1. LAW AND (NATURAL) ORDER: GENETIC BIOTECHNOLOGIES IN THE US LEGAL SYSTEM Karin Patzke4/26/13 Experiments in Methods

2. Overview- Abstract  Research focus  Precedent - judicial interpretation of intellectual property  Legal technologies - legal practices and interpretations of law  Scales of adjudication - patent applications, appellate court opinions and Supreme Court rulings.

3. Structure of this Proposal  Overview  Hegemonic Backdrops, Shifts in Sign Systems, Historicizing a Project  Why Now? and Binaries  Hierarchy of Questions Three Literatures  Core Concepts  Study Components  Methodological, Empirical, and Theoretical Inquiry  Structure of the Project  Field Sites and Time Line  Conclusion: Possible Implications of Research

4. Overview – Background and Shifts  Innovations and new discoveries in biotech, specifically in genetics, challenge legal definitions of innovation.  AMP v. Myriad  Patents and trade secrets  Protectionism and globalism  Multiple Actors:  Justice Breyer, Judge Posner  Scales of adjudication and legal technologies

5. Overview – Research Questions  How are social concerns of genetic health care diagnostics reconciled in adjudication?  What are the roles of legal precedent, regulation, and established industry practices?  How do plaintiffs, defendants and the law attempt to maintain the status quo after rulings?  What alternative structures and actors emerge?  What are the global impacts of US patent rulings for genetics?  What regulatory structures are manipulated to reflect US regulations?  What alternative structures have emerged?

6. Overview – Core Concepts  Economic and Legal Concepts:  Innovation/Utility/Manufacture Science and economic incentives  Healthcare and Genetics:  Information/Public/Nature Population health and governance

7. Study Components – Methods  Qualitative Research Methods:  Participant observation Internship ‘Clerking’  Structured and unstructured interviews  Discursive analysis Archival legal and policy documents Ethnographic observations

8. Study Components - Theory  Science and economics  Public health and private research  Genetics and Innovation

9. Study Components – Field Sites  US courts and archives  Supreme Court and Appellate Court Oral arguments Rulings Clerks Offices  Law Offices:  ACLU  PubPat  Biotech Labs / Patent repositories  Advocacy Groups  Genetic Alliance

10. Study Components – Time Line  Year One  Summer 2013 Preliminary theoretical and empirical research Archival research and discourse analysis  Fall 2013 Continuation of archival research Applications for internships, interviews  Spring 2014 Prep. for dissertation proposal and internship  Year Two  Summer 2014 Law clerk internship  Fall 2014 Application for 2 nd internship  Spring 2015 Prep. For internship  Year Three  Summer 2015 – 2 nd internship  Write dissertation  Validation and omission interviews.

11. Possible Implications/Conclusions