Biotechnology has given us the power to manipulate genes, proteins and organisms. It has the potential to revolutionize the way that diseases are diagnosed and treated, our food is produced, our energy is generated and how we deal with our waste. However the patentability of Biotech invention is judged not differently than other invention, except the exploitation of certain Biotechnological inventions may be regulated by legislation beyond patent legislation.
What is a patent?
Patent may be granted for inventions and give the owner the righ to prevent others from using the invention.
What can be patented?
In general, the patent system allows patent protection to be obtained for products, processes and methods of use. Example: Diagnostic Assays, Screening methods, purification protocol, sequencing protocol and cell culture technique.
Except the patentability in UK and EPO (European patent Office) are inventions which concern processes for cloning human being, modifying the germ line and genetic identity of a human being, use of embryos for commercial and industrial process.
Patenting a micro-organisms and animals
The patenting of micro-organisms is not new. Patent were granted for types of yeast in Belgium in 1833.For example the r-DNA technology is coming up with different possible combination which is found to be very useful in biotechnology, medicine and research. One of the best example is Recombinant- Human Insulin which has completely replaced the Insulin available from the animals for the treatment of Insulin-dependent diabetes.
Indian Biotechnology patent laws and Invention
A patent grants the patentee the right to exclude others from commercially using the patented invention for a period of twenty years. The underlying assumption is that, through exclusivity, potential inventors are incited to devote their resources to R&D of new products and inventions, because of the prospect of acquiring patents and, therefore, exclusivity in the exploitation for a limited period of time. In view of the immensely high investments needed for the development of biotechnological products, this presumption would particularly apply to bio-industry.
In particular where the invention concerns a drug there will need to be data from in vitro assays, and preferably also in vivo data, that shows that the drug is effective in treating the relevant condition
Moral Implication and Bioethics
The patenting of genes is a controversial issue in terms of bioethics. First, some believe it is unethical to patent genetic material because it treats life as a commodity. Second, some say that living materials occur naturally, and therefore cannot be patented.[9] Finally, there is the fear that allowing patents on genetic material will undermine the dignity of people and other animals by subjecting their genes to ownership by other people.
The last major ethical issue involving gene patents is how the patents are used post-issuance. A major concern is that the use of patented materials and processes will be very expensive or even prohibited to some degree by conditions the patent owner sets.
Summary
A typical argument in favour of biotech patents is that they enable companies to earn money that the companies in turn invest in further research. Without these patents, some worry that companies would no longer have the resources or motives to perform competitive, viable biotech research.
Some biotech products take many years to develop. In such cases a patent application might be filed many years before a product is ready for market. Surely, a certain level of prediction may be needed when drafting the patent application to ensure that the eventual form of the product is covered.
So from the onset it can be worthwhile thinking in terms of constructing a portfolio of cases, and giving consideration to where each case fits within the portfolio.
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