Scott Brown

1
Industry Bilski Concerns

• Scott Brown
• VP, General Counsel and Global Head of NIBR
  Patents
• IPCC Phoenix March 2009

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Novartis Institutes for BioMedical Research (NIBR)
Closing end of 2009
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Integrated Approach to New TargetsOne pathway,
many diseases and unique medicines
Breastcancer
Antibodies
Bone-lossdiseases(e.g., osteoporosis, multiple
myeloma)
Coloncancer
LMW compounds
siRNA
Livercancer
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Capturing the Power of Mechanistic Focus From
All of Rare, to Segments of Common Disorders
Rheumatoid Arthritis
Muckle-Wells
IL-1 Dependant
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Capturing the Power of Mechanistic Focus From
All of Rare, to Segments of Common Disorders
Rheumatoid Arthritis
Muckle-Wells
IL-1 Dependant
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Mechanism-based Expansion Anti-IL-1ß for a
Spectrum of Inflammatory Disorders
Anti-IL-1ß Antibody
U.S. Patients
Muckle-Wells
1000
in PhIII
1 - Neonatal Onset Multisystem Inflammatory
Disease 2 - Systemic Onset Juvenile Idiopathic
Arthritis 3 - Chronic Obstructive Pulmonary
Disease
6 IR Day November, 2008 Tim Wright
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NIBR Proof-of-Concept Strategy A Unique Approach
Proof of Concept Designs
Parallel Indication Expansion Studies
Analysis for Safety and Efficacy Markers

• 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

• Efficacy in multiple indications tested in
  parallel
• Exploration across therapeutic areas (no silos)
• Guided by the science and unmet medical need

• Emerging genetics and genomics technology permits
  rapid assessment of safety and efficacy markers
• Patient segmentation and customized therapies

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Biomarkers/Diagnostics are Mission-Critical

• Disease identification
• Safety monitoring
• Efficacy surrogates
• Efficacy predictors

• Patient stratification
• Endpoints
• Companion diagnostics

competitive advantage
patents provide exclusivity
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The Baby Out With the Bath Water
Bilski unpleasant surprise
now what?
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How to React?
what does Bilski really mean?
are all BM/D created equal?
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How to React?