of Biological Material >> Can Live Forms Be Patened?
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Can Live Forms Can be Patented? - Although there was initial resistance to the patents of living organisms, this has now been overcome in most industrialized countries. In India there is still some discussion and we are arguing against the patent of life forms, although eventually we may have to agree to the international practice of patenting life forms, if they fulfil the minimum requirement of invention, novelty and utility.

This decision of patenting life forms. was initially influenced, when in 1980 a US Court allowed the following patent in the famous Chakrabarty case. A bacterium from the genus Pseudomonas containing therein at least two stable energy generating plasmids, each of said plasmids providing a separate hydrogen degradative pathway

The subject of the above claim is an organism, which was made more effective in treating oil spills by manipulating a natural Pseudomonas. Question, therefore, is whether something that already existed in nature can be patented. This is known as the 'Product of Nature' problem in patent law.

Patent law makes a distinction between invention and discovery and docs not allow patent for a discovery. In view of this, if isolation of a substance from nature is mere discovery, it may not be patentable. However, if a substance found in nature has first to be isolated from its surroundings and a process is developed I to obtain it from nature, then this process may be patentable as suggested by European Patent Office (EPO).

Furthermore, if the substance is characterized and is 'new' having 'no previously recognized existence', then the substance per se may also be patentable. Antibiotics and other microbial metabolites or a newly isolated microorganism are examples of such patentable substances.

Preparations of pure proteins or vitamin B12 by sophisticated purification techniques or by recombinant DNA methods are other examples. Before 1951, Vitamin B12 had been available only as crude liver extracts, which were of no use for therapeutic application, but a patent claim for pure vitamin B 12 has been allowed in USA.

Microorganisms such as E. coli, in which human genes have been incorporated for production of human insulin, human growth hormone, human tissue plasminogen activator (t-PA), etc have been recognized for patents in USA. Microbial cells engineered to produce antigens and antibodies also qualified for patents.

A protein may be modified by altering the gene sequences responsible for its synthesis. This alteration mayor may not amount to infringement of a protein patent. Several cases dealing with patents of products of nature have been recently contested in US courts and a few will be briefly described to illustrate the issue.
 

 
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