1. Gene Patenting Connecticut Invention Convention
Gene Patenting
Connecticut Invention Convention

2. What is DNA? A naturally occurring molecule found in all living things
Found in the nucleus of all human cells
DNA

3. What is a gene?
Types of Mutations
Each small sequence of DNA codes for a specific trait. For example, eye or hair color. These are called genes.
Some traits are coded for by multiple genes or sequences.
Some genes or sequences code for more than one trait.
If we change the sequence in the gene, we can change the trait. This is called a mutation.
A normal sequence
Substitution
Addition
Deletion

4. What is a patent? A reminder:
A patent keeps other people from making or selling your invention without your permission.
The U.S. Patent and Trademark Office defines it as the following:
“A patent is an intellectual property right granted by the Government of the United States of America to an inventor ‘to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States’ for a limited time in exchange for public disclosure of the invention when the patent is granted” (U.S. PTO, 2015).
Types of patents: utility patents, design patents, plant patents

5. The Situation
Myriad Genetics is a company that was started in 1994 by researchers who attempted to understand the genetics of breast cancer. Were there genes that, when mutated, helped to cause breast cancer?
Two genes, BRCA1 and BRCA2, were discovered by Myriad filed a patent for the gene itself and a diagnostic test that women could take to figure out whether they had mutated copies of the genes.
The patent allows Myriad to be the only company to offer these diagnostic tests.
The question: is DNA patentable? If so, under what conditions?

6. The Task
One group will develop an argument defending Myriad Genetics, Inc. The other group will develop an argument for the prosecution: the Association for Molecular Pathology, the University of Pennsylvania, the American Civil Liberties Union (ACLU), and the Public Patent Foundation.
Together, write a three-page double-spaced essay detailing three reasons for your overall argument. Cite your sources and be specific in your reasoning.

7. The Task
You will then be asked to engage in a class-wide debate, which will be structured as follows:
6 minutes – Association for Molecular Pathology, Initial Prosecution
6 minutes – Myriad Genetics, Inc., Initial Defense
3 minutes – Association for Molecular Pathology, Rebuttal 1
3 minutes – Myriad Genetics, Inc., Rebuttal 1
3 minutes – Association for Molecular Pathology, Rebuttal 2
3 minutes – Myriad Genetics, Inc., Rebuttal 2
1 minute – Association for Molecular Pathology, Closing Argument
1 minute – Myriad Genetics, Inc., Closing Argument

8. Keep in Mind
At the time of Myriad applying for its BRCA1 and BRCA2 patents, it is estimated that there were about 2000 isolated gene patents.
The Human Genome Project allowed for the discovery of the entire DNA sequence. The project ended in about 2003.
Since then, the practice of gene patenting has decreased.
U.S. Patents last for 20 years. Myriad’s patents, filed in 1994, would have expired in 2014.
Myriad was only able to spend a lot of money to research and develop the BRCA tests because of their patents, which virtually guaranteed that they would be able to make their money back.

9. Association for Molecular Pathology v. Myriad Genetics, Inc.
Naturally occurring molecules (DNA sequences) cannot be patented
Natural phenomenon, or law of nature, even if it is separated from the body
Artificially created DNA can be patented
If Myriad had created a synthetic form of the genes, they would be eligible for a patent.
The Supreme Court ruled in favor of the Association for Molecular Pathology.