Upload
dna2z
View
2.211
Download
1
Embed Size (px)
DESCRIPTION
Maintaining control of pharmaceutical drug innovation is key for national security, public health, and economic development. We know that much of late-stage development has gone overseas, but the question remains: Where are drugs invented? Using the DrugPatentWatch.com database I demonstrate a model to track pharmaceutical globalization using patents, and reveal the locations of pharmaceutical innovation.
Citation preview
www.CommercialBiotechnology.com
Globalization of Drug Discovery
Drug Discovery Partnerships: Filling the PipelineOctober 17th 2011Yali Friedman, Ph.D. – [email protected]
www.CommercialBiotechnology.com
Globalization of Drug Discovery
Why it matters:- Challenges of not having domestic drug R&D
How to measure it:- Using patents to track globalization of innovation
www.CommercialBiotechnology.com
Global Biopharma Overview
Location matters• Workforce cost, availability• Access to skilled management, supportive
services• Proximity to innovative science and markets
Who is doing what, where?
www.CommercialBiotechnology.com
Technology producers vs. consumers
Innovators • Drugs tailored to domestic healthcare needs
• Reliant on others to develop drugs for domestic needs• Non profit-enabling
diseases are unlikely to attract investment
Followers
Importers Exporters
•Gain foreign currency
•Tax revenues from domestic companies and workers
www.CommercialBiotechnology.com
Strong market opportunities drive innovation
Why is the U.S. the world leader in biotechnology?• World’s largest prescription drug market– Not divided like European countries
• World’s strongest patent protection• World’s largest absolute expenditures on R&D– The U.S. once spent more on R&D than the rest of the world
combined• No government price controls
But, who is inventing the next generation of drugs?
www.CommercialBiotechnology.com
What happens when you don’t develop drugs?
Case Study: Philippines• Limited domestic drug production capacity• Must purchase essential medicines from foreign countries
with higher wage-costs (e.g. Singapore)– This is effectively reverse-offshoring
• Government has a limited budget, must make difficult decisions about how much of which vaccines to buy
• Domestic production would reduce costs, preserve foreign currency, keep revenues domestic, and could train workers for innovative drug development
www.CommercialBiotechnology.com
Acquiring Medicines
Develop a domestic drug development industry• Pros: Can develop drugs for domestic needs, can drive tax
revenues, can derive foreign currency from exports• Cons: Expensive, takes time, requires unwavering government
support
Buy drugs from foreign countries:• Pros: No need to invest in risky R&D, gain access to best drugs
produced by global leaders• Cons: Expensive, depletes foreign currency, doesn’t generate
tax revenues
www.CommercialBiotechnology.com
Solution: Produce foreign drugs locally
Weak patent laws enable domestic production of drugs developed elsewhere
• Pros: Low-cost domestic production of many drugs using domestic workers, tax revenues from production and sales
• Cons: Reduced foreign investment by global firms, reduced motivation to develop drugs for locally-endemic conditions
www.CommercialBiotechnology.com
Costs of Weak Patent Protection
India (mostly) adopts TRIPS accords in 1995• Amends patent laws to protect product patents, with the
notable extra criteria that new drug products must “differ significantly in properties with regard to efficacy”
• In 2007 Novartis failed to obtain a patent on Glivec (sold as Gleevec in the US)
• Novartis CEO: unfavorable patent ruling is “not an invitation to invest in Indian research and development.” Company will redirect hundreds of millions of dollars in investments to countries where it has greater IP protection.
www.CommercialBiotechnology.com
Who benefits from not patenting Glivec?
Novartis provides Glivec free to most patients in India• Because Indian manufacturers would be unable to
compete with Novartis’ free domestic distribution, their target markets would likely be in other countries, where they could potentially erode Novartis’ market.
Is India forfeiting investments from Novartis simply so that Indian companies can sell Novartis’ drugs
abroad? Does this serve the public?
www.CommercialBiotechnology.com
Mexico accepts Amgen drugLong-standing law:• International drugmakers must conduct at least some of their
manufacturing in Mexico
Pros: Training of Mexican workersInstallation of domestic biotechnology infrastructureFacilitates growth of domestic biotechnology industry
Cons: Some companies may decide not to sell drugs inMexico, depriving the country of valuable medicines
Amgen insists that they only want to have one manufacturing facility, in California
Mexico amends rule• Defines a list of drugs (e.g. anti-HIV, vaccines, hormones) able to be
imported without Mexican manufacturing facilities
www.CommercialBiotechnology.com
Overcoming weak/poor markets
Mectizan• River blindness drug developed by Merck• Affected individuals unable to pay for drug, so Merck distributes
the drug for free• This model is unsustainable. Doesn’t incentivize development of
drugs for these conditions, instead relying on companies to support tangential discoveries.
OneWorld Health, Bill & Melinda Gates Foundation, etc.• Non-profit drug company solicits foundation support to actively
develop shelved drugs for neglected populations
www.CommercialBiotechnology.com
Meeting national needs: Economic Development
Three basic models
India, Brazil, Thailand• Weak IP, focus on generic production and foreign sales
Israel, Cuba, maybe India• Moderate IP, leverage generic production skills to develop innovative
drugs
Singapore, Puerto Rico• Strong IP, attract manufacturing investments from global leaders
www.CommercialBiotechnology.com
Where are drugs invented?Friedman, Y. (2010) “Location of pharmaceutical innovation: 2000–2009” Nature Reviews Drug Discovery 9:835-836
www.CommercialBiotechnology.com
Indexed patents covering FDA-approved drugs
Source: DrugPatentWatch.com
www.CommercialBiotechnology.com
Assigned relative inventorship based on inventor locations
www.CommercialBiotechnology.com
US is slipping, EU stable, Asia rising
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100
1020304050607080
North America
Europe
Central and South America
Middle-east
East and South Asia
Australia
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Global Trends in Drug Inventorship
AustraliaEast and South Asia Middle-eastCentral and South AmericaEuropeNorth America
Prop
ortio
n of
dru
g pa
tent
inve
ntor
s
www.CommercialBiotechnology.com
But, which are the leading countries?
www.CommercialBiotechnology.com
And… what about individual US states?
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100
20
40
60
80
100
120
140
Top 10 States for Drug Inventorship
TexasMinnesotaIllinoisFloridaNorth CarolinaPennsylvaniaNew YorkOhioMassachusettsCaliforniaNew Jersey
Adju
sted
num
ber o
f dru
g in
vent
ors
www.CommercialBiotechnology.com
Questions?Yali Friedman, Ph.D.
www.DrugPatentWatch.com
www.CommercialBiotechnology.com
http://www.BiotechBlog.com
www.Logos-Press.com