1. PTT104 Patents and Ethical Issues Department of Chemical Engineering Technology, UniMAP khadijahhanim@unimap.edu.my

2. Introduction to Patents  A patent gives an inventor or researcher exclusive rights to a product and prohibits others from making, using, or selling the product for a certain number of years.  To win a patent, a discovery must meet 3 basic requirements: -It must be novel -Must be nonobvious -Must have some utility.  For biotechnology industry, strong patents mean strong businesses.  Patents are the primary asset by which a successful biotechnology company will be valued during all stages of its development.

3. Introduction to patents  For eg: a team of researchers discover a vaccine against a deadly virus.  Without a patent, no pharmaceutical company would go forward with the daunting tasks of conducting costly clinical trials, obtaining approval and developing a comprehensive marketing plan.  Without patent protection, a rival company could buy the drug off shelf, duplicate it and sell it at discount rate without spending a cent on research.  Patents are normally enforced for up to 20 years from the date of filing. That means other companies can market their own version of the product after the original developers have had exclusive rights for 2 decades.  This plan both encourages new discoveries and prevents long- term monopolies.

4. ETHICS

5. What is ethics??  Ethics are the rules or standards that govern the way people behave and their decisions on the 'right' thing to do.  Ethics are practiced by everyone, every day.  The general principles of ethics are;  respect for life, and  need for a balance between benefit and harm/risk

6. Ethics  Fundamental question that should be ask when dealing with bioethics:  “Should this be done??” instead of “Can this be done??”  And if something should be done, the question becomes “How can it be done in the right way??”

7. Importance of ethics  Ethics is the attempt to help us how we behave when our actions affect other people.  Ethics is important because doing the right thing is important.  It affects how others feel about us and how we feel about ourselves. In addition, there’s good reason to think that there are competitive advantages in being able to position as a responsible company with integrity.

8. Biotechnology and nature  At the early stage of genetic engineering applications (in 1970s), public were very concern about the potential risk & issues related to ethics as the result of application of biotechnology  One primary concern was that genetically engineered bacteria would escape from the lab into the environment, possibly creating new diseases, spreading old diseases in a more virulent manner or creating an imbalance ecosystem that might lead to decimation of some species.  In the end, scientists determined that recombinant DNA technology could be controlled in a way that would preserve safety for humans and for the environment.

9. Ethical issues: GM Crops  The biggest controversy in biotechnology: genetically modified (GM) organisms/ GM crops.  The aim: to produce plants that can resist pests, disease or harsh climates allowing better production.  GM crops present several areas of concern: 1.Involve the plant itself -Need to determine if the alterations provide a benefit to the plant or do not produce less vigorous plants. -The integrity of the species is preserved along with alteration (species integrity- maintaining the original genetic composition of a species without major change). -You should ask yourself whether species integrity is important or whether creating a better species is more desirable? -In doing so, determine whether genetic modification of organisms violates any ethical codes.

10. Ethical issues: GM Crops 2. Possible effects of altered plants on the ecosystem and overall biodiversity. -Need to determine the effect of introducing GM plants on local environment. -The desired effects would be increased growth and production but also effect on potential pests and diseases. -For eg: GM crop that is engineered to produce a toxin from Bt that kills corn borer larvae and other insect pests. -One question: whether the toxin could be spread or was confined solely to the corn plant. -Corn is wind pollinated, the pollen might be carried to other plants and be toxic to some insects at a distance. -In recent years, several long-term studies have shown no adverse effects of insect exposure to Bt crops.

11. Ethical issues: GM Crops 3. Need to consider how will it be used, whether it is safe to feed animals/human? -Since the toxin is directed against insects, it seems unlikely it would affect animals/humans. -But making assumption is not enough. Need evidence and tests. -Not only particular gene that is inserted but also other genes/products present in GM crops. For eg antibiotic- resistance genes that are used as selectable markers. -Are these genes still present and can it be transferred to the gut bacteria after ingestion? -Or can it trigger allergic reactions?

12. Ethical issues: GM Crops 4. Besides environmental and health concerns, social and economic questions also arise from the potential use of GM crops. -Ability to modify plants for better, less costly production could change the agriculture industry. -More abundant food could be available at a reduced cost both to farmers and consumers.

13. Ethical issues on stem cell research  Debates on stem cell and cloning- revolve around moral status of the human embryo.  Stem cells have potential in regenerative medicine- allowing repair or replacement of damaged and diseased tissue in many diseases such as heart disease, stroke, Parkinson disease.  Possible sources of stem cell: embryos, fetuses, umbillical cord blood, adult tissues.  Ethical issues: whether it is ethical to destroy early-stage of human embryos for research that may be potentially treat thousands of patients.  The process of harvesting the embryonic stem cells destroys the donor.

15. Ethical issues on stem cell research  Analyzing the issue: -Biologically, the embryo is a member of the human species, starting out on the developmental journey. -There various views of the status of human embryo. -Some think that the embryo is microscopic, not yet possessing a beating heart, brainwaves, arms, legs, therefore they are not a person yet. The embryos are just a clump of cells. -Others believe it is a form of human life deserving of profound respect- a potential person. Deserve the same moral value as any other human species.

16. Ethical issues on stem cell research  Some evidence points to the potential application of embryo research and embryonic stem cells in the treatment of numerous diseases.  Theoretically, embryonic stem cells can form any tissue with the potential to replace any damaged tissues.  This might suggest that it is ethical to destroy human embryos for research.  Currently, there are also evidence that the adult stem cells may be just effective for treating diseases as embryonic stem cells.