Preliminary Course Outline and Readings as of July 2, 2014 Biotech: Law, Business and Regulation: Fall, 2014 LAW 3733 CRN 94778 3 Credits T: 6:10-­‐9:00 PM August 26 What is biotechnology and why does the law care about it? There will be no class on August 26. However, everyone should do the following required readings, study the syllabus and the course outline, and submit a 1-­‐2 page statement to me by email to griem@clm.com by August 27 addressing three questions – 1) why you are taking this class, 2) what legal issues you are particularly interested in exploring, and 3) what is the common name for Dihydrogen Monoxide. This statement will not form any part of your grade, and is purely for my information in making the class as engaging as possible for everyone. Required Readings 1. Sutton, LAW AND BIOTECHNOLOGY, pp. 1-­‐18. A short introduction to commercially valuable biotechnology and a short discussion of the history of biotechnology development.
2. Wellons at al., BIOTECHNOLOGY AND THE LAW, Introduction to Biotechnology and the Law, Chapter I, pp. 1-­‐23.
3. “Dihydrogen Monoxide FAQ,” available at http://www.dhmo.org/facts.html. This mock FAQ illustrates a number of the essential issues we will discuss during the term – (1) biotechnology is everywhere, (2) biotechnology can be enormously useful and frighteningly dangerous at the same time, and (3) how the law addresses biotechnology issues depends in large part on how they are presented and perceived. Optional Readings
Refresher on biology available at http://www.ebi.ac.uk/microarray/biology_intro.html. This is a biology refresher – read to the extent you find it necessary to remember these topics from college or high school. “Guide to Biotechnology 2008”, skim pages 32-­‐75, available at http://www.bio.org/sites/default/files/BiotechGuide2008.pdf. Don’t worry about the exact sales figures, new products, etc. This will give you a sense of what the biotechnology industry is. There is also a glossary at the end that may be helpful throughout the class. September Federal Regulation of Biotechnology Foods 2 We will briefly review the Syllabus, this Outline, and last week’s readings and then discuss the development of government regulation of foods as the advent of scientific techniques that permit direct generic alterations drove an expanded role for the Federal Government in balancing the risks and benefits that come from genetic alteration of foods. Page 1 of 6 7447645.1 Readings 1. Sutton, LAW AND BIOTECHNOLOGY, pp. 31-­‐81. 2. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER XV, APPROVAL PROCESS FOR BIOTECHNOLOGY PRODUCTS IN AGRICULTURAL USE, pp. 661-­‐676. Optional additional reading: 1. Monsanto position on labeling food and ingredients developed from GM seeds, available at http://www.monsanto.com/newsviews/Pages/food-­‐labeling.aspx 2. Center for Food Safety Citizen Petition to the FDA asking FDA to mandate GMO food labeling, available at http://www.centerforfoodsafety.org/files/ge-­‐labeling-­‐petition-­‐
10-­‐11-­‐2011-­‐final.pdf (currently pending before FDA) 3. FDA Statement on the FDA’s Role in Regulating Safety of GE Foods, at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm352067.htm 4. Transgenic fish wins US regulatory backing, available at http://www.nature.com/news/transgenic-­‐fish-­‐wins-­‐us-­‐regulatory-­‐backing-­‐1.12130 September Federal Regulation of Biological Drugs for Human Use 9 We will discuss the government’s regulation of biotechnology-­‐based drugs, primarily through the FDA’s premarketing approval requirements and its implementation of the Biologics Price Competition and Innovation Act of 2010, as well as related legal issues relating to marketing of biosimilars. Readings 1. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER XIII, APPROVAL OF PRODUCTS FOR HUMAN USE, pp. 591-­‐621. 2. Stanton Lovenworth, THE NEW BIOSIMILAR ERA: THE BASICS, THE LANDSCAPE, AND THE FUTURE, available at http://about.bloomberglaw.com/practitioner-­‐
contributions/the-­‐new-­‐biosimilar-­‐era-­‐the-­‐basics-­‐the-­‐landscape-­‐and-­‐the-­‐future/ September Regulation of Biomedical Research 16 We will explore the variety of laws, regulations, and policies that govern biomedical research involving animals and humans that are intended to protect the public as well as the research subjects and scientists, and look at the mixed history of direct genetic therapy. Readings Page 2 of 6 7447645.1 1. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER VIII, REGULATION OF PRECLINICAL RESEARCH, pp. 407-­‐438 (excluding part C of this chapter) 2. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER X, FDA REGULATION OF BIOMEDICAL RESEARCH, pp. 479-­‐508.
Optional:
1. Sheryl Stolberg, The Biotech Death of Jesse Gelsinger, Nov. 28, 1999, available at http://www.nytimes.com/1999/11/28/magazine/the-­‐biotech-­‐death-­‐of-­‐jesse-­‐
gelsinger.html?pagewanted=all&src=pm 2. Krimsky, China’s Gene Therapy Drug, GeneWatch, Nov.-­‐Dec. 2005, available at http://www.tufts.edu/~skrimsky/PDF/Chinese%20Gendicine.PDF 3. FDA Guidance for Industry, Considerations for the Design of Early-Phase Clinical
Trials of Cellular and Gene Therapy Products, July 2013, available at
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegu
latoryInformation/Guidances/CellularandGeneTherapy/UCM359073.pdf
September Privacy and Use of Personal Health-­‐related Information In the Hands of Others 23 We will study the laws that govern and protect the privacy of individual health and genetic information, and consider the impact of advances in genetic technology on those laws. Readings 1. Sutton, LAW AND BIOTECHNOLOGY, pp. 215-­‐216, 224-­‐229. 2. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER XI, PRIVACY ISSUES FOR BIOTECHNOLOGY COMPANIES , pp. 509-­‐544. (excluding parts D, E and F). 3. Overview of laws prohibiting genetic discrimination published by NIH’s National Human Genome Research Institute, available at http://www.genome.gov/10002077
Optional
1. Excerpt from Rebecca Skloot, THE IMMORTAL LIFE OF HENRIETTA LACKS,
available at http://www.oprah.com/world/Excerpt-From-The-Immortal-Life-ofHenrietta-Lacks_1
2. Carl Zimmer, A Family Consents To A Medical Gift, 62 Years Later, available at
http://www.nytimes.com/2013/08/08/science/after-decades-of-research-henriettalacks-family-is-asked-for-consent.html?_r=0
September Genetic Testing and The Use of Genetic Information by Individuals Page 3 of 6 7447645.1 30 We will consider the laws surrounding genetic diagnostic tests and the use of genetic information by the individuals who provided it, primarily in connection with pre-­‐natal screening and personal genetic code testing services like 23AndMe. Readings: 1. Sutton, Biotechnology and the Law, pp. 273-­‐274. 2. Diagnostic Kits/USA Regulation Review, available at http://cyber.law.harvard.edu/commonsbasedresearch/Diagnostic_Kits/USA_Regulatio
n_Review 3. FDA Warning Letter to 23andme, Inc., dated November 22, 2013, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.ht
m Optional 1. American Congress of Obstetricians and Gynecologists, ACOG Committee Opinion, June 2008 on Ethical Issues In Genetic Testing, available at https://www.acog.org/Resources_And_Publications/Committee_Opinions/Commi
ttee_on_Ethics/Ethical_Issues_in_Genetic_Testing 2. Clinical Sequencing News, August 21, 2013, Q&A: The Limitations of Noninvasive Prenatal Testing, available at http://www.genomeweb.com/sequencing/qa-­‐
limitations-­‐noninvasive-­‐prenatal-­‐testing 3. FDA Untitled Letter to 23andme, Inc., dated June 10, 2010, available at http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM2
15240.pdf 4. NYT Article on conflicting results from different testing organizations, at http://www.nytimes.com/2013/12/31/science/i-­‐had-­‐my-­‐dna-­‐picture-­‐taken-­‐with-­‐
varying-­‐results.html?hp October 7 Building a Biotechnology Company We will consider how a biotechnology product is developed by a company, including how the necessary technology is acquired and protected, and how the developers of the technology are compensated. GUEST SPEAKER: Jeff Kopacz, Patent Counsel, Alnylam Pharmaceuticals. Readings Page 4 of 6 7447645.1 1. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER IV, ACQUISITION OF BIOTECHNOLOGY – TECHNOLOGY TRANSFER, pp. 139-­‐190. 2. Board of Trustees of the Leland Stanford Junior University v. Roche Molecular
Systems, Inc., http://www.supremecourt.gov/opinions/10pdf/09-1159.pdf
October 14 Patent Issues Relating to Biotechnology We will discuss patent issues particularly relevant to biotechnology, and review three recently decided Supreme Court decisions in this area. Readings
1. Sutton, LAW AND BIOTECHNOLOGY, pp. 167-­‐178. 2. Association for Molecular Pathology v. Myriad Genetics, Inc., http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf
3. Mayo Collaborative Servs. v. Prometheus Medical Labs.,
http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf
4. Bowman v. Monsanto Co., http://www.supremecourt.gov/opinions/12pdf/11796_c07d.pdf
October 21 Biotechnology Patent Litigation We will review essential elements and issues in a biotechnology patent litigation, in order to understand the power and limitations of patent protection and the high cost involved in asserting and defending patent rights. We will also review a recent controversial Supreme Court decision addressing antitrust risk attendant to settlement of Hatch-­‐Waxman pharmaceutical patent litigation claims. Readings 1. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER XIX, BIOTECHNOLOGY PATENT LITIGATION FOR THE NON-­‐PATENT ATTORNEY, pp. 813-­‐855. 2. FTC v. Actavis, Inc., http://www.supremecourt.gov/opinions/12pdf/12-416_m5n0.pdf
October 28 Legal Issues For the Successful Biotechnology Product -­‐ Reimbursement and FDA Post-­‐
Marketing Requirements We will review two important areas of law relevant to successful marketing and commercialization of a biotechnology product – insurance reimbursement and FDA post-­‐
marketing requirements. We will also review the major changes to the US healthcare system implemented by the Patient Protection and Affordable Care Act Readings 1. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER XII, MEDICAL REIMBURSEMENT, pp. 563-­‐
590. Page 5 of 6 7447645.1 2. Wellons et al, BIOTECHNOLOGY AND THE LAW, CHAPTER XVI, LEGAL REQUIREMENTS AFTER APPROVAL, pp. 677-­‐706. Optional 1. Summary of Provisions in the Patient Protection and Affordable Care Act, available at http://obamacarefacts.com/summary-­‐of-­‐provisions-­‐patient-­‐protection-­‐and-­‐
affordable-­‐care-­‐act.php (skim and focus on headings) 2. Supreme Court ObamaCare: Ruling on Obamacare, available at http://obamacarefacts.com/supreme-­‐court-­‐obamacare.php November 4 November 11 November 18 November 25 TBD Criminal and Civil Law and Biotechnology We will review other recent developments in criminal and civil law that illustrate the power and danger of advancing biotechnology technology. Readings 1. Sutton, Biotechnology and the Law, 283-­‐306. 2. Sutton v. King, http://www.supremecourt.gov/opinions/12pdf/12-­‐207_d18e.pdf 3. Rogers-­‐Duell v. Chen, 6518-­‐11, NYLJ 1202627559235, at *1 (Sup., LA, Decided November 4, 2013). Student Presentations TBD Student Presentations TBD Student Presentations TBD Final Examination Will be taken during the scheduled examination period. Closed Book. Page 6 of 6 7447645.1