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Student Project: Patentability of Genes: AMP v. Myriad Genetics

This research guide will facilitate a legal analysis about whether genes should be patented by providing primary, secondary and other source materials.

Science

Science References

[1] Section ii "What is DNA", Handbook "Cells and DNA", Genetics Home Reference, National Library of Medicine, NIH.
[2] Section iv "What is a gene", Handbook "Cells and DNA", Genetics Home Reference, National Library of Medicine, NIH.
[3] Understanding Cancer Series, "Gene Testing" slide show, National Cancer Institute, NIH.
[4]  NCI Perspective, "The benefits of looking across many genomes", National Cancer Institute, NIH.

Landmark Case

 Association for Molecular Pathology v. Myriad Genetics, Inc. 

Holding: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but synthetic complementary DNA ("cDNA") is patent eligible because it is not naturally occurring.

Judgment: Affirmed in part and reversed in part, 9-0, in an opinion by Justice Thomas on June 13, 2013. Justice Scalia filed an opinion concurring in part and concurring in the judgment.

Video of Plaintiff's position in Myriad case

Amicus Curiae Briefs for Myriad case

Opposing views from two highly renowned scientists and a distinguished law professor.  See also the SCOTUSblog for numerous amicus curiae briefs from medical associations, legal associations and public advocacy groups.

Dr. James Watson, who along with Francis Crick, discovered the helical structure of DNA, has long supported that human genes should not be patented.  He left his position at NIH because the NIH supported gene patenting and Dr. Watson was publicly opposed.  This brief is a well-documented chronicle of the history of DNA research, including the Human Genome Project in which Dr. Watson was instrumental.  He reflects on the law as well as the science and fully supports that genes should not be patentable.

Dr. Ananda Chakrabarty is the inventor of a genetically-engineered bacteria designed to treat oil spills.  His invention was deemed patent-eligible in the case of Diamond v. Chakrabarty, 447 U.S. 303 (1980). Prior to this landmark decision, living organisms were considered patent-ineligible.  Dr. Chakrabarty has a keen interest in patent law and has written articles discussing the application of 35 U.S.C. Section 101 to patenting human genes.

Professor Eileen Kane is a registered attorney before the PTO, a professor of Intellectual Property and Patent Law and has a PhD in molecular biology.  Her work is focused on patent law and life sciences, particularly in the field of genetics.  Her position is that genes should not be patentable.

Selections from ScotusBlog