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
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