Sandra Park, ACLU Women’s Rights Project, spark@aclu.org

Tarrytown Meeting, July 2012 – Genetic Information: Rights and Responsibilities

Gene Patenting

The U.S. Patent & Trademark Office has issued patents on human genes for more than 20 years. In 2009, twenty plaintiffs represented by the ACLU and PUBPAT filed a lawsuit challenging patents on two genes correlated to hereditary breast and ovarian cancer, BRCA1 and BRCA2. The plaintiffs argue that these patents are invalid because they claim laws and products of nature and impede, rather than advance, scientific inquiry and medical advancement. The lawsuit is now before the U.S. Court of Appeals for the Federal Circuit for the second time, after the Supreme Court ordered re-consideration in light of its recent decision invalidating a medical method patent.

The government’s practice of granting monopolies on genetic information through patents on “isolated DNA” and closely related method claims, and the ways patent holders’ exercise their rights, have serious consequences for the development of genetic research and clinical practice.

Notes for initial presentation:

· Update on Mayo v. Prometheus and gene patents litigation, Association for Molecular Pathology v. USPTO [also known as Myriad Genetics case]

· Gene patents’ role in creating monopolies on particular genetic information

· Gene patents’ role in shaping research agendas

· Gene patents’ role in limiting genetic testing and testing providers and shaping the provision of genetic testing

· Policy directions; partnerships and collaborations

Possible readings:

· Briefs and opinions in the Myriad case are available at www.aclu.org/brca

· Mildred Cho, Patently Unpatentable: implications of the Myriad court decision on genetic diagnostics (2010): http://cirge.stanford.edu/documents/Patently%20unpatentable.pdf

· HHS Secretary Advisory Committee on Genetics, Health & Society gene patents report (2010):

http://oba.od.nih.gov/oba/sacghs/reports/SACGHS_patents_report_2010.pdf

· Lori Andrews, "Genes and Patent Policy: Rethinking Intellectual Property Rights," 3 Nature

Reviews Genetics 803-808 (October 2002