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Patenting of Biological Material
Patenting of Biological Material Introduction
International Conventions
International Cooperation
Obligations with Patent Applications
Implications of Patenting
When Can Live Forms be Patented

When Can Live Forms be Patented
Although there was initial resistance to the patents of living organisms, this has now been overcome in most industrialized countries.
In India also, after some debate, an agreement has been reached to accept 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 Chakraborty case.

A bacterium from the genus Pseudomonascontaining 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.

Oil Eating Bacteria

Oil Eating Bacteria (genetically Engineering Pseudomonas), Which Were the First Living Organisms to be Protected Under a Standard US PAtent; These are Used for Cleaning up oil Spills. (From Sci. Amer.,March)

Patent law makes a distinction between invention and discovery and does 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 been isolated from its surroundings and a process is developed 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 persemay 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 B₁₂ has been allowed in USA.



	if the proteins have different reactive properties, the modified patentable itself
	if both proteins have identicalreactive properties, the modified version may be an infringement
	if the modified protein has both unique and previously patented features, its maker may not need to pay a licensing fee for some unique applications

Microorganisms such as E. coliin 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 may or may not amount to infringement of a protein patent. Several cases dealing with patents of products of nature have been contested in US courts and a few will be briefly described to illustrate the issue.