Biotechnology - Bio safety issues

Bio patent
With emergence of modern biotechnology, one important issue raised which is the legal characterization and treatment of trade related biotechnological processes and products, commonly called intellectual property . In simple words, intellectual property is a 'product of mind'.
In biotechnology,one of the most important examples of intellectual property is the processes and products, which result from development of genetic engineering techniques through use of restriction enzymes to create recombinant DNA. The rights to protect this property are called intellectual property rights (IPR). Intellectual property rights include rights relating to literary, artistic, scientific works, inventions in all fields, industrial designs, trademarks, commercial names, etc. Intellectual property rights include patents, Copyright, trade marks and trade secrets.

A patents is a government granted and secured legal right to prevent other from making, using or selling the inventions covered by patent. A patent is a personal property which can be licensed or sold like any other property.

Under USA law, a patent means grant of right to exclude other from making, using or selling an inventions for a 17years period. The Indian Patent Act(1970) allows process patents but not product patents. The duration of the patent in india is five years from date of grant of patent or seven years from date of filling the application, whichever is less.

Patenable subject matter should meet 3 requirements as utility, novelty and statutory subject matter. Difference countries have different patent laws and these can be modified from time to time.Complaints of infringement of these patents are decided by courts in accordance with patent law of that country.

Patenting of life forms or biological material is called biopatenting and such a patent is called biopatent. Before, 1980, life forms could not be patended and the discovery of oil-eating bacterium (genetically engineered Pseudomonas) by a non-resident indian scientist Dr. Chakraborty (called 'super bug', used for cleaning up oil spills) was first to be patended under standard US patent (i.e., first biopatent). genetically engineered mouse called 'oncomouse' (carrying a human cancer gene) was protected by a US patent in 1988 and this was another milestone in patenting of life forms or biopatents. Issue of biopatents has also been recently discussed in india.

In plant biotechnology, live plants, naturally occuring  microbes, micro propagation, tissue and organ culture techniques, biological controlo pests or hybrid varieties cannot be protected using patents. New crop varieties cannot be patended but transgenic animals and plants can be patended.

The genes and DNA sequences which normally fulfill the requirement of patents have no difficulty in getting patent protection. In 1991, the National Institute of Health (NIH). USA, applied to patent some DNA sequences useful in human gene mapping. This application was opposed on the grounds that it will slow down  the flow of scientific information and stop international co-operation and it failed because of cost.  A second application on DNA patenting by a private company was turned down on the grounds that the research has been done with public money. But in 1997, th eUS patent office agreed to allow patenting of gene strands with no biological function  but likely to have indutrial use. The result is that big academic labs and companies have been sequencing and patenting sequences in order tosecure private investment. In order to distinguish  DNA sequences from their natural counterparts (which cannot be patended), a patent application must state tht the invention has been purified or isolated or is part of recombinant  molecule or vector. Some pharmaceutical companies and NIH (National Institute of Health ) are compiling public databases of sequences toensure public acces. Further donor content is a concern in human DNA patenting .

Terminator technology for seed protection:
A patent under the title'control of plant Gene Expression' was issued on March 3, 1998 jointly to delta and pineland (D and PL) and the US department of Agriculture (USDA). A canada based NGO, RAFI (Rural Advancement Foundation International) dubbed the technology as 'Terminator technology', as they beleived that it will be used to ensure that farmers may not be able to save the seeds from their harvest for replanation. The inventors of this technology have already applied for the patents in atleast 78 countries. Indian governemnt has banned the entry of any seed material into the country that may carry terminator gene and has decided not to grant patent to D and PL for terminator technology.

Patended method for terminator technology is based on a gene that produces a protein that is toxic to plant and thus does not allow the seed to germinate (RIP gene).

Arther Dunkel's Suggestion (1991, 92): Arther Dunkel's then director General, GATT ( General Agreement of Tariff's and Trade ) gave some suggestions for india, which include:

i. India will have to patent laws by 2003 to finally open the agriculture sector for patended biotechnology

ii. India will not be able to give any kind of subsidies for production of oil seeds or pulses as the international prices of these commodities  are lower than domestic price.

iii. India  will have to introduce product patents and to increase in duration of patents.

iv. India will have to open its markets to foreign patent holders.