Regulations in Biotechnology

Question 1

What are HeLa cells?

Answer 1

HeLa cells are a line of cells derived from Henrietta Lacks that can survive and reproduce in the lab, used for various medical research.

Named after Henrietta Lacks, these cells have contributed significantly to biomedical research.

Question 2

What are some applications of HeLa cells?

Answer 2

HeLa cells have been used to study:
* Effects of toxins
* Drugs
* Hormones
* Viruses
* Radiation effects
* Vaccine development

They were crucial in developing the polio vaccine and more recently, the COVID-19 vaccine.

Question 3

What barriers exist in commercializing biotechnology?

Answer 3

Barriers include:
* Lack of appropriate technology
* Limited infrastructure
* Intellectual property rights issues
* Biosafety concerns
* Market mechanisms
* Local politics
* Poverty and disparities

These factors can hinder the growth and accessibility of biotech innovations.

Question 4

What does Intellectual Property Rights (IPR) protect?

Answer 4

IPR protects inventors from unfair use of their inventions by others.

Question 5

What can be patented?

Answer 5

Items that can be patented include:
* Composition of matter (compounds)
* Processes or procedures
* Machines
* Improvements of any of these categories

Must be new, inventive, useful, and have industrial capability.

Question 6

What items cannot be patented?

Answer 6

Items that cannot be patented include:
* Artistic creations
* Mathematical models
* Business schemes

These are generally considered non-patentable subject matter.

Question 7

What was the significance of the Diamond vs. Chakrabarty case?

Answer 7

This Supreme Court case established that genetically modified organisms could be patented.

Question 8

What is the controversy surrounding the patenting of human genes?

Answer 8

Patenting human genes can hinder vital research and access to genetic testing, as seen with Myriad Genetics’ patent on BRCA1.

This controversy raises ethical questions about ownership of genetic material.

Question 9

Fill in the blank: The exclusive right granted for an invention of a product or process is known as a _______.

Answer 9

[patent]

Question 10

Examples of Intellectual Property Rights

Answer 10

1. Copyright (artistic stuff)
2. Confidential Information (the “know how”. ex. trade secrets)
3. Breeders Right (creations such as plant varieties by ex. scientists)
4. Trademarks (logos)
5. Patents

Question 11

Application Process for a Patent

Answer 11

• Filling Fee
• Search and Examination
• Publication
• Maintanence Fee

Slide 13