Diagnostic Kits/Paper

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]

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