: STEPB020399 Evolution of IPR and Pharmaceutical Discovery and Development
Eric R. Larson, Ph.D.
Pfizer, Inc.
Central Research Division
Conference on Intellectual Property Rights:
How Far Should They Be Extended?
Areas of Leverage/Focus : STEPB020399 Areas of Leverage/Focus Discovery and Development Timeframes, Complexity
Attrition
Regulatory Environment
Final therapeutic uses
Freedom to Operate
Pharmaceutical Patents - The Changing Landscape : STEPB020399 Pharmaceutical Patents - The Changing Landscape Primary uses
Processes and intermediates
Bulk forms
Simple formulations
Composition of matter Expansive numbers of uses
Methods of treatment
Mechanism of action
Packaging
Delivery profiles
Dosing regimen
Dosing range
Dosing route
Combinations
Screening Methods
Chemistry Methods
Biological Target
Field of use
Primary uses
Processes and intermediates
Bulk forms
Simple formulations
Composition of matter 1980’s 1990’s
Innovation will continue, IP sources increase : STEPB020399 Innovation will continue, IP sources increase Business Models Portfolio Decision and Analysis, Finance, Marketing
Enabling software IT, Biometrics
Patient Markers Genomics, Clinical Diagnostics and Measurements
Expansive numbers of uses Clinical, Discovery Biology, Drug Safety, Marketing
Methods of treatment Clinical, Discovery Biology
Mechanism of action Disc. Biology, Molecular Biology
Field of use Disc. Biology, Molecular Biology
Delivery profiles Clinical, Drug Metabolism, Pharm R&D
Dosing regimen Clinical, Drug Metabolism, Pharm R&D
Dosing range Clinical, Drug Metabolism, Pharm R&D
Dosing route Clinical, Drug Metabolism, Pharm R&D
Combinations Clinical, Discovery Biology, Gen. Pharm ,Marketing
Packaging Pharm R&D, Marketing
Screening methods Discovery Biology, Drug Safety, Drug Metabolism
Chemistry Methods Discovery Chemistry, Process R&D
Biological Target Genomics, Discovery Biology
Primary uses Discovery Biology, Clinical
Processes and intermediates Discovery Chemistry, Process R&D
Bulk form Discovery Chemistry, Process R&D, Pharm R&D
Simple formulations Discovery Chemistry, Pharm R&D
Composition of matter Discovery Chemistry, Process R&D Claims for each NCE - Potential Inventors
Costs to ensure freedom to operate : STEPB020399 Costs to ensure freedom to operate Capture
In-license
Work-around
Valuation is critical