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SANA 2.22.13 - Global Access Licensing (UAEM)

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Joel Miller

on 22 February 2013

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Transcript of SANA 2.22.13 - Global Access Licensing (UAEM)

Global Access Licensing Possibilities Enabled by Global Access Licensing IP flexibilities Academic Technology Licensing Stauvidine (Zerit) Global problems What Happened? Or: How students at a prominent research university got Bristol-Myers Squibb to expand access to a life saving HIV medication Yale licensed d4t exclusively to Bristol Myers Squibb.
The company set a monopoly price: 40mg dose for $5/day ($1705/yr)
over 1 billion people in the world live on <$2/day
In South Africa, MSF and the Treatment Action Campaign bought low-price, generic d4t to save the lives of the HIV+ poor.

Current GAL strategies Non-enforcement Clauses Non Exclusive licensing Reach-through Provisions Right to Sublicense Incentives to reward accessibility Where to go from here? IT and the developing world Parallel example The changing role of
the technology transfer office How can we help communicate emerging GAL-enabled technologies with inventors/entrepreneurs in the developing world?
1. Which existing networks can we communicate with?
2. How can we construct/maintain a searchable database? How can academic TTOs network better with innovators in the developing world?
Take into account new networking and communication technologies
e.g., ANDI MSF has just launched a patent opposition database - a completely complementary project to ours
What is a Patent? Flexibilities found in TRIPS and reaffirmed in the Doha Declaration can be used by developing countries to balance out some of the adverse effects of patents on access.
These include: compulsory licensing, parallel importation, flexible definitions of patentable subject matter, and flexibility with respect to data exclusivity Affordable production of medical technologies in L(M)ICs
Ability to innovate on top of academic technologies
Ability to modify technologies to local problems and applications FLARE Foundation Near-infrared light is everywhere, but our eyes can’t see it. Even so, near-infrared light is special because it can penetrate several millimeters into the body, whereas the visible light we’re all used to just bounces off the surface. Because of this feature, near-infrared light has the potential to revolutionize surgery by giving physicians, veterinarians, and surgeons the ability to see tumors, nerves, lymph nodes, and other structures that now remain hidden.

The FLARE™ Foundation is a 501(c)(3) non-profit organization dedicated to making near-infrared light-based technology available to as many patients as possible worldwide. Our model is based on open-source information exchange, education, and research, all designed to maximize societal impact. Some research reagents are available for free so new ideas can be tested quickly. Others can be purchased on our Exchange, with proceeds funding our other charitable activities. Commercial partners are free to innovate on the technology platform.

Our ultimate goal is to create a worldwide community of patients, scientists, and doctors, all working together to get the most societal value out of new medical technology. .. We imagine a day when low-cost versions of technology are used in places around the world that would never otherwise have the opportunity. We imagine a day when scientists exchange both positive and negative results to speed up what is otherwise a slow process for improvement. FLARE Foundation MIT UAEM alum speaks out
Sanjat Kanjilal, MD, HST ‘10 MIT UAEM at work 6/2001:
BMS files “agreement not to sue”, allowing South African generic production of d4t
97% decrease in cost
Cost of treatment in S. Africa plummets to $0.10/day ($36.50) in 60 days. I once helped create a drug that could enable millions of people to lead better and longer lives…

More recently, it became apparent that the drug Dr. Lin and I had developed was not reaching millions of desperately suffering people because they lacked the money to purchase it.”

NYTimes Editorial: “The Scientist’s Story”
March 19, 2001 By William Prusoff. Haiti Uganda Impact of Generic Competition Democratic National Convention (DNC) 2008 Platform:
Renewing America’s Promise (p. 44):

“We also support the adoption of humanitarian licensing policies that ensure medications developed with the U.S. taxpayer dollars are
available off patent in developing countries.”

http://www.democrats.org/a/party/platform.html Msf.org.za Storify.com Storify.com phrtoolkits.org afronline.org nature.com doctorswithoutborders.org “Our intellectual property should not become a barrier to essential health-related technologies needed by patients in developing countries.” Changing the game of academic tech transfer: autm.net/endorse Current Signatories to the Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies (SPS) "Patents give the owner the right to exclude other parties from: making, using, selling, offering to sell, or importing an invention." (cited from http://www.ipo.org) March-in Rights (8)
Discretion to Refuse to File or Enforce Patents in Developing Countries (10)
Reservation of Right to Grant Nonexclusive License to Qualified Humanitarian Organizations (3)
Pause Moment before Enforcement (2)
Reduced or Zero Royalty Rates (4)
Due Diligence (6)
Donated Royalties (1)
Term Sheet Statement (3)
Right to Reference Regulatory Filings (1) Global Access: Implementation of the Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies
Fall 2009-Spring 2011 Tech development
pipeline development of therapeutics
storage and transport of water
organ and tissue protection and preservation technology
target and inhibitors thereof for therapeutic use
platform for the discovery/detection of emerging pathogens
platform for immune profiling of patients and populations for drug discovery and diagnostic use
technologies for therapeutic use
methods for optimizing compounds
cell therapy Karolina Maciag, maciag@post.harvard.edu
Adriana Benedict, abenedict@jd14.law.harvard.edu

Universities Allied for Essential Medicines (UAEM)
www.essentialmedicine.org Our Vision
Universities and publicly funded research institutions will be part of the solution to the access to medicines crisis by promoting medical innovation in the public interest and ensuring that all people regardless of income have access to essential medicines and other health-related technologies.

Our Mission
As a non-profit organization rooted in a global movement of university students, UAEM aims to
(1) promote access to medicines and medical innovations in low- and middle-income countries by changing norms and practices around academic patenting and licensing,
(2) ensure that university medical research meets the needs of people worldwide and
(3) empower students to respond to the access and innovation crisis.

www.uaem.org Bristol Myers Squibb launched a lawsuit for patent infringement against the South African generic company, essentially asserting that it is acceptable to die of a treatable infection so long as you are poor enough. BUT THEN... First synthesized at Wayne State University in Detroit, Michigan
Discovered by William Prusoff at Yale to be effective against HIV
Subsequently licensed to BMS for global production
Quickly became the top selling anti-retroviral in the world
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