Wednesday, 15 April 2015

Paper 6 - General Science and Technology

Life Science
Syllabus - Biotechnology: Introduction of Biotechnology, its potential to improve human life and national economy through agriculture (biofertilizers, biopesticides, biofuels, genetically modified crops), industrial development and employment generation. Areas of application -pharmaceuticals, human healthcare, food technology, energy generation etc., Efforts of government in promoting biotechnology in the country. Ethical, social, legal and IPR (intellectual property rights) issues related to biotechnological development. 

Biotechnology – An Introduction to Biotechnology

[Biosafety] Genetically Modified Crops, Bt-Brinjal, Cartagena & Nagoya Protocol: Meaning, Issues

GS3 Science-Tech: Biotechnology, Robotics, Nanotech, Computer/IT awareness, Space-tech, Agro, Defense

Biotechnology: Meaning, Technologies and Applications in India(8617 words)

Various Applications of Plant Biotechnology

United Nations Conference on Trade and Development
The Biotechnology Promise

Har Gobind Khorana: Essay on Har Gobind Khorana

Industrial Biotechnology : An Introduction to Industrial Biotechnology and it’s Applications

Biotech could take India ahead

Biocon’s breast cancer drug to hit markets next month

Defending India’s patent law

Algae proposed as a viable source to produce cheaper biofuel

Indian biotech aiming to be $100-bn sector by 2025: Shaw

Bioechnology(Government promotion in India)

Modi bets on GM crops for India's second green revolution

GEAC clears field trials for GM crops

Ethical Issues in Genetic Engineering and Transgenics

Convention on Biological Diversity

Cartagena Protocol on Biosafety

Nagoya Protocol

Genetically-modified foods (GM foods) are been in the news lately. European environmental organizations, India and public interest groups have been actively protesting against usage of GM foods for months. 
The former environment minister of India told the apex regulator of genetically modified organisms (GEAC) that it failed to properly use available science to determine the safety to human health and environment in 2010.
There is fierce opposition from activists even to the introduction of the Biotechnology Regulatory Authority Bill (BRAI) in Parliament, meant to evolve a scientific basis for the regulatory process.

What is GM CROPS?
•These crops have been modified in the laboratory to enhance desired traits such as increased resistance to herbicides or improved nutritional content. 
The enhancement of desired traits are undertaken through breeding, but conventional plant breeding methods are  time consuming and are often not very accurate.
•Transgenic (or genetic modification) technology, which includes Bt (Bacillus thuringensis toxin) crops, combats abiotic stresses and improve nutritive quality of the grain. 
•Transgenic technology is only one component of agri-biotech, which includes non-GM options such as marker-assisted selection breeding (MAS), reverse breeding, grafting non-GM scion onto GM-root stocks etc.
•Genetic engineering can create plants with the exact desired trait very rapidly and with great accuracy. For example, plant geneticists can isolate a gene responsible for drought tolerance and insert that gene into a different plant. The new genetically-modified plant will gain drought tolerance as well.
•Not only can genes be transferred from one plant to another, but genes from non-plant organisms also can be used. The best known example of this is the use of B.t. genes in corn and other crops. B.t., or Bacillus thuringiensis.

Purpose of research on GM crops
•To overcome national issues concerning lost revenues for farmers, breeding companies and consumers, brain drain and lost technology innovations, reduced agricultural productivity and sustainability, foregone health benefits, especially reducing malnutrition.
•If rice could be genetically-engineered to contain additional vitamins and minerals, nutrient deficiencies could be alleviated. For example, blindness due to vitamin A deficiency is a common problem in third world countries

GM crop features
•GM is not a stand-alone technology. It can blend with conventional technologies, including organic farming. In fact, it is ideal to have a Bt crop as central to organic farming, since the overall objective is to decrease use of chemical pesticides.
•Thus, drought-tolerant maize and quality protein maize have been developed using Market Assistant Selective Breeding (MAS). Golden rice has been developed using the GM approach with two genes, one from daffodil and another from a soil bacterium.

GM crop promises to meet needs in many ways like
Pest resistance
Crop losses from insect pests can be staggering, resulting in devastating financial loss for farmers and starvation in developing countries.
Herbicide tolerance
Farmers often spray large quantities of different herbicides (weed-killer) to destroy weeds, a time-consuming and expensive process.
Disease resistance
Plant biologists are working to create plants with genetically- engineered resistance to these diseases.
Cold tolerance
Unexpected frost can destroy sensitive seedlings. An antifreeze gene from cold water fish has been introduced into plants such as tobacco and potato.  
Drought tolerance/salinity tolerance
Creating plants that can withstand long periods of drought or high salt content in soil and groundwater will help people to grow crops in formerly inhospitable places.
Malnutrition is common in third world countries where impoverished peoples rely on a single crop such as rice for the main staple of their diet. However, rice does not contain adequate amounts of all necessary nutrients to prevent malnutrition.

Reasons for embargo on GM crops
•Technical expert committee of India feels that the technology in the field of biotechnology is relatively new and there is limited information on safety, especially food safety.
•Effects of long-term and widespread consumption and commercial release of GM crops in the environment.
•No enough or extensive field trails to evaluate the health and environmental aspects of allowing GM crops.
•Concentration of intellectual property and resources for research on GM crops in the private sector was resulting in perverse and exploitative relationships of public institutions with the private sectors in developing countries and that these had not been successful in meeting the development and sustainability goals. ( this view held that the control of GM crop biotechnology by private sector was affecting the ability to deploy it towards the public good in developing countries).
•The cost of GM seeds is the fastest growing expense for U.S. farmers who are simultaneously suffering from weeds resistant to the herbicides excessively used on GM crops and pests resistant to the insecticides over-used in Bt crops. That likely would be India’s experience had it commercialized Bt brinjal which was developed with the least effective form of Bt for the target pest.

Transgenic (or genetic modification) technology in India and necessary developments and limitations
•In our country, agricultural biotechnology has been reduced to Bt (Bacillus thuringensis toxin)-crops and further restricted to Bt cotton and Bt brinjal.
•If India has become a cotton-exporting country from a cotton-importing one, Bt cotton has played an important role in this change. The sustainability of Bt cotton would require both gene pyramiding along with IPM, NPM strategies, including crop rotation.
•Livestock fed on Bt corn are the main source of meat products, imported even by Europe. One needs to worry about water availability, loss of soil fertility and hostile weather conditions. Scientists are already looking for a cold shock protein to overcome drought stress, or a nitrate reductase gene that lets the organism grow with 100 times less nitrogen than normal.

GM technology of US (vs.) NON-GM’s of European countries
•Western Europe’s maize yields match or exceed the U.S.’ yields using less pesticide. The yields in wheat and oilseed rape are increasing at an even faster rate in Western Europe than in the U.S. and Canada.
•This indicates a dangerous trend: those countries choosing to innovate in agriculture using GM are demonstrating lower productivity increases and greater dependence on chemical inputs in all crops compared to economically and environmentally comparable countries choosing to not use GM crops.
•GM products attract the strictest intellectual property (IP) rights instruments possible in agriculture (e.g., process patents).

The very existing issue draws national concern as major part of Indian population is under poverty. Now as our whole country is expecting a lot from FOOD SECURITY BILL. At this very moment if we implement total embargo and oppose BRAI in parliament, it will not solve the problem of food scarcity and poverty in our country. Sole dependency on GM crops poses a greater threat in future for children suffering from under and malnutrition.

India being a part of GM technology needs genes from plants with deep roots that can use water and nutrients very effectively. These areas of research are extremely important and must be protected from hypothetical risks. Growing GM and NON-GM crops parallelly can ease some difficulties to a particular extent.                       

Supporting communities with education on nutrition and farmers with technologies that build up their soils manage pests with little or no application of pesticide and manufactured fertilizers gives them the means and independence to grow a variety of crops and livestock to meet their dietary needs and sell their surplus in local markets. 

This investment in agriculture is not as good at making intellectual property, but better for growing food. To support India’s mainly small holder farming requires removing the penalties and incentives on the public scientist to develop primarily technologies that bring direct revenue to their institutions. Instead, invest in them with public money and measure their success by the yields of farmers, the reduction of pesticides and fertilizer they use, and the increase in their wealth and health.

India needs agriculture technology policy. Expert group need to decide year after year which crop, which trait and which strategy has to be used. Bt brinjal embargo cannot seal the fate of our country. These contentious issues can be debated only if the bill is introduced in our parliament. 

GMOs and Related issues
What are GMOs?
Genetically Modified Organisms- Refers to the organisms such as yeast, plants, animals etc whose genes have been altered.

How are GMOs made?
Aim is to change the genetic make-up. So, it can be changed by inserting new gene or modifying existing one.
Can be done by- Making the cell membrane more porous and inserting new gene into cell by electric shock, gene gun, cold temperature shock etc
Occurs in nature too.

Use of GMOs?
-Better varieties of crops (more productivity, shelf life, flood and drought resistance) = Genetically Modified Crops (GMCs)
-Ornamental organisms (GloFish was the first such organism)
-Better meat (genes can be stimulated for more muscle growth)
-Gene therapy, research etc

Why is it in news?
1.Technical Expert Committee established by Supreme court recommended a 10 yr moratorium on field trials of GMCs
2.BRAI Bill
3.Mutation breeding technology developed by BARC
4.Human cloning
5.‘Next Generation Sequencing’
6.Gene Therapy

1. TEC’s moratorium:
-The report criticizes the state of regulatory affairs with regard to modern biotechnology 
-Moratorium until there is more definitive information from sufficient number of studies as to the long-term safety of Bt in food crops
-no desperate shortage of food in India. It recommended that the release of GM crops for which India is a centre of origin or diversity as in Bt brinjal should not be allowed.
Why GMCs should be allowed?
1.GM crops are already widely used. Last yr, 12% of global crop area was grown with GE varieties of Soyabean, maize, cotton, rapeseed, sugarbeet
2.Over next 50 yrs, global demand for agricultural products may double. Agricultural supply needs to be doubled without straining the environment
3.Agriculture needs to be treated as a knowledge driven industry, not just a traditional vocation
4.India has become a cotton exporting country from cotton importing one because of Bt Cotton. Yields increased by 25%. Insecticide spray reduced by 50%
5.China has 6000 PhDs in agri-biotech alone. India has 8900 PhDs in all Sciences put together. No field trials->No claim substantiated. Too many hurdles for scientists: funding, activists, loss of trial crops, no publications, no products
Conclusion: GMCs should not be considered as a substitute for improved agronomy or other innovations. But a moratorium is not the answer. GMCs require sensible regulation.

Points against GMCs:
1.GMCs have both serious scientific unknowns and lack a clear social benefit, atleast for now
2.GM is a distraction from investing in real solutions by trying to overcome the environment by using genetics
3.Herbicide use is increasing in US since it adopted GM Maize, soybeans and cotton. Insecticide use is much high in US compared to France which does not use GMCs
4.Patent problems- Process patents make the crop very expensive
5.Undermines biodiversity
6.No validated surveillance to know the effect of GMCs on human health
Conclusion- GM is not a permanent solution. Use technology to better soil health, irrigation. Organic farming is a solution too.

2. BRAI BILL: Biotechnology Regulatory Authority Bill
Status: pending in Lok Sabha
Objective: to promote safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures. 
1. The Bill establishes the Biotechnology Regulatory Authority of India [Authority= chairperson, two full time members, and two part time members]
2. Functions of the Authority: regulating the research, transport, import, containment, environmental release, manufacture and use of organisms and products of modern biotechnology.  The Authority has the power to call for information, conduct an inquiry and issue directions for the safety of products or processes of modern biotechnology.
3.Authority’s permission will be required to conduct field trials for certain organisms or products 
4. The Bill will not apply to the clinical trials of drugs, under the Drugs and Cosmetics Act, 1940, and food or food additives or any material under the Food Safety and Standards Act, 2006.  
5. State level body: A State Biotechnology Regulatory Advisory Committee will act as a nodal agency between the state government and the Authority with regard to the regulation of modern biotechnology.
6.Appellate Tribunal: A Biotechnology Regulatory Appellate Tribunal will hear appeals against the decisions, orders or directions of the Authority.  Headed by retd judge of Supreme Court or retd Chief Justice of a High Court
7.Penalties under the Bill: The Bill imposes a penalty for providing false information and conducting an unapproved field trial

3. Mutation Breeding Technology by BARC
Background: Mutation in genes occurs in nature but it is too slow and random. Desired mutation can be generated using genetic manipulation. MBT is a method for this genetic engineering.
MBT started in 1973 with Trombay Groundnut (TG-1) which gave 15-20% higher yield than traditional varieties
BARC is now focusing on oilseeds and pulses as India imports 40% oilseeds and 20% pulses.

4. Human Cloning and IVF (3 parent)
Already discussed by Mrunal: http://mrunal.org/2013/09/science-tech-thehindu-june-july-aug-part-1-of-3-medical-research-healthcare-disease-opv-ipv-cloning-three-person-ivf-monocrotophos-mid-day-meal-deaths-pioglitazone.html#525

5.Next Generation Sequencing
NGS is a method to read whole genomes quickly and cheaply. Mainly chromosomes are looked upon to check for abnormality, diseases such as cancer, heart disease or Alzheimer’s
Why is it in news: A baby was born in US recently after the parents screened the genomes of embryos using NGS and chose the healthiest one for implantation. (First such baby!)
Advantages of NGS:
Pre implantation diagnosis will help so many parents who can’t have a child. It will diagnose possible diseases and prevent miscarriages. [80% of IVF embryos don’t implant or miscarry]
Disadvantages of NGS:
It’ll usher an era of Designer babies (to look for specific behavioural traits, cosmetic traits). Ethical issues!
6.Gene Therapy:
Using genetic engg to cure diseases and disabilities is called Gene therapy. Human gene therapy has been ongoing since 1990, but most of that involved non-heritable genes, called somatic (non-sex cell) gene therapy.
3 parent IVF (already discussed by Mrunal) is a type of germline modification.

Why Germline gene therapy should be allowed?
1.Better lives for many who are condemned to live with genetic diseases
2.It’ll be convergence of NBIC nanotechnology, biotechnology, information technology and cognitive science- to improve human performance. Welcomed by scientists.
Why Germline gene therapy should not be allowed?
1.Problem of designer babies (as in NGS)
2.A new class of underdogs- those who cannot afford gene therapy-would be created
3.Unforeseen, deleterious consequences: Until the child grows, it’ll be difficult to know the exact results.

Intellectual Property Rights(IP) – Are the really Intellectual ??

1) Introduction
2) Patent
3) Bio-Piracy
4) Breast Cancer (Mastec-tomy)/ Case of Hollywood Actress Angelina Jolie
5) Myrid Genetics
6) Case Myriad Genetics vs Association of Molecular Pathology
7) Novartis  vs Supreme Court of India (Land Mark Judgement by Supreme Court)
8) Bayer Cancer Drug
9) What is TRIPS


•Intellectual property rights are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.
•IP are divided into 2 main areas 

a)Industrial property, which includes inventions (patents), trademarks, industrial designs, and geographic indications of source;
b)and Copyright, which includes 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.  Rights related to copyright include those of performing artists in their performances, producers of phonograms in their recordings, and those of broadcasters in their radio and television programs

•It is an exclusive right granted for an invention, which is a product or a process that provides, in general a new way of doing something that offers a new technical solution to a problem.
•A patent provides protection for the invention to the owner of a patent which is granted for a limited of 20 years. Patent protection means that invention cannot be commercially, made, used, distributed or sold with the patent owner’s concern.

Gene Patent

•It is a patent on a specific isolated gene sequence, its chemical composition, the process for obtaining or using it or combination of such claims.
Geographical Indications
•A geographical indication is a sign used on goods that have a specific geographical origin and possess qualities, reputation or characteristics that are essentially attributable to that place of origin.
•Most commonly, a geographical indication includes the name of the place of origin of the goods. Agricultural products typically have qualities that derive from their place of production and are influenced by specific local factors, such as climate and soil. Whether a sign is recognized as a geographical indication is a matter of national law. 
•An appellation of origin is a special kind of geographical indication. It generally consists of a geographical name or a traditional designation used on products which have a specific quality or characteristics that are essentially due to the geographical environment in which they are produced.  The concept of a geographical indication encompasses appellations of origin.
E.g  Darjeeling Tea, Kullu Shawl of Himachal and Mysore Sandal Soap of Karnataka

•Bio-Piracy is the unauthorized use of the genetic resources & the knowledge associated with genetic resources held by the communities living  from Bio-diversity rich countries, which may be infringed upon illegally by industrial enterprises
•Bio-piracy is a part of a larger problem whereby developing countries rich in biodiversity, are exploited by transnational corporations and industries that make use of these resources.
•Bio-piracy, refers to the appropriation, generally by means of patents of legal rights over biological materials by international companies to develop food or medicines, without recompensing the countries from which they are taken

Breast Cancer

•Breast cancer is a type of cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk.
•Breast cancer occurs in humans (men also) and other mammals. A distinct sequence of nucleotide forming part of a chromosome is known as gene. Protein controls structure & function of all the cells that make up the body.
•The complete DNA instruction book or GNOME for humans contain 3 billion bases & about 20,000 genes on 23 pair of chromosomes. And abnormalities in the DNA or abnormal changes may provide wrong set of instructions leading to faulty cell growth and function.
•Most inherited( mostly from parents) cases of Breast cancer are associated with 2 abnormal genes BRC -A1 & BRC-A2 (BR=BREAST & C=CANCER)
•Function of BRC-A genes is to repair cell damage & keep the breast cells growing normally, but when these genes contain abnormality or mutation(The changing of the structure of a gene, resulting in a variant form that may be transmitted to subsequent generations) these genes do not function normally & breast cancer risk increases
Mastectomy ( Greek word: breast + removal )
•A mastectomy is surgery to remove a breast. It is performed either to treat or to prevent breast cancer. Only high-risk patients have surgery to prevent cancer. 
•There is a relationship between diet and breast cancer, including an increased risk with a high fat diet, alcohol intake, and obesity. Other risk factors include radiation and shift-work
There are four main types: (Not important)
•Total mastectomy - removal of breast tissue and nipple
•Modified radical mastectomy - removal of the breast, most of the lymph nodes under the arm and often the lining over the chest muscles
•Lumpectomy - surgery to remove the tumor and a small amount of normal tissue around it
•Radical mastectomy - the removal of the breast, lymph nodes and chest muscles. This is no longer common

Case of  Angelina Jolie

•Angelina Jolie drew headlines with her announcement that she has undergone a preventative double mastectomy. A blood test revealed that she carries a damaged BRCA1 gene -- a defect that greatly increases the odds of a woman getting breast cancer. 
•She had  an 87 percent chance of developing the disease, she decided to undergo a prophylactic double mastectomy, an operation that reduced her risk to 5 percent.
•The first issue is the test. The BRCA1 and BRCA2 tests, which may have saved Jolie's life, cost $3,000 to administer (Please note this – Its very costly not affordable by everyone.)

Myriad Genetics
•Myriad genetics is a molecular diagnostic company based in salt lake city in U.S.A
•Myriad was having exclusive licensing right in the U.S for breast cancer analysis & testing- this is a molecular diagnostic product used for analysis of BRC-A1 & BRC-A2 to evaluate a women’s risk of developing hereditary breast cancer. It helps women to determine if they have BRC-A1 & BRC-A2 gene mutations which will be helpful in determining the preventive & guiding therapy.
•Myriad genetics for its breast cancer risk assessment involving the genes BRC-A1 & BRC-A2 was charging significantly about $3000, those arguing against the patenting of the genes claimed that the high cost of the test was due to the monopoly over it by Myriad genetics, so a case was filed against Myriad genetics in the U.S  court

Case Myriad Genetics vs Association of Molecular Pathology

•The Association for Molecular Pathology along with several other medical associations, doctors and patients sued the United States Patent and Trademark Office (USPTO) and Myriad Genetics to challenge several patents related to human genetics. The patents cover the BRCA1 and BRCA2 genes and certain mutations that indicate a high risk of developing breast cancer.
•The suit also challenged several method patents covering diagnostic screening for the genes. They also argued that the patents limit scientific progress. Limits patents to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.
•By patenting the genes, Myriad had exclusive control over diagnostic testing and further scientific research for the BRCA genes. Myriad argued that once a gene is isolated, and therefore distinguishable from other genes, it could be patented.
•Holding: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but synthetic complementary DNA ("cDNA") is patent eligible because it is not naturally occurring.
•Judgment: Affirmed in part and reversed in part., 9-0, in an opinion by Justice Thomas on June 13, 2013. Justice Scalia filed an opinion concurring in part and concurring in the judgment.
•Because of these ruling patients will have greater access to genetic testing & scientists can engage in research on these genes without the fear of being sued.

Novartis  vs Supreme Court of India (Land Mark Judgement by Supreme Court)

•Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, ranking number two in sales (46.806 billion US$) among the world-wide industry in 2010.
•It had developed a ground breaking super expensive cancer drug called Gleevac( Novartis Had gained patent protection for this drug in some 40-odd countries) for which it wanted patent rights in India(patent rights are different for different countries)
•Case was filed and Supreme court of India rejected the application which was a landmark judgment
Reasons for Rejection
•Novartis failed to prove the drug was “patentable”, the drug under review did not demonstrate any “significant of efficacy”(capability to produce an effect) over available generics & its active ingredient was already known
•This is a pretty common method by Pharmaceutical companies to evergreen patent protection by making minor modifications to drugs approaching Patent expiry ( 20 years …. Hope u remember or getting bored??)
•And in this way for many American Pharmaceutical companies it is easy to make market in India (India is huge market. An average man spends around 70% of his income on medicines and health problems)
•Existence of Robust property rights are a key bench mark for development as they reflect institutional strength (via a judiciary)
•India has over 28 lakh cancer patients. Supreme Court judgment can make a way for cancer patients getting cheaper drugs as a 1-month dose of Gleevec costs around Rs 1.2 Lakh and the same generic drugs manufactured by Indian company for the same period is priced at Rs 8000.

Bayer Cancer Drug

•An Indian patent appeals Board upheld  a decision to allow a domestic company to sell a generic version of BAYER AG(German chemical and pharmaceutical company) cancer drug NEXAVAR, in blow for global drug makers efforts to hold on to monopolies on high price medicine.
•This ruling was again a landmark as it paves the way for the issue of more so called compulsory licenses as governments particularly in emerging markets such as China & Thailand, battle to bring down health care costs & provide access to affordable drugs to treat diseases such as cancer, HIV-AIDS.
•The Indian Patent Office(IPO) is administered by the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM). This is a subordinate office of the Indian Government and administers the Indian law of Patents, Designs and Trade Marks
•IPO allowed NATCO Premium Pharma (Indian Company) to sell the generic Nexavar at Rs 8800 or $160 for a month’s dose but for which Bayer was charging Rs 2,80000(only .. lolz)
•Bayer challenged it & the board did order NATCO Pharma to pay a royalty of 7% on sales of generic Nexaver to Bayer
India’s vision = Kidney & Liver cancer drug should be available at an affordable price to everybody

What is Trips?

•The Agreement on Trade Related Intellectual Property Rights (TRIPS) was negotiated with other international trade agreements during the Uruguay Round trade negotiations of the GATT (General Agreement on Tariffs and Trade) from 1986 to 1994.
•As one of the World Trade Organization (WTO) agreements, it is totally binding for all WTO Member States (whether a previous GATT Member or a new WTO one)
•Taking into account the transitional periods allowed to developing and least-developed countries by the TRIPS Agreement.
•The TRIPS Agreement sets minimum standards in the field of intellectual property (IP) protection (such as copyrights, patents, and trademarks) that all WTO Member countries have to respect.
•To achieve this goal, WTO Members have to modify their intellectual property laws to make them consistent with the new WTO standards.

•For instance, the TRIPS Agreement states that all patents shall be available for at least 20 years from the filing date, whereas before TRIPS the patent term varied greatly among countries (7, 10, 17 or 20 years). All WTO Members have to incorporate this 20-year patent term in their own patent law.

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