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Principles of Plant Genetics and Breeding

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280 CHAPTER 15<br />

Part B<br />

Please answer the following questions:<br />

1 What is a patent?<br />

2 What is the importance <strong>of</strong> intellectual property rights in biotechnology?<br />

3 Not all inventions are patentable. Explain.<br />

4 What is a utility patent?<br />

5 Patents are not always the best protection <strong>of</strong> an invention against illegal use. Explain.<br />

6 A patent is not a “positive right”. Explain.<br />

7 Give two specific public concerns about the development <strong>and</strong> application <strong>of</strong> biotechnology.<br />

8 What agencies oversee the regulation <strong>of</strong> biotechnology in the USA?<br />

9 Describe how the FDA regulates products.<br />

10 How is regulation <strong>of</strong> biotechnology in the USA different from what obtains in the EU?<br />

11 What are the pros <strong>and</strong> cons <strong>of</strong> labeling for the biotechnology industry?<br />

12 Give four common sources <strong>of</strong> allergens. Discuss the importance <strong>of</strong> allergenicity in risk assessment.<br />

Part C<br />

Please write a brief essay on each <strong>of</strong> the following topics:<br />

1 Discuss the concept <strong>of</strong> “freedom <strong>of</strong> use” in patent law.<br />

2 List <strong>and</strong> discuss the basic steps in applying for a patent.<br />

3 Distinguish between ethics, morals, <strong>and</strong> values.<br />

4 In terms <strong>of</strong> ethics, what is your opinion about the development <strong>and</strong> application <strong>of</strong> biotechnology?<br />

5 What role should the public play in the way the biotechnology industry operates?<br />

6 Discuss the concept <strong>of</strong> substantial equivalence in risk assessment.<br />

7 Discuss the precautionary rule <strong>and</strong> is application in risk regulation.<br />

8 The public must view the regulating agencies <strong>of</strong> biotechnology as trustworthy. Explain why this is necessary.<br />

9 List <strong>and</strong> discuss two common misconceptions about biotechnology.<br />

10 No technology is without potential for adverse impacts. Explain.

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