4.2 Legal Considerations in Biotechnology
Patents

the grant of a property right to the inventor, issued by the USPTO

  • Limited monopoly of 20 years
Requirements
Specific, substantial, and credible. 
1. Utility (usefulness)
2. Novelty (not disclosed to the public)
3. Non-obviousness (inventive over what is known to the public)
Biotechnology Patents
To protect your probe (ex. primer) design, you should patent the sequence, which means in effect that you're patenting the gene
Advantages
  • Encourages Research and Development
  • Public disclosure prevents wasteful duplication of effort
  • Research is forced into new, unexplored areas.
Disadvantages
  • Patenting a part of nature! - 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
Legal Issues
Should genes be patented?
Purpose
  • To exclude others from making, using, or selling the invention in the US or importing the invention into the US
  • Does NOT grant inventor right to make, use, sell or import. 
  • To increase the pool of public technical knowledge.
Gene Patents
The USPTO has issued patents for genes, gene fragments, SNPs, and gene tests
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 purpose
Supreme Court Case
In June 2013, the Supreme Court struck down the patents on genes. Particularly looking at BRCA genes. (breast cancer genes)
- the company that owned the genes charged very high licensing costs
-came up with a test using the Sanger Method that costs a LOT
- nobody else could even come up with creating another method without getting procesuted.
-Researchers couldn't see how it worked and stuff too. 
Repurcussions
Companies can now sell BRCA kits for a LOT less; people can now do research on the gene, people can look for different mutations, basically opens up research in this area. 
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