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Pharmaceutical globalization: Where are drugs invented?
 

Pharmaceutical globalization: Where are drugs invented?

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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 ...

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.

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    Pharmaceutical globalization: Where are drugs invented? Pharmaceutical globalization: Where are drugs invented? Presentation Transcript

    • Globalization of Drug Discovery
      Drug Discovery Partnerships: Filling the Pipeline
      October 17th 2011
      Yali Friedman, Ph.D. – editor@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
    • 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?
    • Technology producers vs. consumers
      • Drugs tailored to domestic healthcare needs
      • Gain foreign currency
      • Tax revenues from domestic companies and workers
      Innovators
      • Reliant on others to develop drugs for domestic needs
      • Non profit-enabling diseases are unlikely to attract investment
      Followers
      Importers
      Exporters
    • 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?
    • 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
    • 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
    • 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
    • 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.
    • 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?
    • Mexico accepts Amgen drug
      Long-standing law:
      International drugmakers must conduct at least some of their manufacturing in Mexico
      Pros: Training of Mexican workers
      Installation of domestic biotechnology infrastructure
      Facilitates growth of domestic biotechnology industry
      Cons: Some companies may decide not to sell drugs in
      Mexico, depriving the country of valuable medicines
      Amgen insists that they only want to have onemanufacturing 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
    • 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
    • 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
    • Where are drugs invented?
      Friedman, Y. (2010) “Location of pharmaceutical innovation: 2000–2009” Nature Reviews Drug Discovery 9:835-836
    • Indexed patents covering FDA-approved drugs
      Source: DrugPatentWatch.com
    • Assigned relative inventorship based on inventor locations
    • US is slipping, EU stable, Asia rising
    • But, which are the leading countries?
    • And… what about individual US states?
    • Questions?
      Yali Friedman, Ph.D.
      editor@CommercialBiotechnology.com
      www.DrugPatentWatch.com
      http://www.BiotechBlog.com
      www.CommercialBiotechnology.com
      www.Logos-Press.com