Diagnostic Kits/Paper

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Are patents clogging the pipeline: The effects of intellectual property on commercialization and access to genetic diagnostics
(A Summary Paper of our Research to date)
By Carolina Rossini, Andrew Clearwater, and Mackenzie Cowell

Last Draft: December 3, 2009

Introduction

Description of the GDx Market

Defining Genetic Diagnostics

from Educational_Materials#Field_Definition

Brief History of GDx and Related Technology

  • chemical patents at turn of century (see Palombi's work)

Overview of IP Landscape

from Overview_of_Economics_of_Intellectual_Property_in_Kits see overview]

Patent Protection

Bayh-Dole

Licensing

When IP Does and Does Not Work Effectively

Our Research Questions

Our Methodology

Forces affecting the GDx Industry

  • Revolutionary technical advances
  • Regulatory process
  • payer system (public & private insurance)
  • Intellectual Property
    • Case Law
    • Proposed Alternative Protection Schemes
      • Patent Pools
      • Patent Clearing Houses
  • Licensing
    • Licensing Approaches
    • Compulsory Licensing
    • Licensing Behavior

Existing and Evolving GDx Models

Commercialization of Basic Research

  • Licensing of research to existing GDx company
  • Licensing of research to new GDx start-up
  • Usage of research in public domain by existing GDx company? (multiplex kits?)

Paths to Market

  • ASRs
  • Kits
  • DTC

Discussion

Conclusions

Bibliography