Transcript What Big Pharma seeks in developing partnerships with

Innovation in the Pharmaceutical Industry
through Partnerships with Academia & Industry
Malcolm Skingle CBE DSc PhD
Director – Academic Liaison
Drug Discovery
January 26th 2011
Annual Icelandic Medical Conference
Medical Research Symposium
Talk Plan
- Changing Landscape in the Pharma Industry
- Innovation in Pharmaceuticals
- The Future for Pharma & Healthcare
- Discovery Partnerships in Academia (DPAc)
- Concluding remarks
Changing Landscape
in the
Pharma Industry
Drug Development is a costly & risky business
 It takes up to15 years to develop a new




$ million

drug
Estimated full cost of bringing a new
chemical or biological entity to market
For every 5-10,000 molecules
($ million – year 2005 $)
synthesised & screened for activity,
only 250 reach pre-clinical
development, only 5 reach clinical
1318
1400
trials and only one reaches the market
1200
Cost to develop a drug in 2006:
1000
802
$ 1.318 billion
800
Only 2 of 10 marketed drugs ever
600
produce revenues that match or
318
400
138
exceed R&D costs.
200
Pharmaceuticals are generally cheap
0
1975
1987
2001
2006
and easy to copy – generic companies
Year
enter mature markets developed by
innovator with low entry costs
Source: J.A. Di Masi and H.G. Grabowski, ‘The Cost of
These features are probably unique to
Biopharmaceutical R&D: Is biotech Different? Managerial
and Decision Economics 28 (2007): 469-479
the pharmaceutical industry
R&D Productivity decreases
the innovation gap is getting wider
60
$55
53
$54
45
40
30
26
30
27
25
$26
22
20
10
$39
35
28
$12
$13
$13
$15
$17
$19
40
$43
39
$21
$30
24
$32
$33
31
$39
35
30
GAP
25
21
$23
18
17
20
18
14
15
10
5
0
92
93
94
95
96
97
98
New Drug Approvals (NMEs)
Source: Burrill & Company; US Food and Drug Administration.
Note: NMEs do not include BLAs
99
00
01
02
03
04
05
06
PhRMA Member R&D Spending
07
0
Pharma R&D ($ billions)
New Drug Approvals (NMEs)
50
50
Pressures on the Pharma Industry
 R&D spend continues to rise
 The blockbuster model is unsustainable
 Drugs not being reimbursed in some countries if
they are not sufficiently differentiated
 There are higher regulatory risks post-launch
 Pricing discussions continue
Over 6,000 compounds in development
Number of Compounds in
Development in 2007
3,000
2,742
2,500
2,000
1,704
1,415
1,500
1,000
540
500
0
Japan
Europe
Rest of World
Source: Adis R&D Insight Database, customized run (December 2007)
USA
Competition in Therapeutic Innovation
• Many scientists seeking to solve same problems in different
or similar ways from similar starting points at the same time
 The first to market is generally quickly followed by several
others
–
–
–
–
>15 beta blockers
9 protease inhibitors
15 NSAIDs
>10 statins
 The first mover is rarely the most successful
 The period of exclusivity for first movers is shrinking &
Pharma are becoming more conservative
The period of exclusivity for first entrants to a
therapeutic class is decreasing (US data)
7.2
7.7
1960s (n=8)
8.2
First-in-Class Approval Period
1970s* (n=9)
10.2
5.9
1980-84 (n=5)
7.2
5.1
1985-89 (n=14)
4.1
2.8
1990-94 (n=15)
1995-98 (n=18)
Mean
Median
3
1.8
1.2
Years
Source: DiMasi & Paquette (2004)
Compound differentiation
 New drugs tested against “gold standards”
 Patent competition drives improvements:
Increased Efficacy
Decreased Side-effects
Decreased ADRs
Decreased drug-drug interactions
Decreased dosing
Specialised drug delivery systems
 Patients benefit from a range of products with differing
characteristics
Quarterly Enalapril sales in the UK
Quarterly Enalapril Sales in the UK
25,000
Protection
Expiry
Sales (£ million)
20,000
15,000
10,000
5,000
0
92 993 993 994 994 995 995 996 996 997 997 998 998 999 999 000 000 001 001 002
9
1
1
1
1
1
1
1
1
2
2
1
1
1
1
1
1
1
2
2
2
P
P
P
P
P
P
P
P
P
P
R
R
R
R
R
R
R
R
R
R
S E MA S E MA S E MA S E MA S E MA S E MA S E MA S E MA S E MA S E MA
TR R TR R TR R TR R TR R TR R TR R TR R TR R TR R
Q QT Q QT Q QT Q QT Q QT Q QT Q QT Q QT Q QT Q QT
Source: IMS Health MIDAS database
The patent cliff:
Pfizer will lose $13bn of income when the Lipitor patent
expires in 2011.
Eli Lilly will lose up to 75% of its revenue over the next 8
years unless it has new drugs to make up this loss.
 Forcing risk averse Pharma companies to
diversify their approaches to R&D
Innovations in the
Pharma Industry
Step Change Therapeutic Innovations
1st generation
2nd generation
3rd generation
genomics / proteomics
cell pharmacology/
molecular biology
natural products
and derivatives
drugs against
targets identified
genetic engineering
from disease genes
receptors
chronic
degenerative
disease associated
serendipity
New Therapeutic Cycles
enzyme
Biotech drugs
with ageing,
inflammation,
cancer
lipid lowerers
ACE-inhibitors
H2-antagonists
beta blockers
NSAIDS
psychotropics
penicillins
sulphonamides
aspirin
1900
1950
1960
1970
1980
1990
2000
2010
2020
2030
2040
Rapidly Changing Market
Biologicals gaining market share
12
New drug product sales growth (2007-12)
8
6
anti-hypertensives
bronchodilators
anti-rheumatics
2
4
anti-hyperlipidaemics
anti-bacterials
anti-psychotics
anti-diabetics
anti-virals
vaccines
0
Market Share %
10
oncology
-10
-5
0
5
10
% Sales Growth: CAGR 2007-2012
15
20
Emergent science drives new disease
opportunities
Where science and unmet need converge
Opportunities in “new” diseases featured in the business plan
Core diseases
5
HPS
Key emergent areas of
science
Idiopathic Fibrotic NSIP
SIDS
Infant RDS
LAM
IPF
Fibrotic ILD Assoc RA
Berylliosis
Idiopathic BOOP
ARDS
Progressive, Fibrotic ILD
(inc. IPF, NSIP, ILD Assoc CTDs - RA / SLE / Sys Scl)
4
Silicosis
Cystic Fibrosis
Fibrotic ILD Assoc Sys Scl
Unmet Need Index
Fibrotic ILD Assoc SLE
BPD
AAT Deficiency
Sarcoidosis
3
Bronchiolitis
Bronchiectasis
PAH
RSV
Histoplasmosis
2
Lung repair
COPD, fibrotic lung diseases
(IPF, ILD, CF)
HP - Farmer's Lung
COPD
Chronic Cough
Asthma
Nasal polyposis
Influenza
PE
Legionellosis
Neuronal mechanisms
Rhinitis, asthma, COPD,
cough
Peanut Allergy
OSA
Chronic sinusitis
AR
Atopic dermatitis
Pneumonia
NAR - Pure AR - Pure + Mixed
Bronchitis - acute
1
0
100
1,000
10,000
100,000
1,000,000
US Population Prevalence/Incidence (Log Scale)
10,000,000
100,000,000
Immunomodulation
Asthma, allergic rhinitis
Changing Trends in Pharma/Biotech
 Management consultants, automation and HR:
In the ’90s consulting companies offered their services to Pharma.
– Robotics for screening 1,000,000 compounds/week.
– Combinatorial Chemistry.
– “me too” compounds.
 The rise of Biotech:
Antibodies were validated as drugs, small innovative companies cash starved
therefore ripe for take over (could solve Pharma’s pipeline problem). How do you
copy a biotech product (no generics).
 Health Budgets are finite:
The amount paid for healthcare is no more than 15% of GDP
Drugs must offer value (NICE).
Biomedical innovation:
The last 50 years
• new technologies:
 applied pharmacology – agonists and
antagonists
 genetic engineering – therapeutic
proteins, imaging, arrays and antibodies
 bioengineering advances – hips and
pacemakers
• but…
 economic model is unsustainable
 lacking productivity
 US health reforms starting to bite

& we cannot focus only on “developed
nations”
Emerging Markets will
outgrow Developed Markets by 2020
$526.48B
2020 Growth$400B
Profile:
Turkey,
$52B
Europe,
$123B
Europe,
$162.30B
BRIC countries, Mexico, South Korea &
Turkey
12-13% growth p.a
Korea,
$66B
Mexico,
$60B
Assuming
2% growth
per year
Brazil,
$60B
US, $276B
Russia,
$38B
India,
$44B
US,
$364.18B
Total sales $400billion by 2020
$55B
China,
$82B
Cf Mature
markets
(USA
&
Europe)
low
Year: 2006
Year: 2020*
single digit growth
Source: IMS MIDAS 2006 sales data, Total Pharmaceutical Market
* Extrapolations from 2006 to 2020 based on IMS projection and % of 2006 sales
GSK turnover growth in 2009
despite decline in US Pharma
+7%
+19%
Rest of
Pharma
£2.2bn
+22%
Japan Ph
£1.6bn
+20%
-13%
Consumer
£4.7bn
US growth rate impacted by
losses to generics
US
Pharma
£9.2bn
Emerging
Markets Ph
£3.0bn
Europe
Pharma
£7.7bn
+9%
2009 Turnover £28.4bn (+3%)
CER growth rates
Rest of Pharma includes Stiefel sales of £248m
The Future for Pharma
& Healthcare
The world today:
The population challenge
60% of the worlds population is in Asia
Cf. 5% of the world population in N.America
N.America currently purchase almost 40% of
the worlds Pharmaceuticals.
This is unsustainable
Possible game changers
looking out 20 years
• genomic medicine & epidemiology
• companion diagnostics
• pharmacogentics
• stem cell therapeutics
• synthetic biology
• nanotechnology
• bioengineering
• computational sciences
• digital pathology
• decision support systems
• medical imaging
• neurology
• infectious disease
The changing face of
biological innovation
• population (prevention)
• longevity (diabetes, neurological diseases,
cancer)
• cost of healthcare (price, volume, companion
diagnostics, efficacy)
• infectious disease (re-emergence of TB,
influenza, potential for vaccines and
therapeutics, drug resistance)
• counterfeiting
• understanding of genetics critical to human
medicine.
Iceland’s Unique Offering:
“Genetic correction of Prostate
Specific
Icelandic Heart
Antigen values using sequence
variants
Association
associated with PSA levels”
The Icelandic Cancer Society
Gudmundsson et al,
Science Translational Medicine 15th December 2010
University Hospital
The Future:
 Increased emphasis on in silico analysis
 Pulling disparate datasets together to create new
knowledge
Genetic information
Species linkages – mouse, zebra fish, human
Spatial information – protein structures
Epidemiology
Screening data
Imaging data
Genomic medicine:
Treatment of metastatic malignant melanoma with selective
inhibitor of BRAF V600E (Plexxicon 4032)
Before
Courtesy of Dr Grant McArthur
15 days after
Academic - Pharma
Partnerships
Innovation through Partnership
Pharma
-Specific agonists &
antagonists
-- Biological reagents
Clinical academics
-Deeper understanding of
physiological & pathological
control mechanisms
Publications
Q: Why place Chemical Probes in the Public Domain?
A: Potent and selective small molecules provide complimentary (if not
better) target validation to genetic methods as evidenced by their
scientific impact
Compound
Receptor
Papers
Citations
Years
h-index
g-index
GW1929
PPARg
317
11063
14
47
100
GW0742
PPARd
392
7212
10
41
78
GW4064
FXR
250
4482
8
37
61
SR12813
PXR
127
4628
8
33
67
GW9662
PPARg
528
4513
8
32
50
GW3965
LXR
181
3073
7
29
53
GW7647
PPARa
118
2312
7
22
47
CITCO
CAR
73
711
5
14
24
Data compiled from Google Scholar, October 5, 2007
All compounds were made available by GSK to the Public Domain
through commercial suppliers (Sigma-Aldrich and Tocris)
h-index: a metric of scientific impact, combining quality and quantity of citations
g index: a modification of the h-index with more weight on highly-cited articles
Discovery Partnerships in
Academia (DPAc)
DPAc aims to leverage the unique expertise of
both academia and industry...
Academia
Industry
• In depth biological insight
• Hit generation & assay development
• Target and pathway expertise
• Medicinal chemistry
• In vivo disease models
• Clinical disease insight
• Key opinion leaders
• Quantitative biology
• Preclinical development
• Integrated discovery & development
• Regulatory & commercial
infrastructure
Discovery Partnerships
with Academia
GSK resource and expertise to progress project
Large scale protein
production
Target
Feasibility
HTS capacity
2 million compound set
Assay
Development
Medicinal chemistry
and computational
molecular design
Lead
Identification
Selectivity
screening
Early Lead
Optimisation
PK-PD
modelling
Late Lead
Optimisation
Preclinical development
(safety assessment, pharmacy,
chemical development, DMPK)
Encoded Library technology
>10million compounds
Flexible, high tech
assay platforms
Synthetic & analytical
chemistry
Discovery Partnerships
with Academia
DPAc focus on early drug discovery and future
pathway options to launch
Target
Some assays in
validation data
place
DPAc
Shared
Project
Target
Feasibility
Assay
Dev
Drug Discovery
Initiated
GSK Internal
Project
AcDPU Shared
Project
Early molecules
identified
Lead
ID
Lead
Identified
In vitro
Screen
Initiated
CS to
FTIH
Phase
I
First dose
human
Advanced assets
identified
Early
LO
Late
LO
Lead
Identified
In vivo
Phase
IIa
Candidate
Selection
Phase
IIb
Phase
III
P III
start
DPAc project
can transition at
any stage but
likely around CS
Registration
Launch
Discovery Partnerships
with Academia
Activities shared between academics and GSK
3-6 mths
Target
Feasibility
9-12 mths
9-12 mths
9-12 mths
Assay
Development
Lead
Identification
Early Lead
Optimisation
Drug Discovery
Initiated
Screen
Initiated
Lead identified
in vitro
9-12 mths
Late Lead
Optimisation
Lead identified
in vivo
Typical GSK activities
Assay feasibility
Tool generation
Value of GSK
£
contribution
Value research
support & reward
Reagent generation
Assay development
£
£
Screening
Chemistry
Screening
Chemistry
DMPK
Chemistry
DMPK
Safety
Pharmacy
££
£££
£££
£
Assay development
Typical academic activities
£
Physiological assays
Candidate
Selection
£
Physiological assays
In vitro and in vivo
££
Physiological assays
In vivo models
+ downstream
development
milestones
and/or royalty
Discovery Partnerships
with Academia
DPAc looks for leading academics working on a
target or pathway with high therapeutic potential
DPAc Partnership Criteria
Therapeutic
hypothesis
Coherent and supportable hypothesis that modulation of target will
produce an effect expected to be of therapeutic benefit
Target defined
Specific drug target identified, with some understanding of type of
pharmacology desired
(Exclusive) enabling
expertise
Academic partner has know-how, experience, expertise essential to
progressing the target which is not (readily) found elsewhere
Tractability
A path to identification of a drug molecule can be defined
Target knowledge suggests that a drug-like molecule can be generated
Requirement for
GSK contribution
GSK has capability which will help progress to the next milestone
Discovery Partnerships
with Academia
Conclusions:
 GSK are keen to promote a more open culture for
sharing ideas & data
 Traditional relationships between Academia and
Industry are being re-defined
 Access to public funding will drive areas of science
underpinning the Pharma industry
 Innovative partnership models allow both GSK &
academics better access to science & technology
Thanks for listening
We are looking for
innovation wherever
it may originate
DPAc is a differentiated approach to translating
innovative academic research
What DPAc is………
 Access to GSK’s expertise and
What DPAc is not……

resource in early drug discovery
 The opportunity for academics to

collaborate in drug discovery
 Milestone aligned resourcing

Funding of exploratory
research
Pulling projects into industry
away from academics
Fixed term research funding
Discovery Partnerships
with Academia
DPAc offers a new approach to
collaborative drug discovery
Discovery Partnerships
with Academia……..
...looks for innovative
academic science
...integrates with
academic groups
…that may ultimately deliver
differentiated medicines
from across multiple
therapeutic areas
…to provide resource and
expertise to undertake
early drug discovery in
partnership with
academics
...delivers quality
development
candidates
…through milestone
driven collaborations,
that can then progress
through the GSK
organisation
Discovery Partnerships
with Academia
GSK profile of current
global collaborations
GSK have more academic collaborations than
any other UK company (all sectors)
GSK – UK Academic Research Partners
GSK currently has >500
active research collaborations
ongoing with UK Universities.
Dundee
Glasgow
Ulster
Edinburgh
Newcastle
Durham
Belfast
Leeds
Bradford
Lancaster
Manchester
Liverpool
York
Hull
Sheffield
Nottingham
Loughborough
Leicester
Birmingham
Cambridge
Warwick
Ipswich
Cranfield
Hertfordshire
Buckingham
Essex
Oxford
Reading
Cardiff
Bath Surrey
Canterbury
Bristol
Brighton
Exeter
Portsmouth
Southampton
Two way exchange of knowledge &
technology
Country
No.
Austria
1
Belgium
4
Denmark
4
France
16
Germany
21
Greece
1
Ireland
10
Italy
4
Netherlands
Iceland
Finland
2
Spain
4
Latvia
Denmark
4
Switzerland
15
Lithuania
Russia
Belarus
Ireland
UK
Poland
Holland
Belgium
Lux Germany
Switzerland
Sweden
Estonia
Sweden
4
Norway
Russia
Norway
France
Italy
Corsica
Portugal
Ukraine
Czech R.
Austria
Slovakia
Moldova
Hungary
Romania
Slovenia
Croatia
Bosnia Serbia
& Herz
Bulgaria
Macedonia
Turkey
Albania
Spain
Sardinia
Sicily
EUROPEAN ACTIVE AGREEMENTS BY COUNTRY
Greece
Crete
GSK Agreements by State
WA(3)
MA (15)
MI (6)
OR
North Carolina
Maryland
Pennsylvania
Massachusetts
New York
California
Texas
Michigan
Missouri
Colorado
Connecticut
Virginia
Washington
Georgia
New Jersey
Alabama
Arizona
Delaware
Florida
Iowa
Nebraska
Oregon
Tennessee
NC
MD
PA
MA
NY
CA
TX
MI
MO
CO
CT
VA
WA
GA
NJ
AL
AZ
DE
FL
IA
NE
OR
TN
CT(3)
NE
NJ(2)
IA
DE
CO(3)
CA (9)
VA(3)
PA (19)
NY (10)
TN
AL
AZ
GA( 2)
NC (20)
FL
1 Agreement
2-3 Agreements
MO (4)
TX (7)
4-9 Agreements
10-18 Agreements
19-20 Agreements
January 2008-April 2010
MD (19)
GSK Academic Spend 2009
3000000
2500000
2000000
1500000
1000000
500000
0
GSK funding to Harvard in 2009 was >£9m
£10,000,000
£9,000,000
£8,000,000
£7,000,000
£6,000,000
£5,000,000
£4,000,000
£3,000,000
£2,000,000
£1,000,000
£0
Immune Disease Institute,
Harvard Stem Cell Institute,
MGH,
Dana Farber Cancer Institute,
Brighams & Womens,
MIT
How large Corporates are
changing their business models
to embrace Open Innovation
Data Sharing Agreements
GSK have collected bloods from clinical trials for
more than a decade
Genetic analysis on cohorts of >20,000 patients
Need to combine datasets with other well
phenotyped collections to find significant trends
e.g MRC £500k + GSK £500k
Nick Wareham (University of Cambridge) Obesity/Diabetes
Peter McGuffin (KCL) Bipolar disorder
Developing Chemical Probes for Epigenetics
No structures disclosed
Structures disclosed
Chemistry @ GSK
X-ray @ Oxford
Public
Domain
Assays @ Oxford
Chemical Probe*
Data to GSK
Only GSK scientists can
view data with compound
structures
Sigma make
probe available
1–5 Compounds meeting probe
criteria for potency and selectivity:
* e.g. Potency <100nM, Selectivity
>100, Cellular activity <1uM
A future model for Drug Discovery?
Wellcome Trust Epigenetics Collaboration
GSK-WT-SGC
Partnership
Public
Domain
Chemical
Tractability
Chemical
Probes
Drug
Discovery
Chemistry (GSK)
Screening (WT-NIH)
Structure (SGC)
No restrictions
on use or
publication
Proprietary Target Validation
(Re)Screening
Lead optimization
Pharmacology
DMPK
Toxicology
Chemical development
Clinical development
Enable Academic
Target Validation
Open Access
Pharmaceutical
Industry
Proprietary
The realities of having the best pipeline
GlaxoSmithKline
Merck
Bristol Myers Squibb
Novartis
Johnson & Johnson
Sanofi-Aventis
AstraZeneca
Pfizer
Wyeth
Eli Lilly
Roche
Abbott Labs
Schering Plough
AVERAGE
Pipeline renews
60% of sales
0.0x
0.1x
0.2x
0.3x
0.4x
Lehman Brothers PharmaPipelines (Sept 2007)
Pharma Replacement Power – NPV
LB Method: [NPV of recent launches (06-07) + NPV of pipeline opportunities from ‘08-’13] / NPV of products marketed before 2006.
0.5x
0.6x
0.7x
ScienceUK/US
baseGlobal
attracts
R&D spend
PharmaMarket
share &
World R&D spend
60
•
Global Pharma sector
50
37.64%
40
30
20
10
2.46%
0
UK market
UK R&D
US market
US R&D
MRC
MRC translational activities
TSB
Translational
Research
Support
Developmental Pathway
Funding Scheme
Developmental
Clinical Studies
Translational Stem Cell Research Programme
NIHR
Basic research
Prototype
discovery
and design
Pre-clinical
development
Early
clinical
trials
Late
clinical
trials
Targeted initiatives to alleviate bottlenecks
Continued
commitment to
basic lab,
clinical and
population
research
Infrastructure/Resources
Methodology
Training
Capacity building
Developmental Pathway Funding Scheme
(DPFS)
 Cornerstone of the MRC’s Translational Strategy
 Launched at end of April 2008
 Planned expenditure of at least £25m over next 3 years
– Guidance of £250k-750k; 1-2 years per project
– Will consider larger scale proposals where justified
 Projects do not need to originate from MRC funded research
 Goal oriented rather than hypothesis-led
 Funding is milestone-based
– Projects will be required to submit quarterly and
milestones progress reports
– Failure to meet a milestone may result in funding being
terminated
Scope of the DPFS
 Examples of proposals:
– validating an association between a fundamental
discovery & a preventive, diagnostic or disease process
(target validation)
– developing candidate therapeutic entities - from
discovery up to early evaluation in humans
– developing candidate diagnostics or medical devices from prototype design up to early evaluation in humans
– developing a new research tool to overcome a
bottleneck in the development of therapies or diagnostics
Drug Development Costs Escalate
MRC
MRC translational activities
TSB
Translational
Research
Support
Developmental Pathway
Funding Scheme
Developmental
Clinical Studies
Translational Stem Cell Research Programme
NIHR
Basic research
Prototype
discovery
and design
Pre-clinical
development
Early
clinical
trials
Late
clinical
trials
Targeted initiatives to alleviate bottlenecks
Continued
commitment to
basic lab,
clinical and
population
research
Infrastructure/Resources
Methodology
Training
Capacity building
Developmental Pathway Funding Scheme
(DPFS)
• Cornerstone of the MRC’s Translational Strategy
• Launched at end of April 2008
• Planned expenditure of at least £25m over next 3 years
– Guidance of £250k-750k; 1-2 years per project
– Will consider larger scale proposals where justified
• Projects do not need to originate from MRC funded
research
• Goal oriented rather than hypothesis-led
• Funding is milestone-based
– Projects will be required to submit quarterly and milestones
progress reports
– Failure to meet a milestone may result in funding being
terminated
Scope of the DPFS
– validating an association between a fundamental
discovery & a preventive, diagnostic or disease
process (target validation)
– developing candidate therapeutic entities - from
discovery up to early evaluation in humans
– developing candidate diagnostics or medical
devices from prototype design up to early evaluation
in humans
– developing a new research tool to overcome a
bottleneck in the development of therapies or
diagnostics
MRC Industrial Collaboration Applications
(MICAs)
• MICAs are aimed at encouraging &
supporting collaborative research projects
between academic researchers & industry
• The key feature of this scheme is its
flexibility, especially the level & nature of
the industry contribution
MRC Industrial Collaboration Applications (MICAs)
 MICAs are aimed at encouraging & supporting collaborative
research projects between academic researchers & industry
 The key feature of this scheme is its flexibility, especially the
level & nature of the industry contribution
Without patents there would be no innovation
 Given the costs & risks of drug development, without a period

of exclusivity against copyists there would be no investment
in pharmaceutical innovation
Pharma do not seek therapeutic area exclusivity (anti-virals,
antibiotics)
Patent protection promotes
therapeutic & innovative competition
Changing Landscape of I.P
 More small companies owning & licensing basic IP
 Many companies not in manufacturing, only
generating technology/IP
 More patent aggregators, who take on patents from
universities & small companies
 Patents used as bargaining chips