Tania Simoncelli is Senior Advisor to the Director of the Broad Institute of MIT and Harvard. Prior to that position, she worked for two years as Assistant Director for Forensic Science and Biomedical Innovation within the White House Office of Science and Technology Policy. From 2010–2013, she worked in the Food and Drug Administration Office of the Commissioner. From 2003–2010, Simoncelli worked as the Science Advisor to the American Civil Liberties Union (ACLU), where she advised the organization on emerging developments in science and technology that pose challenges for civil liberties.
In December 2013, Simoncelli was named by the journal Nature as one of "ten people who mattered this year" for her work in spearheading the development of the ACLU's successful legal challenge to the patenting of human genes.
Simoncelli has spoken, written, and advised on a number of contemporary science policy issues, including personalized medicine, gene patenting, forensic DNA data banks, pesticide testing in humans, and academic freedom. She is co-author with Sheldon Krimsky of Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties (Columbia University Press: 2010).
From 1982 to 2013, the US Patent and Trademark Office (USPTO) accepted patents on isolated DNA sequences as a composition of matter. Simoncelli has stated that this became a "significant barrier to biomedical discovery and innovation." From 2005 to 2009, Simoncelli, as the American Civil Liberties Union's science advisor, worked with ACLU lawyer Chris Hansen to file a case against Salt Lake City-based Myriad Genetics. Myriad Genetics held a complete monopoly on BRCA testing in the United States as Myriad had held the patents on the gene associated with increased risk for breast cancer, the (BRCA1) gene, since 1995 and on the BRCA2 gene since 1998. The company charged $3000 a test and, in Simoncelli's words, "refused to update its test to include additional mutations that had been identified by a team of researchers in France." The lead plaintiff of 20 plaintiffs represented by Hansen in the ACLU-sponsored lawsuit was the Association for Molecular Pathology (AMP). In March 2010, the Southern District Court of New York Judge Robert Sweet ruled in favor of the AMP that all the challenged claims were not patent eligible. Myriad appealed this decision, and the case went before the United States Court of Appeals for the Federal Circuit, which, although affirming part of the district court's ruling, also partly overturned it, ruling instead that isolated DNA sequences are patent eligible. Ultimately, the case went before the Supreme Court, which, in a unanimous decision on June 13, 2013, invalidated Myriad's claims to isolated genes in Association for Molecular Pathology v. Myriad Genetics, ruling that merely isolating genes that are found in nature does not make them patentable.
- "Tania Simoncelli". Harvard University. Retrieved July 2, 2017.
- The White House, OSTP Leadership and Staff
- The White House Blog
- Ten people who mattered this year, Nature, 18 December 2013
- U.S. Food and Drug Administration, Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development, October 2013 (Prepared by T. Simoncelli).
- Park, S. and Simoncelli, T. (Fall 2012), Making the Case Against Gene Patents, 9 (2), The SciTech Lawyer
- Andrew Ma (September 24, 2013), "HLS Panel Discusses Gene Patents", The Harvard Crimson,
- Alvin Powell (November 14, 2013), Genes Without Patents, The Harvard Gazette
- Simoncelli, T. and S. Krimsky, “A New Era of DNA Collections: At What Cost to Civil Liberties?” American Constitution Society for Law and Policy, August 2007.
- Simoncelli, T., “Dangerous Excursions: The Case Against Expanding Forensic DNA Databases to Innocent Persons,” Journal of Law, Medicine & Ethics, Vol. 34, No. 2 (Summer) 2006, pp. 390-397.
- Krimsky, S. and T. Simoncelli, “Testing Pesticides in Humans: Of Mice and Men Divided by Ten,” JAMA, Vol. 297, No. 21 (June 6) 2007: pp. 2405-2407.
- Simoncelli, Tania, and Jay Stanley. Science Under Siege: The Bush Administration's Assault on Academic Freedom and Scientific Inquiry. New York, NY: American Civil Liberties Union, 2005.
- Tania Simoncelli (November 2014), Should you be able to patent a human gene?, Ted Talks, retrieved December 31, 2016
- Schwartz, John; Pollack, Andrew (March 29, 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved March 29, 2010.
- "ACLU Challenges Patents On Breast Cancer Genes: BRCA". American Civil Liberties Union. June 26, 2012. Retrieved 2012-06-28.
- Association for Molecular Pathology v. Myriad Genetics (12-398 569), United States Supreme Court (USSC), June 13, 2013