Transcript NU 2012 * PBP 2013: Budget Review Approach

Intellectual Property and Innovation …
The Virtuous Cycle
Khaled Mansour
Area Managing Director,
Janssen, Middle East, West Asia and Africa
The Value of
Innovation
Innovation is important
• Pharmaceutical innovation has accounted for 73 percent of
the total increase in life expectancy between 2000 and 2009
• Increases in life expectancy resulting from better treatment
of cardiovascular disease alone have been conservatively
estimated as bringing benefits worth more than $500 billion
a year.
• According to Harvard health economist David Cutler, Virtually
every study of medical innovation suggests that changes in
the nature of medical care over time are clearly worth the
cost.
Innovation isn’t easy or inexpensive
• Once a lifesaving drug or treatment exists, it’s easy to take it
for granted.
• We sometimes forget the years of toil these things take to
develop; the millions spent to bring a new drug or treatment
from theory to actuality.
Innovation is Risky, Slow an Expensive
- New drug development takes an average of 10–15 years.
- Innovation cost have risen from an av. of $800M per drug in 2003 to $2.6B in 2014
Drug
Discovery
~ 5,000 – 10,000
Preclinical
Clinical Trials
250
FDA Review Scale-Up to
Mfg.
Post-Marketing
Surveillance
5
3 – 6 YEARS
PHASE
1
PHASE
3
PHASE
2
NUMBER OF VOLUNTEERS
20–
100–500
100
6 – 7 YEARS
1,000–
5,000
NDA SUBMITTED
ONE FDAAPPROVED
DRUG
IND SUBMITTED
PRE-DISCOVERY
COMPOUNDS
0.5 – 2
YEARS
INDEFINITE
The Virtuous Cycle of Innovation
Clinical Trials
Safety &
Efficacy
Reference
Product
Generic
Development
IP Expires
Discovery
R&D
Resources
free
to Innovate
Generic
Product
Document
Bioequivalence,
Quality &
Integrity
6
| Nelson working document | March 2015 | Business Use Only
The Value of
Intellectual Property
Importance of Strong IP Rights
U.S. Patents Granted in Pharmaceutical Technology, Selected Years
1997–2012,
Location of Inventor by Region/Country
United States,
52.6%
European
Union,
25.9%
China, 0.7%
Japan, 9.9%
Asia,* 3.6%
All Others,
7.3%
IPR is the incentive to Invest and Innovate
Where do new drugs come from?
Biopharmaceutical IP Benefits
Developing Economies
• Strong, positive, and well-recognized correlation between foreign
direct investment inflows and reliable IP regimes1
• High-quality and high-quantity tech transfers leading to faster
growth in domestic firms
• The presence of innovative pharmaceuticals provides increased
benefits to a country’s economy and the health of its population:
speedier drug diffusion3, decreased costs of hospitalizations and
non-drug expenditures with new medicines4, and increases in
longevity5
MYTH: “IP is Unfair to Developing Nations”
• FACT: Few of the approximately 400 drugs on the World
Health Organization’s model essential drug list have ever
been patented in the world’s poorest countries.
Intellectual Property Protection –
Incentive for Innovation
• 3 Key Components of Effective IP
Systems
– Patent System
• Patentability Standards
• Term of Protection
Patent System
Patent
Enforcement
– Patent Enforcement
• “Linkage”
• Effective resolution of patent
issues before an infringing
product is allowed to enter the
market (including an effective
judicial system)
Intellectual Property
– Regulatory Data Protection (RDP)
• Protection independent of
patents that prohibits: (1)
disclosure of commercially
valuable data by governments;
and (2) reliance on commercially
valuable data for approval of third
party products for a fixed time
period
Regulatory
Data Protection
Conclusion
•Patients benefit most from IP rights –
drug breakthroughs and advances.
•We can have both IP and access.
•But erosion of IP rights globally
threatens to undermine future drug
development.