Fifth Annual Health Law and Policy Institute at American University, Washington
College of Law. Schedule for one credit course, Introduction to Genetics and the Law.
Instructor: Gail Javitt, Counsel, Sidley Austin, LLP and Research Scholar, Berman
Institute of Bioethics, Johns Hopkins University.
Day 1: Wednesday, June 27, 2012
9:00-9:15: Welcome and introductions/Course Overview
9:15-10:15: Genetics 101
10:15-10:35: Break
10:35-12:00: Legal Issues in Genetic Testing: Reproductive and Other Contexts
12:00-1:20: Lunch
1:20-3:00 Genetics and the Family
3:00-3:20 Break
3:20-5:00 Genetic Privacy/Genetic Discrimination
Day 2: Thursday, June 27, 2012
9:00-10:30 FDA Regulation of Genetic Technologies
10:30-10:50 Break
10:45-12:00 FDA Regulation of Genetic Technologies (cont’d)
12:00-1:20 Lunch
1:20-2:30 Whose Genome is It Anyway: Patenting, Ownership, and Control
2:30-2:50 Break
2:50-5:00 Whose Genome is It Anyway: Patenting, Ownership, and Control (cont’d)
Day 1 course materials (to be watched/read prior to day 1)
[Recommended but not required: Rent GATTACA if you have not already seen it]
Genes and Health (video)
http://www.dnapolicy.org/video/gnh/index.htm
Genes and Environment (video)
http://www.dnapolicy.org/video/gne/index.htm
Frequently Asked Questions About Genetic Testing
http://www.genome.gov/19516567
William Saletan, Fetal Flaw: The abortion politics of new prenatal tests. Slate, June 1,
2012.
http://www.slate.com/articles/health_and_science/human_nature/2012/06/non_invasive_
prenatal_testing_will_abortion_politics_impose_new_restrictions_on_fetal_diagnosis_.ht
ml
Crockin et al, Genetics Tests are Testing the Law, Trial (2006)
https://jscholarship.library.jhu.edu/bitstream/handle/1774.2/980/Trial10-1606.pdf?sequence=1
Spoto, M. Appeal court rules N.J. woman must adopt baby born through artificial
insemination of a surrogate (Mar. 18, 2011), available at
http://www.northjersey.com/news/Appeals_court_rules_NJ_woman_must_adopt_baby_b
orn_through_artificial_insemination_of_a_surrogate.html
Javitt G. (2008) Sometimes I feel like a motherless child: Maryland’s high court
confronts new reproductive realities. Maryland Bar Journal XLI: 40-45.
javit%20edited%20
article[2].pdf
Hudson, K., Holohan, M.K., Collis, F.S. Keeping Pace with the Times – The Genetic
Information Nondiscrimination Act of 2008, N. Eng. J. Med 2008: 358:2661-2663,
http://www.nejm.org/doi/full/10.1056/NEJMp0803964
Jessica L. Roberts, The Genetic Information Nondiscrimination Act as an
Antidiscrimination Law, 86 Notre Dame L. Rev 597 (2011).
86_Notre_Dame_L._
Rev._597,_[1].rtf
Day 2 Course Materials (to be read prior to day 2)
Javitt, G. 2007. In Search of a Coherent Framework: Options for FDA Oversight of
Genetic Tests. Food and Drug Law Journal 62: 617-652
http://www.dnapolicy.org/resources/Javitt_FDLJ.pdf
Jeffrey N. Gibbs, Personalized Medicine: Panacea or Pipedream? FDLI Update 2008,
http://www.hpm.com/pdf/GIBBSPMEDICINE.PDF
Javitt, G. Which Way for Genetic Test Regulation? Science 466: 816-818 (2010)
http://www.nature.com/scitable/content/ne0000/ne0000/ne0000/ne0000/14053835/46681
6a.pdf#toolbar=0
Javitt_final_revised.
pdf
Federal District Court Rules That Isolated Human DNA Is Not Patentable Subject
Matter (April 2, 2010), http://www.sidley.com/files/News/3f4bc07a-0281-4e24-8870165355a01acd/Presentation/NewsAttachment/2191ce2d-ecc4-472f-a85e1a7688f14727/GLS_IP_Update_04%2002%2010.pdf
Supreme Court Holds that Method of Correlating Blood Level of Metabolites to Drug
Dosage Adjustment is Not Patentable Subject Matter (March 21, 2012),
http://www.sidley.com/sidleyupdates/Detail.aspx?news=5136
Moore v. Regents of University of California, 51 Cal.3d 120 (Cal. 1990), available at
http://www.eejlaw.com/materials/Moore_v_Regents_T08.pdf (skim, pay attention to
dissent in particular)
Javitt G., Why Not Take All of Me? Reflections on The Immortal Life of Henrietta Lacks
and the Status of Participants in Research Using Human Specimens (2010). Minn. J.
Law Sci. Tech 11:713-55
11_Minn._J.L._Sci._
&_Tech._713,_.DOC
Lewis, et al., State Laws Regarding the Retention and Use of Residual Newborn
Screening Blood Samples, Pediatrics 127:703-712 (2011).
703.full.pdf
Higgins v. Texas Dept. of State Health Services,
http://media2.kxan.com/PDF/bloodspotlawsuit.pdf