Introduction

According to Wikipedia a "Patent is a set of rules granted as an exclusive right by government, for a limited period of time in consideration of disclosure of invention by an applicant".

Biotechnology is a set of techniques by which human being modify the living things or use them as tools. With the help of biotechnology we can improve the quality of living and make the life comfort. But in today’s era there are lot of plagiarism or poaching of ideas/inventions are taking place, so to avoid this type of issues the government had set up some set of rules. This set of rules can be termed as PATENT .

A biological patent is a patent on an invention in the field of biology. The patent law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.


Biotechnology: An Introduction

The United Nation Convention on Biological Diversity defines Biotechnology as

"Any technology application that uses biological systems, living organism, or derivatives thereof to make or modify the products or process for specific use"

Biotechnology mainly attracts on the pure biological science such as microbiology, Genetics, Animal cell culture, Molecular biology, Biochemistry and in many cases is also depends on the knowledge and methods from outside the field of the biology such as chemistry, physics, Information technology etc. Biotech is an emerging sector observing the exponential grown in the sub sectors like Bio-informatics, Agri-biotech, Bio-pharmaceutical etc. Presently the need of biotechnological techniques, process and procedure has arisen to such an extent because in the advance in technology and scientific discoveries and experiments. Hence biotechnology is one of the emerging field throughout the globe.

Advances in Biotechnology

The spark of biotechnology can be found years back ago when our descendants used to make beer by the fermentation process. So from the fermentation process till the crop breeding and many more, biotech has played the key role. The advancement in biotechnology are listed below

1) Crop Yield - Using the techniques of conventional plant breeding, one or two genes may be transferred from a highly developed crop variety to transfer a new character, so that would increase its yield.

2) Reduced exposure of crops to environmental stresses - Drought and excessively salty soil are two important restraining factors in crop yield. Using Biotechnology, crops may be developed with genes that will enable them to survive biotic and abiotic stresses and effectively meet such restraining factors.

3) Increased nutritional potentials - Proteins in foods may be changed to increase their nutritional qualities. Proteins in legumes and cereals may be altered to provide the amino acids needed by human beings for a balanced diet.

4) Improved taste, texture or form of food - Modern biotechnology can be used to slow down the process of decomposition so that fruit can ripen longer on the plant and then be transported to the consumer with a still reasonable shelf life. This alters the taste, texture and appearance of the fruit. More importantly, it could expand the market

5) Production of pest resistance plant:

a. BT cotton - The bacterium Bacillus thuringiensis (Bt) is a family of over 200 different proteins which naturally produce chemicals harmful to selective insects, The gene coding for Bt toxin has been inserted into cotton, causing cotton to produce this natural insecticide in its tissues.

b. Protection against nematodes - A nematode Meloidogyne incognita infects tobacco plants and reduces their yield. The specific genes ( in the form of c DNA) from the parasite are introduced into the plant using, Agrobacterium as the vector. The genes are introduced in such a way that both sense/coding RNA and antisense RNA are produced Since these two RNAs are complementary, they from a double stranded RNA (ds RNA) This neutralizes the specific RNA of the nematode, by a process called RNA interference. As result the parasite cannot line in the transgenic host and the transgenic plant protected from the pest.

Biological Patent

A Biological Patent is an intellectual property right relating to Biological inventions. It is an exclusive right granted by the Government to an inventor over his invention for a limited period of time. Patentable inventions include a new product or process, involving an inventive step and capable of being made or used in an industry. It means the invention to be patentable should be technical in nature. It should also meet the following criteria:

• Novelty: The matter disclosed in the application is not published in India or elsewhere before the date of filing of the patent application in India

• Inventive Step: The invention is not obvious to a person skilled in the art in the light of the prior publication / knowledge / document.

• Industrially Applicable: Invention should possess utility so that it can be made or used in an industry.

However, in order to leverage funding or to recoup your investment in biotech research, there is usually one prerequisite required by private and, increasingly, public funders - a clearly defined biotech patent right to the invention. Consequently, without patent protection for usable inventions, investments in science diminish.

The following are protected under the Biological Patent Right:

a. Genetic Industrial Patents - Isolated DNA sequences, proteins to which functions have been attributed, and other metabolites are usually viewed in patent terms as chemical compounds, much like a new organic drug molecule. The unique sequence of the nucleotides or amino acids that you have uncovered constitutes a novel biological molecule (much like a novel chemical molecule) and may thus be patentable. In addition, vectors containing your nucleotide sequence and cells containing the vector / DNA may also be patented, provided they are new.


b. Diagnostics Patents - Primers used for diagnostic purposes may be protected by way of patents, as well as kits containing such primers. Single nucleotide polymorphisms and expressed sequence tags may under certain strict conditions be considered patentable and of use in diagnostics, but they may fall foul of the utility patent requirement discussed above. In addition, novel antigens and receptors that you have located may also be protected by way of a patent, provided you have ascribed a function to them. Novel monoclonal antibodies and immunological tests (such as ELISA tests) using novel antibodies are also worthy of biotechnological patent protection. In addition, other novel diagnostic tests may also be patentable.

c. Pharmaceutical and chemical sciences patents - Novel purified chemical or pharmaceutical compounds are patentable, as well as their pharmaceutically acceptable isomers and salts. Crude extracts in which a compound is enriched may also be patentable, depending on the level of enrichment relative to the natural, unfractionated state. Importantly, novel pharmaceutical carriers may also be patented.

Assets of Biological Patents

1) A patent gives the inventor the right to stop others from manufacturing, copying, selling or importing the patented goods without permission of the patent holder.

2) The patent holder has exclusive commercial rights to use the invention.

3) The patent holder can utilize the invention for his/her own purpose.

4) The patent holder can license the patent to others for us. Licensing provides revenue to business by collecting royalties from the users.

5) The patent holder can sell the patent any price they believe to be suitable.

6) The patent provides protection for a predetermined period (20 years) which keeps your competitors at bay.

7) Patents are partially responsible for advancements in medical science, biotechnology, drug chemistry, computers etc.

8) Patents reward inventors with the aforementioned advantages and hence, creates bigger and better discoveries.

Drawbacks of Biological Patents

1) A patent is an exclusive right provided to a patent holder in exchange for the public disclosure of their invention. A full description with claims is published and can generally be viewed by anyone with the internet including your competitors.

2) After the exclusive patent period (20 years) has passed, other individuals or companies can freely use the invention without any permission from, or paying royalties to the inventor.

3) Applying for patent can be a very lengthy, time consuming process.

4) Cost of patent filing may be surpass the actual financial gains. If a patent is to be filed further in different countries, then again the cost increases. After the patent grant, annual fees should be paid to the respective patent offices, otherwise the patent period may lapse.


Conclusion

As the biotechnologist are not aware of the basics of law, i.e. IPR (Intellectual property right) so the government should introduce the basic courses of LAW in the field of biotechnology, so that the biotechnologist will be aware of the basic knowledge of law. Expansion in the technology is growing rapidly, IPR (Intellectual property right) have become important in areas like global compititinal, high innovation risk, high investment in R&D, production and marketing



About Author / Additional Info:
An avid science explorer. Budding Biotechnologist