Biotech SKCHILE

Views:
 
     
 

Presentation Description

This presentation describes intellectual property in Biotech.

Comments

Presentation Transcript

PowerPoint Presentation:

IPR on Biotechnology Intellectual Property of Biotech Dr. Satish Chile Professor of Botany Govt. P.G. College Seoni, India

PowerPoint Presentation:

If IPR existed in our time we would have been Billionaire.

PowerPoint Presentation:

This apple had property right to fall on Newton only so that the Newton's law could be framed. I’m sure this will not fall on my head

Intellectual Property Rights :

Intellectual Property Rights IPRs refers to “the legal ownership of by a person or business of an invention/ discovery attached to a particular product/ process which protects the owner against unauthorized copying or limitation.”

PowerPoint Presentation:

What is Biotechnology ? Biotechnology includes: Recombinant DNA and Genetic Engineering Cell Cultures Waste Treatment and Utilization Enzymes and Biocatalysts Fuels Nitrogen Fixation Fermentation and Pharmaceuticals Hybrids and Transgenic Plants

PowerPoint Presentation:

Why is Biotechnology Important for India? For a country like India, biotechnology is a powerful enabling technology that can revolutionize agriculture, healthcare, industrial processing and environmental sustainability . Biotechnology as a business segment for India has the potential of generating revenues to the tune of US$ 10 million and creating one million jobs by 2020 through products and services. Clinical development services can generate in excess of US$ 1.5 billion while bio-services or outsourced research services can garner a market of US$ 1 billion over this time scale.

PowerPoint Presentation:

Why is Biotechnology Important for India? With approximately 400 industries, the growth of the biotech sector in India has been rapid. Currently, the bio-pharma sector occupies the largest market share of 76% followed by bio-agro 8.42%, bio-services 7.70%, industrial products 5.50% and bio-informatics 2.45%.

PowerPoint Presentation:

Under biotechnology, one of the most important examples of intellectual property is the processes and products , which result from the development of genetic engineering techniques through the use of restriction enzymes to create recombinant DNA. If these research are taken as intellectual properties this will encourage industries to, allocate labour, research and development (R&D) units and 3. funding to facilitate the production of commercially marketable items .

PowerPoint Presentation:

In intellectual properties, many legal and public policies, which are impediments to biotechnological research are also being challenged and are, therefore, undergoing changes. Example of IP is the development of crop varieties, which are protected through 'plant breeder's rights' or PBRs (PBRs are available in developed countries) Through PBR, the plant breeder who developed a variety enjoys the exclusive right for marketing the variety, although use of the variety for further breeding or for replantation of seed saved by a farmer is permissible.

PowerPoint Presentation:

In some country recently patents for genetic materials (plants and animals) have also been allowed . So that the patented material can neither be used for further breeding, nor will the farmers be allowed to save and use the seed for cultivation, without paying a fee to the patent holder. Similarly, if patents on superior animal breeds are allowed, a dairy farmer will find that a calf born to his hybrid cow will belong to the company, which sold him the animal.

PowerPoint Presentation:

These intellectual property rights affect (favourably as well as unfavourably) the conservation, availability and use of plant and animal genetic resources (PGR and AGR). The impact of IPR on the availability of genetic diversity will also be witnessed. There are also arguments against patenting life forms like transgenic animals and plants, because these patents will work as impediments in free exchange of genetic materials for improvement of crops and livestock.

PowerPoint Presentation:

IPRs may also adversely affect food security, use of evolved agricultural practices, biological diversity and ecological balance and the livelihood of the poor in developing countries.

PowerPoint Presentation:

IP divided into two categories- Industrial property- Inventions (patents), trademarks , industrial designs, geographical indications of source . Copyright- Literary and artistic works, such as novels, poems and plays, films, musical works, artistic works such as drawings ,paintings, photographs and sculptures, and architectural designs .

PowerPoint Presentation:

Patents are usually allowed for a specified period. The duration of the patent in India is 5 years from the date of grant of patent or 7 years from the date of filing the application. In India, The Indian Patents Act of 1970 allows process patents, but no product patents for foods, chemicals, drugs and pharmaceuticals.

Indian Patent Act, 1970:

Indian Patent Act, 1970 With limited resources for R&D, the Act was created to encourage process patenting rather than novel product development. The weak patent system has had a significant impact on innovative capacities because it has emphasized process innovation, rather than product innovation Changes in the Patent Act, –Product Patents –Longer patent term (20 year) –Stronger compliance and enforcement mechanism

What can be Claimed?:

What can be Claimed? – Diagnostic tests – Research tools – Gene therapy – Therapeutic proteins Sensors –Bioinformatics –Sequences –Pharmaceuticals

PowerPoint Presentation:

Potential Areas for Investment in the Indian Biotechnology Sector Agriculture and Food Biotechnology Industrial Biotechnology Preventive and Therapeutic Medical Biotechnology Regenerative and Genomic Medicine Pharmaco-genomics Bio-engineering and Nano-biotechnology Bio-informatics and IT Enabled Biotechnology Clinical Biotechnology and Research Services

PowerPoint Presentation:

A patented pharmaceutical, in USA, is subject to regulatory purview of Food and Drug Administration (FDA) before its clinical use is allowed; Under the U.S. Federal Insecticide, Fungicide and - Rodenticide Act, genetically engineered microbial pesticides require Environment Protection Agency (EPA) permits, before they are released; Use of excessively noisome genetically engineered inventions might also be curtailed under local nuisance ordinances. Examples -

Patents in Biotechnology:

Patents in Biotechnology •1980 -First Cohen-Boyer recombinant DNA patent •1984 -Cell line derived from human leukemia patient patented •1986 -Genetically engineered corn patented •1988 -Harvard Onco -mouse patent •1991 -Isolated human bone marrow stem cells patent.

Intellectual Property Rights (IPR) - Copyright:

Intellectual Property Rights (IPR) - Copyright Copyright is a set of exclusive rights granted to the author or creator of an original work, including the right to copy, distribute and adapt the work. The best example of copyright is the authored and edited books, or audio and video cassettes, which can not be reproduced without the permission of the person (author, editor or publisher), who holds the copyright. In biotechnology, the copyright may cover DNA sequence data which may be published.

PowerPoint Presentation:

However, an alternative sequence coding for same protein may be prepared using wobble in the genetic code, so that the copyright is not infringed. Computer data bases and photomicrographs of DNA instruction manuals related to biotechnology can also be copyrighted. The protection to copyright is limited, however, since although one may not be allowed to photocopy the present book on biotechnology due to copyright, but the ideas given in the book can be used for any purpose.

Intellectual Property Rights (IPR) and Plant Genome Resources (PGR) :

Intellectual Property Rights (IPR) and Plant Genome Resources (PGR) In industrialized countries, crop varieties are subject to intellectual property rights in the form of PBR (Plant Breeder's Rights). However, the present intellectual property right (IPR) systems do not promote, nor were they designed to promote, the protection of diversity of whole ecosystems or unmodified plants (biodiversity). For instance, if PBR is extended to all plants, as is currently being discussed at the international level, this might help in extending breeding work to more crops, which in turn will contribute to the development of greater crop diversity. it is significant that changes are being proposed by some industrialized countries to the General Agreement on Tariffs and Trade (GATT) and to World Intellectual Property Organization (WIPO).

GATT (General Agreement of Tariffs and Trade):

GATT (General Agreement of Tariffs and Trade) GATT was formed in 1949 . In 1995 the GATT was replaced by WTO , which modifies the terms of agreements from time to time and places them for consent from as many as about 157 countries . WTO has made the world a better place to do business by allowing more free and fruitful flow of goods and services.

PowerPoint Presentation:

WTO Member Countries

TRIP (Trade Related Intellectual Property):

TRIP (Trade Related Intellectual Property) The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) is an international treaty administered by the World Trade Organization (WTO) which sets down minimum standards for most forms of intellectual property (IP) regulation within all member countries of the World Trade Organization. TRIPs deals with the following IPRs – Copyright and related rights; Patents; Trademarks; Geographical indications, including appellations of origin; Industrial designs; Integrated circuit layout-designs; Protection of undisclosed information Control of anti-competitive practices in contractual licenses .

Comparison of India's Patent Act and TRIPs:

Comparison of India's Patent Act and TRIPs Indian Patent Act of 1970 TRIPs Only process not product patents in food, medicines, chemicals Process and product patents in almost all fields of technology Term of patents 14 years; 5-7 in chemicals, drugs Term of patents 20 years Compulsory licensing and license of right Limited compulsory licensing, no license of right

PowerPoint Presentation:

Indian Patent Act of 1970 TRIPs Several areas excluded from patents (method of agriculture, any process for medicinal surgical or other treatment of humans, or similar treatment of animals and plants to render them free of disease or increase economic value of products) Almost all fields of technology patentable. Only area conclusively excluded from patentability is plant varieties; debate regarding some areas in agriculture and biotechnology Government allowed to use patented invention to prevent scarcity Very limited scope for governments to use patented inventions Comparison of India's Patent Act and TRIPs

PowerPoint Presentation:

Intellectual Property Rights of Biotechnology : Legal Aspects Changes to Indian legislation in keeping with international legislative framework Subsequent to the enactment of TRIPS, Indian Patent law has changed in the following ways : A uniform twenty (20) years for all patents granted after May 20, 2003; A reciprocal arrangement with all convention countries, union of countries and inter-governmental organizations; Products made patentable in all fields of technology from January 1, 2005; The extension of the rights of the patentee; For product patent applications on pharmaceuticals and agro-chemicals filed before January 1, 2005, under the mail box system, request for examination is to be filed within thirty six months from the date of priority.

PowerPoint Presentation:

Intellectual Property Rights of Biotechnology : Its Regulatory Framework Legislative framework : The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 as amended from time to time, regulate recombinant pharma products. Authorities : The Drugs Controller General of India (DCGI), the State Drugs Controller and the Recombinant Drugs Advisory Committee (RDAC) constituted by the Ministry of Health and Family Welfare regulate the recombinant pharma products.

PowerPoint Presentation:

Steps involved in the approval process of a biotechnology product - Proposal (examination of proposal in light of the bio-safety regulation and guidelines) Approval of Review Committee on Genetic Manipulation (RCGM) (Examination of information for R&D work, approval of pre-clinical trial based on evaluation of data physico-chemical and biochemicals characterization of the process and the final product Genetic Engineering Approval Committee Drugs Controller of India (Approves Clinical Trials and Containment Facilities and Evaluates Clinical Trials) Intellectual Property Rights of Biotechnology : Its Regulatory Framework

PowerPoint Presentation:

Intellectual Property Rights of Biotechnology : Its Regulatory Framework Proposals to streamline the process : The Institutional Bio-Safety Committee will monitor all development work (up to 20 litres) and recommend to RCGM for Animal Toxicity Tests (ATT) & Scale Up. RCGM will evaluate the recombinant technology and grant permission for scale up – R&D, review and approve for pre-clinical animal toxicity tests and evaluate ATT data and recommend to DCGI for Human Clinical Trial (HCT). DCGI will permit Human Clinical Trials, review Human Clinical Trial Data, grant permission for Manufacture and Marketing of the product and inspect the facility where the product is manufactured. GEAC will review the manufacturing process to ensure that the LMO (Living Modified Organism) is “inactivated” during the process and send its recommendations to the Drugs Controller General of India within the specified time.

PowerPoint Presentation:

Future Proposals by the Indian Government to further steam-line the Regulatory Aspect of the Indian Biotechnology sector National Biotechnology Regulatory Authority In-service Center for Training of Professionals Guidelines for Transgenic Research Special Regulatory Cell Review Committee on Genetic Manipulation (RCGM) Evaluation of Recombinant Technology

PowerPoint Presentation:

Thanks

authorStream Live Help