PROTECTION OF BIOTECHNOLOGICAL INVENTIONS

By: N. Shreya Mohan (MSIWM042)

Introduction-

Intellectual property rights (IPR) are designed to allow novel technologies to be available so that the scientist or company receives a reward for the initiative established. Intellectual property possessions can be any codified knowledge, innovation, or anything of actual or potential economic value that has arisen from rudimentary research, analysis, and manipulation of biological systems, industrial application, or for commercial use.

The various types of biotechnological inventions may be grouped into the following-

Approaches/processes of generating useful products.
Numerous products, for example- Antibiotics, vitamins, etc.
Applications of various processes/products, for example, the use of a promoter sequence to regulate gene action.
DNA sequences and the proteins.
Strains of microorganisms, cell lines are obtained by genetic modification.
Methods for genetic modification of organisms.

Patenting of Genes and DNA Sequence–

An artificially synthesized gene is patentable in almost all countries. A patented gene holds exclusive rights to the specific DNA sequence. Once patented, the holder of the patent dictates how the gene needs to be used (whether commercially or clinically) for a minimum of 20 years from the date of the patent. In the USA, genes isolated from the organisms are patentable; gene aroA (shows glyphosate resistance) isolated from a mutant bacterium was the first to be patented. For a patent to be granted in India, it should not be covered in the negative list in Section 39 which provides an extensive list of what are not the inventions under the Indian Patents Act. The act came into force in 1972 amending the Patent act,1970.

The three conditions in order to fulfil the rules imposed by Indian patent act are :

• It should be a novel creation

• It should involve an inventive step for the mankind

• There should be various industrial applications.

Ananda Mohan Chakrabarty got the first US patent for a genetically modified organism in 1981. He discovered a method for cross-linking in such a way that it fixed all the 4 plasmids to a much stabler microbe called Pseudomonas putida capable of consuming 2-3 times faster than previous strains. Its unique characteristic was hydrocarbon degradation, therefore the name was given as “multiplasmid hydrocarbon-degrading Pseudomonas”/superbug. Prof. Chakrabarty’s momentous research has since paved the way for many patents on genetically modified micro-organisms and other life forms for the coming years.

Can Life forms be patented?

The main arguments in favouring the patent of genetically modified life forms are

-They perform novel and useful functions

-They generate economic benefits

-Their production requires large financial and technical innovative inputs

However, the chief objections are usually based on ethical, moral, and religious considerations such as

-They are products of nature and hence should not be fiddled with

-Their genetic modification does not prove an industrial invention

-The inventions cause cruelty to animals

But in 1985, a patent was granted in the USA for a maize plant by overproducing tryptophan through plant tissue culture. Later, in 1988, a genetically engineered mouse called “OncoMouse” was the first mammal to be patented. It was primarily used for cancer research. The animal designed by Philip Leder and Timothy A Stewart of Harvard University used to carry a specific gene called known as an activated oncogene. The activated oncogene increased the mouse’s resistance to cancer, and thus the mouse is a promising model for cancer research. The patenting of OncoMouse, and the extensiveness of the claims made in those patents, were well-thought-out to be unreasonable by many of their colleagues. But, amid the controversies, it was finally patented in 1992.