BRCA Genes Decision Not Final Ruling

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By: Judith Westman, M.D.
Professor, Clinical Internal Medicine
Clinical Director, Division of Human Genetics

On March 29, a U.S. district court judge issued a decision which invalidated patents (New York Time article) held by Myriad Genetics and the University of Utah Research Foundation on the BRCA1 and BRCA2 genes, the two genes responsible for strongly inherited forms of breast and ovarian cancers.  The judge ruled that the patents were improperly granted because genes are a natural product.

The group which brought the lawsuit included patients, the American College of Medical Genetics, the American Civil Liberties Union, the American Society for Clinical Pathology, and other groups.  While arguments were made by the defendants that negating patents on genes would have a tremendous impact on the development of new biotechnologies, the plaintiffs argued successfully that Myriad’s monopoly on the test kept prices high and prevented other laboratories from making improvements in the testing process for the BRCA genes. 

Scientists are able now to sequence the entire genetic code of an individual, or at the very least, sequence the portions of the code which are most involved in the structure and function of humans (the exome).  If individuals and companies are able to patent sections of the genetic code and prohibit its use or dissemination by others, you might be able to have your exome sequenced but the report would be redacted with large areas blacked out because of patents.  Such gaps would significantly impede our ability to interpret how changes in different genes interact with each other and cause the variety of diseases and traits we see in individuals. 

This controversy pits two basic U.S. philosophies – capitalism vs the ability to know yourself at a fundamental and molecular level. 

If you were part of the appeals court, and this case will most certainly be appealed, which way would you rule?

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One response to “BRCA Genes Decision Not Final Ruling

  1. We can just hope that the monopoly on the BRCA gene patent is overturned soon.

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