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Scott Brown
VP, General Counsel and Global Head of NIBR Patents
IPCC Phoenix March 2009
Industry Bilski Concerns
2
Novartis Institutes for BioMedical Research (NIBR)
United States
Cardiovascular & Metabolism
Infectious Diseases
Oncology
Ophthalmology
Musculoskeletal
Center for Proteomic Chemistry
Molecular Pathways
Global Discovery Chemistry
Biologics Center
IT Automation & Support
Translational Sciences
United Kingdom
Gastrointestinal
Respiratory
IT Automation & Support
Translational Sciences
Switzerland
Gastrointestinal
Musculoskeletal
Nervous System
Oncology
Autoimmunity, Transplantation & Immunology
Center for Proteomic Chemistry
Global Discovery Chemistry
Biologics Center
IT Automation & Support
Translational Sciences
China
Infectious Diseases
Oncology
Epigenetics
Translational Sciences
Japan
Translational Sciences
France*
Translational SciencesIndia
Translational Sciences
* Closing end of 2009
Integrated Approach to New TargetsOne pathway, many diseases and unique medicines
Breastcancer
Bone-lossdiseases(e.g., osteoporosis, multiple myeloma)
Coloncancer
Livercancer
Antibodies
LMW compounds
siRNA
3
Capturing the Power of Mechanistic Focus: From All of Rare, to Segments of Common Disorders
Rheumatoid ArthritisMuckle-Wells
IL-1 Dependant
4
Rheumatoid ArthritisMuckle-Wells
5
Capturing the Power of Mechanistic Focus: From All of Rare, to Segments of Common Disorders
IL-1 Dependant
COPD3
Diabetes 15 million
20 millionin PoC trials
in PoC trials
NOMID1
Rheumatoid Arthritis 3 million
1000in PhII
in PhII
SJIA211,000in PhII
in PhIIGout 3 million
Mechanism-based Expansion: Anti-IL-1β for a Spectrum of Inflammatory Disorders
Muckle-WellsU.S. Patients
1000
Anti-IL-1β Antibodyin PhIII
6 | IR Day | November, 2008 | Tim Wright
1 - Neonatal Onset Multisystem Inflammatory Disease2 - Systemic Onset Juvenile Idiopathic Arthritis 3 - Chronic Obstructive Pulmonary Disease
NIBR Proof-of-Concept Strategy: A Unique Approach
Proof of Concept Designs
Early inclusion of patients with disease in trials
Targeting genetically defined diseases and subsets provides robust data with few subjects
Efficacy potential for the compound and its target are established rapidly
Parallel Indication Expansion Studies
Efficacy in multiple indications tested in parallel
Exploration across therapeutic areas (no “silos”)
Guided by the science and unmet medical need
PoC indication
Expansion 1
Expansion 2
Expansion 3
Analysis for Safety and Efficacy Markers
Emerging genetics and genomics technology permits rapid assessment of safety and efficacy markers
Patient segmentation and customized therapies
8
Biomarkers/Diagnostics are Mission-Critical
Disease identification
Safety monitoring
Efficacy surrogates
Efficacy predictors
Patient stratification
Endpoints
Companion diagnostics
competitive advantage
patents provide exclusivity
9
The Baby Out With the Bath Water
Bilski: unpleasant surprise
now what?
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How to React?
what does Bilski really mean?
diseasestate
patientAE
propensity
post-admineffects
patientefficacy
propensity
are all BM/D created equal?
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How to React?
diseasestate
patientAE
propensity
post-admineffects
patientefficacy
propensity
different treatment under Bilski?
different claiming strategies?
enforceable claims?
