Pune University BE Biotechnology IPR Bioethics and Regulations
B.E. (Biotechnology) IPR, BIOETHICS AND REGULATIONS (2008 PatternIP)
(Elective – IV) (Sem. -II)
Time :3 Hours] [Max. Marks :100
Instructions to the candidates:-
1) From section I answer Q.I or Q.2, Q.3 or Q.4, Q.5 or Q.6 and from section II answer Q.7 or Q.8, Q.9 or Q.IO, Q.II or Q.12.
2) Answers to the two sections should be written in separate answer books.
3) Neat diagrams should be drawn wherever necessary.
SECTION – I
Q1 What is ICMR code? What does it consist of? Explain in short about 12 principles laid down under statement on general principles? 
Q2) What are ethics and how do they relate to business conduct? What is a code of ethics? What are the essential elements of a code of ethics? What is the difference between ethics and compliance? 
Q3) Read carefully following case and answer the questions. 
Confirmed fish kills in North Carolina were observed in 1994 in the Pamlico and Neuse Estuaries. Fish losses were reported to be in the millions. Reports of dead fish found floating in North Carolina tidal waters caused a great deal of concern. In the summer of 1997, thousands of fish were killed in the Pocomoke River on Maryland’s Eastern Shore. Consequently, the public was banned from a five-mile stretch of the scenic waterway. Local watermen had begun reporting gaping red sores on fish almost a year previously but the fish kills and public ban brought this issue to national attention.
Research has shown that Pfiesteria piscicida, a single-cell microorganism, is responsible for the fish kills in North Carolina, and is suspected to be the cause of fish kills in Maryland as well. Pfiesteria piscicida has a complex life cycle that may include 24 flagellated, amoeboid, and encysted stages or forms. Pfiesteria may live for years in tiny, cyst-like shells buried in river bottom sediment, then hatch when conditions are right. Conditions supporting and/or encouraging Pfiesteria are a combination of warm water temperatures (70F); increased levels of phosphorous, ammonium, and suspended solids;
moderate to low salinity levels; and increased rainfall or runoff. When large numbers of fish swim into an area where Pfiesteria are present their excreta triggers encysted cells to emerge and become toxic. Other stages of Pfiesteria can also become toxic in the presence of fish excreta (amoeboid and flagellated cells). The small cells swim toward the fish prey and give off potent toxins which make the fish lethargic and often cause bleeding sores and hemorrhaging. Once fish are “incapacitated, Pfiesteria feeds on the sloughed epidermal tissue, blood, and other substances that leak from the sores. When the fish are dead, flagellataed stages transform to amoeboid stages and feed on the fish remains or, if conditions become unfavorable for the Pfiesteria, the Pfiesteria cells make protective outer coverings and sink to the bottom of the river as dormant cyst stages. All of these changes can take place in a matter of hours.
Pfiesteria outbreaks in North Carolina were shown to occur in waters that were heavily nutrient enriched. Possible sources of nutrients flowing into the water include sewage treatment plants, fertilizer runoff, chicken and hog manure, phosphate mines, and municipal wastewater treatment plants where effluents are rich in phosphorus and nitrogen.
The primary contributor to the problem in North Carolina, however, seems to be the state’s large confinement hog-farming operations. After the outbreak in Maryland, a leading environmental group called for reforms in the handling of manure from the Eastern Shore’s millions of chickens. Chicken waste is often applied to fields as fertilizer. Rain washes the nitrogen and other nutrients in the manure into the surrounding waters. The Pocomoke River, at its headwaters, drains the largest chicken-producing country in the nation. Maryland’s Delmarva Peninsula houses some 625 million chickens. Governor Glendening of Maryland has announced that farmers may soon be subject to regulations on animal waste disposal.
Maryland’s top farm official has been quoted as saying that poultry farmers have been responsible in their handling of chicken waste. A spokesman for the poultry industry rejects the suggestion that chicken manure is responsible for the Pfiesteria outbreak, saying bird waste is well-managed. Farming advocates also note that if regulatory measures target only one possible source, the regulations might unfairly cause producers to go out of business. Farmers work on small profit margins under current management practices.
- Do you think that news reports, researchers, and politicians unfairly blame farmers without looking at other possible causes?
- If large poultry or hog operations are shown to be the primary cause of the Pfiesteria outbreaks, should the producers be required to get rid of
these animals? or reduce them to a certain number that will produce less waste?
3. The chicken industry spokesman said that “bird waste is well-managed”, implying that there is no cause for concern. Do you believe this statement? Can you think of. assurances from another industry that were later proven false? How much of the public perception is formed by what we read and see and how much is formed by previous experiences?
Should large, corporate, farms be allowed only in less populated states? Does a land owner have the right to use their land as they wish?
Q4) Read the following case and answer the questions on the basis of ethics.
Genaro Moura (GM) and Oswaldo Fernandes (OF) are farmers who grow their crops in neighbouring fields. GM has planted a non-sweet forage maize that is genetically engineered to contain high levels of essential amino acids. He has followed all regulations but has not informed anyone that he is planting transgenic plants. This is because he is afraid that the environmental organization “Maize Liberation Front” will destroy his plantation and organize a campaign against him.
His neighbour OF, is opposed to genetic modification and uses only organic methods of agriculture. He is under a strict contract to sell his crop of sweet corn to the Gerber Baby Food Company. His crop must be certified as organic (under current regulations, organic food must be free of any transgenic material).
GM has noticed that lately, some of the corn kernels of his own crop that he has eaten, are sweet. He suspects that some of the pollen from OF’s field has drifted into his field and has pollinated his plants.
This does not affect the value of his crop. But he realises that pollen from his genetically modified plants may have also drifted into his neighbour’s field. GM realises that if foreign genes have been transfered to OF’s maize, the entire organic crop will be rejected by the Gerber Baby Food Company.
GM decides NOT to inform OF that his crop may be contaminated with foreign genes.
1. Has GM made the right decision?
2 What do you think OF should do? Justify your position.
- Did OF make the right decision? Justify your answer.
- Did OF do the right thing? Justify your answer.
Q5) What is a patent? Explain the conditions to be satisfied by an invention to be patentable? What are the essential patent documents to be generated and submitted by a potential patentee? Explain in detail about patent cooperation treaty (PCT). 
Q6) Describe the following in detail. 
a) Patenting in biotechnology
b) patent search
SECTION – II
Q7) What does copyright cover? What are the rights of a copyright holder? What is the term of a copyright? What is the rule for the transfer of copyright?
Q8) What is mean by trademark? What are well known trademarks and associated trademarks? How are terms certification trademarks and collective marks defined in the act? What is the term of a registered trademark? 
Q9) Depict the hierarchal structure in Indian biotechnology and explain the functions of each one in short. 
Qi 0) What is GMP? What are its advantages? Explain it in detail related to anyone biotech product to ensure successful marketing applications 
Qll) Write in detail about :
Define quality assurance and quality control. What is the difference between QA and QC? Explain in detail about the steps involved in QC of any one biotech product. 
Q12) What is international trade? Why there is need for international trade? What are the principal objectives of the Indian international trade?