4.1 Ethical and Legal Considerations in Biotechnology
4.1 Ethical and Legal Considerations in Biotechnology
Key ELSE Issues
Understanding issues associated with your technologies
Code of Ethics for Engineers
Safety and Trust
Patents
Why patents are important, who is involved in the patent review process (engineers, lawyers, USPTO) Should genes and genomic info be patentable?
Requirements for Granting Patents
1. Utility (usefulness) 2. Novelty (not disclosed to the public) 3. Non-Obviousness (inventive over what is known to the public
Biotechnology Patents
Can you own a gene? To protect your probe (ex. a primer) design, you should patent the sequence, which means n effect that you are patenting the gene
Advantages
Nobody will invest in R&D required to bring the discovery to practical use without exclusive rights (encourageing people to R&D)
Public disclosure prevents wasteful duplication of effort
Research is forced into new, unexplored areas
Disadvantages
Patent holders are being allowed to patent a part of nature - a basic constituent of life
Private companies who own certain patents can monopolize certain gene test markets
"Patent stacking" may discourage product development because of high royalty costs owed to patent owners of the sequence
Current Legal Issues with Owning a Gene Patent
Description
ELSE
Economic - What is the cost of the new technology? Benefit? Legal - Who owns the genetic info? Should genes be patented? Societal - What is the psychological impact and social stigma due to genetic differences? Ethical - Who has access to genetic info?
Ethical Decision-Making
It is important to know how to make ethical decisions: -safety/welfare/trust of public -trust between colleagues -development of skill and habit to think rationally and objectively about ethical issues -focus on teaching a rational approach to a decision
Individuals, institutions, or organizations with vested interest in the project/outcome
Purpose
-Delineate how to promote the public good -Provide guidance and support for responsible engineering practice -Establish shared minimum standards of conduct
Types
Description
NSPE Code of Ethics
Description
AMA Code of Medical Ethics
Guidelines for Biomedical Research included
CoE Honor Code
Preparation for the codes in the real world. The national engineer and medical codes
Limitations
General Wording (hard to interpret)
Proliferation of Codes - many specific professional societies have their own codes.
Codes can be flawed
Conflict of Interest - Can professional societies create ethical standards for themselves?
What is a Patent?
the grant of a property right to the inventor, issues by the USPTO
prevents others from making, using, or selling the invention in the US or importing the invention to the US
Does NOT grant inventor right to make, use, sell, or import
US Patents are effective ONLY within the US, US territories, and US possessions
Why issue patents?
To increase the pool of scientific knowledge; inventors don't want other peoples to copy what they are working on. To protect intellectual property and prevent other people from stealing your idea.
Exchange
Gov't gives protection for 20 years, individuals disclose their scientific knowledge
Requirements
The USPTO has issues patents for genes. Requirements: - Identify novel genetic sequences -Specify the sequence's product -Specify how the product functions -Enable one skilled in biotechnology to use the sequence for its stated purpose